FBIO - Checkpoint Therapeutics Strengthens Intellectual Property Protection for Cosibelimab with New U.S. Patent Issuance | Benzinga
Upcoming PDUFA goal date of January 3, 2024
U.S. patent protection for cosibelimab through at least May 2038
WALTHAM, Mass., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that the U.S. Patent and Trademark Office ("USPTO") has issued a new patent (U.S. Patent No. 11,834,505) covering a method of treating various cancers, including cutaneous squamous cell carcinoma ("cSCC"), through the administration of cosibelimab.
The USPTO previously issued a composition of matter patent (U.S. Patent No. 10,590,199), specifically covering cosibelimab, or a fragment thereof. Together, these patents protect Checkpoint's differentiated and potential best-in-class anti-PD-L1 antibody, cosibelimab, in the U.S. through at least May 2038, not including any potential patent term extension under the Hatch-Waxman Act.
Checkpoint's Biologics License Application ("BLA") for cosibelimab is currently under review by the U.S. Food and Drug Administration ("FDA") as a potential new treatment for patients with locally advanced and metastatic cSCC, with an upcoming Prescription Drug User Fee Act ("PDUFA") goal date of January 3, 2024.
"With less than five weeks remaining before our assigned PDUFA date for cosibelimab, we look forward to cosibelimab potentially joining an approved class of immunotherapies with combined worldwide annual sales exceeding $35 billion," said James Oliviero, President and Chief Executive Officer of Checkpoint. "We believe our broad U.S. patent portfolio, expiring no earlier than May 2038, provides the potential for cosibelimab to be further developed into a market leading drug, not only in cSCC, but also in additional indications, both as a monotherapy and as the PD-L1 backbone for new combination regimens."
About Cosibelimab
Cosibelimab is a potential best-in-class, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 ("PD-L1") and blocks the PD-L1 interaction with the programmed death receptor-1 ("PD-1") and B7.1 receptors. Cosibelimab's primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently ...