Fate Therapeutics Inc. is making big changes. The company told Janssen Biotech Inc. it was not interested in continuing the collaboration and option agreement cut in 2020 that could have brought Fate up to $3 billion. Fate also is halting four solid tumor natural killer (NK) cell programs to concentrate on two of its NK cell programs and two T-cell programs, all while reducing headcount to 220 employees in the first quarter of 2023.
Wuxi Biologics (Cayman) Inc. is providing an exclusive license to GSK plc for a preclinical bispecific T-cell engaging antibody along with the option of three additional bi- and multispecific TCE antibodies developed by Wuxi. In exchange, Wuxi will receive an up-front payment of $40 million and up to $1.46 billion in additional payments for research, development, regulatory and commercial milestones across the four TCE antibodies. Wuxi Biologics, of Shanghai, is also eligible to receive tiered royalties on net sales.
Hadasit Medical Research Services and Development Ltd. and BIRAD – Research & Development Company Ltd. have inked a development deal with Immix Biopharma Inc. for tissue specific therapeutics based on their jointly developed anti-B-cell maturation antigen CAR T cells targeting plasma cell technology.
Geron Corp. executives highlighted a potential billion-dollar market opportunity for imetelstat on the back of positive phase III data for the telomerase inhibitor in patients with lower-risk myelodysplastic syndromes (MDS), news that sent shares (NASDAQ:GERN) rising 36% and could portend the first regulatory win for a scientific approach the company has pursued since the 1990s.
Immunotherapy company Cartherics Pty Ltd. is leading a consortium that received a AU$5.4 million (US$3.6 million) grant from the Medical Research Futures Fund to develop a new approach to enhance cancer therapy by engaging the patient’s own immune system to complement CAR cell therapy.
Two weeks ahead of its Jan. 6, 2023, PDUFA date, the U.S. FDA has approved the bispecific Lunsumio (mosunetuzumab) to treat adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. It’s the first bispecific antibody approved for treating any type of non-Hodgkin lymphoma (NHL). FL is the most common slow-growing form of NHL.
Two deals for antibody-drug conjugates inked since May between Merck & Co. Inc. and Sichuan Kelun-Biotech Pharmaceutical Co. Ltd. have blossomed eight months later into the year’s biggest agreement, one that could bring Kelun-Biotech up to $9.3 billion in development, regulatory and sales milestones.
Sciclone Pharmaceuticals Holdings Ltd. has obtained marketing approval in China for Danyelza (naxitamab) for patients with relapsed or refractory high-risk neuroblastoma. The drug, in combination with granulocyte macrophage colony-stimulating factor, was approved to treat pediatric patients aged 1 and above, as well as adults, who have relapsed or refractory high-risk neuroblastoma in the bone or bone marrow and have demonstrated a partial or minor response to prior therapy or stable disease.
Anocca AB raised €25 million (US$26.5 million) in venture debt financing from the European Investment Bank to maintain its progress toward the clinic. “We’re quickly moving towards regulatory filings next year,” CEO and co-founder Reagan Jarvis told BioWorld. The company aims to start its first clinical trial in 2024.
While new data from Arcus Biosciences Inc. and Gilead Sciences Inc. didn't do much to calm an unsteady development corridor, researcher, developers and analysts still hold out hope for the TIGIT pathway. The Arcus-Gilead randomized phase II study combining anti-TIGIT domvanalimab and anti-PD1 antibodies for treating first-line, metastatic non-small-cell lung cancer produced positive results, including improvements in median progression-free survival (PFS) and six-month landmark PFS rates vs. monotherapy. But a hefty dent in Arcus' shares provide a reminder of TIGIT’s fragility as a field, and a reminder of the phase III failure in May for Roche Holding AG unit Genentech Inc.'s anti-TIGIT immunotherapy tiragolumab, which dragged down the share value of several other class entrants. Arcus stock (NASDAQ:RCUS) dipped deeply on Dec. 20 on the new data’s release, but rallied on Dec. 21 by closing 7.5% upward at $22.15 each.
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