Pliant Therapeutics, Inc. (NASDAQ: PLRX) is capturing attention with promising trial results for its cancer therapy, despite a sharp stock decline.
Pliant Therapeutics on Thursday released interim data from its Phase 1 dose escalation trial of PLN-101095.
The trial evaluated PLN-101095 in combination with Merck & Co. Inc.’s (NYSE: MRK) Keytruda (pembrolizumab) in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors.
PLN-101095 is the fourth clinical-stage drug candidate to be generated from Pliant’s integrin-based drug development platform.
In a heavily pretreated patient population with advanced and/or metastatic solid tumors refractory to ICIs, PLN-101095 demonstrated antitumor activity in combination with pembrolizumab.
Data
Across the three highest dose cohorts, there were four responders, consisting of one confirmed complete response (CR) and three partial responses (PR) (two confirmed, one unconfirmed) out of the 10 secondary ICI refractory patients.
Clinical responses were observed in patients with cholangiocarcinoma, melanoma, head and neck squamous cell carcinoma, and non-small cell lung cancer (NSCLC).
The median time on treatment in these patients is 15 months. 60% of secondary refractory patients demonstrated stable disease or tumor reduction.
All responding patients showed increases (4- to 13-fold vs. baseline) in plasma interferon gamma (IFN-γ) after a 14-day run-in period of monotherapy with PLN-101095.
IFN-γ is a cytokine measured in the blood that plays a key role in the immune system’s response to infections and other diseases.
No non-responders showed meaningful increases in IFN-γ.
PLN-101095 was generally well tolerated across all doses tested and demonstrated a dose-dependent pharmacokinetic profile.
What Next?
Pliant plans to accelerate the development of PLN-101095 with the initiation of a Phase 1b indication expansion trial assessing NSCLC and other tumor types with a strong mechanistic rationale for integrin inhibition in 2026.
Final data from this trial will be presented at an upcoming scientific conference.
PLRX Price Action: Pliant Therapeutics shares were down 20.45% at $1.22 at the time of publication on Thursday. The stock is trading near its 52-week low of $1.10, according to Benzinga Pro data.