Pharma Focus Asia

Pliant Therapeutics Announces FDA Clearance of Investigational New Drug Application for PLN-101095

Friday, February 03, 2023

Pliant Therapeutics 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 tumours that are resistant to immune checkpoint inhibitors (ICIs) is expected to initiate in the second quarter of 2023.

PLN-101095 represents the third programme to advance into clinical development, targeting a significant unmet need of cancer patients with a suboptimal response to immune checkpoint inhibitors. Depending upon the preclinical activity in tumour models with PLN-101095 in combination with immune checkpoint inhibitors, will be evaluated in patients with solid tumours.

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

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