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SOMERVILLE, Mass.--(BUSINESS WIRE)--Dec 8, 2024-- bluebird bio, Inc. (Nasdaq: BLUE) today announced new and updated data from LYFGENIATM (lovotobegligene autotemcel, or lovo-cel) gene therapy for patients with sickle cell disease who have a history of vaso-occlusive events (VOEs). The data will be presented at the 66 th American Society of Hematology (ASH) Annual Meeting and Exposition in an oral presentation on Sunday, December 8 at 9:30 a.m. Pacific Time and a poster presentation on Sunday, December 8 at 6 p.m. Pacific Time. As of July 2024, 70 patients were treated across the full lovo-cel clinical development program, with follow-up beyond 9 years in the earliest treated patients. “Data presented at ASH demonstrate that the potentially transformative benefits of LYFGENIA are sustained through additional long-term follow-up and consistent across sub-populations, including patients with overt stroke, not studied in any other clinical development program of gene therapy for sickle cell disease.” said Richard Colvin, M.D., Ph.D., chief medical officer, bluebird bio. “These data continue to distinguish LYFGENIA as the most deeply studied gene therapy for sickle cell disease, with the most patients treated, longest follow-up, and broadest range of clinical presentations evaluated across the field.” Updated efficacy data continue to support sustained, transformational impact on VOE burden and hematologic markers of disease An update on clinical response to lovo-cel in patients living with sickle cell disease focused on 58 patients who received lovo-cel in the HGB-206 Group C (n=36) and HGB-210 (n=22) studies, following enhancements to the manufacturing and treatment protocols, will be presented in Oral Presentation #511: An Update on Lovotibeglogene Autotemcel (lovo-cel) Clinical Trials for Sickle Cell Disease (SCD) and Analysis of Early Predictors of Response to Lovo-cel. Median follow-up time was 47.7 months (4.0 years), with 15 study participants having 5 or more years of follow-up. Stacy Rifkin-Zenenberg, DO, Hackensack Meridian Health said: “These data demonstrate that the significant clinical benefits of lovo-cel for people living with sickle cell disease are durable through continued long-term follow-up. Additionally, the number of patients treated, and duration of follow-up, has enabled detailed exploration of the pharmacology and mechanism of action of LVV gene therapy for sickle cell disease, providing even greater support that one-time treatment with lovo-cel has the potential to permanently address the underlying cause of sickle cell disease.” As of the July 2024 cutoff date, all patients continued to have stable production of anti-sickling adult hemoglobin after infusion through last follow-up (median >40% HbA T87Q ) and total Hb at last visit was 12.4 (6.6, 15.1) g/dL and was stable without transfusion support post engraftment. VOEs and severe vaso-occlusive events (sVOEs) were eliminated or significantly reduced in all patients. Specific findings include: The safety profile of the lovo-cel treatment regimen was generally consistent with underlying sickle cell disease and the known effects of myeloablative conditioning. There were no cases of graft failure or graft-versus-host disease (GVHD), no vector-related complications, and no insertional oncogenesis. For complete safety information please refer to the U.S. Prescribing Information noted below. Data from patients with sickle cell disease and a history of overt stroke show no recurrence of stroke following treatment with lovo-cel The first focused analysis of the clinical impact of lovo-cel on patients with sickle cell disease with a history of stroke, including overt stroke, will be presented in Poster Presentation #3576: Participants with a History of Stroke in Lovotibeglogene Autotemcel (lovo-cel) Clinical Trials. Data showed that patients with a history of overt stroke remained stable without recurrent stroke up to 9 years post-treatment (n=6), with median follow-up of 6.5 years. Jennifer Jaroscak, MD, Director, Pediatric Non-Malignant Transplant, Medical University of South Carolina, said “We are extremely pleased to report that no study participants with a history of overt or silent stroke experienced recurrent strokes following treatment with lovo-cel gene therapy, despite discontinuing transfusions. This finding is remarkable, as these patients face an exceedingly high risk of subsequent strokes, and transfusions alone provide only modest protection against secondary strokes. These data are unique in the field as lovo-cel is the only gene therapy for sickle cell disease with data on patients with a history of stroke.” Overt ischemic stroke is a devastating complication of sickle cell disease and requires lifelong chronic transfusions or allogeneic hematopoietic stem cell transplantation, which carry significant risk of complications. One