Immuneering Corp. has received FDA clearance of its IND application for IMM-1-104, paving the way for the company to initiate a phase I/IIa trial of this oral, once-daily small molecule in development for the treatment of advanced RAS-mutant solid tumors.
Scientifically at least, the biggest story coming out of the European Society for Medical Oncology (ESMO) 2022 Congress is the success of cell therapy in solid tumors. “During this ESMO, there is a lot of novelty coming from T-cell therapies,” John Haanen told the audience at his joint keynote speech with Ton Schumacher – so much so that Haanen and Schumacher, both group leaders at the Netherlands Cancer Institute, left antibodies out of their keynote session in order to do justice to the advances in cell therapies.
Monte Rosa Therapeutics Inc. has received FDA clearance of its IND application for MRT-2359, a potent and selective GSPT1-directed molecular glue degrader (MGD).
Immuneering Corp. has submitted an IND application to the FDA to support a phase I/IIa trial of IMM-1-104, an oral once-daily small molecule in development for the treatment of advanced RAS-mutant solid tumors.
Japan’s Healios K.K. is in discussions with Japan’s Pharmaceutical and Medical Devices Agenc about the regulatory path forward for its Multistem somatic stem cell products, for which it conducted phase II/III trials in ischemic stroke and a phase II trial in acute respiratory distress syndrome.
Having initiated its first two clinical trials in non-small-cell lung cancer since January, Nuvalent Inc. said it expects to unveil preliminary dose-escalation data before year-end. Ahead of the data, Nuvalent's phase I/II Arros-1 trial evaluating NVL-520, a kinase inhibitor, in patients with advanced ROS1-positive NSCLC and other solid tumors, continues to enroll participants.
Japan’s Healios K.K. is in discussions with Japan’s Pharmaceutical and Medical Devices Agenc about the regulatory path forward for its Multistem somatic stem cell products, for which it conducted phase II/III trials in ischemic stroke and a phase II trial in acute respiratory distress syndrome.
Innovent Biologics Inc. has formed a partnership with Sanofi SA to jointly develop and commercialize two of Sanofi’s oncology candidates in combination with sintilimab in China, namely SAR-408701 (tusamitamab ravtansine) and SAR-444245.
Sichuan Kelun-Biotech Pharmaceutical Co. Ltd. out-licensed an investigational antibody-drug conjugate (ADC) for the treatment of solid tumors to Merck & Co. Inc. in a deal worth up to $936 million. Sichuan, China-based Kelun-Biotech will receive $35 million up front in the deal and is eligible to receive up to $901 million in future development, approval and commercial milestone payments, as well as tiered royalties on net sales.
Sichuan Kelun-Biotech Pharmaceutical Co. Ltd. out-licensed an investigational antibody-drug conjugate (ADC) for the treatment of solid tumors to Merck & Co. Inc. in a deal worth up to $936 million. Sichuan, China-based Kelun-Biotech will receive $35 million up front in the deal and is eligible to receive up to $901 million in future development, approval and commercial milestone payments, as well as tiered royalties on net sales.
