New Preclinical Data Highlights Potential for CPI-818 (ITK Inhibitor) as a Therapy for Acute Graft Versus Host Disease in Patients Receiving Bone Marrow Transplantation

BURLINGAME, Calif., Dec. 13, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced new preclinical data demonstrating the potential of CPI-818, the company’s ITK inhibitor, for the prevention and therapy of acute graft versus host disease (aGVHD) in patients receiving allogeneic hematopoietic cell transplantation (bone marrow transplantation). The data will be presented today in a poster at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition.

Bone marrow transplantation is a potentially curative therapy for patients with a variety of blood disorders, including blood cancers, certain solid cancers, hemoglobinopathies such as sickle cell disease, and immune deficiencies. However, its use has been limited by the pre-conditioning required to prepare the host to receive the transplant and by post procedure complications such as aGVHD, which occurs when engrafted alloreactive T cells produce an inflammatory response in the skin, gastrointestinal tract and liver. Current therapies for aGVHD, which have limited effectiveness, include steroids, ruxolitinib and other immunosuppressive drugs.

CPI-818 is an investigational, orally bioavailable, covalent inhibitor of ITK designed to have low nanomolar affinity. In vitro studies have shown that it potently inhibited T cell receptor signal transduction.

Preclinical Data Presented at ASH
The study evaluated CPI-818 in two mouse models of aGVHD. Recipient mice were pre-conditioned by having their bone marrow ablated with high dose radiation, and then received an allogeneic bone marrow transplantation. One group of mice was treated with CPI-818 dosed at 300 mg/kg/day delivered orally throughout the study period (seven days prior to transplant and 90 days post-transplant) and one group was treated in the same manner with a placebo control. The results of the study demonstrated that mice receiving CPI-818 had:

• Statistically significant improvement in GVHD score and survival compared to the placebo group.
• Increased concentrations of anti-inflammatory cytokines.
• Increased numbers of T suppressor cells in their spleens.
  

Collectively, the data demonstrated that ITK inhibition with CPI-818 has potential as a targeted approach to prevent or treat aGVHD through the suppression of T cell activation and proliferation, reducing concentrations of pro-inflammatory cytokines and increasing the concentration of anti-inflammatory cytokines. The study authors concluded that CPI-818 was the most potent and selective ITK inhibitor reported to date and these data highlight its promise as potentially a novel agent for the prevention or treatment of aGVHD.

“Acute graft versus host disease is a significant barrier to expanding the curative potential of bone marrow transplantation,” said Marcel van den Brink, MD, PhD, lead author of the study and Head, Division of Hematologic Malignancies at Memorial Sloan Kettering Cancer Center in New York, NY. “This preclinical data suggests that ITK inhibition with CPI-818 has the potential to be a novel agent that could prevent or treat aGVHD.

Corvus is studying CPI-818 in a Phase 1/1b clinical trial that was designed to select the optimal dose of CPI-818 and evaluate its safety, pharmacokinetics, 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. Corvus’ partner in China, Angel Pharmaceuticals, plans to initiate a Phase 1/1b clinical trial of CPI-818 for the treatment of refractory T cell lymphomas in early 2022, with the potential to expand into autoimmune diseases over time. Angel Pharmaceuticals will be responsible for all expenses related to executing the trial in China.

“This study broadens the potential applications of CPI-818 to include aGVHD, which is a significant complication of bone marrow transplant,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “The data presented in these studies further strengthen the scientific rationale of T cell modulation through inhibition of ITK signaling pathways and support the mechanism and role of ITK inhibition in human diseases such as T cell lymphoma and autoimmunity.”

Details regarding the poster presentation, which will be available in the poster hall and via the virtual event platform, are as follows:

Monday, Dec. 13, 6:00 p.m. to 8:00 p.m. ET
Poster Session: Highly Selective Irreversible ITK Inhibitor CPI-818 Reduces Acute Graft-Versus Host Disease
Abstract #3814
Presenter: Sarah Lindner, MD, from Memorial Sloan Kettering Cancer Center in New York, NY

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 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 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 possess dual properties: 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 normal immune function. 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.

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, such as CPI-818’s potential as a targeted approach to prevent or treat aGVHD through the suppression of T cell activation and proliferation, reducing concentrations of pro-inflammatory cytokines and increasing the concentration of anti-inflammatory cytokines; the Company’s ability and Angel Pharmaceutical’s ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including Angel’s plans to initiate a Phase 2 clinical trial of CPI-818; and the timing of the availability and announcement of clinical data and certain other product development milestones. 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 September 30, 2021, filed with the Securities and Exchange Commission on November 1, 2021, 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; the impact of the COVID-19 pandemic on the Company’s operations and clinical development plans, as well as the operations of its partners and suppliers; 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