in four patients living with sickle cell disease have a stroke by age 45. Other clinical outcomes in patients with a history of stroke—including expression of gene therapy derived anti-sickling hemoglobin (HBA T87Q ), improvements in total hemoglobin, and impact on other hematologic markers—were consistent with those patients’ respective study populations (HGB-206 Group A and HGB-206 Group C). The analysis also included 21 patients who had evidence of silent stroke based on available MRI data at screening. In this cohort there were no reports of recurrent overt or silent stroke among patients with follow-up MRIs, with a median 3.5 years follow-up (.48, 6.88 years). Silent ischemic stroke adversely affects neurocognitive function and is associated with increased risk of overt stroke. It occurs in an estimated 39% of patients with sickle cell disease. Safety findings for participants with a history of overt stroke did not differ from that in the overall treatment group. No increase in hypertension, bleeding issues, prolonged thrombocytopenia or catheter-related thromboses were observed. As previously reported, cases of acute myeloid leukemia were observed in two patients from the HGB-206 Group A cohort who were treated with an earlier version of the therapy prior to enhancements to the treatment and manufacturing processes. Both patients died due to aforementioned leukemia. About LYFGENIATM (lovotibeglogene autotemcel) or lovo-cel LYFGENIA is a one-time ex-vivo lentiviral vector gene therapy approved for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events (VOEs). LYFGENIA works by adding a functional β-globin gene to patients’ own hematopoietic (blood) stem and progenitor cells (HSPCs). Durable production of adult hemoglobin with anti-sickling properties (HbAT87Q) is possible following successful engraftment. HbAT87Q has a similar oxygen-binding affinity to wild-type HbA, limits sickling of red blood cells and has the potential to reduce VOEs. The Phase 1/2 HGB-206 study of LYFGENIA is complete and the Phase 3 HGB-210 study evaluating LYFGENIA is ongoing. bluebird bio is also conducting a long-term safety and efficacy follow-up study (LTF-307) for patients with sickle cell disease who have been treated with LYFGENIA in bluebird bio-sponsored clinical studies. Indication LYFGENIA is indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events (VOEs). Limitations of Use Following treatment with LYFGENIA, patients with α-thalassemia trait (-α3.7/-α3.7) may experience anemia with erythroid dysplasia that may require chronic red blood cell transfusions. LYFGENIA has not been studied in patients with more than two α-globin gene deletions. Important Safety Information Boxed WARNING: HEMATOLOGIC MALIGNANCY Hematologic malignancy has occurred in patients treated with LYFGENIA. Monitor patients closely for evidence of malignancy through complete blood counts at least every 6 months and through integration site analysis at Months 6, 12, and as warranted. Hematologic Malignancy Hematologic malignancy has occurred in patients treated with LYFGENIA (Study 1, Group A). At the time of initial product approval, two patients treated with an earlier version of LYFGENIA using a different manufacturing process and transplant procedure (Study 1, Group A) developed acute myeloid leukemia (AML). One patient with α-thalassemia trait (Study 1, Group C) has been diagnosed with myelodysplastic syndrome (MDS). The additional hematopoietic stress associated with mobilization, conditioning, and infusion of LYFGENIA, including the need to regenerate the hematopoietic system, may increase the risk of a hematologic malignancy. Patients with sickle cell disease have an increased risk of hematologic malignancy as compared to the general population. Patients treated with LYFGENIA may develop hematologic malignancies and should have lifelong monitoring. Monitor for hematologic malignancies with a complete blood count (with differential) at least every 6 months for at least 15 years after treatment with LYFGENIA, and integration site analysis at Months 6, 12, and as warranted. In the event that a malignancy occurs, contact bluebird bio at 1-833-999-6378 for reporting and to obtain instructions on collection of samples for testing. Post-Marketing Long Term Follow-Up Study: Patients who intend to receive treatment with LYFGENIA are encouraged to enroll in the study, as available, to assess the long-term safety of LYFGENIA and the risk of malignancies occurring after treatment with LYFGENIA by calling bluebird bio at 1-833-999-6378. The study includes monitoring (at pre-specified intervals) for clonal expansion. Delayed Platelet Engraftment Delayed platelet engraftment has been observed with LYFGENIA. Bleeding risk is increased prior to platelet engraftment and may continue after engraftment in patients with prolonged thrombocytopenia. Two patients (4%) required more than 100 days