Theratechnologies to Present Preclinical Data at AACR Demonstrating Synergy Between TH1902 and Anti-PD-L1 Immunotherapy in Cold Tumor Model

Rhea-AI Summary

Theratechnologies (THTX) announced new findings on sudocetaxel zendusortide (TH1902), showcasing its potential to enhance anti-PD-L1 immunotherapy and induce tumor infiltrating lymphocytes in melanoma models. The studies also reveal TH1902's activity in SORT1+ triple-negative and HER2+ breast cancers. Presentations at the upcoming AACR meeting will highlight its efficacy in various tumor types and the connection to high SORT1 expression. The FDA has granted fast track designation for TH1902 targeting sortilin-positive tumors. However, a Phase 1 trial is currently on partial clinical hold as patient recruitment was paused in December 2022.

Positive

• Sudocetaxel zendusortide (TH1902) shows potential in enhancing anti-PD-L1 therapy in melanoma models.
• Data supports TH1902's efficacy in treating SORT1+ triple-negative and HER2+ breast cancers.
• TH1902 has received FDA fast track designation for treating sortilin-positive recurrent advanced solid tumors.

Negative

• Patient recruitment for the Phase 1 clinical trial was voluntarily paused in December 2022, leading to a partial clinical hold by the FDA.
• The company is preparing responses to FDA queries regarding trial protocol.

• Data show that sudocetaxel zendusortide (TH1902) can induce tumor infiltrating lymphocytes and potentiate anti-PD-L1 immunotherapy in a melanoma mouse model

• Two other studies highlight activity of TH1902 in SORT1+ triple-negative and HER2+ breast cancers, as well as high expression of SORT1 in various tumor types, compared with healthy tissues
  

MONTREAL, March 14, 2023 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that new data will be presented demonstrating the promise of its SORT1+ Technology™ platform of proprietary peptides, and of its lead investigational peptide drug conjugate (PDC) candidate, sudocetaxel zendusortide (TH1902), in enabling targeted delivery of anticancer therapy.

The new data, to be presented in three poster sessions at the 2023 annual meeting of the American Association for Cancer Research (AACR) being held April 14-19 in Orlando, Fla., highlight a synergistic effect of sudocetaxel zendusortide in combination with programmed death-ligand 1 (PD-L1), checkpoint inhibitor therapy in a melanoma mouse model; high expression of the sortilin (SORT1) receptor in multiple tumor types compared to healthy tissues; and the rationale for using sudocetaxel zendusortide as a potential therapeutic approach in SORT1-positive triple-negative breast cancer (TNBC) and HER2-positive breast cancers.

“We are particularly encouraged by the potential synergistic activity of sudocetaxel zendusortide when combined with an anti-PD-L1 checkpoint inhibitor in a melanoma model,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies. “Our new data continue to support the clinical development of sudocetaxel zendusortide as a single agent and in combination with other anticancer therapies. Together, the AACR poster presentations provide fresh insights to guide our oncology program, and our efforts to bring advanced personalized therapies to patients with cancer.”

Theratechnologies will present the following data on Tuesday April 18, 2023, from 9:00am-12:30pm Eastern Time (ET) at AACR 2023:

Title: The peptide-drug conjugate sudocetaxel zendusortide (TH1902) potentiates anti-tumoral activity of the anti-PD-L1 checkpoint inhibitor and induces immune cell infiltration in a B16-F10 syngeneic melanoma model

• Presenting Author: Michel Demeule, Ph.D., Theratechnologies
• Session Category: Clinical Research Excluding Trials
• Session Title: Molecular Targeted Therapies 2
• Location: Poster Section 42
• Poster Board Number: 24
• Abstract Presentation Number: 4499

Title: Sudocetaxel zendusortide (TH1902), a peptide-drug conjugate for the treatment of sortilin-positive (SORT1+) TNBC and Her2-positive breast cancers

• Presenting Author: Cyndia Charfi, Ph.D., Theratechnologies
• Session Category: Clinical Research Excluding Trials
• Session Title: Molecular Targeted Therapies 2
• Location: Poster Section 42
• Poster Board Number: 18
• Abstract Presentation Number: 4493

Title: Differential expression of a novel transport receptor, SORT1 (sortilin), in cancer versus healthy tissues that can be utilized for targeted delivery of anti-cancer drugs

• Presenting Author: Guylaine Roy, Ph.D., Theratechnologies
• Session Category: Experimental and Molecular Therapeutics
• Session Title: Identification of Molecular Targets 1
• Location: Poster Section 17
• Poster Board Number: 30
• Abstract Presentation Number: 3942

About SORT1+ Technology™ and Sudocetaxel Zendusortide (TH1902)

Theratechnologies is currently developing a platform of proprietary peptides called SORT1+ Technology^TM 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.

Sudocetaxel zendusortide (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 was voluntarily paused on December 1, 2022. In alignment with this decision, the FDA placed the trial on partial clinical hold and the Company is currently preparing responses to their questions and planning a protocol amendment.

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 "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 SORT1+ Technology™ platform of proprietary peptides, and of its lead investigational TH1902 in enabling targeted delivery of anticancer therapy, the potential treatment of cancer, including potentially in combination with other anticancer therapies, using TH1902, and the resumption of the Phase 1 clinical trial using 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 results from our pre-clinical trial will be replicated into humans during our Phase 1 clinical trial and subsequent ones, if any, TH1902 will prove safe and effective and will be approved by regulatory authorities for the treatment of cancer, and we will resume our Phase 1 clinical trial using TH1902. 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, the impossibility to demonstrate the safe and effective use of TH1902 in our clinical trials, the impossibility to resume the Phase 1 clinical trial using TH1902 if the FDA does not approve any amendment to our Phase 1 clinical trial protocol studying TH1902, the incapacity of the Company to obtain positive results from the continuous development of its SORT1+ Technology^TM platform, and the incapacity to find a partner for the development of our SORT1+ Technology^TM platform. We refer current and potential investors to the “Risk Factors” section of our Annual Information Form dated February 27, 2023 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 28, 2023 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.

Contacts:

Media inquiries:
Julie Schneiderman
Senior Director, Communications & Corporate Affairs
communications@theratech.com
1-514-336-7800

Investor inquiries:
Elif McDonald
Senior Director, Investor Relations
ir@theratech.com
1-438-315-8563

FAQ

What are the recent findings about TH1902 presented by Theratechnologies?

The findings indicate that TH1902 can enhance anti-PD-L1 immunotherapy and shows efficacy in treating SORT1+ breast cancers.

When will Theratechnologies present data on TH1902?

Data on TH1902 will be presented on April 18, 2023, at the AACR annual meeting.

What is the current status of TH1902's clinical trial?

The Phase 1 clinical trial for TH1902 is on partial clinical hold due to paused patient recruitment since December 2022.

Has TH1902 received any regulatory designations?

Yes, TH1902 has been granted fast track designation by the FDA for the treatment of sortilin-positive recurrent advanced solid tumors.

What patient population is TH1902 targeting?

TH1902 targets patients with sortilin-positive recurrent advanced solid tumors, including SORT1+ triple-negative and HER2+ breast cancers.