Pliant Therapeutics disclosed that its Phase 1 dose‑escalation study of the oral integrin inhibitor PLN‑101095, given with pembrolizumab, produced one confirmed complete response and three partial responses among 10 patients in the three highest dose cohorts, yielding a 40 % overall response rate in a heavily pre‑treated, immune‑checkpoint‑inhibitor‑refractory population. The median duration of response was 15 months as of November 30, 2025, indicating durable activity in a difficult‑to‑treat cohort.
The interim data also showed that all responding patients experienced large increases in plasma interferon‑γ after a 14‑day run‑in period of PLN‑101095 monotherapy, with 4‑ to 13‑fold elevations versus baseline. This biomarker signal supports the drug’s mechanism of action—blocking TGF‑β activation in the tumor microenvironment—and may guide patient selection in future trials.
Safety was manageable; only two patients discontinued because of adverse events and no dose‑limiting toxicities were reported. The safety profile aligns with the modest toxicity observed in earlier integrin‑inhibitor studies and supports the feasibility of combining PLN‑101095 with pembrolizumab.
Pliant’s Q3 2025 earnings beat analyst expectations, reporting an EPS of –$0.43 versus a consensus of –$0.53, largely due to disciplined cost control and the termination of the BEACON‑IPF fibrotic‑disease program, which reduced R&D spend. The company’s cash position is projected to fund operations through 2028, giving it the runway to pursue the oncology program while managing the cash burn associated with early‑stage development.
The company plans to launch a Phase 1b expansion trial in 2026, focusing on non‑small cell lung cancer and other tumor types with a strong mechanistic rationale. The expansion will test higher doses and longer treatment durations, aiming to confirm the durability of responses and further validate the IFN‑γ biomarker.
Pliant’s stock advanced 6.5 % in pre‑market trading on December 4, 2025, driven by the clinical efficacy signals, the biomarker validation, and the company’s strong financial runway. CEO Bernard Coulie noted that the data “surpassed our expectations” and that the biomarker “gives us confidence in PLN‑101095’s development.” The market reaction reflects optimism that the drug could address a significant unmet need in ICI‑refractory cancers while the company’s cash position mitigates immediate financial risk.
Bernard Coulie added that the discontinuation of BEACON‑IPF was disappointing but that the company remains committed to analyzing the full data set to evaluate next steps for bexotegrast’s development. This headwind is offset by the oncology program’s momentum and the company’s ability to fund future studies.
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