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lodibet go The new, 12-team College Football Playoff brings with it a promise to be bigger, more exciting, more lucrative. Perfect or 100% fair? Well, nobody ever believed that. The first expanded playoff bracket unveiled Sunday left a presumably deserving Alabama team on the sideline in favor of an SMU squad that finished with a better record after playing a schedule that was not as difficult. It ranked undefeated Oregon first but set up a possible rematch against Ohio State, the team that came closest to beating the Ducks this year. It treated underdog Boise State like a favorite and banged-up Georgia like a world beater at No. 2. It gave Ohio State home-field advantage against Tennessee for reasons it would take a supercomputer to figure out. It gave the sport the multiweek tournament it has longed for, but also ensured there will be plenty to grouse about between now and when the trophy is handed out on Jan. 20 after what will easily be the longest college football season in history. All of it, thankfully, will be sorted out on the field starting with first-round games on campuses Dec. 20 and 21, then over three succeeding rounds that will wind their way through traditional bowl sites. Maybe Oregon coach Dan Lanning, whose undefeated Ducks are the favorite to win it all, put it best when he offered: "Winning a national championship is not supposed to be easy.” Neither, it turns out, is figuring out who should play for it. The Big Ten will lead the way with four teams in the tournament, followed by the SEC with three and the ACC with two. The lasting memory from the inaugural bracket will involve the decision that handed the ACC that second bid. Alabama of the SEC didn't play Saturday. SMU of the ACC did. The Mustangs fell behind by three touchdowns to Clemson before coming back to tie. But they ultimately lost 34-31 on a 56-yard field goal as time expired. “We were on pins and needles,” SMU coach Rhett Lashley said. “Until we saw the name ‘SMU’ up there, we were hanging on the edge. We're really, really happy and thankful to the committee for rewarding our guys for their total body of work." The Mustangs only had two losses, compared to three for the Crimson Tide. Even though SMU's schedule wasn't nearly as tough, the committee was impressed by the way the Mustangs came back against Clemson. “We just felt, in this particular case, SMU had the nod above Alabama,” said Michigan athletic director Warde Manuel, the chairman of the selection committee. “But it’s no disrespect to Alabama’s strength of schedule. We looked at the entire body of work for both teams.” Alabama athletic director Greg Byrne was gracious, up to a point. “Disappointed with the outcome and felt we were one of the 12 best teams in the country,” he said on social media. He acknowledged — despite all of Alabama’s losses coming against conference opponents this season — that the Tide’s push to schedule more games against teams from other major conferences in order to improve its strength of schedule did not pay off this time. “That is not good for college football," Byrne said. Georgia, the SEC champion, was seeded second; Boise State, the Mountain West champion, earned the third seed; and Big 12 titlist Arizona State got the fourth seed and the fourth and final first-round bye. All will play in quarterfinals at bowl games on Dec. 31-Jan. 1. Clemson stole a bid and the 12th seed with its crazy win over SMU, the result that ultimately cost Alabama a spot in the field. The Tigers moved to No. 16 in the rankings, but got in as the fifth-best conference winner. The conference commissioners' idea to give conference champions preferable treatment in this first iteration of the 12-team playoff could be up for reconsideration after this season. The committee actually ranked Boise State, the Mountain West Champion, at No. 9 and Big 12 champion Arizona State at No. 12, but both get to skip the first round. Another CFP guideline: There’s no reseeding of teams after each round, which means no break for Oregon. The top-seeded Ducks will face the winner of Tennessee-Ohio State in the Rose Bowl. Oregon beat Ohio State 32-31 earlier this year in one of the season’s best games. No. 12 Clemson at No. 5 Texas, Dec. 21. Clemson is riding high after the SMU upset, while Texas is 0-2 against Georgia and 11-0 vs. everyone else this season. The winner faces ... Arizona State in the Peach Bowl. Huh? No. 11 SMU at No. 6 Penn State, Dec. 21. The biggest knock against the Mustangs was that they didn't play any big boys with that 60th-ranked strength of schedule. Well, now they get to. The winner faces ... Boise State in the Fiesta Bowl. Yes, SMU vs. Boise was the quarterfinal we all expected. No. 10 Indiana at No. 7 Notre Dame, Dec. 20. Hoosiers coach Curt Cignetti thought his team deserved a home game. Well, not quite but close. The winner faces ... Georgia in the Sugar Bowl. The Bulldogs got the No. 2 seed despite a throwing-arm injury to QB Carson Beck. But what else was the committee supposed to do? No. 9 Tennessee at No. 8 Ohio State , Dec. 21. The Buckeyes (losses to Oregon, Michigan) got home field over the Volunteers (losses to Arkansas, Georgia) in a matchup of programs with two of the biggest stadiums in football. The winner faces ... Oregon in the Rose Bowl. Feels like that matchup should come in the semifinals or later. Get poll alerts and updates on the AP Top 25 throughout the season. Sign up here . AP college football: https://apnews.com/hub/ap-top-25-college-football-poll and https://apnews.com/hub/college-football

Skidding No. 10 Kansas hopes to get right vs. NC StateNone

100 percent of evaluable patients for minimal residual disease (MRD) testing achieved MRD negativity in MajesTEC-5 as induction therapy and MajesTEC-4 as maintenance therapy SAN DIEGO , Dec. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new frontline data featuring TECVAYLI ® (teclistamab-cqyv) from two investigational studies in patients with newly diagnosed multiple myeloma (NDMM) in induction and maintenance settings. The MajesTEC-5 ( Abstract #493 ) and MajesTEC-4 ( Abstract #494 ) studies establish the potential of TECVAYLI ® for use in newly diagnosed patients, with promising efficacy and a tolerable safety profile. These data were highlighted as oral presentations at the 2024 American Society of Hematology (ASH) Annual Meeting. 1,2 Forty-nine patients with transplant-eligible NDMM were treated with TECVAYLI ® in combination with DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj), lenalidomide and dexamethasone (Tec-DRd) or DARZALEX FASPRO ® , bortezomib, lenalidomide and dexamethasone (Tec-DVRd) as induction therapy in the MajesTEC-5 study. 1 All patients who were evaluated for MRD negativity after cycle 3 of induction therapy achieved MRD negativity (10 -5 ) and maintained through cycle 6. 1 "These data from the MajesTEC-5 study build on the growing body of evidence of TECVAYLI combinations that support the potential combinability of TECVAYLI with other effective therapies, demonstrating high rates of MRD-negative responses for evaluable patients with newly diagnosed multiple myeloma," said Rachel Kobos, M.D., Vice President, Oncology Research & Development, Johnson & Johnson Innovative Medicine. "At Johnson & Johnson, our deep expertise and understanding of multiple myeloma has shaped the regimens we're developing, including our bispecific antibodies in new combinations, and we're committed to exploring the full potential of our therapies to improve outcomes for patients." The safety profiles were manageable and consistent with individual safety profiles. 1 No treatment-emergent adverse events (TEAEs) led to study treatment discontinuation or death; cytokine release syndrome (CRS; Grade 1 or 2) occurred in 65 percent of patients. 