Checkmate Pharmaceuticals Presents New Clinical Trial Translational Data with Vidutolimod at the 2021 American Association for Cancer (AACR) Annual Meeting

Rhea-AI Summary

Checkmate Pharmaceuticals (CMPI) announced promising results from its Phase 1b trial of vidutolimod in combination with pembrolizumab for advanced melanoma patients resistant to anti-PD-1 therapy. At the AACR Virtual Clinical Trials session, new translational data showed that a significant 93% of participants had progressive disease previously. Despite high baseline disease severity, the combination treatment demonstrated consistent response rates across various patient characteristics. Notably, clinical responses were linked to serum CXCL10 induction rather than traditional predictive markers.

Positive

• 93% of patients had progressive disease on prior PD-1 blockade, indicating severe baseline status but showing robust treatment necessity.
• Response rates to vidutolimod in combination with pembrolizumab were consistent regardless of patient characteristics, suggesting broad applicability.
• Clinical activity correlated with serum CXCL10 induction and inflammatory gene expression, indicating potential for improved treatment strategies.

Negative

• None.

CAMBRIDGE, Mass., April 11, 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 the presentation of new translational data from Checkmate’s Phase 1b trial of vidutolimod (CMP-001) in combination with pembrolizumab in patients with advanced anti-PD-1 refractory melanoma.

Vidutolimod (CMP-001) demonstrates improved response in noninflamed anti–PD-1 refractory melanoma and response is associated with serum CXCL10 (Abstract #: 5231: NCT02680184)

During the 2021 AACR Virtual Clinical Trials with Novel Immuno-oncology Strategies Session on April 11 from 4:00 – 5:45pm ET, Jason Luke, MD, Director, Cancer Immunotherapeutics Center, UPMC Hillman Cancer Center, and Associate Professor of Medicine, University of Pittsburgh School of Medicine, presents new translational data from an ongoing Phase 1b study of vidutolimod in combination with pembrolizumab in patients with PD-1 blockade refractory advanced melanoma.

Key highlights from these clinical data include:

• 93% of patients had progressive disease as their last response assessment on prior PD-1 blockade therapy, 42% had an elevated LDH, and the median sum of the target lesions longest diameter was 6.7 cm, indicating advanced disease
• Response rates to vidutolimod in combination with pembrolizumab were similar across baseline patient characteristics including BRAF mutation, LDH level, number of prior systemic cancer treatments, best response to prior PD-1 blockade therapy, and prior ipilimumab
• Responders and non-responders were not distinguished by baseline tumor characteristics including PD-L1 CPS, IFNg transcriptional signature, CD8+ T cells, or nonsynonymous mutations
• All patients showed the expected rapid induction of anti-Qb antibodies to the virus-like particle (VLP), which facilitate the pharmacodynamic response to vidutolimod, and the antibody titers were not associated with clinical response
• Clinical activity of vidutolimod in combination with pembrolizumab was associated with serum CXCL10 induction magnitude, induction of an inflammatory gene expression profile, and CD8+ T cells in injected and noninjected tumors
  

“These translational data provide new insights into the rapid pharmacodynamic responses to vidutolimod and support the conclusion that clinical responses to treatment are not associated with the previously-described predictive markers for response to PD-1 blockade such as inflamed tumors,” said Dr. Jason Luke.

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 TLR9 agonist delivered as a biologic virus-like particle 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 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 Yearly Report on Form 10-K for the full year ended December 31, 2020 dated March 29, 2021, 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 the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.

FAQ

What were the results of the CMPI Phase 1b trial for vidutolimod?

The trial showed that 93% of patients had progressive disease on prior treatment, yet the combination with pembrolizumab exhibited consistent response rates across various baseline characteristics.

What is the significance of CXCL10 in the CMPI trial?

CXCL10 levels were associated with clinical activity in the trial, indicating that results may depend on serum induction rather than traditional predictive markers.

When was the new data for CMPI presented?

The new translational data was presented on April 11, 2021, during the AACR Virtual Clinical Trials Session.

What is the focus of Checkmate Pharmaceuticals?

Checkmate Pharmaceuticals focuses on developing therapies that leverage the immune system to combat cancer, specifically through its product candidate vidutolimod.