Wednesday, October 27, 2021
Corvus Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, today announced that the IND application submitted by its partner in China, Angel Pharmaceuticals Ltd. (Angel Pharma), has been approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to initiate a Phase 1/1b clinical trial of Corvus’ small molecule ITK inhibitor CPI-818 for the treatment of relapsed/refractory T-cell lymphomas (TCL) in China.
Corvus co-founded Angel Pharma to develop its pipeline in greater China and currently holds an equity stake of 49.7% in the company. Angel Pharma licensed the rights from Corvus to develop, manufacture and commercialize CPI-818 in greater China and is responsible for all expenses related to its development in China.
“Our strategy to partner with Angel Pharma to accelerate global development of our products is advancing,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “There is a higher incidence and prevalence of T-cell lymphomas in China, and a significant need for new treatment options. The Angel Pharma team has been efficiently moving the development process forward and has partnered with top lymphoma clinical experts. CPI-818 is the only clinical stage ITK-inhibitor in China, and is positioned to become a potential novel therapy for T-cell lymphoma and more broadly for autoimmune diseases, which we plan to explore over time.”
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. 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 (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. As reported in December 2020 at the American Society of Hematology (ASH), of seven patients with peripheral T cell lymphoma, there has been one complete response lasting over 15 months and one partial response lasting for over five months.
About Angel Pharmaceuticals
Angel Pharma is a privately held biopharmaceutical company developing a pipeline of precisely targeted investigational medicines for cancer, autoimmune, infectious and other serious diseases in China. Angel Pharma was launched through a collaboration with U.S.-based Corvus Pharmaceuticals and investments from investors in China. Angel Pharma licensed the rights to develop and commercialize Corvus’ three clinical-stage candidates – mupadolimab, CPI-818 and ciforadenant – in greater China and obtained global rights to Corvus’ BTK inhibitor preclinical programs. Under the collaboration, Corvus currently has a 49.7% equity stake in Angel Pharma excluding 7% of Angel’s equity reserved for issuance under the Angel ESOP, and Corvus has designated three individuals on Angel’s five-person Board of Directors. For more information, visit www.angelpharma.com.
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.
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 in patients with autoimmune diseases. Corvus is conducting a Phase 1/1b trial in patients with refractory T-cell lymphomas in the United States and Angel Pharma, which has rights to CPI-818 in China, is leading a global Phase 1/1b trial in patients with relapsed/refractory (R/R) T-cell lymphomas.
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of mupadolimab and CPI-818, the Company’s ability and Angel Pharma’s ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including Angel Pharma’s plans to initiate a clinical trial of CPI-818 and whether CPI-818 has the potential to expand into the treatment of autoimmune diseases over time. 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 June 30, 2021, filed with the Securities and Exchange Commission on or about August 2, 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; 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.
Chief Financial Officer
Corvus Pharmaceuticals, Inc.