Pliant Therapeutics Reports Strong Enrollment in FORTIFY Trial of PLN-101095, Appoints Oncology Veterans to Board
核心洞察
Pliant Therapeutics' FORTIFY Phase 1b trial of PLN-101095 in ICI-refractory solid tumors is enrolling ahead of schedule, with interim data expected in 2027.
Updated Phase 1 biomarker data presented at AACR showed coordinated T-cell reactivation cascade, including increases in IFN-γ, CXCL9, and granzyme-B in all responders.
The company appointed Flavia Borellini, Ph.D. and Robert Iannone, M.D., M.S.C.E. to its Board of Directors, adding deep oncology drug development and commercialization expertise.
Pliant Therapeutics announced that enrollment in FORTIFY, its Phase 1b indication expansion trial of PLN-101095, is progressing ahead of schedule, the company reported alongside its second quarter 2026 financial results. The trial is evaluating the oral, small-molecule dual selective inhibitor of αvβ8 and αvβ1 integrins in combination with pembrolizumab for patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors.
"In the second quarter, we continued to execute across the portfolio, led by strong enrollment in FORTIFY," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. "With the appointments of Flavia and Robert to the board, Pliant now has deep global oncology drug development and commercialization expertise at this important time for our oncology program."
FORTIFY Trial Design and Progress
FORTIFY (NCT0670706) is a Phase 1a/1b open-label, dose-escalation and indication expansion trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab. The Phase 1b expansion portion will enroll up to 102 patients across three cohorts: non-small cell lung cancer (搜索) (NSCLC), clear cell renal cell carcinoma (搜索) (ccRCC), and tumors with high tumor mutational burden.
Patients receive PLN-101095 at a dose of 1,000 mg twice daily as monotherapy for 14 days, after which pembrolizumab is added as combination therapy. Interim data from the trial is expected in 2027.
Biomarker Data Presented at AACR
In July, at the American Association for Cancer Research's (AACR) Drug Discovery and Development conference, Pliant presented updated Phase 1 monotherapy biomarker data for PLN-101095. The findings demonstrated that all responding patients showed large increases in plasma interferon gamma (IFN-γ), a modulator of anti-tumor immunity, after 14 days of monotherapy.
Updated data revealed that blocking αvβ8 by PLN-101095 also resulted in increases in CXCL9, a recruiter of T cells, and granzyme-B, a marker for cytotoxic arming, in responding patients. The coordinated increases in IFN-γ, CXCL9, and granzyme-B after PLN-101095 monotherapy signal a shift in the tumor microenvironment that could potentially resensitize tumors to pembrolizumab. Notably, no non-responders experienced increases in these biomarkers.
Board Appointments Strengthen Oncology Expertise
Pliant appointed two seasoned oncology drug development leaders to its Board of Directors. Flavia Borellini, Ph.D., brings more than 25 years of executive management experience in the biopharmaceutical industry with a focus on the global development of targeted oncology drugs from preclinical to commercial stage. Robert Iannone, M.D., M.S.C.E., currently serves as Executive Vice President, Research and Development and Chief Medical Officer at Jazz Pharmaceuticals, and brings more than two decades of executive drug development and regulatory leadership, including the approval of several targeted and immuno-oncology medicines.
Integrin-Targeted Delivery Platform
Beyond its oncology program, Pliant continues to advance its proprietary integrin-targeted drug-delivery platform, which utilizes cell-specific integrin receptors to deliver drug payloads, including siRNAs, to selective tissue types. Current preclinical programs are focused on delivering siRNAs to skeletal muscle cells and other tissues. The company plans to provide additional detail on the platform, including initial treatment indications, in the second half of 2026.
Financial Position
For the second quarter of 2026, Pliant reported research and development expenses of $16.7 million, down from $32.2 million in the prior-year quarter, primarily due to completing close-out activities for BEACON-IPF, the Phase 2b/3 study of bexotegrast, in 2025 and reduced personnel-related expenses. General and administrative expenses were $7.1 million, compared to $13.4 million in the prior-year quarter.
Net loss for the quarter was $22.4 million, compared to $43.3 million in the same period last year. As of June 30, 2026, the company held cash, cash equivalents, and short-term investments of $159.6 million, which it expects to be sufficient to fund operations into the second half of 2028.