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

03 Feb 2023
pipelinereview.com
Orphan DrugINDPhase 1Fast TrackPhase 2
Phase 1 clinical study initiation expected in the second quarter of 2023
SOUTH SAN FRANCISCO, CA, USA I February 02, 2023 I Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today 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 inhibitorsPD(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.
Pliant Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis. Pliant's lead product candidate, bexotegrast (PLN-74809), is an oral small molecule dual selective inhibitor of αvß6 and αvß1 integrins that is in development in the lead indications for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in IPF and PSC and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant is currently conducting Phase 2a trials of bexotegrast in the lead indications of IPF and PSC. Pliant has also developed PLN-1474, a small molecule, selective inhibitor of αvß1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis, which Pliant has transferred to Novartis pursuant to our development partnership. Pliant is initiating a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. In addition to clinical stage programs, Pliant currently has a preclinical program targeting muscular dystrophies. For additional information about Pliant Therapeutics, visit www.PliantRx.com and follow us on Twitter, LinkedIn, Facebook and YouTube.
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