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.
Y-Mabs Therapeutics Inc. has received FDA clearance of its IND application for CD38-SADA, the company’s second program within its SAYA Y-PRIT (Self-Assembly DisAssembly Pre-targeted Radioimmunotherapy) theranostic platform.
Bloomsbury Genetic Therapies Ltd. has announced U.S. and E.U. orphan drug designations for BGT-NPC, an investigational gene therapy for the treatment of Niemann-Pick disease type C (NPC). BGT-NPC is an investigational AAV9 gene therapy designed to provide a potentially curative solution to NPC patients following a one-time injection in the cerebrospinal fluid.
The FDA has cleared IND applications for UBT-251 injection, a long-acting triple-targeted glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP)/glucagon receptor agonist developed by The United Bio-Technology (Hengqin) Co. Ltd., a wholly owned subsidiary of The United Laboratories International Holdings Ltd., for adult type 2 diabetes and for overweight or obese subjects.
Baudax Bio Inc.’s lead clinical candidate, TI-168, has been awarded U.S. orphan drug designation by the FDA for the treatment of hemophilia A with inhibitors. TI-168 is a next-generation, factor VIII (FVIII)-specific regulatory T-cell (Treg) therapy designed to address hemophilia A in patients with FVIII inhibitors.