Ideaya Biosciences Inc. has submitted an IND application to the FDA for IDE-574, a KAT6/7 dual inhibitor with potential to treat hormone receptor-positive breast cancer and lung adenocarcinoma. A phase I trial of IDE-574 monotherapy is expected to begin in the first quarter of next year.
Avencell Therapeutics Inc. has received clinical trial clearances from the FDA and EMA to conduct a phase I/II trial (Quadvance) of AVC-203 for the treatment of relapsed or refractory B-cell malignancies.
CSPC Pharmaceutical Group Ltd. has obtained IND clearance from the FDA to conduct clinical trials in the U.S. with SYH-2069 for weight management in individuals with obesity or overweight and at least one weight-related comorbidity.
Lynk Pharmaceuticals Co. Ltd. has received IND clearance from the FDA for LNK-01006, an allosteric TYK2 inhibitor with potential to treat neurodegenerative diseases.
Vectory Therapeutics BV has obtained IND clearance from the FDA for a phase I/II trial (PIONEER-ALS) of VTX-002, a first-in-class vectorized antibody targeting TDP-43 pathology in amyotrophic lateral sclerosis (ALS). VTX-002 delivers an engineered antibody designed to selectively target toxic species of TDP-43.
Latus Bio Inc. has reported IND clearance by the FDA for LTS-101, a gene therapy candidate to treat the CNS manifestations of late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease. The FDA has also granted orphan drug, rare pediatric disease and fast track designations to LTS-101.
Ideaya Biosciences Inc. has received IND clearance from the FDA for the initiation of a phase I trial to evaluate IDE-034, a bispecific B7H3/PTK7 TOP1 antibody-drug conjugate.
Phrontline Biopharma Suzhou Co. Ltd. closed a $60 million pre-A+ financing round led by Lapam Investment, with participation from nine other investors. The funds raised will support Phrontline’s development of next-generation antibody-drug conjugate (ADC) candidates.
Peptidream Inc. has submitted IND applications to the FDA to initiate phase I studies of [225Ac]PD-32766, as a potential radiotherapeutic, and [64Cu]PD-32766, as the radiodiagnostic pair, for patients with clear cell renal cell carcinoma (ccRCC).
Evotec SE has received a $5 million milestone payment from Bristol Myers Squibb Co. (BMS), following the acceptance of an IND application by the FDA in the companies’ strategic protein degradation partnership.
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