Sun Pharma Advanced Research Co. Ltd. has filed an IND application with the FDA for SBO-154 for the treatment of solid tumors. A global phase I study is planned in advanced solid tumors.
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials with SYS-6040 for advanced solid tumors.
Allogenica SAS has been awarded a €2.5 million (US$2.7 million) grant under the French government’s France 2030 program to help advance its universal CAR T candidate, XL-001, for CD19-positive hematologic cancers.
Black Diamond Therapeutics Inc. is getting $70 million up front and could earn up to $710 million in milestone payments in a deal with Servier for phase I-stage BDTX-4933, a small-molecule candidate targeting both RAS mutations and RAF alternations for treating solid tumors, including non-small-cell lung cancer.
Celltrion Inc. is on a biosimilar roll with the U.S. FDA this month, having gained clearance of Stoboclo and Osenvelt as products referencing Amgen Inc.’s biologic, denosumab (Prolia, Xgeva), along with Omlyclo becoming the first and only interchangeable biosimilar to omalizumab (Xolair, Genentech Inc. and Novartis AG).
Sutro Biopharma Inc. has announced plans to prioritize its three wholly owned preclinical programs in its next-generation antibody-drug conjugate (ADC) pipeline, while deprioritizing additional investment into development of luveltamab tazevibulin across all indications.
Celltrion Inc. is on a biosimilar roll with the U.S. FDA this month, having gained clearance of Stoboclo and Osenvelt as products referencing Amgen Inc.’s biologic, denosumab (Prolia, Xgeva), along with Omlyclo becoming the first and only interchangeable biosimilar to omalizumab (Xolair, Genentech Inc. and Novartis AG).
Finnish cancer immunotherapy specialist Valo Therapeutics Oy has raised €19 million (US$20.7 million) in a round that attracted Italian and Australian investors, and funding the company to the completion of the ongoing phase Ib trial of its lead program in the treatment of solid tumors.
Researchers from Vicero Inc. have developed a Vincobody platform, which allows for design of novel proprietary VHH antibody fragments that possess the efficacy of dual checkpoint blockade while mitigating the toxicity limitations of current monoclonal antibody therapies.
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials with JMT-108 for advanced malignant tumors.