1 No patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS). 1 Grade 3/4 TEAEs included lymphopenia (43 percent), neutropenia (57 percent) and infections (35 percent). 1 "There remains opportunity to achieve even deeper and more sustained outcomes for a broader patient population in the frontline setting," said Marc S. Raab , M.D., Heidelberg University Hospital, Germany .* "These data reinforce the potential of TECVAYLI when used in earlier lines and show that TECVAYLI can be leveraged to optimize existing standard regimens in combination." Results from the safety run-in of the Phase 3 MajesTEC-4 study highlighted the potential of TECVAYLI ® to be administered as a maintenance therapy following autologous stem cell transplant (ASCT). 2 MajesTEC-4 is the first study to present data on a B-cell maturation antigen (BCMA) bispecific as monotherapy or combination therapy after ASCT. 2 Low rates of non-hematologic Grade 3/4 TEAEs and discontinuation of treatment due to all TEAEs (5.3 percent) were observed. CRS events were all Grade 1/2, mostly occurring during step-up dosing, and ICANS was not observed. Neutropenia and infections were the most common Grade 3/4 TEAEs. 2 Grade 3/4 neutropenia at 6 months showed a decreased trend in cohorts 2 and 3 with less frequent TECVAYLI ® dosing (cohort 1: 94 percent, cohort 2: 63 percent, cohort 3: 47 percent). 2 A similar trend was observed for all-grade infections (cohort 1: 94 percent; cohort 2: 78 percent; cohort 3: 77 percent). 2 All evaluable patients in cohort 1 who underwent MRD assessment after 12 months of therapy were MRD negative, and 100 percent of evaluable patients assessed in cohorts 2 and 3 were also MRD negative at cycle 6. 2 Further analysis of combination therapies will be evaluated in the Phase 3 MajesTEC-7 study, which is currently enrolling. About MajesTEC-5 Study MajesTEC-5 ( NCT05695508 ) is an ongoing, Phase 2 study of teclistamab and talquetamab, evaluating the safety and efficacy of combination regimens in participants with newly diagnosed transplant eligible multiple myeloma. 3 About MajesTEC-4 Study MajesTEC-4 ( NCT05243797 ) is an ongoing, multicenter, randomized, open-label, Phase 3 study of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone in participants with newly diagnosed multiple myeloma as maintenance therapy following autologous stem cell transplantation. 4 About MajesTEC-7 Study MajesTEC-7 ( NCT05552222 ) is a Phase 3 randomized study comparing teclistamab in combination with daratumumab SC and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab SC and lenalidomide (Tal-DR) versus daratumumab SC, lenalidomide, and dexamethasone (DRd) in participants with newly diagnosed multiple myeloma who are either ineligible or not intended for autologous stem cell transplant as initial therapy. 5 About TECVAYLI ® TECVAYLI ® (teclistamab-cqyv) received approval from the U.S. FDA in October 2022 as an off-the-shelf (or ready-to-use) antibody that is administered as a subcutaneous treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. 6 The European Commission (EC) granted TECVAYLI ® conditional marketing authorization (CMA) in August 2022 as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy. In August 2023 , the EC granted the approval of a Type II variation application for TECVAYLI ® , providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months. TECVAYLI ® is a first-in-class, bispecific T-cell engager antibody therapy that uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. In February 2024 , the U.S. FDA approved the supplemental Biologics License Application (sBLA) for TECVAYLI ® for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma who have achieved and maintained a CR or better for a minimum of six months. For more information, visit www.TECVAYLI.com . About DARZALEX FASPRO ® and DARZALEX ® DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for nine indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible. It is the only subcutaneous CD38-directed antibody approved to treat patients with MM. DARZALEX FASPRO ® is co-formulated with recombinant human hyaluronidase PH20, Halozyme's ENHANZE ® drug delivery technology. DARZALEX ® is the first CD38-directed antibody approved to treat multiple myeloma. DARZALEX ® -based regimens have been used in the treatment of more than 585,000 patients worldwide and more than 239,000 patients in the U.S. alone. In August 2012 , Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab. For more information, visit https://www.darzalexhcp.com. About Multiple Myeloma Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. 7 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors. 8 Multiple myeloma is the third most common blood cancer worldwide and remains an incurable disease. 9 In 2024, it was estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 people would die from the disease. 10 People living with multiple myeloma have a 5-year survival rate of 59.8 percent. 11 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections. 12,13 TECVAYLI ® IMPORTANT SAFETY INFORMATION WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL- ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI ® . Initiate treatment with TECVAYLI ® step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI ® until CRS resolves or permanently discontinue based on severity. Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious and life- threatening reactions, can occur in patients receiving TECVAYLI ® . Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI ® until neurologic toxicity resolves or permanently discontinue based on severity. TECVAYLI ® is available only through a restricted program called the TECVAYLI ® and TALVEY ® Risk Evaluation and Mitigation Strategy (REMS). INDICATION AND USAGE TECVAYLI ® (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). WARNINGS AND PRECAUTIONS Cytokine Release Syndrome - TECVAYLI ® can cause cytokine release syndrome (CRS), including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 72% of patients who received TECVAYLI ® at the recommended dose, with Grade 1 CRS occurring in 50% of patients, Grade 2 in 21%, and Grade 3 in 0.6%. Recurrent CRS occurred in 33% of patients. Most patients experienced CRS following step-up dose 1 (42%), step-up dose 2 (35%), or the initial treatment dose (24%). Less than 3% of patients developed first occurrence of CRS following subsequent doses of TECVAYLI ® . The median time to onset of CRS was 2 (range: 1 to 6) days after the most recent dose with a median duration of 2 (range: 1 to 9) days. Clinical signs and symptoms of CRS included, but were not limited to, fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase elevation). Initiate therapy according to TECVAYLI ® step-up dosing schedule to reduce risk of CRS. Administer pretreatment medications to reduce risk of CRS and monitor patients following administration of TECVAYLI ® accordingly. At the first sign of CRS, immediately evaluate patient for hospitalization. Administer supportive care based on severity and consider further management per current practice guidelines. Withhold or permanently discontinue TECVAYLI ® based on severity. TECVAYLI ® is available only through a restricted program under a REMS. Neurologic Toxicity including ICANS - TECVAYLI ® can cause serious or life-threatening neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). In the clinical trial, neurologic toxicity occurred in 57% of patients who received TECVAYLI ® at the recommended dose, with Grade 3 or 4 neurologic toxicity occurring in 2.4% of patients. The most frequent neurologic toxicities were headache (25%), motor dysfunction (16%), sensory neuropathy (15%), and encephalopathy (13%). With longer follow-up, Grade 4 seizure and fatal Guillain-Barré syndrome (one patient each) occurred in patients who received TECVAYLI ® . In the clinical trial, ICANS was reported in 6% of patients who received TECVAYLI ® at the recommended dose. Recurrent ICANS occurred in 1.8% of patients. Most patients experienced ICANS following step-up dose 1 (1.2%), step-up dose 2 (0.6%), or the initial treatment dose (1.8%). Less than 3% of patients developed first occurrence of ICANS following subsequent doses of TECVAYLI ® . The median time to onset of ICANS was 4 (range: 2 to 8) days after the most recent dose with a median duration of 3 (range: 1 to 20) days. The most frequent clinical manifestations of ICANS reported were confusional state and dysgraphia. