Theseus Pharmaceuticals Receives U.S. FDA Orphan Drug Designation for THE-630 for the Treatment of Advanced Gastrointestinal Stromal Tumors (GIST)
CAMBRIDGE, Mass., Feb. 2, 2022 /PRNewswire/ -- Theseus Pharmaceuticals, Inc. (Theseus) (NASDAQ: THRX), a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development and commercialization of transformative targeted therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company's lead candidate THE-630, a small-molecule oral pan-variant KIT inhibitor, for the treatment of patients with advanced gastrointestinal stromal tumors (GIST).
"We are pleased to have received ODD for THE-630 so quickly after the initiation of the first-in-human trial. This designation from the FDA emphasizes the need to bring better therapeutic options to patients with advanced GIST," said David Kerstein, M.D., Chief Medical Officer at Theseus. "For patients living with GIST, progression through standard lines of therapy is often associated with the emergence of resistance mutations in KIT. We look forward to evaluating the clinical potential of THE-630 to inhibit these resistance mutations in patients who've exhausted available therapies and when used in earlier lines of therapy."
The FDA's Office of Orphan Products Development grants ODD status to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. ODD provides benefits to drug developers designed to support the development of drugs and biologics for small patient populations with unmet medical needs. These benefits include assistance in the drug development process, tax credits for qualified clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity.
About Theseus Pharmaceuticals, Inc.
Cautionary Statement Regarding Forward Looking Statements
Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, such as those described from time to time in the reports Theseus files with the Securities and Exchange Commission (SEC), including Theseus' Form 10-Q for the quarter ended September 30, 2021 filed with the SEC on November 15, 2021. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this press release are based on the current expectations of Theseus' management team and speak only as of the date hereof, and Theseus specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
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Company Codes: NASDAQ-NMS:THRX