CAR-T

A new biotech co-founded by Paul Stoffels has formed to take on the CAR T cell assets of Galapagos almost a year after the company—now known as Lakefront Biotherapeutics—abandoned them.
Caribou Biosciences entered the scene in 2011 and went public in 2021. Over the course of its existence, the biotech has received funding and support from a handful of Big Pharma players, including Novartis, AbbVie and Pfizer.
Not a month after reports of three deaths in autoimmune trials for Novartis’ CAR T cell therapy ignited a debate about the use of these treatments in nonfatal diseases, Kyverna Therapeutics reported data bolstering its case to bring to market the first CAR T for an autoimmune disease.
FDA
Summit Therapeutics scores a $2 billion equity investment from AstraZeneca to support ivonescimab’s late-stage development; uniQure crashes after four-year data from its Huntington’s disease gene therapy failed to impress; Kyverna Therapeutics brings new light to a struggling CAR T space in autoimmune disease.
Ten patients out of 20 who received Johnson & Johnson and Legend Biotech’s Carvykti remained alive at five years of follow up.
Kyverna Therapeutics’ miv-cel showed improved mobility and a favorable safety profile at one year in patients with stiff person syndrome, further derisking an upcoming FDA application, William Blair said on Thursday. The biotech plans to file for priority review this year.
Blood centers have the donors, resources and community footprint drug sponsors need to solve supply chain issues around cell and gene therapies.
Bristol Myers Squibb is positioning arlo-cel for quadruple-class exposed patients, which could help reduce competition with an upcoming multiple myeloma CAR T therapy from Gilead Sciences, according to BMO Capital Markets.
After downsizing by 50% last year, Arsenal Biosciences is again laying off employees. This time, 99 people are getting cut as part of a strategic shift to focus the company’s R&D efforts on in vivo CAR T therapies.
Novartis suspended multiple studies of a CAR T candidate after three patients who received the therapy suffered fatal cases of immune effector cell-associated hemophagocytic syndrome. BMS, meanwhile, paused some CAR T trials after separately observing “transient and reversible inflammatory events” with its therapy.
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