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Monitor patients for signs and symptoms of neurologic toxicity during treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold or permanently discontinue TECVAYLI ® based on severity per recommendations and consider further management per current practice guidelines. Due to the potential for neurologic toxicity, patients are at risk of depressed level of consciousness. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of TECVAYLI ® step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves. TECVAYLI ® is available only through a restricted program under a REMS. TECVAYLI ® and TALVEY ® REMS - TECVAYLI ® is available only through a restricted program under a REMS called the TECVAYLI ® and TALVEY ® REMS because of the risks of CRS and neurologic toxicity, including ICANS. Hepatotoxicity - TECVAYLI ® can cause hepatotoxicity, including fatalities. In patients who received TECVAYLI ® at the recommended dose in the clinical trial, there was one fatal case of hepatic failure. Elevated aspartate aminotransferase (AST) occurred in 34% of patients, with Grade 3 or 4 elevations in 1.2%. Elevated alanine aminotransferase (ALT) occurred in 28% of patients, with Grade 3 or 4 elevations in 1.8%. Elevated total bilirubin occurred in 6% of patients with Grade 3 or 4 elevations in 0.6%. Liver enzyme elevation can occur with or without concurrent CRS. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TECVAYLI ® or consider permanent discontinuation of TECVAYLI ® based on severity. Infections - TECVAYLI ® can cause severe, life-threatening, or fatal infections. In patients who received TECVAYLI ® at the recommended dose in the clinical trial, serious infections, including opportunistic infections, occurred in 30% of patients, with Grade 3 or 4 infections in 35%, and fatal infections in 4.2%. Monitor patients for signs and symptoms of infection prior to and during treatment with TECVAYLI ® and treat appropriately. Administer prophylactic antimicrobials according to guidelines. Withhold TECVAYLI ® or consider permanent discontinuation of TECVAYLI ® based on severity. Monitor immunoglobulin levels during treatment with TECVAYLI ® and treat according to guidelines, including infection precautions and antibiotic or antiviral prophylaxis. Neutropenia - TECVAYLI ® can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI ® at the recommended dose in the clinical trial, decreased neutrophils occurred in 84% of patients, with Grade 3 or 4 decreased neutrophils in 56%. Febrile neutropenia occurred in 3% of patients. Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local institutional guidelines. Monitor patients with neutropenia for signs of infection. Withhold TECVAYLI ® based on severity. Hypersensitivity and Other Administration Reactions - TECVAYLI ® can cause both systemic administration-related and local injection-site reactions. Systemic Reactions - In patients who received TECVAYLI ® at the recommended dose in the clinical trial, 1.2% of patients experienced systemic-administration reactions, which included Grade 1 recurrent pyrexia and Grade 1 swollen tongue. Local Reactions - In patients who received TECVAYLI ® at the recommended dose in the clinical trial, injection-site reactions occurred in 35% of patients, with Grade 1 injection-site reactions in 30% and Grade 2 in 4.8%. Withhold TECVAYLI ® or consider permanent discontinuation of TECVAYLI ® based on severity. Embryo-Fetal Toxicity - Based on its mechanism of action, TECVAYLI ® may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TECVAYLI ® and for 5 months after the last dose. ADVERSE REACTIONS The most common adverse reactions (≥20%) were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets. Please read full Prescribing Information , including Boxed WARNING, for TECVAYLI ® . DARZALEX FASPRO ® INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONS DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma: IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS DARZALEX FASPRO ® is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase, or any of the components of the formulation. WARNINGS AND PRECAUTIONS Hypersensitivity and Other Administration Reactions Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO ® . Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO ® . Systemic Reactions In a pooled safety population of 1249 patients with multiple myeloma (N=1056) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPRO ® as monotherapy or in combination, 7% of patients experienced a systemic administration-related reaction (Grade 2: 3.2%, Grade 3: 0.7%, Grade 4: 0.1%). Systemic administration-related reactions occurred in 7% of patients with the first injection, 0.2% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 2.9 hours (range: 5 minutes to 3.5 days). Of the 165 systemic administration-related reactions that occurred in 93 patients, 144 (87%) occurred on the day of DARZALEX FASPRO ® administration. Delayed systemic administration-related reactions have occurred in 1% of the patients. Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision. Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO ® . Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO ® depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions. Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products. If ocular symptoms occur, interrupt DARZALEX FASPRO ® and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO ® . Local Reactions In this pooled safety population, injection-site reactions occurred in 7% of patients, including Grade 2 reactions in 0.8%. The most frequent (>1%) injection-site reaction was injection-site erythema. These local reactions occurred a median of 5 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO ® . Monitor for local reactions and consider symptomatic management. Neutropenia Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX FASPRO ® until recovery of neutrophils. In lower body weight patients receiving DARZALEX FASPRO ® , higher rates of Grade 3-4 neutropenia were observed. Thrombocytopenia Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Consider withholding DARZALEX FASPRO ® until recovery of platelets. Embryo-Fetal Toxicity Based on the mechanism of action, DARZALEX FASPRO ® can cause fetal harm when administered to a pregnant woman. DARZALEX FASPRO ® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPRO ® and for 3 months after the last dose. The combination of DARZALEX FASPRO ® with lenalidomide, thalidomide, or pomalidomide is contraindicated in pregnant women because lenalidomide, thalidomide, and pomalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, thalidomide, or pomalidomide prescribing information on use during pregnancy. Interference With Serological Testing Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO ® . Type and screen patients prior to starting DARZALEX FASPRO ® . Interference With Determination of Complete Response Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO ® -treated patients with IgG kappa myeloma protein. ADVERSE REACTIONS In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO ® monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, headache, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, upper respiratory tract infection, peripheral sensory neuropathy, constipation, pneumonia, and peripheral edema. The most common hematology laboratory abnormalities (≥40%) with DARZALEX FASPRO ® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin. Please click here to see the full Prescribing Information for DARZALEX FASPRO ® . About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com . Follow us at @JanssenUS and @JNJInnovMed . Janssen Research & Development, LLC and Janssen Biotech, Inc. are both Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of TECVAYLI ® (teclistamab-cqyv ) and DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023 , including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments. * Marc S. Raab , M.D., has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. 