Theratechnologies Announces Publication of TH1902 Preclinical Data in Peer-Reviewed Journal, Cancer Science

Rhea-AI Summary

Theratechnologies (THTX) has published significant preclinical data on TH1902 for treating sortilin-positive triple negative breast cancer (TNBC) in the journal Cancer Science. This research indicates the in vivo efficacy and safety of TH1902, a peptide-drug conjugate (PDC) aiming to improve targeted cancer therapy. The FDA has granted fast track designation to TH1902, which is undergoing Phase 1 trials. The study highlights SORT1 expression as a potential biomarker, reinforcing the promise of TH1902 in addressing unmet needs in cancer treatment.

Positive

• Publication of peer-reviewed data for TH1902 confirms its efficacy and safety against TNBC.
• TH1902 received FDA fast track designation for treating sortilin-positive recurrent advanced solid tumors.
• SORT1+ Technology™ demonstrates improved anti-tumor activity and reduced toxicity in preclinical models.

Negative

• None.

MONTREAL, Aug. 13, 2021 (GLOBE NEWSWIRE) -- Theratechnologies, Inc. (Theratechnologies, or Company) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, announced today the publication of data from its preclinical research of TH1902 for the treatment of sortilin-positive triple negative breast cancer (TNBC) in the peer-reviewed journal Cancer Science, confirming the in vivo efficacy and safety of TH1902 against TNBC through a SORT1 receptor-mediated mechanism.

The article is titled “TH1902, a new docetaxel-peptide conjugate for the treatment of sortilin-positive triple-negative breast cancer.”

“This publication in a highly-respected cancer journal represents the first peer-reviewed scientific paper for our lead investigational PDC TH1902 and further validates the novel approach of our SORT1+ Technology™ for the treatment of sortilin-expressing cancers. Our team of scientific researchers are pleased to add to the growing body of scientific evidence of sortilin expression as a potential targetable biomarker for various hard-to-treat cancers, and we have great hope that TH1902 represents a promising avenue in the treatment of personalized cancer therapy,” said Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer at Theratechnologies.

Cancer Science is a well-recognized peer-reviewed journal and the official journal of the Japanese Cancer Association (JCA). The article can be accessed online here.

About SORT1+ Technology™
Theratechnologies is currently developing a platform of new proprietary peptides for cancer drug development targeting SORT1 receptors called SORT1+ Technology^TM. SORT1 is a receptor that plays a significant role in protein internalization, sorting and trafficking. It is highly expressed in cancer cells compared to healthy tissue making it an attractive target for cancer drug development. Expression has been demonstrated in, but not limited to, ovarian, triple-negative breast, endometrial, skin, lung, colorectal and pancreatic cancers. 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.

The Company’s innovative peptide-drug conjugates (PDCs) generated through its SORT1+ Technology^TM demonstrate distinct pharmacodynamic and pharmacokinetic properties that differentiate them from traditional chemotherapy. In contrast to traditional chemotherapy, Theratechnologies’ proprietary PDCs are designed to enable selective delivery of certain anticancer drugs within the tumor microenvironment, and more importantly, directly inside SORT1 cancer cells. Commercially available anticancer drugs, like docetaxel, doxorubicin or tyrosine kinase inhibitors are conjugated to Theratechnologies’ PDC to specifically target SORT1 receptors. This could potentially improve the efficacy and safety of those agents.

In preclinical data, the Company’s SORT1+ Technology^TM has shown to improve anti-tumor activity and reduce neutropenia and systemic toxicity compared to traditional chemotherapy. Additionally, in preclinical models, SORT1+ Technology^TM has shown to bypass the multidrug resistance protein 1 (MDR1; also known as P-glycoprotein) and inhibit the formation of vasculogenic mimicry - two key resistance mechanisms of chemotherapy treatment.

About TH1902
TH1902 combines Theratechnologies’ proprietary peptide to the cytotoxic drug docetaxel. TH1902 is currently Theratechnologies’ lead investigational PDC candidate for the treatment of cancer derived from its SORT1+ Technology™. 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 for the treatment of cancers where the sortilin receptor is expressed.

The Company is also evaluating TH1904 in preclinical research, a second PDC derived from its SORT1+ Technology^TM TH1904 is conjugated to the cytotoxic drug doxorubicin.

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.

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 use of TH1902 for the potential treatment of of sortilin-positive TNBC and other sortilin-expressed cancer types, and the conduct of our clinical trial with TH1902.

Although the Forward-Looking Statements contained in this press release are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on these statements since actual results may vary from the Forward-Looking Statements. Certain assumptions made in preparing the Forward-Looking Statements include that: the current COVID-19 pandemic will have limited adverse effect on the Company’s operations and its business plan; the Company will succeed in pursuing the conduct of its Phase 1 clinical trial using TH1902; research and development activities using peptides derived from its SORT1+ Technology^TM will yield positive results allowing for the development of new drugs for the treatment of cancer; and the Company’s business plan will not be substantially modified.

Forward-Looking Statements assumptions are subject to a number of risks and uncertainties, many of which are beyond Theratechnologies’ control that could cause actual results to differ materially from those that are disclosed in or implied by such Forward-Looking Statements. These risks and uncertainties include, but are not limited to, those related to or arising from: the adverse impact of the ongoing COVID-19 pandemic on (a) the Company’s sales efforts and sales initiatives, (b) the capacity of the Company’s suppliers to meet their obligations vis-à-vis the Company, (c) the Company’s research and development activities, (d) the health of the Company’s employees and its capacity to rely on its resources, as well as (e) global trade; the Company’s ability to successfully conduct its Phase 1 clinical trial using TH1902 in various types of cancer; the Company’s capacity to acquire or in-license new products and/or compounds; and the Company’s estimates regarding its capital requirements.

We refer current and 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 related to the Company. 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
communications@theratech.com
514-336-7800

For investor inquiries:
Leah Gibson
Senior Director, Investor Relations
ir@theratech.com
617-356-1009

FAQ

What is TH1902 and its significance in treating TNBC?

TH1902 is a peptide-drug conjugate developed by Theratechnologies, targeting sortilin-positive triple negative breast cancer, showing promising efficacy and safety in preclinical studies.

What peer-reviewed data was published regarding TH1902?

Data published in Cancer Science confirms the in vivo efficacy and safety of TH1902 against TNBC, marking a significant milestone for its development.

What is the current status of TH1902 clinical trials?

TH1902 is currently undergoing Phase 1 clinical trials for treating cancers expressing the sortilin receptor, following its fast track designation by the FDA.

How does SORT1+ Technology™ impact cancer treatment?

SORT1+ Technology™ aims to enhance targeted delivery of anticancer drugs within tumors, potentially improving treatment efficacy and reducing side effects compared to traditional chemotherapy.