post treatment with LYFGENIA to achieve platelet engraftment. Patients should be made aware of the risk of bleeding until platelet recovery has been achieved. Monitor patients for thrombocytopenia and bleeding according to standard guidelines. Conduct frequent platelet counts until platelet engraftment and platelet recovery are achieved. Perform blood cell count determination and other appropriate testing whenever clinical symptoms suggestive of bleeding arise. Neutrophil Engraftment Failure There is a potential risk of neutrophil engraftment failure after treatment with LYFGENIA. Neutrophil engraftment failure is defined as failure to achieve three consecutive absolute neutrophil counts (ANC) ≥ 0.5 × 109 cells/L obtained on different days by Day 43 after infusion of LYFGENIA. Monitor neutrophil counts until engraftment has been achieved. If neutrophil engraftment failure occurs in a patient treated with LYFGENIA, provide rescue treatment with the back-up collection of CD34+ cells. Insertional Oncogenesis There is a potential risk of lentiviral vector-mediated insertional oncogenesis after treatment with LYFGENIA. Hypersensitivity Reactions Allergic reactions may occur with the infusion of LYFGENIA. The dimethyl sulfoxide (DMSO) or dextran 40 in LYFGENIA may cause hypersensitivity reactions, including anaphylaxis. Anti-retroviral Use Patients should not take prophylactic HIV anti-retroviral medications for at least one month prior to mobilization and until all cycles of apheresis are completed. There are some long-acting anti-retroviral medications that may require a longer duration of discontinuation for elimination of the medication. If a patient is taking anti-retrovirals for HIV prophylaxis, confirm a negative test for HIV before beginning mobilization and apheresis of CD34+ cells. Hydroxyurea Use Patients should not take hydroxyurea for at least 2 months prior to mobilization and until all cycles of apheresis are completed. If hydroxyurea is administered between mobilization and conditioning, discontinue 2 days prior to initiation of conditioning. Iron Chelation Drug-drug interactions between iron chelators and the mobilization process and myeloablative conditioning agent must be considered. Iron chelators should be discontinued at least 7 days prior to initiation of mobilization or conditioning. Do not administer myelosuppressive iron chelators (e.g., deferiprone) for 6 months post-treatment with LYFGENIA. Non-myelosuppressive iron chelation should be restarted no sooner than 3 months after LYFGENIA infusion. Phlebotomy can be used in lieu of iron chelation, when appropriate. Interference with PCR-based Testing Patients who have received LYFGENIA are likely to test positive by polymerase chain reaction (PCR) assays for HIV due to integrated BB305 LVV proviral DNA, resulting in a possible false-positive PCR assay test result for HIV. Therefore, patients who have received LYFGENIA should not be screened for HIV infection using a PCR-based assay. Adverse Reactions The most common adverse reactions ≥ Grade 3 (incidence ≥ 20%) were stomatitis, thrombocytopenia, neutropenia, febrile neutropenia, anemia, and leukopenia. Three patients died during LYFGENIA clinical trials; one from sudden cardiac death due to underlying disease and two from acute myeloid leukemia who were treated with an earlier version of LYFGENIA using a different manufacturing process and transplant procedure (Study 1, Group A). Pregnancy/Lactation Advise patients of the risks associated with myeloablative conditioning agents, including on pregnancy and fertility. LYFGENIA should not be administered to women who are pregnant, and pregnancy after LYFGENIA infusion should be discussed with the treating physician. LYFGENIA is not recommended for women who are breastfeeding, and breastfeeding after LYFGENIA infusion should be discussed with the treating physician. Females and Males of Reproductive Potential A negative serum pregnancy test must be confirmed prior to the start of mobilization and re-confirmed prior to conditioning procedures and before LYFGENIA administration. Women of childbearing potential and men capable of fathering a child should use an effective method of contraception (intra-uterine device or combination of hormonal and barrier contraception) from start of mobilization through at least 6 months after administration of LYFGENIA. Advise patients of the options for fertility preservation. Please see full Prescribing Information for LYFGENIA including Boxed WARNING and Medication Guide . About bluebird bio, Inc. bluebird bio is pursuing curative gene therapies to give patients and their families more bluebird days. Founded in 2010, bluebird has been setting the standard for gene therapy for more than a decade—first as a scientific pioneer and now as a commercial leader. bluebird has an unrivaled track record in bringing the promise of gene therapy out of clinical studies