1 Raab, Marc, S., et al, 493 Phase 2 Study of Teclistamab-Based Induction Regimens in Patients with Transplant-Eligible (TE) Newly Diagnosed Multiple Myeloma (NDMM): Results from the GMMG-HD10/DSMM-XX (MajesTEC-5) Trial. 2024 American Society of Hematology Annual Meeting. December 2024 . 2 Zamagni, Elena, et al., 494 Phase 3 Study of Teclistamab (Tec) in Combination with Lenalidomide (Len) and Tec Alone Versus Len Alone in Newly Diagnosed Multiple Myeloma (NDMM) As Maintenance Therapy Following Autologous Stem Cell Transplantation (ASCT): Safety Run-in (SRI) Results from the MajesTEC-4/EMN30 Trial. 2024 American Society of Hematology Annual Meeting. December 2024 . 3 GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5 (HD10/DSMMXX). https://clinicaltrials.gov/study/NCT05695508 . Accessed November 2024 . 4 Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation (MajesTEC-4). https://clinicaltrials.gov/study/NCT05243797 . Accessed November 2024 . 5 A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma (MajesTEC-7). https://classic.clinicaltrials.gov/ct2/show/NCT05552222 . Accessed November 2024 . 6 U.S. FDA Approves TECVAYLI ® (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. https://www.jnj.com/u-s-fda-approves-tecvayli-teclistamab-cqyv-the-first-bispecific-t-cell-engager-antibody-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma . Accessed November 2024 . 7 Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. Am J Hematol. 2020;95(5):548-5672020;95(5):548-567. http://www.ncbi.nlm.nih.gov/pubmed/32212178 8 National Cancer Institute. Plasma Cell Neoplasms. https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq . Accessed November 2024 . 9 City of Hope. Multiple Myeloma: Causes, Symptoms & Treatments. https://www.cancercenter.com/cancer-types/multiple-myeloma . Accessed November 2024 . 10 American Cancer Society. Key Statistics About Multiple Myeloma. https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html#:~:text=Multiple%20myeloma%20is%20a%20relatively,men%20and%2015%2C370%20in%20women . Accessed November 2024 . 11 SEER Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute. https://seer.cancer.gov/explorer/ . Accessed November 2024 . 12 American Cancer Society. What is Multiple Myeloma? https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html . Accessed November 2024 . 13 American Cancer Society. Multiple Myeloma Early Detection, Diagnosis, and Staging. https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html . Accessed November 2024 . Media contacts: Sarah Freeman sfreem21@its.jnj.com Christie Corbett ccorbet6@its.jnj.com Investor contact: Lauren Johnson investor-relations@its.jnj.com U.S. Medical Inquiries +1 800 526-7736 View original content to download multimedia: https://www.prnewswire.com/news-releases/tecvayli-teclistamab-cqyv-demonstrates-potential-as-frontline-combination-therapy-for-patients-with-newly-diagnosed-multiple-myeloma-302325575.html SOURCE Johnson & JohnsonThe new, 12-team College Football Playoff brings with it a promise to be bigger, more exciting, more lucrative. Perfect or 100% fair? Well, nobody ever believed that. The first expanded playoff bracket unveiled Sunday left a presumably deserving Alabama team on the sideline in favor of an SMU squad that finished with a better record after playing a schedule that was not as difficult. It ranked undefeated Oregon first but set up a possible rematch against Ohio State, the team that came closest to beating the Ducks this year. It treated underdog Boise State like a favorite and banged-up Georgia like a world beater at No. 2. It gave Ohio State home-field advantage against Tennessee for reasons it would take a supercomputer to figure out. It gave the sport the multiweek tournament it has longed for, but also ensured there will be plenty to grouse about between now and when the trophy is handed out on Jan. 20 after what will easily be the longest college football season in history. All of it, thankfully, will be sorted out on the field starting with first-round games on campuses Dec. 20 and 21, then over three succeeding rounds that will wind their way through traditional bowl sites. Maybe Oregon coach Dan Lanning, whose undefeated Ducks are the favorite to win it all, put it best when he offered: "Winning a national championship is not supposed to be easy.” Neither, it turns out, is figuring out who should play for it. The Big Ten will lead the way with four teams in the tournament, followed by the SEC with three and the ACC with two. The lasting memory from the inaugural bracket will involve the decision that handed the ACC that second bid. Alabama of the SEC didn't play Saturday. SMU of the ACC did. The Mustangs fell behind by three touchdowns to Clemson before coming back to tie. But they ultimately lost 34-31 on a 56-yard field goal as time expired. “We were on pins and needles,” SMU coach Rhett Lashley said. “Until we saw the name ‘SMU’ up there, we were hanging on the edge. We're really, really happy and thankful to the committee for rewarding our guys for their total body of work." The Mustangs only had two losses, compared to three for the Crimson Tide. Even though SMU's schedule wasn't nearly as tough, the committee was impressed by the way the Mustangs came back against Clemson. “We just felt, in this particular case, SMU had the nod above Alabama,” said Michigan athletic director Warde Manuel, the chairman of the selection committee. “But it’s no disrespect to Alabama’s strength of schedule. We looked at the entire body of work for both teams.” Alabama athletic director Greg Byrne was gracious, up to a point. “Disappointed with the outcome and felt we were one of the 12 best teams in the country,” he said on social media. He acknowledged — despite all of Alabama’s losses coming against conference opponents this season — that the Tide’s push to schedule more games against teams from other major conferences in order to improve its strength of schedule did not pay off this time. “That is not good for college football," Byrne said. Georgia, the SEC champion, was seeded second; Boise State, the Mountain West champion, earned the third seed; and Big 12 titlist Arizona State got the fourth seed and the fourth and final first-round bye. All will play in quarterfinals at bowl games on Dec. 31-Jan. 1. Clemson stole a bid and the 12th seed with its crazy win over SMU, the result that ultimately cost Alabama a spot in the field. The Tigers moved to No. 16 in the rankings, but got in as the fifth-best conference winner. The conference commissioners' idea to give conference champions preferable treatment in this first iteration of the 12-team playoff could be up for reconsideration after this season. The committee actually ranked Boise State, the Mountain West Champion, at No. 9 and Big 12 champion Arizona State at No. 12, but both get to skip the first round. Another CFP guideline: There’s no reseeding of teams after each round, which means no break for Oregon. The top-seeded Ducks will face the winner of Tennessee-Ohio State in the Rose Bowl. Oregon beat Ohio State 