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.
Chengdian (Suzhou) Biopharmaceutical Co. Ltd. has received IND clearance from the FDA, allowing it to initiate a first-in-human phase I trial of CD-001.
Innate Pharma SA has obtained IND clearance from the FDA for IPH-4502, its novel and differentiated topoisomerase I inhibitor antibody-drug conjugate (ADC) conjugated to exatecan targeting Nectin-4 in solid tumors. In nonclinical models, IPH-45 was well tolerated and showed antitumor efficacy in vitro and in vivo.
Chengdian (Suzhou) Biopharmaceutical Co. Ltd. has received IND clearance from the FDA, allowing it to initiate a first-in-human phase I trial of CD-001.
CDR-Life Inc. has reported preclinical data for the CDR-813, a novel antibody fragment-based bivalent T-cell engager targeting preferentially expressed antigen in melanoma (PRAME) on HLA-A*02:01.
Rakuten Medical Inc. has presented preclinical results with RM-0256, a PD-L1-targeted photoimmunotherapy, showing its ability to kill immunosuppressive myeloid cells to activate local and systemic antitumor immunity.
Guangdong HEC Pharmaceutical Co. Ltd. has described programmed cell death protein 1 (PD-1)/PD-1 ligand 1 (PD-L1) interaction inhibitors reported to be useful for the treatment of cancer, infections and autoimmune disease.