WALTHAM, Mass. - Checkpoint Therapeutics , Inc. (NASDAQ:CKPT), a clinical-stage company specializing in immunotherapy and targeted oncology, announced today the completion of its resubmission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for cosibelimab.
This drug is an anti-programmed death ligand-1 (PD-L1) antibody intended for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who cannot undergo curative surgery or radiation.
The resubmission follows a Complete Response Letter (CRL) from the FDA last December, which did not raise concerns about the clinical data, safety, or labeling of cosibelimab, but instead cited issues from a third-party manufacturing inspection. Checkpoint reports that their resubmission strategy agreed upon with the FDA, addresses all approvability deficiencies noted in the CRL.
Cosibelimab has been evaluated in studies for recurrent or metastatic cancers, with pivotal results for metastatic and locally advanced cSCC demonstrating an objective response rate of 55% and a complete response rate of 26% in locally advanced cSCC, and 50% and 13% respectively in metastatic cSCC. These findings were supported by longer-term data from July 2023 showing an increase in complete response rates over time.
The antibody is described as potentially differentiated from other marketed PD-1 and PD-L1 antibodies due to its high affinity and sustained tumor occupancy, which may reactivate the immune response against tumors. Additionally, cosibelimab's functional Fc domain may induce antibody-dependent cell-mediated cytotoxicity (ADCC), potentially enhancing its efficacy.
Checkpoint Therapeutics, founded by Fortress Biotech, Inc. (NASDAQ:FBIO), focuses on developing novel treatments for solid tumor cancers. Beyond cosibelimab, Checkpoint is also working on olafertinib, a targeted anti-cancer agent for non-small cell lung cancer.
This announcement is based on a press release statement.
InvestingPro Insights
Checkpoint Therapeutics, Inc. (NASDAQ:CKPT) has made a notable stride with the resubmission of the BLA for cosibelimab. As investors consider the potential impact of this development on the company's financial health and stock performance, certain real-time data from InvestingPro can provide deeper insights.
InvestingPro Data highlights a market capitalization of $75.54 million for CKPT, indicating the size of the company in the competitive biotech landscape. Notably, the company's revenue for the last twelve months as of Q1 2024 stands at $0.07 million, with a significant decline in revenue growth of -61.14% during the same period. This decline could be a point of concern for investors looking for growth in the biotech sector. Additionally, the company's gross profit margin is reported at an unusually high negative percentage of -53189.71%, reflecting substantial costs relative to its revenue.
In terms of valuation, CKPT is trading at a high revenue valuation multiple, which is an InvestingPro Tip that suggests the stock may be priced optimistically relative to its current financial performance. This could be particularly relevant for investors evaluating the potential upside of the stock in light of the recent regulatory submission.
Another InvestingPro Tip worth noting is that CKPT holds more cash than debt on its balance sheet, providing some financial stability as it navigates the regulatory review process for cosibelimab. However, it's important for investors to consider that the company is not profitable over the last twelve months and does not pay a dividend to shareholders, which may influence investment decisions depending on individual risk tolerance and investment goals.
For investors seeking further analysis and additional InvestingPro Tips, there are 6 more tips available for CKPT at https://www.investing.com/pro/CKPT. To access these insights, use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, providing a valuable resource for those looking to make informed investment decisions in the biotech sector.
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