Highlights new interim data from CPI-818 Phase 1/1b study in patients with relapsed T cell lymphomas

Program covers scientific rationale, preclinical and clinical data for its three programs – mupadolimab (anti-CD73), ciforadenant (adenosine 2A receptor antagonist) and CPI-818 (ITK inhibitor)

Company to webcast its R&D Symposium today at 9:00 am ET / 6:00 am PT

BURLINGAME, Calif., May 10, 2022 (GLOBE NEWSWIRE) --  Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, is hosting an R&D Symposium today in New York City. During the event, which will also be available via webcast, the Company plans to provide updates on its three clinical programs: mupadolimab (anti-CD73), ciforadenant (adenosine 2A receptor antagonist) and CPI-818 (ITK inhibitor).

“Current therapies for T cell lymphoma have limited efficacy, highlighting the need for new approaches that rely on novel mechanisms of action,” said Neel K. Gupta, M.D., Clinical Assistant Professor of Medicine at Stanford University School of Medicine – Division of Oncology. “The monotherapy activity and responses in advanced refractory T cell lymphoma seen with the ITK inhibitor CPI-818 so far is impressive. Its novel mechanism of action and safety provide many opportunities for single agent and combination with other therapies both in front line and relapsed disease settings, giving CPI-818 the potential to be an important new therapeutic option for T cell lymphoma patients.”

New CPI-818 Phase 1/1b Data
The R&D Symposium will include a review of patient case studies from the ongoing Phase 1/1b clinical trial of CPI-818 in patients with relapsed T cell lymphomas, including peripheral T cell lymphoma (PTCL), cutaneous T cell lymphoma (CTCL), angioimmunoblastic T cell lymphoma (AITL) and others. In this trial, which was designed to select the optimal dose of CPI-818, doses of 100, 200, 400 and 600 mg taken twice a day were given to successive cohorts of patients. The 200 mg dose was identified as the optimal dose, and at this dose, four of five patients are responding to therapy as follows (with an April 30, 2022 cut-off date):

• PTCL patient achieved a complete response lasting 12 months on CPI-818 treatment with complete remission duration extending an additional 7 months with no further therapy (total complete remission duration of 19 months)
• PTCL patient achieved a partial response with treatment ongoing
• AITL patient that is responding on treatment
• CTCL patient achieved nodal complete response with treatment lasting 21 months
• In addition, a PTCL patient receiving the 600 mg dose achieved a partial response that lasted for several months; the patient went on to receive a bone marrow transplant
• Lab studies on the blood and tumors of responding patients showed:
  • Evidence for Th1 skewing
  • Evidence for increase in T effector cells in blood and tumor
  • Evidence for increase activation of T cells in tumor and blood
  • Evidence that CPI-818 does not directly kill the cancer cells; rather the effects appear to be mediated by the patient’s immune response against the tumor
  • Identification of a dose level that drives Th1 cell differentiation without compromising T effector cell function
    

CPI-818 is a novel compound that Corvus founders invented and developed based on their prior experience and success with the first BTK inhibitor, ibrutinib.

“We have learned a tremendous amount about ITK, T cell biology and potential indications for this therapy from the development of CPI-818,” said Richard A. Miller, M.D., Chief Executive Officer & President of Corvus Pharmaceuticals. “The new interim data from our Phase 1/1b study are consistent with our pre-clinical results, and the research of others, which reveal the role of ITK in T cell function, and the exquisite regulation of T cell differentiation by ITK. Based on this, we believe CPI-818 could be used to enhance anti-tumor immunity in T cell lymphoma and solid tumors by stimulating anti-tumor T cells to attack the cancer cells. The mechanism, and preclinical data, also support its role in immune mediated diseases such as allergy and autoimmunity.”

“We are expanding our CPI-818 Phase 1/1b study with a focus on the 200 mg BID dose in PTCL. Angel Pharmaceuticals, our Chinese partner, is also enrolling patients, which we anticipate will help accelerate overall development timelines. Our goal is to share additional data from both studies later this year, and if current trends continue, we anticipate initiating a global Phase 2 clinical trial. We will also be evaluating CPI-818’s potential in front line combination therapy with chemotherapy and preparing for clinical studies in autoimmune diseases,” added Dr. Miller.

