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.
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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.
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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.
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Goldman Sachs’s new fund—its first dedicated to life sciences—will focus on early- to mid-stage therapeutics companies with multiple assets. Genetic medicine, cell therapy, immunotherapy, and artificial intelligence are among the areas of investment interest for the firm.
Galapagos is a latecomer to CAR T-therapy, but the drugmaker hopes its technology for producing cell therapies at a clinical site will help it stand out. Galapagos has encouraging preliminary data from two early-stage programs and it just begun Phase 1/2 testing of its third cancer cell therapy.
AstraZeneca is paying $1 billion up front to acquire Gracell Biotechnologies, a clinical-stage cell therapy developer. The deal is the latest in a series of AstraZeneca moves intended to expand its presence in the burgeoning cell therapy field.
CAR T-therapies for cancer are now under tighter FDA scrutiny as the agency opens an inquiry regarding reports that some patients who received these cell therapies went on to develop new cases of cancer. The FDA said benefits of these therapies still outweigh their risks, but it is evaluating the need for regulatory action.
Gilead Sciences is increasing its stake in partner Arcellx and expanding the cell therapy alliance the companies started in 2022. The deal expands the lead partnered program to more cancers and gives Gilead a chance at another Arcellx cell therapy candidate made with different technology.