Chimeric Therapeutics Ltd. has received FDA clearance of its IND application for CHM-2101, a first-in-class CDH17 chimeric antigen receptor (CAR) T cell therapy for gastrointestinal (GI) cancers.
Researchers from Shanghai Henlius Biotech Inc. presented the discovery and preclinical characterization of HLX-42, a next-generation EGFR-targeting antibody-drug conjugate (ADC) being developed for the treatment of cancer.
The FDA has accepted Mustang Bio Inc.’s IND application of MB-109 for the treatment of recurrent glioblastoma (GBM) and high-grade astrocytoma. MB-109 is a treatment regimen combining MB-101 (City of Hope-developed IL13Rα2‐targeted CAR T-cell therapy) and MB-108 (Nationwide Children’s Hospital-developed HSV-1 oncolytic virus).
Ankyra Therapeutics Inc. has received approval of its IND application by the FDA and its clinical trial application (CTA) by Health Canada for its lead agent, ANK-101, a novel tumor-directed anchored immune medicine.
Kalivir Immunotherapeutics Inc. has announced FDA clearance of an IND application for a phase I study of ASP-1012 (formerly VET2-L2) in participants with locally advanced or metastatic solid tumors. The trial is expected to begin in the first quarter of next year.
Endogena Therapeutics Inc. has received FDA clearance of its IND application for EA-2351 for geographic atrophy, an advanced form of age-related macular degeneration (AMD).
Vaxcyte Inc. has received FDA clearance of its IND application for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease.
Caribou Biosciences Inc. has received FDA clearance of its IND application for CB-012, an allogeneic anti-C-type lectin-like molecule-1 (anti-CLL-1) chimeric antigen receptor (CAR) T-cell therapy. CLL-1 is highly expressed on acute myeloid leukemia (AML) cells and leukemic stem cells, but it is not expressed on hematopoietic stem cells.