Checkmate Pharmaceuticals Announces Initiation of Patient Dosing in Potential Registration Trial of Vidutolimod (CMP-001) in Patients with Anti-PD-1 Refractory Advanced Melanoma
Checkmate Pharmaceuticals (NASDAQ: CMPI) announced the initiation of patient dosing in a Phase 2 trial for vidutolimod (CMP-001) combined with nivolumab, targeting anti-PD-1 refractory advanced melanoma. This trial aims to evaluate the safety and efficacy of this combination therapy. Melanoma is among the most diagnosed cancers in the U.S., with significant unmet needs for patients who have progressed post anti-PD-1 therapy. The trial's data could support a biologics license application for the treatment.
- Initiation of Phase 2 trial for vidutolimod in combination with nivolumab, important for melanoma treatment.
- Melanoma presents a significant unmet medical need, potentially increasing the demand for vidutolimod.
- Dependence on trial results for product commercialization creates uncertainty regarding the timeline for market entry.
CAMBRIDGE, Mass., May 04, 2021 (GLOBE NEWSWIRE) -- Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) (“Checkmate”), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, today announced that patient dosing was initiated in a Phase 2 trial intended to assess the efficacy and safety of vidutolimod (CMP-001) in combination with nivolumab for the treatment of patients with anti-PD-1 refractory advanced melanoma. Vidutolimod is an advanced generation Toll-like receptor 9 (TLR9) agonist, delivered as a biologic virus-like particle utilizing a CpG-A oligodeoxynucleotide as a key component. Checkmate previously announced initiation of dosing in patients in an additional trial which is evaluating the efficacy and safety of vidutolimod in combination with nivolumab compared to nivolumab monotherapy in patients with first-line metastatic or unresectable melanoma. The data from these two trials are intended to support a biologics license application for the treatment of patients with anti-PD-1 refractory advanced melanoma.
“Initiation of dosing in this pivotal trial is an important milestone as we move towards potential registration of vidutolimod in melanoma,” said Barry Labinger, President and Chief Executive Officer of Checkmate. “Melanoma is estimated to be the fifth most diagnosed cancer in the United States, with more than 100,000 new cases and 7,000 deaths per year. There is a significant unmet medical need for patients who have progressed following treatment with anti-PD-1 therapy since there is no well-established standard of care.”
Checkmate previously announced initiation of patient dosing in a Phase 2 trial of vidutolimod in combination with pembrolizumab to evaluate safety and efficacy in patients with first-line head and neck cancer.
Additional information about the Phase 2 anti-PD-1 refractory melanoma trial and the Phase 2/3 melanoma study, including participating investigative sites, can be found here: https://checkmatepharma.com/pipeline/clinical-trials/melanoma/.
Information about Checkmate’s HNSCC trial can be found here: https://checkmatepharma.com/pipeline/clinical-trials/head-and-neck-squamous-cell-carcinoma/.
About Checkmate Pharmaceuticals
Checkmate Pharmaceuticals is a clinical stage biotechnology company focused on developing its proprietary technology to harness the power of the immune system to combat cancer. Checkmate Pharmaceuticals’ product candidate, vidutolimod (CMP-001), is an advanced generation Toll-like receptor 9 (TLR9) agonist, delivered as a biologic virus-like particle utilizing a CpG-A oligodeoxynucleotide as a key component, designed to trigger the body’s innate immune system to attack tumors in combination with other therapies. Information regarding Checkmate Pharmaceuticals is available at www.checkmatepharma.com.
Availability of Other Information About Checkmate Pharmaceuticals
Investors and others should note that we communicate with our investors and the public using our website (www.checkmatepharma.com), our investor relations website (ir.checkmatepharma.com), and on social media (Twitter and LinkedIn), including but not limited to: investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Checkmate Pharmaceuticals posts on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Forward Looking Statements
Various statements in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. These statements include those regarding our product candidate, including its development and therapeutic potential and the advancement of our clinical and preclinical pipeline; expectations regarding the results and analysis of data; and expectations regarding the timing, initiation, implementation and success of its planned and ongoing clinical trials for vidutolimod (CMP-001), and the benefits and related implications of current and future partnerships and/or collaborations. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. These forward-looking statements are subject to risks and uncertainties, including those related to the development of our product candidate, including any delays in our ongoing or planned preclinical or clinical trials, the results from clinical trials, including the fact that positive results from a trial may not necessarily be predictive of the results of future or ongoing clinical trials, the impact of the ongoing COVID-19 pandemic on our business, operations, clinical supply and plans, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, and obtaining, maintaining and protecting our intellectual property. These and additional risks are discussed in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ending December 31, 2020, as filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act 1933, as amended, which is available on the Securities and Exchange Commission’s website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in Checkmate’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Checkmate undertakes no duty to update this information unless required by law.
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