Pliant Therapeutics Announces FDA Clearance of Investigational New Drug Application for PLN-101095, A Novel Integrin Inhibitor for the Treatment of Solid Tumors

Pliant Therapeutics, Inc., a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for PLN-101095, an oral, small molecule, dual selective inhibitor of integrins αvβ8 and αvβ1. A Phase 1 first-in-human study evaluating PLN-101095 in patients with solid tumors that are resistant to immune checkpoint inhibitors (ICIs) is expected to initiate in the second quarter of 2023.

“PLN-101095 represents our third program to advance into clinical development, this time targeting significant unmet need of cancer patients with a suboptimal response to immune checkpoint inhibitors,” said Éric Lefebvre, M.D., Chief Medical Officer at Pliant Therapeutics. “Based on the compelling preclinical activity seen in tumor models with PLN-101095 in combination with immune checkpoint inhibitors, we look forward to evaluating this combination in patients with solid tumors.”

PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins in development for the treatment of solid tumors resistant to immune checkpoint inhibitors. TGF-β plays an important anti-inflammatory role in the tumor micro-environment, promoting fibrosis, preventing T-cell infiltration and inhibiting the release of pro-inflammatory cytokines. Increased TGF-β signaling is recognized as a potential cause of resistance to checkpoint inhibitors, such as anti-PD-(L)1 therapies, seen in many tumors. PLN-101095 targets αvβ8 and αvβ1 integrins expressed in the tumor microenvironment, regulating TGF-β activation with the goal of re-sensitizing tumors to PD(L)-1 inhibitors.

Phase 1 Study of PLN-101095

The Phase 1 study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of PLN-101095. Additional details will be disclosed upon trial initiation.