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UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event
reported): July 25, 2024
Checkpoint
Therapeutics, Inc.
(Exact Name of Registrant as Specified in
charter)
Delaware |
|
001-38128 |
|
47-2568632 |
(State or Other Jurisdiction of Incorporation) |
|
(Commission File Number) |
|
(IRS Employer Identification No.) |
95
Sawyer Road, Suite
110,
Waltham, MA 02453
(Address of Principal Executive Offices)
(781) 652-4500
(Registrant’s telephone number, including
area code)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Exchange
Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common
Stock, par value $0.0001 per share |
CKPT |
Nasdaq
Capital Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth
company ¨
If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 8.01. Other Events.
On July 25, 2024, Checkpoint Therapeutics, Inc.
issued a press release to announce that the U.S. Food and Drug Administration (“FDA”) accepted Checkpoint’s resubmission
of its Biologics License Application for cosibelimab, its anti-programmed death ligand-1 antibody, as a potential new treatment for adults
with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.
The FDA has set a Prescription Drug User Fee Act goal date of December 28, 2024.
A copy of such press release is being furnished
as Exhibit 99.1 to this report.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The following exhibit is furnished herewith:
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: July 25, 2024 |
Checkpoint Therapeutics, Inc. |
|
(Registrant) |
|
|
|
By |
/s/ James F. Oliviero |
|
|
James F. Oliviero |
|
|
President and Chief Executive Officer |
Exhibit 99.1
Checkpoint Therapeutics Announces FDA Acceptance
of BLA Resubmission of Cosibelimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma
| · | PDUFA
goal date of December 28, 2024 set by FDA |
Waltham, MA – July 25, 2024 –
Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company,
today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for review Checkpoint’s resubmission
of its Biologics License Application (“BLA”) for cosibelimab, its anti-programmed death ligand-1 (“PD-L1”) antibody,
as a potential new treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (“cSCC”) who
are not candidates for curative surgery or curative radiation. The resubmission has been accepted as a complete response to the FDA’s
December 2023 complete response letter (“CRL”) and the FDA has set a Prescription Drug User Fee Act (“PDUFA”)
goal date of December 28, 2024.
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 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 Cosibelimab
Cosibelimab is a potential differentiated, high
affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to 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 marketed PD-1 and PD-L1 antibodies
through sustained high tumor target occupancy of PD-L1 to reactivate an antitumor immune response and the additional potential benefit
of a functional Fc domain capable of inducing antibody-dependent cellular cytotoxicity (“ADCC”) for potential enhanced efficacy.
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 differentiated 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, 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 resubmission of our BLA for cosibelimab and review
thereof, our belief that the BLA resubmission addresses all the issues in the CRL, our belief about the comprehensive nature of our
BLA resubmission and reaching alignment with the FDA on our cosibelimab BLA resubmission strategy, our ability to work with our
third-party CMO and the 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 regulatory review timelines, the commercial potential of cosibelimab, if approved, and the potential
differentiation of cosibelimab, including a potentially favorable safety profile as compared to the currently available anti-PD-1
therapies and the dual mechanism of action of cosibelimab translating into potential enhanced efficacy. Factors that could cause our
actual results to differ materially include the following: the risks and uncertainties associated with the regulatory review
process; uncertainties regarding the timeline of FDA review of the resubmitted BLA; any inability to successfully work with the FDA
to find a satisfactory solution to address any concerns in a timely manner or at all during the review process for the BLA,
including any inability to provide the FDA with data, analysis or other information sufficient to support an approval of the BLA;
our, and our third party CMO’s, ability to adequately address the issues raised in the CRL; any facility inspection or
re-inspection required for our third party CMO or otherwise during the review process for the BLA; whether the FDA accepts the data
and results as included in the BLA resubmission at levels consistent with the published results, or at all; our ability to execute a
partnering relationship for the commercialization of cosibelimab, if approved, on acceptable terms, if at all; the risk that our
third-party CMO will not 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
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