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Corvus Pharmaceuticals Announces Orphan Drug Designation Granted to Soquelitinib for the Treatment of T Cell Lymphoma

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Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS) has received Orphan Drug Designation from the FDA for its lead ITK inhibitor candidate, soquelitinib, for the treatment of T cell lymphoma. The company is set to initiate a Phase 3 registrational clinical trial for soquelitinib in patients with relapsed peripheral T cell lymphoma in the second quarter of 2024. The orphan drug status provides various benefits to the drug developer, including tax credits, exemptions from certain FDA fees, and seven years of post-approval marketing exclusivity.
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The FDA's Orphan Drug Designation for soquelitinib represents a significant step forward for Corvus Pharmaceuticals in addressing peripheral T cell lymphoma (PTCL), a rare and aggressive form of non-Hodgkin's lymphoma. PTCL patients often face limited treatment options, which are frequently accompanied by considerable toxicity. The designation acknowledges the potential of soquelitinib as an innovative therapy that could improve patient outcomes. From a clinical perspective, advancements in targeted therapies like ITK inhibitors are crucial, as they may offer more effective and less toxic treatment alternatives compared to current standards of care.

Moreover, the Orphan Drug Designation comes with various incentives that could expedite soquelitinib's development and reduce costs. The seven-year marketing exclusivity post-approval could also provide a competitive edge within the oncology market, potentially leading to a stronger market position for Corvus Pharmaceuticals upon successful trial outcomes and subsequent FDA approval.

Entering Phase 3 clinical trials is a pivotal moment for any investigational drug, as it signifies a transition from early-stage research to late-stage testing with a larger patient population. For investors, this phase is particularly critical as it often precedes a drug's potential commercialization and can significantly influence the company's valuation. The Orphan Drug Designation could potentially streamline the regulatory process for soquelitinib, potentially leading to a faster time-to-market. This is particularly relevant for Corvus Pharmaceuticals, a clinical-stage company whose financial prospects are closely tied to the progress and success of its lead candidates.

It is also noteworthy that there are no FDA-approved agents for relapsed PTCL, indicating a high unmet medical need and a potentially receptive market for new therapies. Should soquelitinib prove to be safe and effective, it could capture a significant share of this niche market, which would have a profound impact on Corvus's financial health and stock performance.

The orphan drug market is a unique segment within the pharmaceutical industry, often characterized by high drug prices and lower research and development costs relative to non-orphan drugs. The incentives provided by the Orphan Drug Designation, such as tax credits and fee waivers, are designed to encourage the development of treatments for rare diseases, which might otherwise be commercially unviable. For Corvus Pharmaceuticals, these incentives could improve the cost-effectiveness of soquelitinib's development program and potentially enhance profitability upon market entry.

Given the rarity of PTCL and the lack of approved treatments for the relapsed form, soquelitinib could benefit from reduced competition and strong market demand. The exclusivity period post-approval is particularly valuable, as it prevents generic competition and allows the company to set a price point that reflects the drug's value in treating a rare condition. This period of market exclusivity could result in a significant return on investment for Corvus Pharmaceuticals, assuming the drug's successful development and approval.

Company on track to initiate soquelitinib Phase 3 registrational clinical trial in PTCL

BURLINGAME, Calif., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for soquelitinib for the treatment of T cell lymphoma. Soquelitinib, the Company’s lead ITK inhibitor candidate, is expected to advance into a Phase 3 registrational clinical trial in patients with relapsed peripheral T cell lymphoma (PTCL) in the second quarter 2024.

“Peripheral T cell lymphoma is an aggressive subset of non-Hodgkin’s lymphoma typically associated with a poor prognosis,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “For these patients, there is significant need for new therapies given that existing drugs provide limited efficacy and are associated with significant toxicity. There are no FDA approved agents for relapsed PTCL. The orphan drug designation is an important milestone in the development of soquelitinib that reinforces the unmet need for patients with T cell lymphoma.”

FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.

About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Corvus plans to initiate a Phase 3 registrational clinical trial for soquelitinib in patients with relapsed peripheral T cell lymphoma. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com.

About Soquelitinib
Soquelitinib (formerly known as CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. The immunologic effects of soquelitinib lead to what is known as Th1 skewing and is made possible by the high selectivity of soquelitinib for ITK. Research on soquelitinib’s mechanism of action suggests that it has the potential to control differentiation of normal T helper cells and enhance immune responses to tumors by augmenting the generation of cytotoxic killer T cells and the production of cytokines that inhibit cancer cell survival. Soquelitinib has also been shown to prevent T cell exhaustion, a major limitation of current immunotherapy and CAR-T therapies. Optimal doses of soquelitinib have been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company plans to initiate a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL.

Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of the Company’s product candidates including soquelitinib, ciforadenant and mupadolimab; and the timing of the Phase 3 clinical trial commencing for soquelitiniband . 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 three months ended September 30, 2023, filed with the Securities and Exchange Commission on November 7, 2023, 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 soquelitinib and its other product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; 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


The ticker symbol for Corvus Pharmaceuticals, Inc. is CRVS.

The FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. It provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees, and seven years of post-approval marketing exclusivity.

The Phase 3 registrational clinical trial for soquelitinib in patients with relapsed peripheral T cell lymphoma is expected to advance in the second quarter of 2024.

There are currently no FDA approved agents for relapsed PTCL, highlighting the significant unmet need for new therapies for patients with T cell lymphoma.

The co-founder, president, and chief executive officer of Corvus Pharmaceuticals, Inc. is Richard A. Miller, M.D.
Corvus Pharmaceuticals Inc

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About CRVS

corvus pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class agents that target the immune system to treat patients with cancer. with accomplished and talented scientists, and top-tier investors, we are well positioned in an exciting new era of immuno-oncology.