Dr. Christian Marsolais reports

THERATECHNOLOGIES ANNOUNCES DOSING OF FIRST PATIENT IN UPDATED CLINICAL TRIAL OF SUDOCETAXEL ZENDUSORTIDE IN ADVANCED OVARIAN CANCER

Theratechnologies Inc. has dosed the first participant in part 3 of its phase 1 clinical trial of sudocetaxel zendusortide in patients with advanced ovarian cancer. Sudocetaxel zendusortide is an investigational, first-in-class peptide-drug conjugate (PDC) that targets the sortilin (SORT1) receptor, and expedites the internalization and delivery of a cytotoxic payload directly into cancer cells.

"We are excited to dose the first of six patients in part 3 of the phase 1 trial of sudocetaxel zendusortide with its modified design and dosing regimen," said Christian Marsolais, PhD, senior vice-president and chief medical officer at Theratechnologies. "We look forward to building on the efficacy we've observed so far, which is mainly long-term disease stabilization in a number of advanced patients. This first-patient-dosed milestone thus extends the momentum of our oncology clinical development program."

"Patients with chemo-resistant ovarian cancer are in dire need of effective treatment options," said Ira Winer, MD, PhD, FACOG, gynecologic oncology, phase 1 multidisciplinary member at Karmanos Cancer Center and trial investigator. "Based on promising preliminary data during the first parts of the phase 1 trial for sudocetaxel zendusortide, I hope to see both improved tolerability and continued benefit in this patient population as the trial moves onto this next phase."

The announcement follows U.S. Food and Drug Administration (FDA) acceptance on June 2, 2023, of the company's amended protocol for the phase 1 trial. The revised protocol is designed to improve the therapeutic window of sudocetaxel zendusortide and extend its duration of therapy. It includes weekly administration and also narrows the patient population to focus on individuals with high-grade serous ovarian cancer, including high-grade peritoneal or fallopian tube cancer, or high-grade endometrioid cancer -- a population in which sudocetaxel zendusortide has demonstrated preliminary efficacy. After establishing the safety of the initial dose in the first six patients, the study aims to enroll a total of 16 patients in part 3.

Enrolment of the first patient in part 3 of the trial follows closely upon demonstration of anti-tumour activity in parts 1 and 2, as presented at the 2023 annual meeting of the American Society of Clinical Oncology. Details about the study design, participation criteria and contact information for the five U.S. sites simultaneously enrolling patients can be found at the ClinicalTrials website.

About sudocetaxel zendusortide (TH1902) and SORT1+ technology

Sudocetaxel zendusortide is a first-of-its-kind sortilin-targeting PDC, and the first compound to emerge from the SORT1+ Technology 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 tumours that are refractory to standard therapy. Sudocetaxel zendusortide is currently being evaluated in a phase 1 clinical trial.

Theratechnologies has established its SORT1+ Technology platform as an engine for the development of proprietary PDCs that target SORT1 receptor, which is expressed in multiple tumour 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 per cent to 90 per cent of endometrial, ovarian, colorectal, triple-negative breast (TNBC) and pancreatic cancers, making this receptor an attractive target for anti-cancer drug development.

About Theratechnologies Inc.

Theratechnologies is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.

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