and into the real-world setting, having secured FDA approvals for three therapies in under two years. Today, we are proving and scaling the commercial model for gene therapy and delivering innovative solutions for access to patients, providers, and payers. With a dedicated focus on severe genetic diseases, bluebird has the largest and deepest ex-vivo gene therapy data set in the field, with industry-leading programs for sickle cell disease, β-thalassemia and cerebral adrenoleukodystrophy. We custom design each of our therapies to address the underlying cause of disease and have developed in-depth and effective analytical methods to understand the safety of our lentiviral vector technologies and drive the field of gene therapy forward. bluebird continues to forge new paths as a standalone commercial gene therapy company, combining our real-world experience with a deep commitment to patient communities and a people-centric culture that attracts and grows a diverse flock of dedicated birds. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements, such as statements regarding the therapeutic potential of LYFGENIA. Such forward-looking statements are based on historical performance and current expectations and projections about bluebird’s future goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond bluebird’s control and could cause bluebird’s future goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect bluebird bio’s business, particularly those identified in the risk factors discussion in bluebird bio’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by its subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC. These risks and uncertainties include, but are not limited to: the risk that the efficacy and safety results from bluebird’s prior and ongoing clinical trials will not continue or be seen in the commercial context; the risk that there is not sufficient patient demand or payer reimbursement to support continued commercialization of LYFGENIA; the risk of insertional oncogenic or other safety events associated with lentiviral vector, drug product, or myeloablation, including the risk of hematologic malignancy; and the risk that bluebird’s products, including LYFGENIA, will not be successfully commercialized. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, bluebird bio undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. View source version on businesswire.com : https://www.businesswire.com/news/home/20241208134842/en/ CONTACT: Investors: Courtney O’Leary, 978-621-7347 coleary@bluebirdbio.com Media: Jess Rowlands, 857-299-6103 jess.rowlands@bluebirdbio.com KEYWORD: MASSACHUSETTS UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: SCIENCE OTHER SCIENCE BIOTECHNOLOGY RESEARCH GENERAL HEALTH HEALTH GENETICS OTHER HEALTH SOURCE: bluebird bio, Inc. Copyright Business Wire 2024. PUB: 12/08/2024 12:30 PM/DISC: 12/08/2024 12:30 PM http://www.businesswire.com/news/home/20241208134842/en Copyright Business Wire 2024.
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has hinted he could take legal action against Conservative leader after she accused his party of showing of the Tories. Ms Badenoch said the digital counter on Reform’s website was “ ” when it recorded membership on morning ticking past the 131,680 figure declared by the Conservative Party earlier this year. She accused Reform UK of “fakery”. Demanding an apology from Ms Badenoch for what he said were “disgraceful accusations of fraud and dishonesty”, he vowed to take some action in the next two days. “I’m going to take some action in the next couple of days, and I’ve got to decide exactly what it is, but I’m certainly not going to take it lying down,” he said after being asked if he would sue the Tory leader, according to . “I think it’s an absolutely outrageous thing for her to have said. “I know she’s got a very bad temper. I know she’s well known for lashing out at people, but I am not at all happy, and I’m going to take some action.” He said he would confirm within two days what the action would be if she did not apologise for the “intemperate outburst”. It’s the latest twist in the spat between the two parties on the right of UK politics. Despite the dispute, with Reform UK’s ticker showing 143,968 members on Friday night. Labour is the UK’s biggest political party, with 370,450 at the end of last year. As Ms Badenoch made her claim about the Reform UK figure being false, she also suggested the ’ own membership figures had risen in recent weeks, writing on social media: “For a party that pretends to hate the establishment so much, they are copying and pasting the fake Tony Blair/Alister [sic] Campbell’s spin book. “How do I know for certain the Reform announcement is not true? Because the Conservative Party has gained thousands of new members since the leadership election. But we don’t shout about it...we are building quietly and steadily on principles and values, not gimmicks.” Mr Farage said he would gladly invite a firm to audit Reform UK’s membership numbers if the Conservatives did the same. “We understand you are bitter, upset and angry that we are now the second biggest party in British politics, and that the Conservative brand is dying under your leadership,” he wrote on social media. “However, this not an excuse to accuse us of committing fraud.”
