Press Release

SOUTH SAN FRANCISCO, Calif., Nov. 09, 2026 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), today announced the presentation of preclinical proof-of-concept data and new clinical biomarker analyses related to PLN-101095 at the 41^st Annual Meeting of the Society for Immunotherapy of Cancer (SITC).

Poster Presentations

Title: Selective targeting of integrins αvβ8 and αvβ1 improves anti-tumor responses mediated by immune checkpoint inhibition

Nika Rajabian, Ph.D., Postdoctoral Fellow from the National Cancer Institute, presented data demonstrating that blocking of integrins αvβ8 and αvβ1 in combination with anti-PD-1 reduced TGF-β signaling leading to modulation of fibroblastic cell populations in the tumor microenvironment and increased infiltration and activation of cytotoxic CD8⁺ T cells. This resulted in improved anti-tumor activity and survival. Researchers concluded that these data provided rationale for an ongoing, first-in-human phase I clinical trial (NCT06270706) of PLN-101095 in combination with pembrolizumab in solid cancers.

The above reflects work done under a collaboration agreement between the National Cancer Institute and Pliant Therapeutics.

Title: Plasma biomarkers of immune activation predict sensitization to immune checkpoint inhibition (ICI) in patients with advanced solid tumors receiving dual αvβ8/αvβ1 integrin inhibitor PLN-101095

Martin L. Decaris, Ph.D., Vice President of Translational Sciences at Pliant Therapeutics presented new biomarker data from the Phase 1 trial of PLN-101095 showing that early induction of immune activation biomarkers during PLN-101095 monotherapy was associated with subsequent clinical response following pembrolizumab initiation. These findings support the hypothesis that TGF-β pathway inhibition promotes immune activation, T-cell recruitment into the tumor microenvironment, and enhanced cytotoxic effector function.

This poster is available in the Publications section of Pliant’s website www.PliantRx.com.

FORTIFY - PLN-101095 Phase 1b Indication Expansion Trial

PLN-101095 is currently being evaluated in a Phase 1a/1b open-label, dose-escalation and indication expansion trial (NCT06270706) to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095 when administered orally in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. The Phase 1b portion of FORTIFY is an indication expansion trial that is currently enrolling three cohorts of patients with non-small cell lung cancer (NSCLC), tumors with high tumor mutational burden or clear cell renal cell carcinoma. Patients will be treated for 14 days with PLN-101095 dosed at 1,000 mg twice daily as monotherapy, after which pembrolizumab will be added as combination therapy.

About Pliant Therapeutics, Inc.

Pliant Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of integrin-based therapeutics. Pliant’s lead program is PLN-101095, an oral, small molecule, dual-selective inhibitor of α_vß₈ and α_vß₁ integrins, that is being developed for the treatment of ICI-refractory advanced or metastatic solid tumors. PLN-101095 is being investigated in FORTIFY, a Phase 1b indication expansion trial enrolling patients with NSCLC, tumors with high tumor mutational burden or clear cell renal cell carcinoma. Pliant’s preclinical research is focused on tissue-specific delivery and internalization of drug payloads utilizing integrin receptor-binding molecules with programs focused on delivering siRNAs to skeletal muscle cells, adipocytes, and renal cells.

For additional information on Pliant, visit www.PliantRx.com and follow us on X, LinkedIn and Facebook.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include express or implied statements regarding ongoing clinical trial development of PLN-101095, including timing of enrollment and data; the potential benefits of PLN-101095; receipt of Fast Track designation and implications thereof; and Pliant’s plans for the continued development of PLN-101095 among others, including its integrin-based drug delivery platform. Because such statements deal with future events and are based on Pliant’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Pliant could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those related to the development and commercialization of Pliant’s product candidates, including any delays in Pliant’s ongoing or planned preclinical or clinical trials; the risks inherent in the drug development process, including obtaining regulatory approval, even with Fast Track Designation; the impact of current macroeconomic, geopolitical and marketplace conditions on Pliant’s business, operations, clinical supply and plans; Pliant’s reliance on single-source third parties located in foreign jurisdictions, including China, for critical aspects of Pliant development operations; risks regarding the accuracy of Pliant’s estimates of expenses and timing of development, its capital requirements and the sufficiency of its cash to support planned operations; and Pliant’s ability to obtain and maintain intellectual property protection for Pliant’s product candidates; among others. These and additional risks are discussed in the sections titled "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Risk Factors" in Pliant’s Quarterly Report on Form 10-Q for the period ended June 30, 2026, as filed with the Securities and Exchange Commission (SEC) and available on the SEC's website, as may be amended or supplemented with future SEC filings. Unless otherwise noted, Pliant is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

Investor and Media Contact:
Christopher Keenan
Vice President, Investor Relations and Corporate Communications
Pliant Therapeutics, Inc.
ir@pliantrx.com