Theratechnologies Announces Update On Its Preclinical Oncology Research Program; Company Will Continue To Prioritize Its Ongoing Phase 1 Clinical Trial Of Sudocetaxel Zendusortide In Patients With Advanced Ovarian Cancer
Company continues to shift to commercial focus as it seeks partners to advance R&D
MONTREAL, March 22, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX:TH) (NASDAQ:THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that it will phase down its preclinical oncology research activities. The Company will continue to prioritize its ongoing Phase 1 clinical trial of sudocetaxel zendusortide (TH1902), a novel peptide-drug conjugate (PDC), in patients with advanced ovarian cancer. All figures below are in U.S. dollars.
"I am very proud of our exceptional research team, whose work has contributed greatly to the scientific discourse and understanding of advanced cancers," said Paul Lévesque, President and CEO at Theratechnologies. "Our investment in the SORT1+ Technology™ platform over the past five years has generated important evidence on multiple peptide-drug conjugates with different payloads. Now that we have significantly advanced our preclinical program, we are well-positioned to leverage this wealth of data and insights to attract an oncology R&D partner."
The Company will continue to share accumulated preclinical data, including the presentation of two separate posters at the American Association for Cancer Research (AACR) annual meeting, to be held April 5-9 in San Diego, Calif., one of which features data from new PDCs.
Theratechnologies recently announced the initiation of the next cohort of patients in Part 3 of its Phase 1 trial of sudocetaxel zendusortide, in which the first patient has already received treatment at a higher dose. Recruitment has been ramped up at the six trial sites across North America. To date, more than 40 individuals with various types of cancer have been treated with sudocetaxel zendusortide.
The phasing down of research activities is aligned with the Company's focus on its commercial business and will further optimize its organizational cost structure, pursuant to the goal of generating positive Adjusted EBITDAi. These changes are expected to result in a restructuring charge of approximately $625,000 in cash charges related to severance and other expenses and approximately $770,000 in non-cash charges. The company anticipates all charges to be fully taken during 2024.
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i Adjusted EBITDA is a non-IFRS Measure
About Sudocetaxel Zendusortide (TH1902) and SORT1+ Technology™
Sudocetaxel zendusortide is a first-of-its-kind sortilin receptor (SORT1)-targeting PDC, and the first compound to emerge from the Company's broader licensed oncology platform. A new chemical entity, sudocetaxel zendusortide employs a cleavable linker to conjugate (attach) a proprietary peptide to docetaxel, a well-established cytotoxic chemotherapeutic agent used to treat many cancers. The FDA granted Fast Track designation to sudocetaxel zendusortide as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy. Sudocetaxel zendusortide is currently being evaluated in a Phase 1 clinical trial.
Theratechnologies has established the SORT1+ TechnologyTM platform as an engine for the development of PDCs that target SORT1, which is expressed in multiple tumor types. SORT1 is a "scavenger" receptor that plays a significant role in protein internalization, sorting, and trafficking. Expression of SORT1 is associated with aggressive disease, poor prognosis, and decreased survival. It is estimated that SORT1 is expressed in 40% to 90% of endometrial, ovarian, colorectal, triple-negative breast (TNBC), and pancreatic cancers, making this receptor an attractive target for anticancer drug development.