 The following article is sponsored by the clinical communications unit of investor relations firm Redington, Inc. The information contained in this article in no way represents investment advice or opinion on the part of Benzinga or its writers and is intended for informational purposes only.Since its establishment in 2014 by founding company Fortress Biotech, Inc. NASDAQ: FBIO, biopharmaceutical company Checkpoint Therapeutics NASDAQ: CKPT has focused its research on the development of clinical-stage immunotherapies and targeted therapies for a variety of solid tumor indications, including skin and lung cancer. In September of last year, Checkpoint announced that its research efforts have yielded promising results for its lead PD-L1 checkpoint inhibitor, cosibelimab, which is actively enrolling a pivotal clinical trial for the treatment of cutaneous squamous cell carcinoma cSCC, the second most common form of skin cancer. Preliminary clinical results for cosibelimab have shown similar efficacy rates to Libtayo, the only FDA-approved treatment for metastatic or locally advanced cSCC. This could open up a path to what analysts expect to be a 1 to 2 billion annual cSCC treatment market as well as an initial entry point to penetrating the rapidly growing 25 billion annual market for this class of checkpoint inhibitors across all cancer types.President and CEO of Checkpoint Therapeutics James Oliviero sees this strategy of innovative treatment alternatives as the companys core strength.Checkpoint is a simple story of developing novel, differentiated products with validated targets in enormous multi-billion dollar markets, said Oliviero in a recent interview. Introducing a differentiated product at a lower, market disrupting price point can generate hundreds of millions in annual sales while providing patients worldwide with better access to a potential life-saving class of therapy.A Targeted AimAccording to Oliviero, Checkpoints near-term outlook on cosibelimab is directed squarely on disrupting the market exclusivity enjoyed by Libtayo, developed by Regeneron Pharmaceuticals NASDAQ: REGN in the U.S. and Sanofi NASDAQ: SNY internationally. In addition to entering the cSCC treatment market as a potentially lower-priced alternative to Libtayo, Oliviero points to early clinical evidence for cosibelimab as a potentially more tolerable treatment option for cSCC patients, which he attributes to the way in which the drug specifically targets malignant cells as opposed to targeting the patients own immuno-receptors.Libtayo is an anti-PD-1 antibody, which means it targets PD-1 on the T-cells of the bodys immune system, he said. As per recent publications in oncology-focused medical journals, targeting the T-cells with an anti-PD-1 leads to higher rates of moderate to severe immune-related side effects as compared to an anti-PD-L1 antibody such as cosibelimab that targets PD-L1 on tumor cells. Checkpoint has observed lower rates of moderate and severe side effects to date in its ongoing study as compared to Libtayo. Libtayo, approved by the FDA for use in September 2018, generated 75M in quarterly revenue in the fourth quarter of 2019 equating to 300M in annualized revenue for Regeneron and Sanofi. Given this performance, analysts expect the market in cSCC alone could exceed 1 billion.According to Oliviero, interim trial data presented last year at the European Society for Medical Oncology Congress showed that the first 14 patients with cSCC treated with cosibelimab obtained a 50 objective response rate indicating tumor shrinkage of 30 or more. These preliminary results compare well to the 47 objective response rate that led to Libtayos marketing approval in cSCC. Oliviero also indicated encouraging response rate data were also presented in 25 patients with non-small cell lung cancer. Cosibelimab Clinical Program Investor Presentation Checkpoint Therapeutics, April 2020Should these results remain consistent at the conclusion of the ongoing pivotal cSCC trial, Oliviero voiced optimism that the drug could soon be submitted under a Biologics License Application BLA to the U.S. Food and Drug Administration -- and similar international regulatory agencies --for marketing as the worlds second cSCC treatment. Checkpoints next interim cSCC data update is planned for the second half of 2020, with full top-line results expected in 2021.Expansion OpportunitiesAccording to Oliviero, current sales of the entire class of approved anti-PD-1 and anti-PD-L1 checkpoint inhibitors are roughly 25 billion annually. Lung cancer makes up the largest proportion of the sales of this class.Although Checkpoint has focused on cSCC as its first indication for cosibelimab, Oliviero expressed a long-term intention to submit the treatment for potential use in other oncological manifestations, particularly lung cancer.Beyond CSCC, Checkpoint plans to initiate registration pivotal studies in non-small cell lung cancer to expand into this 10-plus billion market, said Oliviero.Existing approved PD-1 inhibitor treatments for lung cancer currently include Keytruda, from Merck Co., Inc. NYSE: MRK, and Opdivo, produced by Bristol-Myers Squibb Company NYSE: BMY. However, just this April, Regeneron and Sanofi released promising clinical data in lowering mortality rates among lung cancer patients with tumors exhibiting high expression of a PD-L1 biomarker. Pending success in further trials in lung cancer, the results are encouraging for Checkpoints current ambitions for cosibelimab.Additionally, combination therapies including an anti-PD-1 or PD-L1 agent are a rapidly emerging approach to improve cancer patients outcomes, with hundreds of these studies underway, Oliviero explained. Approved combination regimens can conceivably increase the checkpoint inhibitor class to well over 60 billion annually in just a few years, and we believe cosibelimab is a great candidate for these studies given the efficacy and safety profile seen to date.Reaching For A New CheckpointWhile Checkpoint is pursuing continued trial data on cosibelimab, the company is also in an active Phase 1 study of a third-generation epidermal growth factor receptor EGFR inhibitor, CK-101, which aims to diminish cancer cell growth. Oliviero explained that Checkpoints EGFR inhibitor is intended to compete with Tagrisso, a 4 billion annual sales drug produced by AstraZeneca PLC NYSE: AZN that interestingly showed an intolerance among 13 of its trial patients, according to Oliviero.However, in the near-term, Checkpoints focus will be on continued efficacy and approval trials for cosibelimab, a strategy that Oliviero maintains should provide a more affordable checkpoint inhibitor treatment alternative throughout the healthcare sector and among patients.With near-term data catalysts from the pivotal study in cSCC planned for the second half of 2020 and 2021, we expect increased visibility of our lead programs near-term market potential, he said. While we are confident we can effectively launch and market cosibelimab ourselves, we are also aware that, upon a successful outcome in the ongoing study, cosibelimab would be viewed by large biotechnology and pharmaceutical companies as a near-term revenue opportunity, with the potential to supplement their portfolios of patent-expiring products.See more from Benzinga Royal Caribbean Cruises: Q1 Earnings Insights Recap: RBC Bearings Q4 Earnings Trump Decides Which States Get Fully Reimbursed By FEMA For Coronavirus Expenditures: WSJC 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved. 