Theratechnologies (THTX) Announces First Patient Dosed in Phase 1 Clinical Trial of TH1902 for Sortilin Positive Solid Tumors

March 24, 2021 7:32 AM EDT
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Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, is pleased to announce that the first patient received a dose of TH1902, its lead peptide-drug conjugate (PDC) for the treatment of sortilin positive (SORT1+) solid tumors.

“This is yet another major achievement for our oncology program. Given the important medical need for novel, targeted cancer treatments, the rapid progression of our promising, unique and innovative approach to fight cancer is a great source of hope for patients,” said Paul Lévesque, President and CEO, Theratechnologies.

“Despite the progress made in recent years in the field of oncology, many patients are unfortunately not responding to current treatments or do not tolerate them well. Targeting the sortilin receptor is an exciting and promising new approach for the potential treatment of cancer. Dosing the first patient with TH1902 brings us closer to a potential much needed new option in oncology,” said Dr. Satish Shah, Medical Director, Gettysburg Cancer Center, Gettysburg, Pennsylvania and Dr. Tina Khair, Research Director, Gettysburg Cancer Center.

About TH1902
TH1902 combines Theratechnologies’ proprietary peptide to docetaxel. The U.S. Food and Drug Administration (FDA) recently granted fast track designation to TH1902 as a single agent for the treatment of all advanced solid tumors expressing sortilin that are refractory to standard therapy. TH1902 is the Company’s lead PDC stemming from Theratechnologies’ SORT1+ Technology™ in oncology.

The Canadian Cancer Society and the Government of Quebec, through the Consortium Québécois sur la découverte du médicament (CQDM), will contribute a total of 1.4 million dollars towards some of the research currently being conducted for the development of Theratechnologies’ targeted oncology platform at the molecular oncology laboratory of Dr. Borhane Annabi at the Université du Québec in Montréal (UQAM).

Phase 1 clinical trial of TH1902
The Phase 1 clinical trial includes a dose-escalating part to evaluate the safety, pharmacokinetics, maximum tolerated dose (MTD) and preliminary anti-tumor activity of TH1902 administered once every three weeks in patients with advanced solid tumors refractory to available anti-cancer therapies.

Once the MTD is determined, it is planned that a total of 40 additional patients will be enrolled to evaluate the potential anti-tumor activity of TH1902 in patients with endometrial, ovarian, colorectal, pancreatic and triple negative breast cancers.

Funda Meric-Bernstam, M.D., Chair of the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center is the Lead Principal Investigator of the Phase 1 trial for TH1902.

The detailed Phase 1 study protocol is available at ClinicalTrials.gov under the identifier number: NCT04706962.




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