Act Genomics (Hong Kong) Ltd. won U.S. FDA approval for its genomic profiling test for solid tumors, Actonco. This marks the first time an Asia-based company has received FDA clearance for a comprehensive genomic profiling test.
Ammax Bio Inc. has entered into an exclusive option with Evopoint Biosciences Co. Ltd. for a worldwide license, excluding Greater China, for the development and commercialization of a novel antibody-drug conjugate (ADC) for treating solid tumors.
Hotspot Therapeutics Inc. has received FDA clearance of its IND application for HST-1011, the company's investigational small-molecule allosteric inhibitor of casitas B-lineage lymphoma-B (CBL-B), an E3 ubiquitin protein ligase critically involved in immune cell response.
Askgene Pharma Inc. has received FDA clearance of its IND application to start a phase I study of ASKG-915, a novel and proprietary anti-PD-1/IL-15 prodrug fusion molecule for the treatment of cancer.
Simcere Pharmaceutical Group Ltd. has received IND approval from China's National Medical Products Administration (NMPA) for two immuno-oncology bispecific antibodies, SIM-0348 and SIM-0237.
Vincerx Pharma Inc. has received FDA clearance of its IND application for VIP-236, a small molecule-drug conjugate (SMDC) for the treatment of advanced solid tumors. A first-in-human study for advanced or metastatic solid tumors is expected to start in the first quarter of next year.
Erasca Inc. has received FDA clearance of its IND application for ERAS-3490, an orally available small-molecule KRAS G12C inhibitor designed to have high central nervous system (CNS) penetration for the treatment of KRAS G12C-mutated solid tumors, including non-small-cell lung cancer (NSCLC).
1st Biotherapeutics Inc. has received clearance from the FDA for its IND application to evaluate FB-849, a small-molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor, in patients with advanced solid tumors.
Researchers from Nalo Therapeutics Inc. presented the discovery and preclinical evaluation of a novel orally bioavailable and brain-penetrant epidermal growth factor receptor (EGFR) inhibitor, NX-019, being developed as a potential therapeutic agent to treat EGFR-mutant solid tumors.
