Shares of Checkpoint Therapeutics Inc. (CKPT), which recently touched a 52-week high of $3.83, have gained more than 90 percent so far this year and trade around $3.
Checkpoint is a clinical-stage biopharmaceutical company developing treatments for patients with solid tumor cancers. The company’s lead drug candidate is Cosibelimab, formerly referred to as CK-301, licensed from Dana-Farber Cancer Institute.
A phase I trial evaluating Cosibelimab as a single agent in patients with advanced cancers is underway. The study, which is designed to enroll 500 participants, involves various cohorts of patients with Lung Neoplasms, Non-Small-Cell Lung Carcinoma, Small Cell Carcinoma, advanced Malignant Mesothelioma, Head and Neck Cancer, Melanoma, Merkel Cell Carcinoma, Renal Cell Carcinoma, Urothelial Carcinoma, Classical Hodgkin Lymphoma, Cutaneous Squamous Cell Carcinoma, Non-Hodgkin Lymphoma, and Endometrial Cancer.
The company plans to submit a Biologics License Application for Cosibelimab as a treatment for patients with metastatic cutaneous squamous cell carcinoma (mCSCC) based on efficacy and safety data from the ongoing phase I trial. The target enrollment in the phase I cohort of patients with metastatic CSCC is about 75 to 100 patients and the primary efficacy endpoint is a confirmed objective response rate (ORR).
Interim results from the phase I trial of Cosibelimab presented at the European Society for Medical Oncology last year, demonstrated a 50% ORR by investigator assessment in the first 14 evaluable patients in the metastatic cutaneous squamous cell carcinoma cohort. One patient achieved a complete response and six patients achieved partial responses in that cohort.
Checkpoint is scheduled to present updated interim safety and efficacy data from the metastatic cutaneous squamous cell carcinoma cohort of the phase I trial of Cosibelimab at the European Society for Medical Oncology (“ESMO”) Virtual Congress this week.
Cutaneous squamous cell carcinoma is a cancer that begins in cells that form the epidermis (outer layer of the skin). It usually occurs on areas of the skin that have been exposed to natural sunlight or artificial sunlight (such as from tanning beds) over long periods of time – say, face, ears, lower lip, neck, arms, or back of the hands. Cutaneous squamous cell carcinoma may appear as a firm red bump, a scaly red patch, an open sore, or a wart that may crust or bleed easily. (Source: National Cancer Institute).
Next up in the pipeline is CK-101, an oral, third-generation, irreversible kinase inhibitor against selective EGFR mutations in non-small cell lung cancer, currently under phase I/II study. Positive phase I interim results from this study were presented at the World Lung Conference in 2018.
The company has no debt and ended June 30, 2020, with $27 million in cash, which is expected to be sufficient through at least 2021.
CKPT has traded in a range of $1.05 to $3.83 in the last 1 year. The stock closed Friday’s trading at $3.32, up 18.57%.
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