China’s National Medical Products Administration approved Carsgen Therapeutics Holdings Ltd.’s NDA for satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid tumors. The autologous Claudin18.2-targeted CAR T was approved for patients with Claudin18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma who have failed at least two prior lines of therapy.
Waypoint Bio has closed a $20 million series A financing round to support its work developing next-generation in vivo CAR T therapeutics for solid tumors using a platform that integrates AI, computer vision and spatial pooled screening.
Pheast Therapeutics Inc. has presented preclinical data on PHST-677, a novel bispecific antibody-drug conjugate (ADC) targeting E-cadherin (CDH1) and Nectin-4.
Beijing Innocare Pharma Tech Co. Ltd. has received IND approval from China’s National Medical Products Administration (NMPA) for ICP-B208, an antibody-drug conjugate targeting CDH17, which is highly expressed in gastrointestinal cancers, including colorectal, gastric and biliary tract cancers and pancreatic ductal adenocarcinoma.
Glyconex Inc. has received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the initiation of a first-in-human phase I trial of GNX-1021, the company’s lead antibody-drug conjugate (ADC) candidate, in patients with advanced gastrointestinal (GI) cancers.
Shanghai Henlius Biotech Inc. has presented preclinical data on HLX-403, its novel anti-CDH17 antibody-drug conjugate (ADC), highlighting its potential for gastrointestinal cancers. A first-in-human trial is expected to commence in the third quarter of this year.
Suzhou Alphamab Co. Ltd.’s HER2 bispecific antibody, anbenitamab (KN-026), combined with chemotherapy has the potential to become a new standard of care for patients with HER2-positive gastric cancer who failed at least one prior line of therapy, according to newly released phase III results that show the combo cut disease progression risk by 75%.
Bio-Thera Solutions Ltd. has synthesized new antibody-drug conjugates comprising trastuzumab targeting HER2 (erbB2) covalently linked to exatecan through a linker reported to be useful for the treatment of cancer, inflammation, autoimmune disorders and infections.
Avacta Therapeutics (Avacta Group plc) has obtained IND clearance from the FDA for FAP-Exd (AVA-6103), a Precision peptide-drug conjugate based on exatecan.
