Theratechnologies Announces Two E-Posters on TH1902 To Be Presented at American Association for Cancer Research (AACR) Annual Meeting 2021
Theratechnologies announced promising new pre-clinical data on TH1902, its peptide-drug conjugate targeting SORT1+ solid tumors. Findings will be presented at AACR Annual Meeting 2021 through two e-posters. TH1902 has received FDA fast track designation for advanced solid tumors expressing sortilin. The company secured $1.4 million in funding from the Canadian Cancer Society and the Government of Quebec for research in targeted oncology. A Phase 1 trial is underway, assessing TH1902's safety and anti-tumor activity across multiple cancer types, with enrollment for further trials planned upon establishing maximum tolerated dose.
- FDA granted fast track designation to TH1902 for advanced solid tumors.
- Secured $1.4 million funding for research from the Canadian Cancer Society and Government of Quebec.
- Positive pre-clinical data presented at AACR Annual Meeting 2021 supports TH1902's efficacy.
- Phase 1 trial results are contingent upon replication of pre-clinical results in humans.
- Risks include potential adverse side effects that could halt clinical trials.
MONTREAL, March 10, 2021 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, is pleased to announce that new positive pre-clinical data on TH1902, its lead peptide-drug conjugate (PDC) for the treatment of sortilin positive (SORT1+) solid tumors, will be presented in two e-posters during AACR Annual Meeting 2021.
Presentation Title: TH1902, a docetaxel peptide-drug conjugate, shows pre-clinical efficacy in several sortilin positive (SORT1+) cancers
Abstract Number: 1313
E-Poster website launch date and time: Saturday, April 10, 2021, 8:30 AM
Presentation Title: Increasing potency of anticancer drugs through SORT1+ Technology: A new targeted approach for the treatment of ovarian and endometrial cancers
Abstract number: 1439
E-Poster website launch date and time: Saturday, April 10, 2021, 8:30 AM
The abstracts are now available at aacr.org.
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 tumours 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.
About SORT1+ Technology™
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
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.
About Theratechnologies
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.
Forward-Looking Information
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 and the timing to initiate a phase 1 clinical trial for TH1902.
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, the timelines to initiate the Phase 1 trial is accurate, we will be able to enroll patients for the Phase 1 trial, treatment with TH1902 will be effective 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 initiating or 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.
For media inquiries:
Denis Boucher
Vice President, Communications and Corporate Affairs
514-336-7800
communications@theratech.com
For investor inquiries:
Leah Gibson
Senior Director, Investor Relations
617-356-1009
lgibson@theratech.com
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