Anitocabtagene autoleucel

Johnson & Johnson and Legend Biotech's additional investment comes just as the so-called Tech Lane facility is set to begin clinical production of Carvykti in a few weeks. On track to meet their long-stated capacity goal for multiple myeloma therapy Carvykti in 2025, Johnson & Johnson and Legend Biotech are already planning the next phase of their cell therapy manufacturing expansion.Based on internal projections for demand, the two companies have approved about $150 million in additional investments to expand the future capacity of a brand-new facility in Ghent, Belgium, Legend CEO Ying Huang, Ph.D., and interim Chief Financial Officer Jessie Yeung said on an investor call Tuesday.J&J and Legend decided on the new investment just as the so-called Tech Lane facility is set to begin clinical production of Carvykti in a few weeks. The site is expected to gain approval to initiate commercial supply by the end of 2025, according to Huang.For the latest expansion, early engineering and design work has begun, and construction is slated to start in the second half of 2025 and expected to be complete in 2028, Yeung said. The addition will primarily provide supplies for the EU market, a Legend spokesperson told Fierce Pharma.Over the last several years, J&J and Legend have been busy working to ramp up their cell therapy manufacturing capacity. Since Carvykti’s initial FDA approval in early 2022, supply constraints have limited the CAR-T therapy’s revenue growth. What’s more, an expanded FDA nod in April 2024 in second-line multiple myeloma roughly tripled the med’s eligible patient population.In one of the pair’s recent efforts to boost supply, contract manufacturer Novartis recently won FDA approval to make commercial supply of Carvykti at its site in Morris Plains, New Jersey, Huang said on the call. Also in New Jersey, J&J and Legend said in the fall of 2022 that they would double the investment in their flagship Raritan manufacturing facility to a total of $500 million. Legend now expects regulatory approval of a new section at that site in the second half of this year.The companies have another site in Ghent, called the Obelisc facility, which began commercial production in the third quarter of 2024 and is now operating at full capacity, according to Legend.These recent expansions will help the companies reach a capacity to be able to produce 10,000 doses of Carvykti on an annualized basis this year, a goal that was outlined in 2023.“By the end of this year, we’ll be in a situation where supply is fully meeting the demand where we are, and then we’ll be able to keep pace,” Alan Bash, Legend’s president of Carvykti, said on Tuesday’s call. But as analysts noted on the call, Wall Street’s 2026 consensus sales projection for Carvykti indicates that market watchers were unsure about whether patient demand will start to taper off.As of Tuesday, Carvykti can be administered at 104 certified treatment centers in the U.S. Meanwhile, growing levels of administration in the outpatient setting—and increased use at community practices—offer “significant upside” to the drug's growth trajectory, Bash said.Recipients of CAR-T therapies need to be monitored for the potentially life-threatening side effect of cytokine release syndrome. Because of Carvykti’s delayed onset of te syndrome, community providers are able to utilize outpatient administration, thereby freeing up limited inpatient space.This factor can help increase overall treatment capacity and therefore boost demand. The proportion of outpatient Carvykti use has increased from about 30% a year ago to more than 50% today, according to Bash.J&J and Legend have a three-stage plan to increase adoption in the community setting, where most multiple myeloma patients are treated. Right now, the drugmakers are reaching out to more than 8,000 community oncologists to educate them on Carvykti and to help them refer patients to certified treatment centers.In the second stage, starting later this year, the pair will identify certain regional hospitals and community accounts that are closely affiliated with large hospitals to administer Carvykti on-site, Bash said. For the third stage, which will begin next year, the goal is to have the drug more widely administered in community oncology practices, he added. Looming competition Another key reason analysts have reservations about Carvykti in 2026 is the expected entry of Gilead Sciences and Arcellx’s rival BCMA CAR-T anito-cel. In a pivotal phase 2 trial in late-line myeloma, anito-cel showed what analysts viewed as competitive efficacy and better safety to Carvykti, with the important caveat that cross-trial comparisons carry inherent flaws.On Tuesday’s call, Huang played down the potential threat of anito-cel for Carvykti in 2026. When approved, anito-cel would be entering the late-line setting, whereas the majority of Carvykti’s revenue mix will come from earlier lines, he argued. By the end of 2025, Legend expects about two-thirds to three-quarters of Carvykti revenue will come from second- to fourth-line treatment, he said.In anito-cel's phase 2 trial, one factor that stood out for the drug was the absence of some delayed neurotoxicities, including Parkinsonism, which has recently emerged as a concern for Carvykti. During Tuesday’s call, Legend executives pointed to a recent single-site study by the Colorado Blood Cancer Institute. The small study of 39 patients suggested that unrestrained absolute lymphocyte count (ALC) expansion is predictable of neurotoxicites following Carvykti treatment and that prophylactic treatment with the steroid dexamethasone may be able to mitigate the effect. The study did not separate delayed neurotoxocities from other neurologic complications.Legend is talking to multiple centers to potentially study this phenomenon in an investigator-initiated trial, and it has incorporated the mitigation strategy into ongoing Cartitude trial programs for Carvykti, Chief Medical Officer Mythili Koneru, M.D., Ph.D., said on Tuesday’s call.As to the real world, Koneru noted that an ALC-based monitoring and mitigation strategy is easily applicable, because it’s “a very typical lab result that is checked very frequently and commonly at all centers, including academic centers as well as in a community setting.”

