Pliant Therapeutics Announces Presentation of PLN-101095 Preclinical and Clinical Data at the 2026 Annual Meeting of the Society for Immunotherapy of Cancer

Early immune activation biomarkers during PLN-101095 monotherapy were associated with later clinical response after pembrolizumab initiation.

Rhea-AI Summary

Pliant Therapeutics (Nasdaq: PLRX) presented preclinical findings and new clinical biomarker analyses for PLN-101095 at the Society for Immunotherapy of Cancer annual meeting.

Preclinical work combining blockade of integrins αvβ8 and αvβ1 with anti-PD-1 treatment showed improved anti-tumor activity and survival. In the Phase 1 trial, early increases in immune activation biomarkers during PLN-101095 monotherapy were associated with subsequent clinical response after pembrolizumab was added; this was an association, not proof of causation.

The ongoing FORTIFY Phase 1a/1b trial evaluates the combination in advanced or metastatic solid tumors resistant to immune checkpoint inhibitors. Its Phase 1b expansion is enrolling cohorts with non-small cell lung cancer, tumors with high tumor mutational burden, or clear cell renal cell carcinoma. Treatment starts with PLN-101095 alone before pembrolizumab is added.

Positive

• Minor pointPreclinical combination findings showed improved anti-tumor activity and survival with integrin blockade plus anti-PD-1 treatment.
• Minor pointPhase 1 biomarkers showed early immune activation associated with subsequent clinical response after pembrolizumab initiation.
• Minor pointFORTIFY Phase 1b expansion is enrolling three patient cohorts with immune checkpoint inhibitor-refractory cancers.

Negative

• None.

Key Figures

Monotherapy lead-in: 14 days PLN-101095 dose: 1,000 mg twice daily Phase 1b cohorts: 3 cohorts

Monotherapy lead-in

14 days

PLN-101095 before pembrolizumab is added

PLN-101095 dose

1,000 mg twice daily

Phase 1b trial monotherapy period

Phase 1b cohorts

3 cohorts

NSCLC, high tumor mutational burden, or clear cell renal cell carcinoma

Previous Clinical trial Reports

1 past event · Latest: Apr 18

Same Type 1 event

1. Apr 18

   Phase 1 data

   24h Move

   -3.0%

   Prior Phase 1 combination data reported confirmed responses, supplying clinical-response context for the new biomarker analysis.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

pharmacokinetics, immune checkpoint inhibitor, tumor microenvironment, cytotoxic CD8+ T cells

4 terms

pharmacokinetics medical

"safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

immune checkpoint inhibitor medical

"patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors"

An immune checkpoint inhibitor is a type of medicine that helps the body's immune system recognize and attack cancer cells more effectively. It works by blocking certain signals that cancer uses to hide from immune defenses, allowing the immune system to target tumors. This breakthrough has led to new cancer treatments, making immune checkpoint inhibitors an important area of growth and innovation in the healthcare industry.

tumor microenvironment medical

"modulation of fibroblastic cell populations in the tumor microenvironment"

The tumor microenvironment is the immediate area surrounding a cancer cell, made up of nearby cells, blood vessels, and support structures that influence how the cancer grows and spreads. It functions like a bustling neighborhood that can either help or hinder the tumor’s development. For investors, understanding changes in this environment can signal the effectiveness of treatments and potential shifts in a cancer-related market.

cytotoxic CD8+ T cells medical

"increased infiltration and activation of cytotoxic CD8+ T cells"

A subtype of white blood cell that recognizes and kills infected or abnormal cells; they are called CD8+ because they display the CD8 protein on their surface and are “cytotoxic” because they directly destroy target cells. They find targets by using their T-cell receptor to detect specific peptide fragments presented on MHC class I molecules, then release toxic proteins (for example perforin and granzymes) or engage death-receptor pathways to induce target-cell death. They must be activated by antigen presentation and supporting immune signals before they become fully cytotoxic, and they act only against cells showing the specific antigen-MHC I combination.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Pliant Therapeutics report about PLN-101095 clinical biomarkers?

Early increases in immune activation biomarkers during PLN-101095 monotherapy were associated with subsequent clinical response after pembrolizumab initiation in the Phase 1 trial. The findings support a hypothesis about immune activation rather than establishing causation.

How is PLN-101095 administered in Pliant Therapeutics' FORTIFY trial?

Patients receive 1,000 mg twice daily of PLN-101095 alone for 14 days, after which pembrolizumab is added as combination therapy. PLN-101095 is administered orally.

What does Pliant Therapeutics' FORTIFY trial evaluate?

The open-label Phase 1a/1b trial evaluates safety, tolerability, pharmacokinetics—how the drug moves through the body—and preliminary evidence of anti-tumor activity. It includes dose escalation and indication expansion in patients with immune checkpoint inhibitor-refractory advanced or metastatic solid tumors.