Pliant Therapeutics Posts 4 Responders with 71% Tumor Reduction, Q2 Phase Ib Planned
Early Phase I data for oral integrin inhibitor PLN-101095 showed four responders (three PRs, one CR) with an average 71% tumor reduction at ≥1,000 mg BID and manageable mild-to-moderate rash. Pliant will start Phase Ib pembrolizumab expansion in Q2 for NSCLC, high TMB and RCC backed by $211M cash runway.
1. Pivot to Oncology
Following discontinuation of its fibrosis program last year, Pliant redirected its integrin-targeting small molecule platform to oncology, positioning itself as an integrin small-molecule specialist. Management continues to evaluate external clinical-stage assets for in-licensing or acquisition that could complement internal oncology efforts.
2. Early Phase I Data for PLN-101095
In initial Phase I monotherapy and pembrolizumab combination cohorts, PLN-101095 dosed at ≥1,000 mg twice daily produced four clinical responses—three partial and one complete—across cholangiocarcinoma, melanoma, NSCLC and head and neck cancer, with an average tumor reduction of 71% and chiefly mild-to-moderate rash.
3. Phase Ib Expansion Plans
Pliant plans to initiate a Phase Ib dose-expansion study in Q2 combining PLN-101095 with pembrolizumab in NSCLC, high tumor mutational burden and renal cell carcinoma cohorts. The study will not select based on interferon gamma biomarkers but aims to refine indications and will deliver data next year.
4. Financial Position and Future Pipeline
The company holds approximately $211 million pro forma cash, sufficient to fund operations into at least H2 2028. Beyond oncology, Pliant is developing a targeted siRNA delivery platform using integrin-binding molecules and exploring business development opportunities to bolster its integrin small-molecule library.