ImmunoMet Therapeutics Receives IND Clearance and Orphan Drug Designation from U.S. FDA for IM156 in Ideopathic Pulmonary Fibrosis and Completes Financing

- Phase 1 clinical study recruitment in healthy volunteers is expected to start in Q1 2021 -

- Pre-clinical studies have demonstrated a strong anti-fibrotic effect in animal models of fibrosis -

- Recently completed Phase 1 trial in oncology patients demonstrated good safety profile -

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 cleared the Investigational New Drug (IND) application for IM156, an investigational Protein Complex 1 inhibitor, being evaluated for idiopathic pulmonary fibrosis (IPF) as well as granting it Orphan Drug Designation. The Company also announced the closing of $7.0M in new financing by both existing and new investors that will be used, in part, to fund the Phase 1 program.

“FDA clearance of an IND for IM156 is a major milestone for ImmunoMet. The unique mechanism of action of IM156 has the potential to address an unmet need in patients with fibrotic disorders and complement the current standard of care,” commented Benjamin Cowen, Chief Executive Officer of ImmunoMet Therapeutics. “Based on results of our recently completed Korean Phase 1 trial of IM156 in oncology patients, we believe that it is the first potent PC1 inhibitor to complete a Phase 1 study with good tolerability. Our preclinical results further demonstrate a strong anti-fibrotic effect at doses previously shown to be well-tolerated in humans.”

ImmunoMet plans to initiate a single-site U.S. Phase 1 study in 32 healthy volunteers designed to characterize the safety, tolerability, pharmacokinetics, and effects of IM156 in Q1 2021. The data from this Phase 1 study will inform the design of a Phase 2 trial in patients with IPF.

About IM 156

IM156 is a protein complex 1 (PC1) inhibitor that targets the 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.

Benjamin Cowen, PhD, MBA
President and CEO
ImmunoMet Therapeutics
bcowen@immunomet.com