This news release is an announcement that the Gettysburg Cancer Center (GCC) has administered the first dose of a new, innovative cancer therapy ever given to a human being anywhere in the world. This is a testament to the dedication and hard work of the doctors and staff of GCC to ensure that Gettysburg and surrounding area have access to the very latest in cancer treatment technology.
THERATECHNOLOGIES ANNOUNCES FIRST PATIENT DOSED IN PHASE 1 CLINICAL TRIAL OF TH1902 FOR SORTILIN POSITIVE SOLID TUMORS
Montreal, Canada – March 24, 2021 – 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.
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+ TechnologyTM 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.
About SORT1+ TechnologyTM
Theratechnologies has developed a peptide which specifically targets sortilin (SORT1) receptors. SORT1 is expressed in ovarian, triple negative breast, skin, lung, colorectal and pancreatic cancers, among others. SORT1 plays a significant role in protein internalization, sorting and trafficking, making it an attractive target for drug development.
It is estimated that the sortilin receptor is expressed in 40 to 90% of cases depending on cancer type.
Commercially available anticancer drugs, like docetaxel, doxorubicin or tyrosine kinase inhibitors are conjugated to Theratechnologies’ investigational novel peptide to specifically target sortilin receptors. This could potentially improve the efficacy and safety of those agents.
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company’s website at www.theratech.com, on SEDAR at www.sedar.com and on EDGAR at www.sec.gov.
This press release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management’s beliefs and assumptions and on information currently available to our management. You can identify forward- looking statements by terms such as “may”, “will”, “should”, “could”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the negatives of these terms, or variations of them. The forward-looking statements contained in this press release include, but are not limited to, statements regarding the development of TH1902 for the potential treatment of various types of cancer, the determination of the MTD and the enrollment of patients in such Phase 1 trial.
Forward-looking statements are based upon a number of assumptions and include, but are not limited to, the following: pre-clinical in vivo results will be replicated in humans during the Phase 1 trial, we will be able to determine the MTD, we will be able to enroll patients for the Phase 1 trial, treatment with TH1902 will be efficacious and safe in various types of cancer and no serious adverse side effects will be discovered from the administration of TH1902 to patients.
Forward-looking statements are subject to a variety of risks and uncertainties, many of which are beyond our control that could cause our actual results to differ materially from those that are disclosed in or implied by the forward-looking statements contained in this press release. These risks and uncertainties include, among others, the risk that the Covid-19 pandemic materially adversely affect the conduct of our Phase 1 trial, we are unable to determine the MTD, results obtained from the administration of TH1902 do not allow the pursuit of additional clinical trials, patients die and such death is related to the administration of TH1902 resulting in the abandonment of our Phase 1 trial, discovery of serious adverse side effects also leading to the abandonment of the Phase 1 trial, difficulty in recruiting patients leading to delays in completing the Phase 1 trial and non- performance by our third-party contract suppliers of their covenants, obligations or undertakings under the terms of our agreements with them.
We refer potential investors to the “Risk Factors” section of our annual information form dated February 24, 2021 available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov as an exhibit to our report on Form 40-F dated February 25, 2021 under Theratechnologies’ public filings for additional risks regarding the conduct of our business and Theratechnologies. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date.
We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.