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. Read More
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. Read More
With $20 million raised in a series B round led by Brandon Capital and Tenmile, Aravax Pty Ltd. is poised to begin phase II trials of its immunotherapy, PVX-108, for peanut allergy. “Our product is unlike other approaches that are in later stages of development, and those products generally use natural extracts from peanuts to treat peanut allergy,” Aravax CEO Pascal Hickey told BioWorld. Read More
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. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Altimmune, Arcus, Athenex, Biolinerx, Erasca, Journey Medical, Magenta, Nanology, Nykode, Oncotherapeutics, Quantum Leap, Regimmune, Satsuma, Simcere, Takeda, Ultimovacs, Verona. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Entrada, Horizon, Idorsia, Invectys, Iveric, Kira, Maia, Merck & Co., Mitsubishi Tanabe, NS, Seagen, Skye. Read More
