Alentis Therapeutics AG has obtained IND clearance from the FDA for ALE.P02, an anti-Claudin-1 (CLDN1) antibody-drug conjugate (ADC) with a tubulin inhibitor payload.
Akeso Pharmaceuticals Inc. scored two approvals from China’s National Medical Products Administration on Sept. 30 before the long Labor Day holiday – one for its PCSK9 inhibitor, ebronucimab, and the second to expand use of PD-1/CTLA4 bispecific antibody cadonilimab in unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, marking the second indication for cadonilimab in China.
Spima Therapeutics SAS has announced its launch with a focus on developing innovative peptide-based immunotherapies for difficult-to-reach targets, especially protein-protein interactions.
Cartherics Pty Ltd. has raised over its target of AU$15 million (US$10.3 million) in an oversubscribed private financing round. Funding will support a clinical trial for CTH-401, the company’s lead cell therapy for ovarian cancer, and expand its pipeline to include other diseases.
Ichnos Glenmark Innovation (IGI) has announced a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) to evaluate IGI’s selective, orally active Casitas B-lineage lymphoma b (Cbl-b) inhibitor GRC-65327.
Suzhou Ribo Life Science Co. Ltd. recently reported on the development and preclinical characterization of a novel blood-brain barrier (BBB)-penetrating oligonucleotide drug, RBD-8088, for the treatment of glioblastoma.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) met for what chairperson Christopher Lieu called, at the end, “an incredibly long day” to decide whether approval of immune checkpoint inhibitors should be restricted in accordance with expression levels of PD-L1.
Bioatla Inc. and Context Therapeutics Inc. have entered into an agreement under which Context has obtained from Bioatla an exclusive, worldwide license to develop, manufacture and commercialize BA-3362, Bioatla’s Nectin-4 x CD3 T-cell engaging (TCE) bispecific antibody.
The FDA has cleared an IND application for a phase I/II study of KSQ-004EX, KSQ Therapeutics Inc.’s second engineered tumor-infiltrating lymphocyte (eTIL) program. KSQ-004EX consists of TIL in which the genes encoding SOCS1 and Regnase-1 are inactivated using CRISPR/Cas9 gene editing.
The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) on Sept. 26 will take up a controversy that’s hardly new: whether approval of immune checkpoint inhibitor drugs should be restricted in accordance with PD-L1 expression.
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