Newco Avidicure NV arrived on the scene with a hefty $50 million in seed funding to advance novel antibody formats the company says will surpass the best qualities of first-generation antibodies, checkpoint inhibitors, T-cell engagers and antibody-drug conjugates.
Newco Brink Therapeutics SAS is poised to work on the next chapter in genome editing after raising €3.5 million (US$4 million) in seed funding to discover and develop programmable recombinase enzymes.
Cartesian Therapeutics Inc. followed up December’s phase IIb data with more good news regarding Descartes-08, offering 12-month efficacy and safety results that whetted Wall Street’s appetite for the phase III Aurora effort ahead. Milos Miljkovic, chief medical officer, told BioWorld that minimum symptom expression – among the areas where Descartes-08 shone, providing relief for “months and months after the last dose of treatment” – is especially important to patients.
“The nation’s scientific enterprise is being decimated.” That statement in an open letter “to the American people” signed by 1,800 members of the U.S. National Academies, is made concrete in a list of 709 NIH grants – and counting – that have been axed since President Donald Trump was inaugurated on Jan. 20. A grant tracker, based on information published by the Department of Health and Human Sciences, and self-reported terminations from scientists, includes 88 vaccine-related projects, 45 cancer research grants and 231 awards made for HIV research.
Anocca AB has secured the first regulatory authorization in Europe for a CRISPR-Cas gene-edited T-cell receptor T-cell therapy trial, with the phase I/II study now due to start over the next three months at sites in Sweden, Germany, Denmark and the Netherlands.
The first clinical data from an FDA-approved trial of a CAR T-cell therapy in the treatment of multiple sclerosis (MS) show the cells cause complete B-cell depletion, leading on to a reset of the immune system that is accompanied by an improvement in symptoms.
Ligachem Biosciences Inc. landed another exclusive licensing deal to develop and commercialize antibody-drug conjugates (ADCs), this time with T-cell receptor therapy specialist Daan Biotherapeutics Inc. for a cancer-targeting antibody.
The U.S. FDA is to temper the alert it put out in November 2023 pointing to a potential risk of CAR T therapies causing de novo malignancies. “There was this issue of possible safety concerns with T-cell lymphomas, with these CAR T cells. I think this year, we are feeling reassured in this regard,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), told the Alliance for Regenerative Medicine briefing at the J. P. Morgan Healthcare Conference on Jan. 13.
The accelerating pace of U.S. FDA approvals for cell and gene therapies is “great for the field and great news for the patients,” but questions remain over commercialization, with “costs remaining stubbornly high.” That was the glass half-full summary of Tim Hunt, president of the industry group, the Alliance for Regenerative Medicine, reprising progress in 2024, and looking forward to the prospects for further growth and the potential impact of the incoming Trump administration in 2025.
Galapagos NV is abandoning its small molecule roots to focus on cell therapy and at the same time splitting in two, with the spinout company, dedicated to acquiring a portfolio of assets, taking the lion’s share of the capital.
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