A multiple myeloma cell therapy has encouraging results analysts say could make it best in its class and a gene-editing therapy is showing early promise in sickle cell disease. Here’s a recap of those developments and others from the annual meeting of the American Society of Clinical Oncology.
Arcellx’s cell therapy for multiple myeloma has shown no signs of the parkinsonism complication observed in clinical testing of Carvykti, a rival product from partners Johnson & Johnon and Legend Biotech. Arcellx is developing its CAR T-treatment under a partnership with Gilead Sciences.
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Roche is acquiring Poseida Therapeutics, a biotech developing allogeneic cell therapies for cancers and immunological indications. The two companies have been partners in hematological malignancies since 2022.
Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability.
Vertex Pharmaceuticals is known for its cystic fibrosis drugs, but the company aims to diversify with a pipeline that reaches more therapeutic areas. CEO Reshma Kewalramani explained Vertex’s strategy during the World Medical Innovation Forum in Boston.
The FDA approved Adaptimmune Therapeutics’ Tecelra as a treatment for advanced cases of synovial sarcoma. It’s the first engineered cell therapy approved for treating a solid tumor.
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Lupus is the lead autoimmune indication for Artiva Biotherapeutics, which has an early-stage clinical trial underway. Artiva’s allogeneic cell therapies are based on natural killer cells.
The CAR T-therapies Abecma and Carvykti may now be used in earlier lines of treatment for multiple myeloma. The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products.
Iovance Biotherapeutics’s Amtagvi is now the first FDA-approved treatment based on type of cell called a tumor-infiltrating lymphocyte. The regulatory nod in advanced melanoma also makes Amtagvi the first cell therapy approved for treating a solid tumor.
Astellas Pharma is working with Kelonia Therapeutics, a startup that develops in vivo CAR T-therapies with technology that precisely delivers genetic cargo to cells. The collaboration combines this tech with a platform from Xyphos Biosciences, a cell therapy developer that Astellas acquired in 2019.
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Cell therapies were first validated in cancer, but Kyverna Therapeutics aims to show they’re safe enough for autoimmune diseases. The biotech plans to deploy its IPO cash across clinical trials in lupus nephritis, multiple sclerosis, systemic sclerosis, and myasthenia gravis.
Autolus will apply the capital to its CAR T-cell therapy currently under FDA review in cancer and in early clinical development in lupus. Meanwhile, BioNTech will gain access to Autolus’s cell therapy manufacturing assets as well as technologies that could support the R&D of in vivo therapies and antibody drug conjugates.
Regeneron Pharmaceuticals is paying $5 million up front for 2seventy bio’s cancer drug pipeline. 2seventy will now focus on a cell therapy commercialized with partner Bristol Myers Squibb while Regeneron adds assets for its newly formed cell therapy division.
Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply.
Startup TrX1 develops cell therapies that function like a particular type of regulatory T cell, or Treg, whose role includes dampening inflammation and inducing long-term tolerance. Based on research from Stanford, TrX1’s lead program is a potential therapy for preventing graft-versus-host disease.