Theratechnologies’ Lead Peptide Drug Conjugate TH1902 Receives FDA Fast-Track Designation

Theratechnologies Inc. recently announced the US FDA has granted fast-track designation to TH1902 as a single agent for the treatment of patients with sortilin positive recurrent advanced solid tumors that are refractory to standard therapy.

“Receiving fast-track designation for TH1902 at this early stage of development is a significant recognition for our SORT1+ Technology and further supports the future development of TH1902. The designation, which applies to all solid tumours expressing sortilin, also highlights the broad applicability and immense medical need for innovative, targeted, and potentially more effective and better-tolerated therapies for cancer,” said Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies.

Theratechnologies announced on January 7, 2021 that it had received a “Study May Proceed” letter from the FDA for the Phase 1 clinical trial of TH1902.

The proposed Phase 1 trial design includes a dose-escalation study to evaluate the safety, pharmacokinetics, maximum tolerated dose (MTD), and preliminary anti-tumor activity of TH1902 administered once every 3 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 where it has been estimated that the sortilin receptor is expressed in 40% to 90% of cases. The Phase 1 trial is expected to be initiated in the second quarter of calendar year 2021 and is designed to identify a recommended dose for Phase 2 development.

Funda Meric-Bernstam, MD, 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 study protocol is available at ClinicalTrials.gov under the identifier number: NCT04706962.

The FDA’s fast-track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose of fast track designation is to bring important new drugs to patients earlier. A drug that receives fast track designation is eligible for some or all of the following:

• More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
• More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
• Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
• Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA

TH1902 combines Theratechnologies’ proprietary peptide to docetaxel. This peptide-drug conjugate (PDC) is the lead candidate 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.

Theratechnologies has developed a peptide that 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.

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 is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. For more information, visit www.theratech.com.