James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We are pleased that the FDA has accepted our BLA resubmission as a complete response after we aligned on our BLA resubmission strategy. We look forward to working closely with the FDA to finalize the review and to the potential opportunity to deliver cosibelimab's unique dual mechanism of action to patients suffering from cSCC." In December 2023, the FDA issued a CRL for the cosibelimab BLA, which only cited findings that arose d ...

Collaboration explores the potential synergistic effects of Checkpoint's anti-PD-L1, cosibelimab, in combination with the autologous T cell therapy, Immuncell-LC This collaboration will initially focus on conducting in vitro combination studies to evaluate the synergistic effects of these two therapies on cancer cell destruction. Positive preliminary data from these studies could potentially pave the way for future in vivo research and clinical studies. James Park, CEO of GC Cell, highlighted the agreement' ...

YONGIN, South Korea and WALTHAM, Mass., July 15, 2024 (GLOBE NEWSWIRE) -- GC Cell (KRX: 144510.KS) and Checkpoint Therapeutics ("Checkpoint") (Nasdaq: CKPT) have announced a collaboration to explore the combined therapeutic potential of cosibelimab, Checkpoint's anti-PD-L1 antibody with dual mechanism of action, with GC Cell's Immuncell-LC, an innovative autologous Cytokine Induced Killer ("CIK") T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells. The anticipated synergy between c ...

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The shares of common stock (or common stock equivalents) described above (but not the unregistered warrants issued in the concurrent private placement or the shares of common stock underlying such unregistered warrants) are being offered by Checkpoint pursuant to a shelf registration statement on Form S-3 (File No. 333- 270843) that was previously filed with the Securities and Exchange Commission ("SEC") on March 24, 2023, an ...

WALTHAM, Mass., July 02, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced it has completed the resubmission of its Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for cosibelimab, its anti-programmed death ligand-1 ("PD-L1") antibody, as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") wh ...

Additionally, in July 2023, Checkpoint announced longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cSCC demonstrating a deepening of response over time, resulting in higher complete response rates than previously reported (55% objective response rate; 26% complete response rate in locally advanced cSCC and 50% objective response rate; 13% complete response rate in metastatic cSCC). Checkpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncolog ...

In December 2023, the FDA issued a CRL for the cosibelimab BLA, which only cited findings that arose during a multi-sponsor inspection of Checkpoint's third-party contract manufacturing organization ("CMO") as approvability issues to address in a BLA resubmission. The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab. Checkpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, ...

James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We're pleased to have reached alignment with the FDA on our BLA resubmission strategy to potentially address all approvability deficiencies outlined in the complete response letter ("CRL") received last December. We're eager to resubmit our BLA and to potentially bring a new and potentially differentiated immunotherapy treatment option to patients with advanced cSCC." This press release contains "forward-looking statements" withi ...

NEW YORK, June 05, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Checkpoint Therapeutics, Inc. (NASDAQ: CKPT) on behalf of long-term stockholders following a class action complaint that was filed against Checkpoint on April 5, 2024 with a Class Period from March 10, 2021 to December 15, 2023. Our investigation concerns whether the board of directors of Checkpoint have breached their fiduciary duties to the ...

NEW YORK, June 03, 2024 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Checkpoint Therapeutics, Inc. (NASDAQ: CKPT) between March 10, 2021 and December 15, 2023, both dates inclusive (the "Class Period"), of the important June 4, 2024 lead plaintiff deadline. SO WHAT: If you purchased Checkpoint securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee ar ...