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.
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.