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Checkpoint Therapeutics Announces Alignment with FDA Enabling Upcoming Cosibelimab BLA Resubmission

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Checkpoint Therapeutics has announced alignment with the FDA on its resubmission strategy for cosibelimab's biologics license application (BLA).

The BLA resubmission aims to gain U.S. marketing approval for cosibelimab as a treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in patients unsuitable for curative surgery or radiation.

The alignment follows a complete response letter (CRL) from the FDA in December 2023, which identified issues with the contract manufacturing organization but did not raise concerns about clinical data, safety, or labeling.

Positive
  • Alignment with FDA on BLA resubmission strategy.
  • No concerns from FDA about clinical data, safety, or labeling for cosibelimab.
  • Potential new treatment for patients with advanced cSCC.
Negative
  • Issues identified with the third-party contract manufacturing organization in the December 2023 CRL.

The announcement by Checkpoint Therapeutics regarding the alignment with the FDA on the resubmission strategy for cosibelimab focuses on a drug intended for treating advanced stages of cutaneous squamous cell carcinoma (cSCC). Having reached this milestone with the FDA signifies strong potential for eventual approval, especially given that the FDA's previous concerns were limited to manufacturing issues rather than the drug's safety or efficacy. Cosibelimab targets PD-L1, which is a protein involved in suppressing the immune response. By blocking it, the drug allows the immune system to attack cancer cells more efficiently.

This treatment could offer a significant new option for patients who cannot undergo surgery or radiation, potentially improving their quality of life and survival rates. The fact that no clinical data concerns were raised previously is a positive indicator for the drug's efficacy and safety profile. However, stakeholders should monitor the FDA's final decision closely, as any further delays could impact timelines and financial forecasts for the company.

From a financial perspective, the alignment with the FDA is a key milestone for Checkpoint Therapeutics, suggesting that the company is likely on the right path to resolving prior issues. This progress can instill investor confidence as it clears a significant hurdle towards bringing cosibelimab to market. The resubmission, if successful, could unlock new revenue streams and potentially drive up the company's stock price.

Given that the issues cited in the complete response letter were related to manufacturing rather than clinical data, the financial risk associated with this resubmission appears lower. Investors should note that the successful commercialization of cosibelimab could lead to a significant market opportunity. However, it is essential to factor in any potential delays or additional FDA requirements that could affect the timeline and associated costs. Monitoring Checkpoint’s financial health and cash runway remains crucial, as bringing a new drug to market is capital-intensive.

WALTHAM, Mass., June 24, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced it has reached alignment with the Food and Drug Administration (“FDA”) on its biologics license application (“BLA”) resubmission strategy for cosibelimab. Accordingly, Checkpoint plans to move forward with a mid-year BLA resubmission seeking the U.S. marketing approval for cosibelimab as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (“cSCC”) who are not candidates for curative surgery or curative radiation.

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.”

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.

About Checkpoint Therapeutics 
Checkpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential best-in-class anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, as a potential new treatment for patients with selected recurrent or metastatic cancers, including metastatic and locally advanced cSCC. Checkpoint is also evaluating its lead small-molecule, targeted anti-cancer agent, olafertinib (formerly CK-101), a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in Waltham, MA and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.checkpointtx.com.

Forward‐Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended, that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding our reaching alignment with the FDA on our cosibelimab BLA resubmission strategy, our ability to address in a BLA resubmission all approvability deficiencies outlined in the CRL received last December, our ability to work with our third-party CMO and the U.S. FDA to adequately address the issues raised in the CRL and execute on a pathway forward for the potential marketing approval of cosibelimab, the adequacy of the responses to the inspection issues submitted to FDA by our third-party CMO, our projections of resubmission and regulatory review timelines, and the potential differentiation of cosibelimab, including a potentially favorable safety profile as compared to the currently available anti-PD-1 therapies and the two-fold mechanism of action of cosibelimab translating into potential enhanced efficacy. Factors that could cause our actual results to differ materially include the following: the risk that our third-party CMO will not pass regulatory inspections or re-inspections, meet deadlines, and/or comply with applicable regulations; the risk that topline and interim data remains subject to audit and verification procedures that may result in the final data being materially different from the topline or interim data we previously published; the risk that safety issues or trends will be observed in the clinical trial when the full safety dataset is available and analyzed; the risk that a positive primary endpoint does not translate to all, or any, secondary endpoints being met; risks that regulatory authorities will not accept an application for approval of cosibelimab based on data from the Phase 1 clinical trial; the risk that the clinical results from the Phase 1 clinical trial will not support regulatory approval of cosibelimab to treat cSCC or, if approved, that cosibelimab will not be commercially successful; risks related to our chemistry, manufacturing and controls and contract manufacturing relationships; risks related to our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks related to our need for substantial additional funds; other uncertainties inherent in research and development; our dependence on third-party suppliers; government regulation; patent and intellectual property matters; competition; unfavorable market or other economic conditions; and our ability to achieve the milestones we project, including the risk that the evolving and unpredictable Russia/Ukraine conflict and COVID-19 pandemic delay achievement of those milestones. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K, and in our other filings with the U.S. Securities and Exchange Commission. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.

Any forward-looking statements set forth in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. This press release and prior releases are available at www.checkpointtx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

Company Contact:
Jaclyn Jaffe
Checkpoint Therapeutics, Inc.
(781) 652-4500
ir@checkpointtx.com

Investor Relations Contact:
Ashley R. Robinson
Managing Director, LifeSci Advisors, LLC
(617) 430-7577
arr@lifesciadvisors.com

Media Relations Contact:
Katie Kennedy
Gregory FCA
610-731-1045
checkpoint@gregoryfca.com


FAQ

What did Checkpoint Therapeutics announce on June 24, 2024?

Checkpoint Therapeutics announced alignment with the FDA on the resubmission strategy for the cosibelimab BLA.

What is cosibelimab intended to treat according to Checkpoint Therapeutics' recent announcement?

Cosibelimab is aimed to treat metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in patients who are not candidates for curative surgery or radiation.

What were the FDA's concerns in the CRL regarding cosibelimab?

The FDA's concerns were related to findings during an inspection of Checkpoint's third-party contract manufacturing organization; there were no concerns about the clinical data, safety, or labeling.

When did Checkpoint Therapeutics receive the CRL from the FDA?

Checkpoint Therapeutics received the CRL from the FDA in December 2023.

What stock symbol represents Checkpoint Therapeutics?

The stock symbol for Checkpoint Therapeutics is CKPT.

Checkpoint Therapeutics, Inc.

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