Pliant Therapeutics has reported interim results from its ongoing Phase I dose escalation trial of PLN-101095, along with pembrolizumab in patients with solid tumours.
The drug evaluation is intended to treat patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic tumours.
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PLN-101095 is a dual selective, oral, small molecule alpha-v beta-8 (αvβ8) and αvβ1 inhibitor, and is the fourth clinical-stage drug developed from the company’s integrin-based platform.
In this study, the drug candidate combined with pembrolizumab showed anti-tumour activity in patients whose advanced or metastatic solid tumours were refractory to ICIs.
Four responses were observed out of ten secondary ICI-refractory participants, among the three highest dose groups, including three partial responses (two confirmed, one unconfirmed) and one confirmed complete response.
Clinical outcomes were noted in patients with head and neck squamous cell carcinoma, cholangiocarcinoma, non-small cell lung cancer, and melanoma.
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By GlobalDataAs of 30 November 2025, the median time on treatment was 15 months, and 60% of secondary refractory patients achieved tumour reduction or stable disease.
All those who responded showed significant increases in plasma interferon gamma (IFN-γ), ranging from four-fold to 13-fold versus baseline, after a 14-day monotherapy run-in with PLN-101095.
The drug was generally observed to be well tolerated throughout all tested doses, with only two discontinuations because of adverse events, and showed a dose-dependent pharmacokinetic profile.
In the trial, 16 patients with nine different tumour types were enrolled in five groups.
Dosing regimens for PLN-101095 monotherapy included 250mg twice a day (BID) for one participant, 500mg BID for two, 1,000mg BID for six subjects, 1,000mg three times daily for four participants, and 2,000mg BID for three patients.
Following monotherapy, pembrolizumab was dosed at 200mg intravenously every three weeks.
Pliant plans to commence a Phase Ib indication expansion trial next year to assess PLN-101095 in non-small cell lung cancer (NSCLC) and other tumour types.
Pliant Therapeutics CEO Bernard Coulie said: “These data surpassed our expectations given the number of clinical responses observed with PLN-101095 in difficult-to-treat ICI refractory tumours in similar Phase I trials.
“The growing validation of PLN-101095’s mechanism of action, including the supportive IFN-γ biomarker correlation, gives us confidence in PLN-101095’s development. We believe PLN-101095 has the potential to create new treatment options for patients in need and deliver significant value for investors.”
In March 2023, Pliant started participant enrolment in the Phase IIa INTEGRIS-PSC trial of bexotegrast (PLN-74809) at 320mg doses in patients with primary sclerosing cholangitis (PSC).
