ImmunoMet Therapeutics Granted Fast Track Designation by U.S. FDA for IM156 in Idiopathic Pulmonary Fibrosis

HOUSTON–(BUSINESS WIRE)–ImmunoMet Therapeutics, Inc., a clinical stage biotechnology company targeting metabolism to develop novel anti-fibrotic and anti-cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead compound IM156, an investigational Protein Complex 1 (PC1) inhibitor, being evaluated for idiopathic pulmonary fibrosis (IPF).

“Fast Track designation is another important milestone for ImmunoMet with the potential to speed our ability to advance IM156 to patients,” commented Benjamin Cowen, Chief Executive Officer of ImmunoMet Therapeutics. “Additionally, we are pleased with the progress we are making in the ongoing U.S. Phase 1 study in healthy volunteers.”

About Fast Track Designation

Fast Track designation is intended to facilitate the development and review of drugs used to treat serious conditions and to fill an unmet medical need. Fast Track designation enables the company to have more frequent interactions with the FDA throughout the drug development process, so that an approved product can reach the market expeditiously.

About IM156

IM156 is a Protein Complex 1 (PC1) inhibitor that targets the oxidative phosphorylation (OXPHOS) pathway, decreasing the supply of energy and anabolic precursors that are required to drive fibrotic disease and tumor growth. IM156, ImmunoMet’s lead drug candidate, is solely owned by ImmunoMet and is currently in development for the treatment of IPF and selected cancers.

About ImmunoMet Therapeutics

ImmunoMet is a clinical stage biotechnology company targeting metabolism for the treatment of fibrotic diseases and cancer. ImmunoMet’s lead molecule, IM156, is a PC1 inhibitor and is the first potent PC1 inhibitor to complete Phase 1 with good tolerability. In addition to IM156, ImmunoMet owns a large library of biguanides with the potential for development, internally or with partners, for multiple indications. The company was founded in 2015, is headquartered in JLABS @ TMC in Houston and has raised $31M to date. For more information about the company, please visit www.immunomet.com.

Forward-Looking Statements

This press release contains “forward-looking statements” concerning the development of ImmunoMet products, the potential benefits and attributes of those products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. ImmunoMet undertakes no obligation to update any forward-looking statements for any reason.

Contacts

Benjamin Cowen, PhD, MBA

President and CEO

ImmunoMet Therapeutics

[email protected]