Bristol Myers Squibb is acquiring 2seventy bio, a deal that gives the pharmaceutical giant full control over the partnered cancer cell therapy Abecma as that product faces headwinds in a competitive multiple myeloma market. According to deal terms announced Monday night, BMS will pay $5 in cash for each share of 2seventy. That represents a 78.5% premium to 2seventy’s closing stock price on Monday, but it’s a far cry from the company’s $38 per share price when it debuted four years ago. The deal values 2seventy at $286 million, or $102 million taking into account the cash reserves it will bring to BMS. Abecma is an autologous cell therapy that was initially developed by Bluebird Bio and was later partnered with BMS. In 2021, 2seventy spun out as a standalone, publicly traded company, taking Bluebird’s cancer cell therapies along with $442 million to support them. The spinout happened months after Abecma became the first CAR T-therapy approved for treating multiple myeloma. But that first mover advantage was short lived, as partners Johnson & Johnson and Legend Biotech won FDA approval in 2023 for Carvykti, a CAR T-therapy for multiple myeloma. Meanwhile, supply chain constraints presented BMS and 2seventy with manufacturing challenges for Abecma. presented by Health Tech The 5 Best Software to Buy for Managing a Spa Franchise Choosing the right software translates directly into better client management, operational efficiency and growth for your spa franchise. Discover which tool is best for your business. By Meevo Last year, the FDA expanded Abecma’s approval to include third-line treatment of multiple myeloma, which expands the market for the product. But that decision was made alongside the expanded approval of Carvykti to second-line use in multiple myeloma. Despite this advantage, Carvykti is associated with a movement disorder side effect that has not been reported with Abecma. More cell therapy competition could be coming. Arcellx has Phase 2 data showing its CAR T-therapy, anito-cel, has efficacy comparable to Carvykti and a safety profile comparable to Abecma. Anito-cell is being developed under a partnership partnered with Gilead Sciences, which brings its cell therapy experience and manufacturing infrastructure. BMS and 2seventy share equally in the profits and losses from sales of Abecma in the U.S. The product generated $402 million in revenue in 2024, a 14% decline from sales in the prior year, according to BMS’s annual report. While sales around the world are growing, in the U.S. — the largest market for Abecma — sales declined. BMS’s profit-sharing cost last year was $43 million. In the fourth quarter of 2024, BMS recorded a $122 million impairment charge for Abecma “primarily resulting from a reduced cash flow forecast due to the evolving competitive landscape,” the annual report stated. BMS said this charge represented a full write-down of the asset. Abecma is the lone remaining asset from 2seventy’s spinout from Bluebird. Last year, 2seventy sold its preclinical and early clinical cell therapy pipeline to Regeneron Pharmaceuticals, then sold hemophilia assets to Novo Nordisk. Those transactions followed a corporate restructuring that cut R&D expenses and focused the business on commercialization of Abecma. Meanwhile, Bluebird has struggled to commercialize its three FDA-approved gene therapies. Last month, Bluebird agreed to an acquisition that takes the cash-strapped company private. Sponsored Post Webinar: Tips To Have Your Practice Succeed This Year This on-demand webinar will offer insights and share tips on helping practices run more efficiently. By Elation Health and MedCity News BMS’s 2seventy acquisition is expected to close in the second quarter of this year. In a note sent to investors Tuesday, Leerink Partners analyst Daina Graybosch wrote that the deal signals modest confidence in the near-term profit potential of Abecma. Also, acquiring the biotech spares BMS the obligation of sharing profits related to the cell therapy. Graybosch noted that 2seventy CEO Chip Baird stated at an investor conference last week that his company’s move toward profitability makes it attractive to larger companies. But Graybosch said it’s unlikely another company will step in with another offer. “While we agree that Abecma will build in profitability this year, we also believe the uncertainty in future revenue streams would be an overhang for any larger company considering an acquisition,” she said. “We see little to no value in 2seventy for any company looking to build a cell therapy business, as 2seventy already divested its R&D assets to Regeneron and Novo Nordisk, and [Bristol Myers Squibb] manufactures and commercializes Abecma.” Photo by Bristol Myers Squibb