SOUTH SAN FRANCISCO - Pliant Therapeutics Inc. (NASDAQ:PLRX) presented updated data from its Phase 1 trial of PLN-101095 combined with pembrolizumab in patients with immune checkpoint inhibitor-refractory advanced or metastatic solid tumors at the American Association for Cancer Research 2026 Annual Meeting today.
The data, covering results through February 27, 2026, showed one confirmed complete response, two confirmed partial responses, and one unconfirmed partial response in patients with cholangiocarcinoma, non-small cell lung cancer, melanoma, and head and neck squamous cell carcinoma, according to a press release statement. The clinical progress comes as Pliant, with a market capitalization of $82.35 million, continues development despite posting a loss per share of $2.43 over the last twelve months. According to InvestingPro analysis, the stock appears slightly undervalued at current levels, trading at $1.33 compared to its Fair Value of $1.37.
The median time on treatment for the three confirmed responders was 19 months, with an average baseline tumor reduction of 89%. All responding patients showed plasma interferon gamma increases of 4- to 13-fold versus baseline after a 14-day run-in period of PLN-101095 monotherapy.
The trial enrolled 16 patients with ten different tumor types across five dose cohorts. Patients received PLN-101095 monotherapy at doses ranging from 250 mg to 2,000 mg twice daily for 14 days, followed by pembrolizumab at 200 mg intravenously every three weeks.
PLN-101095 was generally well tolerated with two discontinuations due to adverse events. Rash was the most common treatment-related adverse event, all Grade 1 or 2, with one Grade 3 event observed. An InvestingPro tip notes that while the company holds more cash than debt on its balance sheet, it is quickly burning through cash -- a critical consideration for investors monitoring the company's runway as it advances clinical trials.
The company has initiated a Phase 1b indication expansion trial enrolling three cohorts of patients with NSCLC, tumors with high tumor mutational burden, or clear cell renal cell carcinoma. Patients will receive PLN-101095 at 1,000 mg twice daily for 14 days before adding pembrolizumab. Interim data is expected in 2027.
PLN-101095 is an oral small molecule inhibitor of integrins αvβ8 and αvβ1 designed to prevent activation of transforming growth factor-β.
In other recent news, Pliant Therapeutics has announced that it will present Phase 1 trial data for its experimental cancer drug, PLN-101095, at the American Association for Cancer Research Annual Meeting. This presentation is scheduled for April 18, 2026, at the San Diego Convention Center and will be part of the Clinical Trials Mini Symposium. Dr. Timothy A. Yap from the University of Texas M.D. Anderson Cancer Center is set to present the data. Additionally, Piper Sandler has adjusted its price target for Pliant Therapeutics, lowering it to $3.00 from a previous target of $4.00. Despite the reduction, the firm maintains an Overweight rating on the stock. This adjustment follows Pliant Therapeutics' fourth-quarter and full-year 2025 earnings report during which the company provided updates on its PLN-101095 program. These developments are part of the company's ongoing efforts and strategies in its research and financial planning.