Checkpoint Therapeutics Announces Cosibelimab Longer-Term Results Demonstrating Substantial Increases in Complete Response Rates in Advanced Cutaneous Squamous Cell Carcinoma

55% objective response rate; 23% complete response rate in locally advanced cSCC

50% objective response rate; 13% complete response rate in metastatic cSCC

Cosibelimab continues to demonstrate a favorable safety profile

Biologics License Application currently under review by U.S. FDA; PDUFA goal date of January 3, 2024

Excerpt from the Press Release:

WALTHAM, Mass., July 27, 2023 (GLOBE NEWSWIRE) — Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced new, longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cutaneous squamous cell carcinoma (“cSCC”). These results demonstrate a deepening of response over time, resulting in substantially higher complete response rates than previously reported. Furthermore, responses continue to remain durable over time with the median duration of response not yet reached in either group. Results determined by independent central review by treatment group were as follows:

Parametera	Locally Advanced cSCC (n=31)				Metastatic cSCC (n=78)
Data cutoff	Mar 2022		Jan 2023		Nov 2021		Jan 2023
Objective response rate (95% confidence interval)	55% (36%, 73%)		55% (36%, 73%)		47% (36%, 59%)		50% (39%, 62%)
Complete response rate	10	%	23	%	8	%	13	%
Partial response rate	45	%	32	%	39	%	37	%
Response ongoing	82	%	82	%	73	%	69	%
Median duration of response	Not reached		Not reached		Not reached		Not reached

^a As assessed by independent central review.

“We are excited to see the substantial increases in the rate of patients experiencing a complete response of their cSCC tumors with further cosibelimab treatment in both our locally advanced and metastatic pivotal trials,” said James Oliviero, President and Chief Executive Officer of Checkpoint. “We believe cosibelimab’s strong efficacy and response durability are driven by its unique two-fold mechanism of action in which cosibelimab binds to PD-L1 with sustained high target tumor occupancy to reactivate the body’s T-cell anti-tumor response, with the addition of a functional Fc domain to activate the body’s natural killer immune cells to induce antibody-dependent cell-mediated cytotoxicity of tumor cells, resulting in a powerful one-two punch to eradicate tumors. We expect this dual mechanism of action to benefit not just immunocompetent patients, but also the large number of difficult-to-treat patients with immunosuppressive conditions or taking immunosuppressive medications who continue to suffer poor outcomes with currently available treatments.”

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