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Dive Brief:The Food and Drug Administration has approved a regimen involving Johnson & Johnsons antibody drugs Tecvayli and Darzalex for relapsed multiple myeloma less than three months after the drugmaker presented study datasuggesting the combination could have curative potential.The regulator reviewed the drug under its new national priority voucher program, which it used proactivelyfollowing J&Js release of the findings at the American Society of Hematology meeting. The approval issued Thursday was the third under that program, following that of an older antibioticand a lung cancer treatment from Boehringer Ingelheim. The review took a total of 55 days, according to the FDA.The decision also converts Tecvaylis authorization from a conditional, accelerated approval to full clearance thats based on its ability to improve survival in early disease.Dive Insight:In multiple myeloma, an influx of treatments have arrived in recent years that target BCMA, a protein found on diseased white blood cells. Some, like Bristol Myers Squibbs Abecma and J&J and Legend Biotechs Carvykti, are engineered cell therapies. Another, GSKs Blenrep, is an antibody-drug conjugate.Tecvayli, by comparison, is a bispecific antibody that binds to BCMA on diseased cells and a protein on immune cells. Its one of several T cell engagersnow available to treat myeloma. And its also now the only one to win a full approval and move beyond late-line settings, giving J&J a leg up over multiple rivals.The data supporting Tecvaylis approval with Darzalex were termed remarkable by one study investigator. The combination was compared with two commonly used standard of care drug regimens using Darzalex as a backbone in those who had progressed or didnt respond to one to three treatment lines.The Tecvayli-Darzalex combination reduced the relative risk of progression or death by 83%. Among those alive and relapse-free at six months, 90% had still avoided cancer progression three years after the studys start, indicating the combination might have curative potential.Cell therapies like Carvkyti offer the chance of a similarly deep and durable benefit. But unlike bispecific drugs, theyre usually administered in specialized facilities able to monitor patients for severe immune-related side effects following treatment.Drugmakers hope T cell engagersopen up treatment to more people who live further away from these specialized centers, even though they can also stimulate the same worrisome immune reactions. Some hospitals are trying to navigate those risks by giving patients symptom monitoring tools and other drugs that can tamp down the immune response. '

Gilead Sciences has struck a deal to buy Arcellx for $7.8 billion to take full control of a CAR-T cell therapy that is on the cusp of approval. Arcellx partnered with Gilead to develop the BCMA-directed CAR-T anitocabtagene autoleucel (anito-cel) in 2022. Gilead invested in Arcellx as part of the agreement and, having invested again when amending the deal in 2023, owns 11.5% of the company. With Gilead on the hook for $530 million in milestones for anito-cel, analysts had speculated about a potential buyout. Gilead made its move Monday, agreeing to pay $115 per share in cash for Arcellx. The offer represents a 68% premium to Arcellx’s 30-day volume-weighted average share price. Arcellx shareholders will receive another $5 per share if cumulative global anito-cel sales hit $6 billion by the end of 2029. Gilead CEO Daniel O’Day discussed the buyout in a statement. “This agreement reflects our conviction in the potential of anito-cel and our intention to move with speed so we can make the most of that potential for patients with multiple myeloma,” O’Day said. “Beyond the potential launch this year, anito-cel could become a foundational treatment for multiple myeloma over time, including earlier lines of therapy.” The FDA is reviewing a filing for approval of anito-cel as a fourth-line treatment for relapsed or refractory multiple myeloma. Gilead applied for priority review, but the Dec. 23 PDUFA date suggests the FDA will assess the filing under its standard pathway. The FDA approved Johnson & Johnson and Legend Biotech’s BCMA-directed CAR-T cell therapy Carvykti in 2022, and it's since attained blockbuster status. But, after speaking to physicians treating multiple myeloma patients, Guggenheim Securities analysts recently said in a note to investors that anito-cel is preferred to the incumbent. The preference reflects the therapies’ safety profiles. Gilead acquired cell therapy operations through its $11.9 billion Kite Pharma takeover in 2017 and sells the CD19-directed treatments Tecartus and Yescarta. The unit has struggled, though, with Gilead’s cell therapy sales falling 7% to $1.8 billion last year. BMO Capital Markets analysts said in a recent note to investors that the anito-cel launch could help Gilead’s cell therapy unit “regain its footing.” Analysts with William Blair viewed the deal terms “favorably,” citing the offer's premium on Arcellx's share price and the strong likelihood that Arcellx will collect the contingent value right tied to anito-cel, according to a Feb. 23 note. The analysts also believe Gilead saw long-term value in Arcellx’s other platforms, as demonstrated in the acquisition premium. The content above comes from the network. if any infringement, please contact us to modify.

Gilead Sciences is buying its CAR-T collaborator Arcellx as its closely-watched multiple myeloma cell therapy nears potential approval and launch. The deal is worth $7.8 billion, when calculated from $115 per share in cash. There is also one contingent value right of $5 per share once certain future sales milestones are met. At the center of the buyout is anito-cel, which is the multiple myeloma CAR-T cell therapy that Gilead and Arcellx are already developing together. The treatment is expected to be a safer option compared to the current go-to CAR-T therapy for multiple myeloma, Johnson & Johnson and Legend Biotech’s Carvykti, which generated $1.9 billion in revenue last year. The two CAR-T treatments have drawn considerable comparisons and led to an intense rivalry between their developers. Gilead has filed for FDA approval of anito-cel and said it plans to launch the cell therapy for fourth-line and later multiple myeloma patients in the second half of this year. Ahead of the buyout announcement, Gilead already owned 12% of Arcellx. The two companies announced their initial partnership in 2022 for the multiple myeloma cell therapy. Through its subsidiary Kite, Gilead currently markets two blood cancer cell therapies, Yescarta and Tecartus.