Last year, Donald Trump Jr.’s longtime fiancee Kimberly Guilfoyle was his proud date to Donald Trump’s annual Christmas celebration at Mar-a-Lago. This year, Guilfoyle was replaced at the Mar-a-Lago holiday festivities by Trump Jr.’s new girlfriend, Palm Beach socialite Bettina Anderson, the Daily Mail reported . Unfortunately for the new lovers, some Trump family allies and insiders are not happy about Anderson’s quick ascension into the family orbit, the Daily Mail also is reporting. The 37-year-old model and influencer was photographed seated next to Trump Jr. at the Christmas Eve dinner table, near the president-elect and his wife Melania Trump. Ivanka Trump, her husband Jared Kushner and their three children also attended the Christmas Eve dinner, Page Six reported . Some of the allies and insiders have told the Daily Mail that Anderson “isn’t MAGA enough,” while two friends of Trump Jr. expressed concern that she’s essentially a shallow influencer and “social climber” who is using Trump’s oldest son to snag an even wealthier and more powerful romantic target — someone like billionaire Elon Musk. “It’s one thing to worry about Palm Beach shenanigans making a stop at Mar-a-Lago,” a source close to the Trump transition team told the Daily Mail. “But to let those problems penetrate the White House is a new level of trouble.” The source appears to be referring to what the Daily Mail said was an “open secret” simmering in Palm Beach circles in the late summer and fall — how 46-year-old Trump Jr. had begun “fooling around” with the younger, Anderson, even while he was still engaged to 55-year-old Guilfoyle, a MAGA firebrand and top Trump campaign fundraiser. Rumors about Trump Jr.’s dalliance with Anderson began in September when images emerged of the couple kissing and cuddling while dining at a restaurant near Mar-a-Lago. Earlier this month, Trump Jr.’s relationship with the 37-year-old Anderson gained public recognition, after Trump announced that he was nominating Guilfoyle to be his ambassador to Greece. Guilfoyle’s nomination was seen by some political observers as a way that Trump could reward the former Fox News host for her political loyalty, while nudging her out of his “immediate sphere” and sending her off to Europe so that his son could openly pursue his new relationship with Anderson. At the time, sources close to Trump Jr. told People that he had became tired of his six-year relationship with Guilfoyle , the former first lady of San Francisco and ex-wife of California Gov. Gavin Newsom-turned Trump loyalist. For one thing, Trump Jr. didn’t like Guilfoyle’s “style,” including her “tight dresses.” He felt that Anderson, with her honey-blonde hair and “Waspy” model looks, would “impress” his father and perhaps make her a more ideal romantic partner. “Don Jr. has always wanted to look good in his father’s eyes,” the political source told People. Apparently, Anderson’s more natural, fun-loving style also was more to Trump Jr.’s taste these days, especially as he saw that she could become his “own Melania Trump equivalent,” a source told People. “She is a party girl, and outgoing, and Don is smitten with her,” a Palm Beach source told People. “Bettina is smart, sexy and savvy and knows it. She likes to have fun,” another source added. “Who knows what, if anything, will come from this.” Trump family members also got tired of Guilfoyle’s attention-seeking ways. Sources told People and the Daily Mail that they expected that Guilfoyle knew about Trump Jr.’s affair with Anderson, but chose “to look the other way because she loves the power and lifestyle.” Once Trump Jr. felt he could shed his public association with Guilfoyle, he began to “flaunt” his romance with Anderson, being photographed holding hands with her during a dinner date with her in Palm Beach in December, the Daily Mail reported. After Trump announced that he wanted to send Guilfoyle to Greece, Trump Jr. and Anderson jetted off to Italy for a romantic getaway, the Daily Mail reported. Anderson also publicly posted photos of love letters and flowers sent to her from Trump Jr., and openly documented their European vacation. Someone described as a “close, personal friend” of Trump Jr. told the Daily Mail that he wasn’t concerned about Anderson. He said he expected there would “be gossip and trash talking, just because that’s kind of the world of Palm Beach and, you know, the universe they live in.” If Trump Jr. has heard any concerns about Anderson, he hasn’t let this friend know, according to