32-31 earlier this year in one of the season’s best games. No. 12 Clemson at No. 5 Texas, Dec. 21. Clemson is riding high after the SMU upset, while Texas is 0-2 against Georgia and 11-0 vs. everyone else this season. The winner faces ... Arizona State in the Peach Bowl. Huh? No. 11 SMU at No. 6 Penn State, Dec. 21. The biggest knock against the Mustangs was that they didn't play any big boys with that 60th-ranked strength of schedule. Well, now they get to. The winner faces ... Boise State in the Fiesta Bowl. Yes, SMU vs. Boise was the quarterfinal we all expected. No. 10 Indiana at No. 7 Notre Dame, Dec. 20. Hoosiers coach Curt Cignetti thought his team deserved a home game. Well, not quite but close. The winner faces ... Georgia in the Sugar Bowl. The Bulldogs got the No. 2 seed despite a throwing-arm injury to QB Carson Beck. But what else was the committee supposed to do? No. 9 Tennessee at No. 8 Ohio State , Dec. 21. The Buckeyes (losses to Oregon, Michigan) got home field over the Volunteers (losses to Arkansas, Georgia) in a matchup of programs with two of the biggest stadiums in football. The winner faces ... Oregon in the Rose Bowl. Feels like that matchup should come in the semifinals or later. Get poll alerts and updates on the AP Top 25 throughout the season. Sign up here . AP college football: https://apnews.com/hub/ap-top-25-college-football-poll and https://apnews.com/hub/college-football

COPENHAGEN, Denmark--(BUSINESS WIRE)--Dec 8, 2024-- Genmab A/S (Nasdaq: GMAB): Genmab A/S (Nasdaq: GMAB) today announced results from the Phase 1b/2 EPCORE ® CLL-1 clinical trial evaluating epcoritamab (Abstract #883), a T-cell engaging bispecific antibody administered subcutaneously, demonstrated an overall response rate (ORR) of 61 percent and a complete response (CR) rate of 39 percent in difficult-to-treat adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) treated with epcoritamab monotherapy. These results, from the monotherapy expansion (EXP) cohort (n=23) of the trial, along with the first safety data from the optimization (OPT) cohort, were presented at the 66 th Annual Meeting and Exposition of the American Society of Hematology (ASH), during the ASH Annual Meeting Press Program. The data will be presented during an oral session on December 9, 2024. In the EXP cohort, the median time to response was two (2.0) months and the median time to CR was 5.6 months. Among all patients in the cohort, median progression-free survival (PFS) was 12.8 months and median overall survival (OS) was not reached (median follow-up was 22.8 months). An estimated 65 percent of patients were alive at 15 months. Among 12 responders evaluable for minimal residual disease (MRD) by next-generation sequencing in peripheral blood, nine patients (75 percent) had undetectable MRD. The most frequent non-hematologic treatment-emergent adverse events (TEAEs) in the EXP cohort were cytokine release syndrome (CRS; 96 percent), diarrhea (48 percent), peripheral edema (48 percent), fatigue (43 percent), and injection-site reaction (43 percent). Cytopenias were common (anemia, 65 percent; thrombocytopenia, 65 percent; neutropenia, 48 percent); however, most patients had baseline anemia and thrombocytopenia, suggesting that these events were largely disease-related. Three cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were reported (one Grade 1; two Grade 2), and there was one clinical tumor lysis syndrome (CTLS) case (Grade 2). These cases did not lead to treatment discontinuation. Four fatal TEAEs occurred - two cases of pneumonia, one case of sepsis and one case of squamous cell carcinoma of the skin. The EXP cohort followed a 2-step step-up dose regimen, and CRS was manageable and primarily low grade (9 percent Grade 1, 70 percent Grade 2, 17 percent Grade 3). In the first data from the separate OPT cohort, which followed a 3-step step-up dose regimen, CRS severity was substantially reduced with only low-grade events (71 percent Grade 1, 12 percent Grade 2). In both cohorts, CRS events primarily occurred following the first full dose, and none led to treatment discontinuation. No ICANS or CTLS cases were reported in the OPT cohort. “These EPCORE CLL-1 data are encouraging, especially as the majority of patients were heavily pre-treated with at least four lines of therapy,” said Alexey Danilov, MD, PhD, Marianne and Gerhard Pinkus, Professor and Director of Early Clinical Therapeutics and Associate Director of the Toni Stephenson Lymphoma Center, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope. “Despite progress in treating chronic lymphocytic leukemia, there remains a tremendous need for additional therapeutic options for high-risk patients whose disease has progressed following standard chemoimmunotherapy and targeted therapies.” Additional data from the EXP cohort showed high response rates in patients with high-risk factors treated with epcoritamab, including TP53 aberrations, IGHV-unmutated disease and double-exposed disease – prognostic markers that are associated with disease progression and decreased survival. i,ii,iii In patients with TP53 aberrations (n=15), the ORR was 67 percent with a CR of 33 percent. Among patients with IGHV-unmutated disease (n=16), the ORR was 63 percent, and the CR was 44 percent. In double-refractory patients, the ORR was 53 percent, and the CR was 37 percent. All patients in the trial had prior chemoimmunotherapy, and most patients had previously received targeted therapies such as BTK and BCL2 inhibitors (double-exposed) and had high-risk disease characteristics. “Chronic lymphocytic leukemia is incurable, and patients often need a variety of treatments throughout their lifetime, especially if their disease has high-risk prognostic factors, has relapsed or has become refractory to the current standard-of-care, including targeted therapies,” said Dr. Judith Klimovsky, Executive Vice President & Chief Development Officer, Genmab. “These early data show the potential therapeutic applicability of epcoritamab in relapsed or refractory chronic lymphocytic leukemia, and further reinforce the potential of epcoritamab as a core therapy for the treatment of B-cell malignancies.” Use of epcoritamab in CLL is not approved in the U.S. or in the EU or in any other territory. The safety and efficacy of epcoritamab for use in CLL have not been established. About Chronic Lymphocytic Leukemia (CLL) Chronic lymphocytic leukemia (CLL) is the most prevalent type of leukemia, affecting over 200,000 people in the United States alone. iv Chronic lymphocytic leukemia can be classified as either slow growing (indolent) or fast growing (aggressive). v CLL is incurable, and many patients will likely relapse and progress on frontline therapies. vi Most patients will experience consecutive episodes of disease progression and will require several lines of treatment in their lifetime. vii,viii About the EPCORE ® CLL-1 Trial EPCORE ® CLL-1 is a Phase 1b/2, open-label, multi-center trial to evaluate the safety and preliminary efficacy of epcoritamab as a monotherapy and in combination with standard of care agents in patients with difficult-to-treat relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), R/R small lymphocytic lymphoma (SLL) and Richter's Syndrome (RS). The trial consists of two parts: a dose-escalation phase (Phase 1b) and an expansion phase (Phase 2). Patients with RS are only included in the expansion phase. The primary objective of Phase 1b is to determine the recommended Phase 2 dose and the maximum tolerated dose as well as establish the safety profile of epcoritamab monotherapy and epcoritamab plus venetoclax in participants with R/R CLL. The purpose of Phase 2 is to assess and evaluate the preliminary efficacy, safety and tolerability profiles of epcoritamab monotherapy and epcoritamab plus venetoclax for patients with R/R CLL and SLL. Additionally, epcoritamab monotherapy and combination therapy will be evaluated in patients with RS to assess their efficacy, safety and tolerability profiles. More information on this trial can be found at https://www.clinicaltrials.gov/ (NCT: 04623541). About Epcoritamab Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody ® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells. ix Epcoritamab (approved under the brand name EPKINLY ® in the U.S. and Japan, and TEPKINLY ® in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication. Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigator's choice chemotherapy ( NCT04628494 ), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL ( NCT05578976 ), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R 2 ) in patients with R/R FL ( NCT05409066 ), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R 2 ) compared to chemoimmunotherapy in patients with previously untreated FL ( NCT06191744 ), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL ( NCT06508658 ). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information. EPKINLY ® (epcoritamab-bysp) U.S. INDICATIONS & IMPORTANT SAFETY INFORMATION What is EPKINLY? EPKINLY is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, or follicular lymphoma (FL) that has come back or that did not respond to previous treatment after receiving 2 or more treatments. EPKINLY is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children. Important Warnings—EPKINLY can cause serious side effects, including: People with DLBCL or high-grade B-cell lymphoma should be hospitalized for 24 hours after receiving their first full dose of EPKINLY on day 15 of cycle 1 due to the risk of CRS and neurologic problems. Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away. EPKINLY can cause other serious side effects, including: Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects. Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY. In DLBCL or high-grade B-cell lymphoma, the most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea. The most common severe abnormal laboratory test results include decreased white blood cells, decreased red blood cells, and decreased platelets. In follicular lymphoma the most common side effects of EPKINLY include injection site reactions, CRS, COVID-19, tiredness, upper respiratory tract infections, muscle and bone pain, rash, diarrhea, fever, cough, and headache. The most common severe abnormal laboratory test results include decreased white blood cells and decreased red blood cells. These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622). Please see Full Prescribing Information and Medication Guide , including Important Warnings. Globally, prescribing information varies; refer to the individual country product label for complete information. About Genmab Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO ® ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X . This Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov . Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab ®; the Y-shaped Genmab logo ®; Genmab in combination with the Y-shaped Genmab logo ®; HuMax ®; DuoBody ®; HexaBody ®; DuoHexaBody ®, HexElect ® and KYSOTM. EPCORE ®, EPKINLY ®, TEPKINLY ® and their designs are trademarks of AbbVie Biotechnology Ltd. i Campo, et al. TP53 Aberrations in Chronic Lymphocytic Leukemia: An Overview of the Clinical Implications of Improved Diagnostics. Haematologica . 2018 Nov 15;103(12):1956–1968. https://haematologica.org/article/view/8691 . ii Galieni, et al. Unmutated IGHV at Diagnosis in Patients With Early Stage CLL Independently Predicts for Shorter Follow-Up Time to First Treatment (TTFT). Leukemia Research. 2024. https://doi.org/10.1016/j.leukres.2024.107541 . iii Zuber, et al. Efficacy and Effectiveness Outcomes of Treatments for Double-Exposed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Patients: A Systematic Literature Review. Cancer Medicine . 2024. https://doi.org/10.1002/cam4.70258 . iv Fedele, et al. Chronic Lymphocytic Leukemia: Time to Care for the Survivors. Journal of Clinical Oncology . 2024. https://ascopubs.org/doi/10.1200/JCO.23.02738 . v Penn Medicine. Chronic Lymphocytic Leukemia (CLL). Accessed November 2024. https://www.pennmedicine.org/cancer/types-of-cancer/leukemia/types-of-leukemia/chronic-lymphocytic-leukemia . vi Odetola, et al. Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL). Curr Hematol Malig Rep . 2023 Jun 6:1–14. doi: 10.1007/s11899-023-00700-z vii Moreno, Carol. Standard Treatment Approaches for Relapsed/Refractory Chronic Lymphocytic Leukemia After Frontline Chemoimmunotherapy. Hematology Am Soc Hematol Educ Program . 2020 Dec 4;2020(1):33-40. doi: 10.1182/hematology.2020000086. viii Leukemia & Lymphoma Society. Relapsed and Refractory CLL. Accessed November 2024. https://www.lls.org/leukemia/chronic-lymphocytic-leukemia/treatment/relapsed-and-refractory . ix Engelberts PJ, et al. DuoBody-CD3xCD20 Induces Potent T-Cell-Mediated Killing of Malignant B Cells in Preclinical Models and Provides Opportunities for Subcutaneous Dosing. EBioMedicine . 2020;52:102625. doi: 10.1016/j.ebiom.2019.102625. View source version on businesswire.com : https://www.businesswire.com/news/home/20241208951291/en/ CONTACT: David Freundel, Senior Director, Global R&D & Portfolio Communications T: +1 609 430 2481; E:dafr@genmab.com Andrew Carlsen, Vice President, Head of Investor Relations T: +45 3377 9558; E:acn@genmab.com KEYWORD: DENMARK EUROPE INDUSTRY KEYWORD: RESEARCH FDA CLINICAL TRIALS BIOTECHNOLOGY HEALTH PHARMACEUTICAL OTHER SCIENCE SCIENCE ONCOLOGY SOURCE: Genmab A/S Copyright Business Wire 2024. PUB: 12/08/2024 11:00 AM/DISC: 12/08/2024 11:02 AM http://www.businesswire.com/news/home/20241208951291/en// NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES // VANCOUVER, BC , Dec. 13, 2024 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (" BioVaxys " or the " Company ") is pleased to announce that it has closed the first tranche (the " First Tranche ") of its previously announced non-brokered private placement (the " Private Placement ") with the issuance of 2,200,000 units (the " Units ") of the Company at a price of $0.05 per Unit for aggregate gross proceeds of $110,000 . Each Unit consist of one (1) common share in the capital of the Company (each, a " Share ") and one (1) whole Share purchase warrant (each, a " Warrant "), whereby each Warrant is convertible into one additional Share at an exercise price of $0.15 until December 13, 2026 , being the date that is 24 months from the date of issue. The Company intends to use the net proceeds of the First Tranche for working capital. No finder's fees were paid in connection with the First Tranche. All securities issued pursuant to the First Tranche are subject to a statutory hold period expiring April 14, 2025 , being the date that is four months and one day from the date of issuance in accordance with applicable securities legislation In addition, the Company announces that it has entered into a debt settlement agreement with an arm's-length consultant of the Company to settle an aggregate of $500,000 in debt owed to the consultant by issuing 5,000,000 Shares at a deemed price of $0.10 per Share (the " Debt Settlement "). The board of directors of the Company has determined that it is in the best interests of the Company to settle the outstanding debt through the issuance of Shares in order to preserve the Company's cash for working capital purposes. All securities proposed to be issued pursuant to the Debt Settlement will be subject to a statutory hold period of four months from the date of issuance in accordance with applicable securities legislation. Closing of the Debt Settlement is conditional upon a number of conditions, including receipt of all applicable corporate and regulatory approvals, including the acceptance