New Positive Data Seem to Support Drug Label Expansion

Checkpoint Therapeutics Inc., the biopharma behind this late-stage monoclonal antibody for metastatic cutaneous squamous cell carcinoma, could use the new trial results to seek approval in the locally advanced presentation of this cancer, too, noted a Ladenburg Thalmann report.

Checkpoint Therapeutics Inc. (CKPT:NASDAQ) reported positive interim data from its pivotal trial of cosibelimab, an anti-PD-L1 antibody, in locally advanced cutaneous squamous cell carcinoma, reported Ladenburg Thalmann analyst Matthew Kaplan in a June 17 research note.

“We are impressed with the initial robust results and believe there is a possibility they could be included in the planned metastatic cutaneous squamous cell carcinoma biologics license application filing and potentially serve as the basis for label expansion to include locally advanced cutaneous squamous cell carcinoma,” Kaplan wrote.

Kaplan noted Ladenburg Thalmann’s target price on Buy-rated Checkpoint Therapeutics is $26 per share, which, when compared to its current $1.07 share price, implies significant return potential for investors.

The Massachusetts-headquartered biopharma is on track to file, later this year, the biologics license application with the U.S. Food and Drug Administration (FDA) for cosibelimab in another form of cutaneous squamous cell carcinoma, metastatic.

Checkpoint presented positive data in this indication at the recent American Society of Clinical Oncology 2022 conference. Of the pivotal trial’s 78 patients with metastatic cutaneous squamous cell carcinoma, 47.4% achieved the primary endpoint of objective response rate; the 95% confidence interval range is 36–59.1. In terms of safety, most treatment-related adverse events were grade 1 or 2; less than 10% were grade 3.

“Pivotal efficacy data reinforce our view cosibelimab has a potential best-in-class efficacy and safety profile in cutaneous squamous cell carcinoma,” Kaplan wrote. “We see strong potential for cosibelimab to grab significant market share in [this] $1 billion-plus market.”

In locally advanced cutaneous squamous cell carcinoma, Checkpoint’s just-released interim cosibelimab data demonstrate a 54.8% objective response rate among the first 31 patients of a planned 80. Kaplan explained these results “significantly exceeded the lower bound of the 95% confidence interval of 25%, which is deemed clinically meaningful by the FDA.”

Further, according to Kaplan, the finding compares well to that of Libtayo’s PD-1 antibody, cemiplimab, in the same indication. The objective response rate with cemiplimab in 78 patients was 44%; the 95% confidence interval range is 32–55.

“These initial [cosibelimab] results bode well for the success of the cosibelimab full locally advanced cutaneous squamous cell carcinoma study results,” Kaplan commented.

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Disclosures for Ladenburg Thalmann & Co., Checkpoint Therapeutics, Inc., June 17, 2022

Analyst Certification: I, Matthew L. Kaplan, attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report, provided, however, that: The research analyst primarily responsible for the preparation of this research report has or will receive compensation based upon various factors, including the volume of trading at the firm in the subject security, as well as the firm’s total revenues, a portion of which is generated by investment banking activities.

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