the Daily Mail. Stacey Bendet, a fashion designer and close friend of Anderson’s, expressed dismay that her friend had become the target of social-climber rumors. “I have been friends with Bettina for a decade, she is the kindest soul, she has the biggest heart, she is witty and wise, hilariously funny, and an Ivy League grad — anyone who says a word otherwise is just another societal example of women fixating on competing verse empowering,” said Bendet, CEO of Alice + Olivia, in a text to the Daily Mail. Anderson has been seen at Alice + Olivia events over the years, the Daily Mail reported. Bendet added in her text: “Don adores her for good reasons!” However, some Trump family allies feel very differently about Anderson and are “doing everything they can” do to get Trump Jr. to end their relationship, the Daily Mail reported. Someone who worked for the Trump campaign the last five years told the Daily Mail that Trump Jr. is “slowly” starting to “wake up” to how Anderson is perceived in MAGA circles. Allies question her MAGA loyalty because of her previous support for the Black Lives Matters movement and her adherence to COVID-19 lockdown rules, the Daily Mail reported. But they also wonder about her “notorious party girl reputation in Palm Beach,” which they think somehow isn’t “highbrow enough” to be associated with the Trump family, the Daily Mail also said. Someone who works in the modeling business and who has known Anderson for years speculated to the Daily Mail that she’s using Trump Jr. as a stepping stone and would prefer to date someone like Musk. People who’ve known Anderson in Palm Beach also told the Daily Mail that she regularly dates wealthy older men. Even though Musk already is the world’s richest man, he stands to gain even more power in the incoming Trump administration, according to critics of both Musk and Trump. These critics note that the billionaire SpaceX founder donated at least a quarter of a billion dollars to support Trump’s campaign, and he’s been rewarded by becoming a regular presence at Trump’s side since his Nov. 5 victory. Musk now is on tap to lead the new DOGE agency, whose purported mission is to drastically reduce federal government spending and “waste.”
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The deadliest air accident ever in South Korea killed 179 people on Sunday when an airliner belly-landed and skidded off the end of the runway, erupting in a fireball as it slammed into a wall at Muan International Airport. Jeju Air flight 7C2216, arriving from the Thai capital Bangkok with 175 passengers and six crew on board, was trying to land shortly after 9 am local time at the airport in the south of the country, South Korea's transport ministry said. Two crew members survived and were being treated for injuries. The twin-engine Boeing 737-800 was seen in local media video landing on its belly at the Muan International Airport and skidding off the runway as smoke streamed out of the engines, before crashing into a wall and exploding in flames, killing everyone on board except two crew plucked from the wreckage. "Only the tail part retains a little bit of shape, and the rest of [the plane] looks almost impossible to recognise," Muan fire chief Lee Jung-hyun told a press briefing. The two crew members, a man and a woman, were rescued from the tail section of the burning plane, Lee said. "Passengers were ejected from the aircraft after it collided with the wall, leaving little chance of survival," a local fire official told families at a briefing, according to a statement released by the fire brigade. Only two peopleboth flight attendantswere rescued from the crash, it said. "Of the 179 dead, 65 have been identified," the country's fire agency said, adding that DNA retrieval had begun. Inside the airport terminal, tearful family members gathered to wait for news. An official began calling out the names of the 65 victims, with each name triggering fresh cries of grief. All of the passengers were Korean apart from two Thais, with the youngest a three-year-old boy and the oldest a 78-year-old, authorities said. The two survivors were transferred to separate hospitals in Seoul, the Yonhap news agency reported. Bits of plane seats and luggage were strewn across the field next to the runway. Authorities combed nearby areas for bodies possibly thrown from the plane, Lee said. Investigators are examining bird strikes and weather conditions as possible factors, Lee said. The control tower had issued a bird strike warning and, shortly afterward, the pilots declared mayday and then attempted to land from the opposite direction, a transport ministry official said. A passenger texted a relative to say a bird was stuck in the wing, the News1 agency reported. The crash was the worst for any South Korean airline since a 1997 Korean Air crash in Guam that killed more than 200 people, transportation ministry data showed. The