of the Canadian Securities Exchange. This news release does not constitute an offer to sell or a solicitation of an offer to buy of any securities in the United States . The securities described herein have not been, and will not be, registered under the United States Securities Act of 1933 , as amended (the " U.S. Securities Act "), or any state securities laws, and may not be offered or sold within the United States except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities laws or pursuant to available exemptions therefrom. About BioVaxys Technology Corp. BioVaxys Technology Corp. ( www.biovaxys.com ), a company registered in British Columbia, Canada , is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on the DPXTM immune-educating technology platform and it's HapTenix© 'neoantigen' tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization, and other immunological fields. DPXTM is a patented antigen delivery platform that can incorporate a range of bioactive molecules to produce targeted, long-lasting immune responses enabled by various formulated components. The DPX platform facilitates antigen delivery to regional lymph nodes and has been demonstrated to induce robust and durable T cell and B cell responses in pre-clinical and clinical studies for both cancer and infectious disease. BioVaxys' common shares are listed on the Canadian Securities Exchange under the stock symbol "BIOV", on the Frankfurt Bourse (FRA: 5LB), and quoted in the US on the OTC Markets. For more information, visit www.biovaxys.com and connect with us on X and LinkedIn. ON BEHALF OF THE BOARD Signed " James Passin " James Passin , Chief Executive Officer Phone: +1 740 358 0555 Cautionary Statements Regarding Forward Looking Information This news release includes certain "forward-looking information" and "forward-looking statements" (collectively " forward-looking statements ") within the meaning of applicable securities legislation. All statements, other than statements of historical fact, included herein, without limitation, the statements relating to the Private Placement and the Debt Settlement, including the expected use of proceeds from the Private Placement and related issuance of the Shares for the Debt Settlement, are forward-looking statements. Forward-looking statements are frequently, but not always, identified by words such as "expects", "anticipates", "believes", "intends", "estimates", "potential", "possible", and similar expressions, or statements that events, conditions, or results "will", "may", "could", or "should" occur or be achieved. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements. These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by BioVaxys, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors, both known and unknown, could cause actual results, performance or achievements to be materially different from the results, performance or achievements that are or may be expressed or implied by such forward-looking statements and the parties have made assumptions and estimates based on or related to many of these factors. Such factors include, without limitation, the impact of any changes that may affect the anticipated use of proceeds from the Private Placement and the ability of the Company to obtain the necessary approvals to proceed with the Debt Settlement. BioVaxys does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by applicable securities laws. The Canadian Securities Exchange has not reviewed, approved nor disapproved the contents of this press release and does not accept responsibility for the adequacy or accuracy of this release. Logo - https://mma.prnewswire.com/media/2415135/5078410/BioVaxys_Technology_Corp_Logo.jpg SOURCE BioVaxys Technology Corp.

Baltimore (7-4) at Los Angeles Chargers (7-3) Monday, 8:15 p.m. EST, ESPN/ABC BetMGM NFL odds: Ravens by 3. Against the spread: Ravens 5-5-1; Chargers 7-3. Series record: Ravens lead 9-5. Last meeting: Ravens beat Chargers 20-10 in Inglewood, Calif., on Nov. 26, 2023. Last week: Ravens lost to Pittsburgh 18-16; Chargers beat Cincinnati 34-27. Ravens offense: overall (1), rush (2), pass (3), scoring (2). Ravens defense: overall (3), rush (26), pass (2), scoring (23). Chargers offense: overall (18), rush (12), pass (19), scoring (18). Chargers defense: overall (11), rush (11), pass (12), scoring (1). Turnover differential: Ravens plus-2; Chargers plus-8. K Justin Tucker missed two field goals last week and is under pressure after spending most of his career beyond reproach. He’s missed six field goals on the season and is 4 for 12 from 50-plus yards since the start of last season. WR Ladd McConkey had a career-high 123 yards on six receptions against Cincinnati. The rookie came up with clutch catches of 28 and 27 yards to set up the game-winning touchdown. Chargers RB J.K. Dobbins vs. Ravens’ run defense. Dobbins showed promise during his time in Baltimore, but he never was able to live up to that potential because of injuries. Now in Los Angeles on a one-year “prove it” contract, Dobbins has nearly matched his most productive season as a professional with 726 yards and eight touchdowns in 10 games. After seeing Pittsburgh run the ball 34 times last week, the Chargers will be glad to copy that bruising approach with Dobbins. The Ravens are allowing 77.5 rushing yards per game, but even the sturdiest defense can buckle against that volume of work, so getting off the field will be critical. Baltimore’s defense has one significant injury concern, with LB Roquan Smith (hamstring) questionable to go this week after he was hurt against the Steelers. The good news is S Kyle Hamilton does not have an injury designation. He has been nursing an ankle problem, although he played against Pittsburgh. ... Chargers OLB Khalil Mack (groin) is questionable after the veteran pass rusher didn’t play against Cincinnati. ... McConkey is also questionable because of a shoulder injury. The Ravens have won four straight over the Chargers in the regular season, but Los Angeles did earn a 23-17 AFC wild-card round upset in January 2019. ... Baltimore cruised to a 34-6 win over the Chargers in its first visit to SoFi Stadium on Oct. 17, 2021. Ravens RB Derrick Henry leads the NFL with 1,185 yards rushing and 15 total TDs (13 rushing and two receiving). He’s also run for a league-high 52 first downs. ... Henry is one rushing TD shy of the Ravens’ single-season record, set by Jamal Lewis in 2003. ... Baltimore QB Lamar Jackson is 6-2 on “Monday Night Football” with 20 TD passes and no interceptions. ... Henry is one of four players in the Super Bowl era to score a TD in each of the first 11 games of a season. The others are O.J. Simpson (1975), John Riggins (1983) and Jerry Rice (1987). ... The Ravens have scored touchdowns on a league-best 77.8% of their red zone trips. ... Jackson needs 124 yards passing and 16 yards rushing for a second consecutive season with 3,000 passing and 600 rushing. Since the AFL-NFL merger, only Randall Cunningham (1988-1990), Cam Newton (2011-12), Josh Allen (2021-22) and Jalen Hurts (2021-23) have accomplished that feat. ... Dobbins ran for two touchdowns against Cincinnati, giving him multiple scores in two of his past three games. He did it twice in 24 games as a Raven. ... OLB Tuli Tuipulotu had 1 1/2 sacks of Bengals QB Joe Burrow, his third straight game with more than one. All seven of Tuipulotu’s sacks this season have come in the past four games, and six of his eight tackles for loss have come in that span. ... The Chargers allowed a season-worst 27 points to Cincinnati after holding each of their previous nine opponents to 20 points or fewer. ... QB Justin Herbert has thrown one interception in 277 attempts this season. That lone pick came in Week 2 at Carolina. ... The Chargers lost their fifth turnover of the season when Herbert fumbled to start the fourth quarter. It was their first turnover at home. ... Los Angeles does not have a takeaway in its past two games. Herbert has heated up after a slow start in terms of fantasy production, having thrown for multiple touchdowns in three of his past four games. He is likely to keep that success going this week. Baltimore has allowed 22 scores through the air, which is tied with Houston for second most in the league, and Herbert should have plenty of chances to add to that total in what could be another high-scoring matchup. AP NFL: https://apnews.com/hub/NFL

