On May 10, 2022 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reportd that it is hosting an R&D Symposium today in New York City (Press release, Corvus Pharmaceuticals, MAY 10, 2022, View Source [SID1234614101]). 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) .
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"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