previous worst on South Korean soil was an Air China crash that killed 129 in 2002. Yonhap news agency cited airport authorities as saying a bird strike may have caused the landing gear to malfunction. Experts, however, said the bird strike report and the way the aircraft attempted to land raised more questions than answers. "A bird strike is not unusual, problems with an undercarriage are not unusual," said Airline News editor Geoffrey Thomas. "Bird strikes happen far more often, but typically they don't cause the loss of an airplane by themselves." Under global aviation rules, South Korea will lead a civil investigation into the crash and automatically involve the National Transportation Safety Board (NTSB) in the United States, where the plane was built. The NTSB said later it was leading a team of US investigators to help South Korea's aviation authority. Hours after the crash, family members gathered in the airport's arrival area, some crying and hugging as Red Cross volunteers handed out blankets. Many victims appeared to be residents of nearby areas returning from vacation, officials said. Families screamed and wept as a medic announced the names of victims identified by their fingerprints. Papers were circulated for families to write down their contact details. Mortuary vehicles lined up outside to take bodies away, and authorities said a temporary morgue had been established. The aircraft was manufactured in 2009, the transport ministry said. The Boeing model involved in the crash, a 737-800, is one of the world's most flown airliners with a generally strong safety record. It was developed well before the MAX variant involved in a recent Boeing safety crisis. It was the first fatal flight for Jeju Air, a low-cost airline founded in 2005 that ranks behind only Korean Air Lines and Asiana Airlines in terms of the number of passengers in the country. Jeju Air CEO Kim E-bae apologised for the accident, bowing deeply during a televised briefing. Kim said that the aircraft had no record of accidents and there were no early signs of malfunction, adding that the airline will cooperate with investigators and make supporting the bereaved its top priority. All domestic and international flights at the airport were cancelled after the accident, Yonhap reported. The crash site smelled of aviation fuel and blood, according to Reuters witnesses. Workers in protective suits and masks combed the area while soldiers searched through bushes. The accident happened only three weeks after Jeju Air started regular flights from Muan to Bangkok and other Asian cities on December 8. Muan International is one of South Korea's smallest airports but it has become much busier in recent years. South Korean acting President Choi Sang-mok, named interim leader of the country on Friday in an ongoing political crisis, arrived at the scene of the accident and said the government was putting all its resources into dealing with the crash. Two Thai women were on the plane, aged 22 and 45, Thai government spokesperson Jirayu Houngsub said. The Thai foreign ministry later confirmed both were among those killed. Thai officials said that there were no abnormal conditions when the plane took off. Both black boxesthe flight data recorder and the cockpit voice recorderhave been found from the crash site, some 288 kilometres southwest of the capital Seoul, deputy transport minister Joo Jong-wan said at a briefing. COMMENTS Comments are moderated and generally will be posted if they are on-topic and not abusive. For more information, please see ourPresident Ferdinand Marcos Jr. —Screengrab from the Presidential Communications Office Facebook page MANILA, Philippines — Malacañang on Sunday issued an advisory affirming its earlier announcement that President Marcos will sign on Monday morning the P6.352-trillion national budget for 2025, amid widespread criticism over several controversial items in the spending plan. The Palace has yet to disclose which items, if any, are to be vetoed from House Bill No. 10800, or the proposed General Appropriations Bill. READ: Marcos to sign 2025 national budget bill on December 3 READ: Marcos ‘thoroughly reviewing’ 2025 budget to conform to charter – Palace The proposed budget has been the subject of sharp criticism by lawmakers and civil society groups over what they described as “questionable” allocations, such as the P26 billion for the Ayuda sa Kapos ang Kita Program (Akap) of the Department of Social Welfare and Development (DSWD). Social Welfare Secretary Rex Gatchalian earlier defended the program, maintaining that it is “not pork barrel since any good Samaritan can refer potential beneficiaries and the barangay has nothing to do with Akap.” Gatchalian said it is the DSWD’s social workers who vet the beneficiaries to make sure that they are eligible for the aid program. —with a report from Jeannette I. 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