Theratechnologies Partner Submits Biologics License Application for HIV Monoclonal Antibody and Long-Acting Investigational Antiretroviral Ibalizumab

Theratechnologies Inc. announced that its partner, TaiMed Biologics, Inc., has completed the submission of a Biologics License Application to the U.S. Food and Drug Administration for ibalizumab for the treatment of multidrug-resistant Human Immunodeficiency Virus-1 (MDR HIV-1).

If approved, ibalizumab will be the first antiretroviral treatment (ART) with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing. As ibalizumab has received the Breakthrough Therapy and Orphan Drug Designations, TaiMed has requested Priority Review for the application.

The ibalizumab BLA is based on data from the phase III TMB-301 study, a single-arm, 24-week study of ibalizumab plus an optimized background regimen (OBR) in treatment-experienced patients infected with MDR HIV-1. Full results from the trial were recently presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2017.

"The BLA submission is an important milestone for patients, physicians and everyone who has worked tirelessly to bring this much-needed medicine to people living with MDR HIV-1," said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc. "This is a significant step toward the expansion of our product portfolio, which reinforces our mission to improve the lives of people living with HIV," added Mr. Tanguay.

As HIV multiplies in the body, the virus sometimes mutates to produce drug-resistant strains. When this occurs, HIV medicines that previously controlled a person's virus may no longer be effective, causing treatment to fail.

Approximately 20,000 to 25,000 Americans with HIV-1 are currently resistant to at least one drug in three different classes of antiretroviral therapies, and up to 12,000 of these patients experience a virological failure over a period of 48 weeks of treatment, requiring their physician to modify their treatment.

"While some people can suppress their viral loads with currently approved treatments, there is an urgent need for new options among those with multidrug resistance," said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer, Theratechnologies Inc.

"We understand that some people living with HIV-1 have special needs, and we will continue to bring solutions to help them live healthier lives," concluded Mr. Tanguay.

Ibalizumab is an investigational humanized monoclonal antibody being developed for the treatment of MDR HIV-1 infection. Unlike other antiretroviral agents, ibalizumab binds primarily to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II molecule binding sites. It potentially prevents HIV from infecting CD4+ immune cells while preserving normal immunological function. Ibalizumab is active against HIV-1 resistant to all approved antiretroviral agents.

Ibalizumab has received "Breakthrough Therapy" designation from the FDA, which is given if a therapy may provide a substantial improvement over what is currently available to address a serious and life-threatening condition. The FDA also granted "Orphan Drug" designation.

For more information about TMB-301 (NCT 02475629) and TMB-311 (NCT02707861), visit ClinicalTrials.gov or ibalizumab-eap.com