NEW YORK, Nov. 08, 2019 -- Checkpoint Therapeutics, Inc. (Checkpoint) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that new.
Checkpoint Therapeutics, Inc. (“Checkpoint”) (CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that feedback from the U.S. Food and Drug Administration (“FDA”) has confirmed the company’s plan to submit cosibelimab for full approval as a treatment for patients with metastatic cutaneous squamous cell carcinoma (“CSCC”) based on efficacy and safety data from the ongoing open-label, multicenter, Phase 1 clinical trial, Study CK-301-101 (NCT03212404). This registration-enabling clinical trial is currently enrolling a cohort of patients with metastatic CSCC, with a target enrollment of approximately 75 to 100 patients and a primary efficacy endpoint of confirmed objective response rate (“ORR”) assessed by independent central review.
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NEW YORK, April 27, 2020 -- Fields Kupka & Shukurov LLP is investigating potential breach of fiduciary duty claims involving the board of directors of Checkpoint.
50% objective response rate observed in cutaneous squamous cell carcinoma (CSCC)40% objective response rate observed in non-small cell lung cancerWell-tolerated safety profile.
A week ago, Checkpoint Therapeutics, Inc. (NASDAQ:CKPT) came out with a strong set of quarterly numbers that could...
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There's been a major selloff in Checkpoint Therapeutics, Inc. (NASDAQ:CKPT) shares in the week since it released its...
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 company's 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, Checkpoint's 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 patient's own immuno-receptors."Libtayo is an anti-PD-1 antibody, which means it targets PD-1 on the T-cells of the body's 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 Libtayo's 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 world's second cSCC treatment. Checkpoint's 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 Checkpoint's 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 Checkpoint's 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, Checkpoint's 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 program's 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: WSJ(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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NEW YORK, May 06, 2020 -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company focused on the acquisition,.
Checkpoint Therapeutics, Inc. (“Checkpoint”) (CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that it will host the Company’s 2020 Annual Meeting of Stockholders (the “Annual Meeting”) virtually due to public health concerns resulting from the coronavirus (“COVID-19”) outbreak, and government-recommended and required limits on public gatherings. Holding the meeting online will also protect the health and safety of the Company’s stockholders, directors and employees. The Annual Meeting of Stockholders will begin at 10:00 a.m. Eastern Time on Thursday, June 4, 2020, and will be conducted in a virtual format only.
James Oliviero has been the CEO of Checkpoint Therapeutics, Inc. (NASDAQ:CKPT) since 2015. This report will, first...
NEW YORK, March 11, 2020 -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition,.
Checkpoint Therapeutics, Inc. (“Checkpoint”) (CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that it is proposing to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering. Checkpoint expects to grant the underwriters a 45‐day option to purchase up to an additional 15 percent of the shares of common stock offered in the public offering. All of the shares of common stock are being offered by Checkpoint.
- U.S. patent protection through at least May 2038- Registration-enabling study of cosibelimab in cutaneous squamous cell carcinoma over one-third enrolled NEW YORK, April 21,.
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NEW YORK, Nov. 07, 2019 -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), a clinical-stage, immunotherapy and targeted oncology company, today announced financial.
Checkpoint Therapeutics, Inc. (“Checkpoint”) (CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the pricing of its previously announced underwritten public offering. Checkpoint is offering 13,400,000 shares of its common stock, par value $0.0001 per share, at a price to the public of $1.27 per share. In connection with the offering, Checkpoint has also granted the underwriters a 45-day option to purchase up to an additional 2,010,000 shares of common stock offered in the public offering, at the same public offering price per share, less underwriting discounts and commissions.