On February 16, 2023 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported an update on the plan to amend and optimize the protocol of its Phase 1 oncology clinical trial with the goal of a timely re-submission to the United States Food and Drug Administration (FDA) (Press release, Theratechnologies, FEB 16, 2023, View Source [SID1234627335]).
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Following a voluntary pause in the study’s enrollment on December 1, 2022, the Company formed a Scientific Advisory Committee (SAC) to help determine the best developmental path forward for TH1902. In addition to the study’s principal investigator, the SAC includes several medical oncologists from across the U.S., who are leading experts in the end-to-end lifecycle of oncology drug development:
Erika Hamilton, MD, director of Breast Cancer and Gynecologic Cancer Research for Sarah Cannon Research Institute at Tennessee Oncology;
Daniel Petrylak, MD, professor of medicine in Medical Oncology and Urology and chief, Genitourinary Oncology at Yale School of Medicine; and
Anthony Tolcher, MD, medical oncologist at Texas Oncology-San Antonio Medical Center.
The Company will continue to seek advice and input from Mace Rothenberg, MD, who is currently a scientific advisor to Theratechnologies.
"We are eager to resume patient enrollment with a revised protocol for TH1902 and have pulled together some of the best scientists in the field of oncology drug development to ensure an optimal amendment," said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies. "Their expert advice will be critical to examining different dosing strategies and patient selection to ultimately improve the chances of success of TH1902."
Theratechnologies is currently analyzing data and preparing responses to questions received from the FDA. This work is well underway and will be considered by the SAC as part of their meeting, which is scheduled for the latter half of March when the analyses are expected to be ready. Once expert advice is considered, the Company intends to promptly amend the protocol and re-submit to the FDA.
Consistent with the Company’s 2023 objective of generating positive adjusted EBITDA1 by fiscal year end, any new investments in TH1902 will be stage gated. Once the Phase 1 clinical trial has resumed, Theratechnologies will also evaluate potential partnerships for TH1902.
1 This is a non-IFRS measure. See "Non-IFRS and Non-U.S. GAAP Measure" below.
About SORT1+ Technology and TH1902
Theratechnologies is currently developing a platform of proprietary peptides called SORT1+ TechnologyTM for cancer drug development targeting SORT1 receptors. The SORT1 receptor plays a significant role in protein internalization, sorting and trafficking. It is highly expressed in cancer cells compared to healthy tissue, which makes SORT1 an attractive target for cancer drug development. Expression of SORT1 is associated with aggressive disease, poor prognosis and decreased survival. It is estimated that the SORT1 receptor is expressed in 40% to 90% of cases of endometrial, ovarian, colorectal, triple-negative breast and pancreatic cancers.
TH1902 is currently Theratechnologies’ lead investigational peptide drug conjugate candidate for the treatment of cancer derived from its SORT1+ Technology. It is the Company’s proprietary peptide linked to docetaxel – a commonly used cytotoxic agent used to treat many cancers. The FDA granted fast track designation to TH1902 as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy. TH1902 is currently being evaluated in a Phase 1 clinical trial, although patient recruitment has recently been voluntarily paused.