Checkpoint Therapeutics Proclaims Alignment with FDA Enabling Upcoming Cosibelimab BLA Resubmission

WALTHAM, Mass., June 24, 2024 (GLOBE NEWSWIRE) — Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and focused oncology firm, right now introduced it has reached alignment with the Meals and Drug Administration (“FDA”) on its biologics license utility (“BLA”) resubmission technique for cosibelimab. Accordingly, Checkpoint plans to maneuver ahead with a mid-year BLA resubmission in search of the U.S. advertising and marketing approval for cosibelimab as a possible new therapy for sufferers with metastatic or regionally superior cutaneous squamous cell carcinoma (“cSCC”) who will not be candidates for healing surgical procedure or healing radiation.

James F. Oliviero, President and Chief Govt Officer of Checkpoint, mentioned, “We’re happy to have reached alignment with the FDA on our BLA resubmission technique to probably handle all approvability deficiencies outlined within the full response letter (“CRL”) obtained final December. We’re desirous to resubmit our BLA and to probably carry a brand new and probably differentiated immunotherapy therapy choice to sufferers with superior cSCC.”

In December 2023, the FDA issued a CRL for the cosibelimab BLA, which solely cited findings that arose throughout a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing group (“CMO”) as approvability points to deal with in a BLA resubmission. The CRL didn’t state any considerations in regards to the medical knowledge bundle, security, or labeling for the approvability of cosibelimab.

About Checkpoint Therapeutics 
Checkpoint Therapeutics, Inc. is a clinical-stage immunotherapy and focused oncology firm targeted on the acquisition, growth and commercialization of novel therapies for sufferers with strong tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a possible best-in-class anti-PD-L1 antibody licensed from the Dana-Farber Most cancers Institute, as a possible new therapy for sufferers with chosen recurrent or metastatic cancers, together with metastatic and regionally superior cSCC. Checkpoint can be evaluating its lead small-molecule, focused anti-cancer agent, olafertinib (previously CK-101), a third-generation epidermal development issue receptor (“EGFR”) inhibitor, as a possible new therapy for sufferers with EGFR mutation-positive non-small cell lung most cancers. Checkpoint is headquartered in Waltham, MA and was based by Fortress Biotech, Inc. (Nasdaq: FBIO). For extra info, go to www.checkpointtx.com.

Ahead‐Trying Statements
This press launch accommodates “forward-looking statements” inside the which means of Part 27A of the Securities Act of 1933 and Part 21E of the Securities Change Act of 1934, every as amended, that contain quite a lot of dangers and uncertainties. For these statements, we declare the safety of the protected harbor for forward-looking statements contained within the Non-public Securities Litigation Reform Act of 1995. Such statements embrace, however will not be restricted to, statements concerning our reaching alignment with the FDA on our cosibelimab BLA resubmission technique, our capability to deal with in a BLA resubmission all approvability deficiencies outlined within the CRL obtained final December, our capability to work with our third-party CMO and the U.S. FDA to adequately handle the problems raised within the CRL and execute on a pathway ahead for the potential advertising and marketing approval of cosibelimab, the adequacy of the responses to the inspection points submitted to FDA by our third-party CMO, our projections of resubmission and regulatory assessment timelines, and the potential differentiation of cosibelimab, together with a probably favorable security profile as in comparison with the presently accessible anti-PD-1 therapies and the two-fold mechanism of motion of cosibelimab translating into potential enhanced efficacy. Components that would trigger our precise outcomes to vary materially embrace the next: the chance that our third-party CMO won’t move regulatory inspections or re-inspections, meet deadlines, and/or adjust to relevant rules; the chance that topline and interim knowledge stays topic to audit and verification procedures that will end result within the remaining knowledge being materially completely different from the topline or interim knowledge we beforehand printed; the chance that issues of safety or tendencies will likely be noticed within the medical trial when the complete security dataset is offered and analyzed; the chance {that a} optimistic main endpoint doesn’t translate to all, or any, secondary endpoints being met; dangers that regulatory authorities won’t settle for an utility for approval of cosibelimab primarily based on knowledge from the Section 1 medical trial; the chance that the medical outcomes from the Section 1 medical trial won’t help regulatory approval of cosibelimab to deal with cSCC or, if accepted, that cosibelimab won’t be commercially profitable; dangers associated to our chemistry, manufacturing and controls and contract manufacturing relationships; dangers associated to our capability to acquire, carry out underneath and preserve financing and strategic agreements and relationships; dangers associated to our want for substantial extra funds; different uncertainties inherent in analysis and growth; our dependence on third-party suppliers; authorities regulation; patent and mental property issues; competitors; unfavorable market or different financial circumstances; and our capability to attain the milestones we mission, together with the chance that the evolving and unpredictable Russia/Ukraine battle and COVID-19 pandemic delay achievement of these milestones. Additional dialogue about these and different dangers and uncertainties could be present in our Annual Report on Kind 10-Ok, and in our different filings with the U.S. Securities and Change Fee. The data contained herein is meant to be reviewed in its totality, and any stipulations, circumstances or provisos that apply to a given piece of data in a single a part of this press launch must be learn as making use of mutatis mutandis to each different occasion of such info showing herein.

Any forward-looking statements set forth on this press launch converse solely as of the date of this press launch. We expressly disclaim any obligation or endeavor to launch publicly any updates or revisions to any forward-looking statements contained herein to mirror any change in our expectations or any modifications in occasions, circumstances or circumstances on which any such assertion is predicated, besides as required by legislation. This press launch and prior releases can be found at www.checkpointtx.com. The data discovered on our web site just isn’t integrated by reference into this press launch and is included for reference functions solely.

Firm Contact:
Jaclyn Jaffe
Checkpoint Therapeutics, Inc.
(781) 652-4500
[email protected]

Investor Relations Contact:
Ashley R. Robinson
Managing Director, LifeSci Advisors, LLC
(617) 430-7577
[email protected]

Media Relations Contact:
Katie Kennedy
Gregory FCA
610-731-1045
[email protected]