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Pliant Therapeutics, Inc. reports clinical and corporate developments for a clinical-stage biopharmaceutical company focused on integrin-based therapeutics. Its lead program, PLN-101095, is an oral small-molecule dual-selective inhibitor of αvβ8 and αvβ1 integrins being developed for solid tumors, including immune checkpoint inhibitor-refractory advanced or metastatic disease.
Company updates commonly cover Phase 1 and Phase 1b oncology data, scientific-conference presentations, combination studies with pembrolizumab, financial results, and healthcare investor-conference participation. Pliant also describes preclinical platform work using integrin receptor-binding molecules for tissue-specific delivery and internalization of drug payloads, including programs directed to skeletal muscle cells, adipocytes, and renal cells.
Pliant Therapeutics (Nasdaq: PLRX) reported that the U.S. FDA has granted Fast Track designation to PLN-101095, an oral dual selective inhibitor of αvβ8 and αvβ1 integrins, in combination with pembrolizumab for the potential treatment of solid tumors resistant to immune checkpoint inhibitors (ICIs).
PLN-101095 is being studied in the Phase 1a/1b FORTIFY trial (NCT06270706), with data expected in 2027. According to Pliant Therapeutics, Fast Track status may allow more frequent FDA interactions, rolling New Drug Application submissions and eligibility for priority review if criteria are met.
Pliant Therapeutics (Nasdaq: PLRX) reported second quarter 2026 results and a corporate update, highlighting strong, ahead-of-schedule enrollment in FORTIFY, its Phase 1a/1b trial of PLN-101095 with pembrolizumab in ICI-refractory solid tumors, targeting up to 102 patients across NSCLC, ccRCC and high tumor mutational burden cohorts. Updated Phase 1 monotherapy biomarker data showed coordinated increases in IFN-γ, CXCL9 and granzyme-B only in responding patients, supporting a potential tumor microenvironment shift. Pliant advanced its integrin-targeted siRNA delivery platform and plans further detail in 2H 2026. Q2 2026 R&D and G&A expenses fell to $16.7M and $7.1M, respectively, with net loss narrowing to $22.4M and cash, cash equivalents and short-term investments of $159.6M, expected to fund operations into 2H 2028. The company also added oncology leaders Flavia Borellini and Robert Iannone to its board.
Pliant Therapeutics (Nasdaq: PLRX) announced the appointment of Flavia Borellini, Ph.D. and Robert Iannone, M.D., M.S.C.E. to its Board of Directors, adding extensive global oncology drug development, regulatory and operational experience as the company advances its integrin-based pipeline, including PLN-101095.
According to Pliant Therapeutics, Dr. Borellini brings more than 25 years of leadership across Acerta Pharma, AstraZeneca and Genentech, where she led development and approvals for multiple targeted therapies. Dr. Iannone contributes over two decades of clinical development and regulatory leadership from Jazz Pharmaceuticals, Immunomedics, AstraZeneca and Merck.
Pliant Therapeutics (Nasdaq: PLRX) will present new data on PLN-101095 at the 2026 ASCO Annual Meeting in Chicago from May 29 to June 2, 2026.
The poster highlights FORTIFY, a Phase 1b indication expansion trial in ICI-refractory advanced or metastatic solid tumors.
Atisama Therapeutics, an Australian clinical-stage biotech, reported that its lead candidate RB042 has progressed into multiple ascending dose (MAD) cohorts in an ongoing Phase 1 trial in healthy volunteers and healthy smokers, with safety and tolerability demonstrated to date.
The company also appointed Dr. Bernard Coulie, President and CEO of Pliant Therapeutics (NASDAQ: PLRX), as Chair of its Board of Directors, adding extensive pulmonary disease and governance experience as RB042 advances through early clinical development.
Pliant Therapeutics (Nasdaq: PLRX) reported a Q1 2026 net loss of $20.0 million, down from $56.2 million, with research and development expenses cut to $13.6 million and general and administrative expenses to $8.2 million. Cash and investments totaled $172.4 million, expected to fund operations into the second half of 2028.
The first participant was dosed in FORTIFY, a Phase 1b indication expansion trial of PLN-101095 in ICI-refractory tumors. Updated Phase 1 data showed one confirmed complete response and two confirmed partial responses in combination with pembrolizumab, with PLN-101095 generally well tolerated.
Pliant Therapeutics (Nasdaq: PLRX) will participate in the RBC Capital Markets Global Healthcare Conference on May 19, 2026. Pliant’s CEO Bernard Coulie, M.D., Ph.D., and CFO Keith Cummings, M.D., will take part in a fireside chat at 11:30 a.m. ET. A live webcast will be available via the company’s Investor Relations Events & Presentation page, and a replay will be archived for 30 days following the event.
Pliant Therapeutics (Nasdaq: PLRX) announced dosing of the first participant in FORTIFY, a Phase 1b open-label indication expansion trial of oral PLN-101095 plus pembrolizumab in ICI-refractory advanced or metastatic solid tumors.
The trial enrolls three expansion cohorts (NSCLC, clear cell RCC, high tumor mutational burden tumors). PLN-101095 is dosed 1,000 mg twice daily for 14 days as monotherapy before adding pembrolizumab. Enrollment is underway; interim data are expected in 2027.
Pliant Therapeutics (Nasdaq: PLRX) presented updated Phase 1a/1b data for PLN-101095 plus pembrolizumab at AACR 2026, with data cutoff Feb 27, 2026. In three confirmed responders median time on treatment was 19 months and average baseline tumor reduction was 89%. PLN-101095 at doses ≥1000 mg BID achieved sustained IC90 coverage; few discontinuations (n=2) were reported and rash was the most common TRAE (all Grade 1–2). A Phase 1b indication expansion is underway with interim data expected in 2027.
Pliant Therapeutics (NASDAQ: PLRX) announced an oral presentation of Phase 1 data for PLN-101095 at the AACR Annual Meeting, April 17-22, 2026, in San Diego.
The Clinical Trials Mini Symposium presentation on April 18, 2026 will report first-in-human results for PLN-101095 as monotherapy and with pembrolizumab in ICI-refractory solid tumors.