Checkmate Pharmaceuticals’ TLR9 Clinical Programs Expand Patient Access to Immunotherapies

Expanding Patient Response to Immunotherapies

Checkmate Pharmaceuticals is investigating CMP-001 in combination with several checkpoint inhibitor immunotherapies across a broad range of solid tumors including lung cancer, melanoma, colorectal cancer, and head and neck cancer, as well as others. We believe that CMP-001 is a potent and highly selective stimulator of the immune system and may provide synergistic clinical benefits when delivered early in a patient’s course of treatment (in checkpoint inhibitor-naïve patients) or after disease progression following therapy with checkpoint inhibitor immunotherapy.

Compelling Proof of Concept for CMP-001

  • Acceptable safety profile
  • Can reverse resistance to PD-1 inhibition when used in combination with checkpoint inhibitors
  • Rapid and durable local and systemic immune responses
  • Responding tumors demonstrate induction of T cell inflamed signature
  • Gene set enrichment and pathway analysis show significant upregulation of TLR, innate immunity signaling pathways, and IFN-responsive genes

Melanoma

Melanoma is the most dangerous type of skin cancer. While it accounts for only 1% of all skin cancers, it is the most difficult to treat with a poor patient prognosis if not detected early.

Early clinical studies have shown that CMP-001, in combination with Merck’s Keytruda® (pembrolizumab), can reverse resistance to PD-1 inhibition in people with melanoma. Results from our early clinical studies in advanced melanoma show durable responses with a favorable safety profile.

Advanced refractory melanoma is our most advanced clinical program and the cornerstone of our clinical development program to date. We are currently enrolling patients into an expanded study to confirm proof of concept of CMP-001 in combination with Keytruda® in individuals whose cancer has progressed after treatment with single agent anti-PD-1 therapy. Based on our experience with CMP-001 in advanced melanoma, we are exploring its potential clinical benefit in other tumor types and other settings.

About the study in neoadjuvant melanoma

Along with our collaborators at the University of Pittsburgh, we are exploring the combination of CMP-001 + Opdivo® (nivolumab), an FDA approved checkpoint inhibitor immunotherapy, for the treatment of melanoma that has spread into lymph nodes in people who are candidates for surgery (neoadjuvant).

More information about our studies investigating CMP-001 in melanoma can be found at clinicaltrials.gov

Non-small Cell Lung Cancer (NSCLC)

Lung cancer is the second most commonly diagnosed cancer. Approximately 80-85% of lung cancers are non-small cell lung cancer (NSCLC). Because early stage lung cancer is often asymptomatic, approximately 80% of people with NSCLC are diagnosed with late stage disease. Checkpoint inhibitors, a type of immunotherapy that releases the brakes on the immune system, are used frequently as a therapeutic option for people with certain types of advanced NSCLC—both at initial diagnosis and for cancer that returns after treatment.

We are evaluating CMP-001 in combination with Tecentriq® (atezolizumab), Roche Genentech’s anti-PD-L1 immunotherapy, in individuals with advanced NSCLC whose disease has progressed after treatment with a checkpoint inhibitor. Patient enrollment in this study is ongoing.

Squamous Cell Cancer of the Head and Neck

Squamous cell carcinomas of the head and neck (SCCHN) include cancers in the throat, lips, mouth, salivary glands and nose. Head and neck cancer accounts for approximately 4% of all cancers in the U.S., and they are twice as common in men than women. The treatment for SCCHN depends on a number of factors, including the exact location of the tumor, the stage of the cancer, and the person’s age and general health. Treatment for head and neck cancer can include surgery, radiation therapy, chemotherapy, targeted therapy, or a combination of treatments including immunotherapy.

Pfizer is investigating the use of CMP-001 in combination with Bavencio ® (avelumab), an FDA approved PD-L1 immunotherapy, and other immune modulators for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the head and neck (SCCHN). Study combinations include:

  • CMP-001 + avelumab
  • CMP-001 + avelumab + utomilumab (4-1BB agonist mAb)
  • CMP-001 + avelumab + PF-04518600 (OX40 agonist mAb)

This study is currently enrolling patients.

More information can be found at clinicaltrials.gov.

Our clinical approach to enhancing patient response to therapy: earlier treatments, expanding indications

To-date, our clinical programs have demonstrated proof-of-concept and validating data to explore CMP-001 in checkpoint resistant cancers, in the advanced, refractory and treatment-naïve settings. While we and our collaborators progress our clinical programs in melanoma, lung cancer and head and neck cancer, we believe the unique mechanism of action of CMP-001 will confer clinical benefits in other solid tumors. We are expanding our programs with CMP-001 to other tumor types and earlier in a patient’s treatment journey including triple negative breast cancer and colorectal cancer.
Investigator-sponsored exploratory studies of CMP-001 early in a patient’s treatment journey:
  • CMP-001+ nivolumab/ipilimumab: colorectal cancer (Sheba Medical Center, Tel Aviv)
  • CMP-001: Neoadjuvant triple negative breast cancer (TNBC) (University of Lausanne, Switzerland)
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