On May 2, 2024 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it will present long-term efficacy, safety and pharmacokinetic (PK) data on the use of its lead investigational peptide-drug conjugate (PDC) candidate, TH1902 (sudocetaxel zendusortide), in patients with solid tumors (Press release, Theratechnologies, MAY 2, 2024, View Source [SID1234642599]). The Company will present the long-term data in a poster session at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which takes place May 31-June 4, 2024, in Chicago, IL.

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The ASCO (Free ASCO Whitepaper) poster represents the first presentation of long-term data from Part 1 (dose escalation) and Part 2 (dose expansion) of Theratechnologies’ Phase 1 clinical trial of sudocetaxel zendusortide in individuals with solid tumors, following preliminary evidence of antitumor activity presented at the 2023 ASCO (Free ASCO Whitepaper) annual meeting. This updated analysis will present further data on long-term efficacy, safety and PK from Parts 1 and 2, focusing specifically on patients receiving sudocetaxel zendusortide at a dose of 300 mg/m2 every three weeks. Patients in this dosing group have cancers with known high expression of sortilin (SORT1), including ovarian cancer, endometrial cancer, triple-negative breast cancer (TNBC) and melanoma. Part 3 (dose optimization) of the Phase 1 trial, in patients with advanced ovarian cancer, is ongoing.

"We have eagerly awaited the updated analysis from Parts 1 and 2 of the Phase 1 trial, as it will provide our first evidence of the long-term effects of sudocetaxel zendusortide in patients with solid tumors," said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. "These safety, efficacy and pharmacokinetics data are particularly timely, in that they will provide valuable context as we continue to evaluate this novel peptide-drug conjugate in Part 3 of this ongoing trial."

Details of the poster presentation are as follows:

June 1, 2024, 9:00 AM-12:00 PM CDT

Presenting Author: Ira Winer, MD, Karmanos Cancer Institute, Detroit, MI

Session Category: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Session Title: Long-term efficacy, safety and PK data of TH1902 (sudocetaxel zendusortide) in solid tumors: A novel SORT1-targeting peptide-drug-conjugate (PDC)

Location: Hall A, McCormick Place Congress Center, Chicago

Poster Board Number: 226

Abstract Presentation Number: 3081

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+ Technology 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 rapid 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.