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Corvus Pharmaceuticals Announces Partner Angel Pharmaceuticals Received IND Approval for Phase 1/1b Clinical Trial of Mupadolimab (Anti-CD73) in China

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Corvus Pharmaceuticals announced the approval of an IND application to initiate a Phase 1/1b clinical trial for mupadolimab in China, in partnership with Angel Pharmaceuticals. Mupadolimab targets CD73 to activate immune responses in patients with relapsed refractory non-small cell lung cancer (NSCLC) and head and neck squamous cell cancers (HNSCC). The trial aims to evaluate the drug’s safety, pharmacokinetics, and efficacy, with plans for a subsequent randomized Phase 2 trial in combination with pembrolizumab and chemotherapy.

Positive
  • IND application for mupadolimab approved in China.
  • Partnership with Angel Pharmaceuticals enhances market reach.
  • Trial evaluates mupadolimab's safety and efficacy, showing potential in NSCLC and HNSCC.
Negative
  • None.

Mupadolimab clinical trial in China will be conducted by Angel Pharmaceuticals

BURLINGAME, Calif., Sept. 26, 2022 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today announced that the IND application to initiate a Phase 1/1b clinical trial of mupadolimab (formerly CPI-006) has been approved by the Center for Drug Evaluation of the China National Medical Products Administration. The study will be conducted by Angel Pharmaceuticals Ltd. (Angel Pharma), Corvus’ partner in China. Mupadolimab is a humanized monoclonal antibody designed to be directed against CD73 with a proposed unique mechanism of activating B cells to generate immune responses to tumor antigens and viruses, in patients with relapsed refractory non-small cell lung cancer (NSCLC) and head and neck squamous cell cancers (HNSCC).

Corvus co-founded Angel Pharma to develop its pipeline in greater China. Angel Pharma licensed the rights from Corvus to develop, manufacture and commercialize mupadolimab in greater China.

Corvus has studied mupadolimab in a Phase 1/1b clinical trial, with a focus on expansion cohorts in patients with (1) HNSCC that have failed previous treatment with anti-PD-1 therapy and chemotherapy and (2) relapsed refractory NSCLC who have failed previous treatment with anti-PD(L)-1 therapy and chemotherapy. Based on the results to-date, Corvus believes this program is ready to advance into a randomized Phase 2 clinical trial evaluating mupadolimab in combination with pembrolizumab and chemotherapy as a potential front-line therapy for the treatment of patients with NSCLC.

“Our partnership with Angel Pharma continues to support the efficient development of our pipeline,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “In our development work, we have characterized mupadolimab’s unique potential as an anti-CD73 antibody that blocks adenosine production and activates the immune system. Angel Pharma’s development strategy is consistent and supportive of our studies, with the potential to further expand mupadolimab’s opportunity in China and globally. They are continuing the development and clinical testing in patients with NSCLC and head and neck cancer.”

Angel Pharma is examining mupadolimab in a Phase 1/1b clinical trial designed to confirm the dose and evaluate the safety, pharmacokinetics, immune biomarkers, and efficacy as a single agent, and in combination with pembrolizumab. Patients with NSCLC and HNSCC are eligible. The clinical trial’s efficacy endpoints are complete response, partial response, disease control rate, duration of response, progression-free survival, and overall survival.

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 strategic collaboration with U.S.-based Corvus Pharmaceuticals and investments from Zhejiang Puissance Capital, Hisun Pharmaceuticals, Tigermed and funds associated with Betta Pharmaceuticals. Corvus owns a 49.7% equity stake in Angel. For more information, visit www.angelpharma.com.

About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus’ lead product candidate is CPI-818, 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. The Company’s second clinical program, ciforadenant (CPI-444), is an oral, small molecule inhibitor of the A2A receptor. Its third clinical program, mupadolimab (CPI-006), is a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical and clinical studies. 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 has been studied in combination with pembrolizumab in a Phase 1b/2 clinical trial in patients with advanced HNSCC 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.

Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of CPI-818, mupadolimab and ciforadenant; the Company’s ability and Angel Pharma’s ability, as well as the timing thereof, to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including Angel Pharma’s planned Phase 1/1b clinical trial of mupadolimab; and the expected trial design of the Company and Angel Pharma’s upcoming planned clinical trials. 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 or Angel Pharma’s control. The Company and Angel Pharma’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, 2022, filed with the Securities and Exchange Commission on August 8, 2022, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. 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:
Aulani Capuchin
Real Chemistry
+1-559-355-2673
acapuchin@realchemistry.com


FAQ

What is the purpose of the mupadolimab clinical trial in China?

The trial aims to evaluate the safety and efficacy of mupadolimab in treating patients with relapsed refractory NSCLC and HNSCC.

When was the IND application for mupadolimab approved?

The IND application was approved on September 26, 2022.

Who is conducting the mupadolimab trial in China?

The trial is being conducted by Angel Pharmaceuticals, a partner of Corvus Pharmaceuticals.

What are the next steps for mupadolimab after the Phase 1/1b trial?

Corvus Pharmaceuticals plans to advance mupadolimab into a randomized Phase 2 clinical trial evaluating its effectiveness in combination with pembrolizumab and chemotherapy.

What is the significance of mupadolimab's mechanism of action?

Mupadolimab is designed to block adenosine production and activate B cells, enhancing the immune response against tumor antigens.

Corvus Pharmaceuticals, Inc.

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