Phase 2 data for Cargo Therapeutics’ CD22-targeting cell therapy show low durability and cases of a severe immune response, some that were classified as grade 4 or 5 serious adverse events. Cargo is discontinuing the study and shifting focus to a different cell therapy on track to begin Phase 1 testing in mid-2025.
Galapagos and Gilead Sciences have both evolved since inking their R&D collaboration agreement in 2019. Separating Galapagos into two offers a way for that company to pursue its cell therapy strategy while also keeping the Gilead alliance alive, executives from both companies said.
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Galapagos said the planned business separation will leave the legacy company free to focus on developing cell therapies for cancer. An accompanying corporate restructuring will shave Galapagos’s headcount by 40%.
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.
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.
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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.
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.
Zelis CEO Amanda Eisel shares her perspective on how the company is solving the problems of a fragmented health financial system to benefit all.
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.
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.