Gurgaon: Lok Sabha Speaker Om Birla and Union law minister Arjun Ram Meghwal inaugurated the country's first Constitution Museum at OP Jindal Global University in Sonipat on Saturday. The museum showcases a photolithographic copy of the Constitution, one of the thousand reproductions available, as its centrepiece. Officials said visitors could experience pre-Independence India through a 360-degree visual presentation, and also view a multimedia presentation that chronologically presents significant events that led to the drafting of the Constitution. To acknowledge the Constituent Assembly members' contribution to the making of the document, nearly 300 sculptured busts have been installed at the facility. A hologram of Dr BR Ambedkar is featured in the mezzanine section of the museum, where his philosophies are also exhibited. The interactive display provides responses derived from his documented speeches and written works. Maharashtra Jharkhand Maharashtra Alliance View i Party View Seats: 288 Results Majority: 145 BJP+ 229 MVA 47 OTH 12 Results : 288 / 288 BJP+ WON Jharkhand Alliance View i Party View Seats: 81 Results Majority: 41 INDIA 56 NDA 24 OTH 1 Results : 81 / 81 INDIA WON Source: PValue Moreover, artists have created installations celebrating constitutional principles. ‘We, The People of India' by Rajesh P Subramanian represents the constitutional value of ‘unity in diversity'. Rahul Gautam's ‘Echoes of Liberty' combines constitutional manuscript elements with contemporary artistic design. ‘Triad of Unity' by Harsha Durugadda connects the concepts of unity, justice, and sovereignty. Nishant S Kumbhatil presents ‘Insaaf Ki Devi', depicting the lady justice with scales, representing judicial impartiality. ‘Equality Before Law' by Pradeep B Jogdand illustrates equality and justice principles. Deval Verma's extensive ‘Map' installation encourages visitors to examine their perspectives on value and beauty. KR Nariman's ‘Freedom' pays tribute to ‘We, the People' who practise constitutional values daily. Rahul Gautam's ‘Founding Mothers' presents an artistic interpretation of a photograph featuring the 15 women Constituent Assembly members, recognising their role in developing India's constitutional framework. The CEO of culture and head of the Centre for Museums, Anjchita B Nair, who is also the curator, said this facility was different from traditional museum formats, which follow a single narrative. Instead, diverse presentation methods were incorporated at the Constitution Museum to create engaging and innovative ways of storytelling. At the inauguration, Speaker Birla said, "India's first Constitution Museum marks a historic milestone. This will tell our future generations about our Constitution, its history, its inception, and the immense efforts that went behind its creation. More than a legal framework, our Constitution is a transformative document that brought about a profound social, economic, and political change. It is not merely a set of laws but a guiding philosophy that continues to lead us towards a more just and inclusive society." Union minister Meghwal said, "The Constitution Museum is a memorial of the significant contribution of Dr Ambedkar, the main framer of the Indian Constitution. I sincerely hope that it is visited by the current legislators of India to get a modern and digital insight into the making of the Constitution." MP Naveen Jindal, who is also chancellor of the university, said, "The museum is a reminder to celebrate the Constitution of the world's largest democracy, and to promote the idea of an Indian constitutionalism as we commemorate the 75th anniversary of the adoption of the Constitution of India on Nov 26 this year."

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Scott Turner, President-elect Donald Trump choice to lead the Department of Housing and Urban Development , is a former NFL player who ran the White House Opportunity and Revitalization Council during Trump’s first term. Turner, 52, is the first Black person selected to be a member of the Republican's incoming cabinet. 24/7 San Diego news stream: Watch NBC 7 free wherever you are Here are some things to know about Turner: From professional football to politics Turner grew up in a Dallas suburb, Richardson, and graduated from the University of Illinois Urbana-Champaign. He was a defensive back and spent nine seasons in the NFL beginning in 1995, playing for the Washington Redskins, San Diego Chargers and Denver Broncos. During offseasons, he worked as an intern then-Rep. Duncan Hunter, R-Calif. After Turner retired in 2004, he worked full time for the congressman. In 2006, Turner ran unsuccessfully as a Republican in California’s 50th Congressional District. Turner joined the Texas House in 2013 as part of a large crop of tea party-supported lawmakers. He tried unsuccessfully to become speaker before he finished his second term in 2016. He did not seek a third term. U.S. & World Vaccines don't cause autism. What does? Here's what to know about the new funding deal that countries agreed to at UN climate talks Motivational speaker and pastor Turner also worked for a software company in a position called “chief inspiration officer” and said he acted as a professional mentor, pastor, and councilor for the employees and executive team. He has also been a motivational speaker. He and his wife, Robin Turner, founded a nonprofit promoting initiatives to improve childhood literacy. His church, Prestonwood Baptist Church, lists him as an associate pastor. He is also chair of the center for education opportunity at America First Policy Institute, a think tank set up by former Trump administration staffers to lay the groundwork if he won a second term. Headed council in Trump's first term Trump introduced Turner in April 2019 as the head of the new White House Opportunity and Revitalization Council. Trump credited Turner with “helping to lead an Unprecedented Effort that Transformed our Country’s most distressed communities.” The mission of the council was to coordinate with various federal agencies to attract investment to so-called “Opportunity Zones," which were economically depressed areas eligible to be used for the federal tax incentives. The role of HUD HUD is responsible for addressing the nation’s housing needs. It also is charged with fair housing laws and oversees housing for the poorest Americans, sheltering more than 4.3 million low-income families through public housing, rental subsidy and voucher programs. The agency, with a budget of tens of billions of dollars, runs a multitude of programs that do everything from reducing homelessness to promoting homeownership. It also funds the construction of affordable housing and provides vouchers that allow low income families pay for housing in the private market. During the campaign, Trump focused mostly on the prices of housing, not public housing. He railed against the high cost of housing and said he could make it more affordable by cracking down on illegal immigration and reducing inflation. He also said he would work to reduce regulations on home construction and make some federal land available for residential construction.Samsung 2TB SSD Originally Priced at $399 Now Available for Just $139 on Amazon

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