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.
Magenta Therapeutics Inc., the developer of an antibody-drug conjugate intended to help prep certain relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome patients for stem cell transplant or gene therapy, has stopped dosing the drug in part of an ongoing trial after observing two cases of serious adverse events (SAEs) possibly related to the candidate.
In a show of commitment to Innate Pharma SA’s antibody-based natural killer cell engager therapeutics (Anket) platform, longstanding partner Sanofi SA is paying €25 million (US$26.5 million) up front and could pay up to €1.35 billion more in preclinical, clinical, regulatory, and commercial milestones for up to three development programs. Innate also stands to receive royalties on eventual product sales.
Ferring Pharmaceuticals A/S has notched another U.S. FDA approval, this time for a bladder cancer treatment, Adstiladrin (nadofaragene firadenovec). The non-replicating adenovirus vector-based gene therapy’s approval comes only weeks after the FDA’s Nov. 30 approval of the privately held company’s Rebyota (fecal microbiota, live), the first fecal microbiota treatment in the U.S. Adstiladrin is another landmark, as the first FDA-approved gene therapy to treat high-risk, non-muscle-invasive bladder cancer. Saint-Prex, Switzerland-based Ferring said it anticipates the product becoming commercially available in the U.S. in the second half of 2023.
New and updated clinical data presented by biopharma firms at the American Society of Hematology annual meeting and exposition, including: Amgen, Beigene, Novartis, Pharming.
As largely expected, Mirati Therapeutics Inc.’s adagrasib gained U.S. FDA accelerated approval ahead of its Dec. 14 PDUFA date, cleared for second-line use in patients with non-small-cell lung cancer (NSCLC) harboring the KRAS G12C mutation, in which it will go up ahead Amgen Inc.’s Lumakras (sotorasib), which has the advantage of a year and a half head start.