Corvus R&D Pipeline Approach 
The R&D Symposium program will cover the scientific rationale, preclinical and clinical data for the Company’s three programs, along with the overarching scientific and clinical strategies driving the Company’s development activities. Key elements of the overarching strategy include:

• Corvus’ precision immunotherapy approach focuses on controlling multiple steps in the “tumor-immunity axis,” which is comprised of the tumor, lymph nodes (LN) and blood stream. The Company’s product candidates are designed to modulate tumor immunity, target precise molecular structures and have broad clinical applications. Specifically, mupadolimab, ciforadenant, and CPI-818 all interact with distinct and connected components of the tumor-immunity axis to enhance immunity to cancers:
  • Mupadolimab is designed to induce the activation of B cells involved in antibody production, and antigen presentation in the tumor, blood and in LN
  • Ciforadenant is designed to block adenosine-induced immunosuppression in tumors and in LN
  • CPI-818 is designed to induce the activation and expansion of T cell subsets involved in killing cancer cells in tumor, in LN and in blood through the skewing of T cell differentiation to a Th1 helper T cell phenotype. The formation of Th1 cells leads to production of T cells that are capable of killing cancer cells and viral infected cells
• Corvus’ clinical development strategy aims to increase clinical development success by first establishing monotherapy activity, followed by potential combinations with other immuno-oncology and standard of care therapies
  

R&D Symposium Details
The R&D symposium will be webcast live from Corvus’s website at www.corvuspharma.com and a replay will be available for 90 days following the event. A copy of the presentation slides will also be available on Corvus’ website after the conclusion of the event. It will be hosted by Corvus President and CEO Richard A. Miller, M.D., and include speakers from Corvus as well as leading researchers:

• Neel K. Gupta, M.D., Clinical Assistant Professor of Medicine at Stanford University School of Medicine – Division of Oncology
• Suresh Mahabhashyam, M.D., Vice President of Clinical Development at Corvus Pharmaceuticals
• Erik Verner, Ph.D., Senior Vice President of Research at Angel Pharmaceuticals
  

About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus’ lead product candidate is mupadolimab (CPI-006), a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical and clinical studies. The Company’s second clinical program, CPI-818, is an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies and is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. Its third clinical program, ciforadenant (CPI-444), is an oral, small molecule inhibitor of the A2A receptor. For more information, visit www.corvuspharma.com.

About Mupadolimab
Mupadolimab (CPI-006) is an investigational, potent humanized monoclonal antibody that is designed to react with a specific site on CD73. In preclinical studies, it has demonstrated immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking. While there are other anti-CD73 antibodies and small molecules in development for treatment of cancer, such agents react with a different region of CD73. Mupadolimab is designed to react with a region of the molecule that acts to stimulate B cells and block production of immunosuppressive adenosine. Mupadolimab is being studied in combination with pembrolizumab in a Phase 1b/2 clinical trial in patients with advanced head and neck cancers and in patients with NSCLC that have failed chemotherapy and anti-PD(L)1 therapy. It is postulated that the activation of B cells will enhance immunity within the tumors of these patients, leading to improved clinical outcomes.

About CPI-818
CPI-818 is an investigational small molecule drug given orally that has selectively inhibited ITK (interleukin-2-inducible T-cell kinase) in preclinical studies. It was designed to block malignant T-cell growth and to modulate immune responses. ITK, an enzyme, is expressed predominantly in T-cells and plays a role in T-cell and natural killer (NK) cell lymphomas and leukemias, as well as in T cell differentiation, T cell receptor signaling and other normal immune functions. Interference with ITK signaling can modulate immune responses to various antigens. The Company believes the inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell lymphomas and leukemias and in patients with autoimmune diseases. The Company is conducting a Phase 1/1b trial in patients with refractory T-cell lymphomas that was designed to select the optimal dose of CPI-818 and evaluate its safety, PK, target occupancy, biomarkers and efficacy. Interim data from the Phase 1/1b clinical trial of CPI-818 for T cell lymphoma demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies.

About Ciforadenant
Ciforadenant (CPI-444) is an investigational small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity.

Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of mupadolimab, CPI-818 and ciforadenant; the Company’s ability and Angel Pharmaceutical’s ability, as well as the timing thereof, to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company’s and Angel’s potential global Phase 2 clinical trial in advanced PTCL; and the timing of the availability and announcement of clinical data and certain other product development milestones, including the timing of results in the Phase 1b/2 clinical trial for CPI-818. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, filed with the Securities and Exchange Commission on May 5, 2022, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of mupadolimab, CPI-818 and ciforadenant; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials; the results of preclinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

INVESTOR CONTACT:
Leiv Lea
Chief Financial Officer
Corvus Pharmaceuticals, Inc.
+1-650-900-4522
llea@corvuspharma.com

MEDIA CONTACT:
Sheryl Seapy
Real Chemistry
+1-949-903-4750
sseapy@realchemistry.com

Source: Corvus Pharmaceuticals, Inc.