New positive data appears to support drug naming expansion :: InvestMacro

Checkpoint Therapeutics Inc. , the biopharmaceutical company behind this monoclonal antibody in late-stage metastatic cutaneous squamous cell carcinoma, could use the results of the new trial to gain approval in the locally advanced presentation of this cancer, the Ladenburg Thalmann report notes.

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

“We were impressed by the strong preliminary results and believe there is potential for their inclusion in the biology license application for planned metastatic squamous cell carcinoma of the skin, potentially serving as the basis for expanding the nomenclature to include locally advanced cutaneous squamous cell carcinoma,” Kaplan wrote.

Kaplan noted that the target price for Ladenburg Thalmann on purchased Checkpoint Therapeutics is $26 per share, which, when compared to the current share price of $1.07, means a significant return for investors.

The Massachusetts-based Biopharma is on track to file a biology license application, later this year, from the U.S. Food and Drug Administration (FDA) for cocipilimab in another form of cutaneous, metastatic squamous cell carcinoma.

Checkpoint presented positive data in this indicator at the recent American Society of Clinical Oncology 2022 conference. Of the 78 patients in the pivotal trial with metastatic cutaneous squamous cell carcinoma, 47.4% achieved the primary objective response rate endpoint; The 95% confidence interval range is 36-59.1. In terms of safety, most of the treatment-related adverse events were Class I or II; Less than 10% were third graders.

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“The pivotal efficacy data reinforce our view that cosibelimab has the best possible efficacy and safety profile in cutaneous squamous cell carcinoma,” Kaplan wrote. “We see strong potential for cosibelimab to capture a significant market share in [this] A market of over a billion dollars.

In locally advanced cutaneous squamous cell carcinoma, recently released interim cosibelimab data from Checkpoint show an objective response rate of 54.8% among the first 31 of the 80 planned patients. These results “significantly exceeded the lower limit of the 95% confidence interval of 25%, which is considered clinically meaningful by the Food and Drug Administration,” Kaplan explained.

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

“this is [cosibelimab] The results bode well for the success of cosibelimab results from the complete locally advanced cutaneous squamous cell carcinoma study results,” Kaplan commented.


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

Analyst Testimony: I, Matthew L. Kaplan, certify that the opinions expressed in this research report accurately reflect my personal views on the safety of the subject and source. Further, no part of my salary has been or will be directly or indirectly related to the specific recommendation or opinions expressed in this research report, provided, however, that: The research analyst primarily responsible for preparing this research report has or will receive Compensation based on various factors, including the company’s trading volume in the security subject of the security, as well as the company’s total revenue, part of which is generated through investment banking activities.

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