Pliant Therapeutics Reports Promising 50% Response Rate for PLN-101095 in Checkpoint-Resistant Solid Tumors
核心洞察
Pliant Therapeutics completed enrollment of its Phase 1 trial for PLN-101095, an oral dual integrin inhibitor designed to overcome immune checkpoint resistance in solid tumors (搜索).
Interim data showed PLN-101095 achieved a 50% objective response rate in the third dose cohort and was well tolerated across all tested doses.
The company expects to report complete trial data including results from the two highest dose cohorts by the end of 2025.
Pliant Therapeutics has completed enrollment of its Phase 1 clinical trial evaluating PLN-101095, an oral dual integrin inhibitor targeting solid tumors (搜索) resistant to immune checkpoint inhibitors. The South San Francisco-based biotechnology company announced that data from all five dose cohorts, including the two highest doses, is expected by the end of 2025.
PLN-101095 is designed as a small molecule dual selective inhibitor of αvβ8 and αvβ1 integrins that aims to overcome checkpoint resistance by blocking TGF-β (搜索) activation in the tumor microenvironment. The Phase 1 open-label, dose-escalation trial is testing PLN-101095 both as monotherapy and in combination with pembrolizumab in patients with solid tumors (搜索) that are resistant to immune checkpoint inhibitors.
Encouraging Interim Efficacy Results
In March 2025, Pliant reported interim data showing PLN-101095 was well tolerated and demonstrated an objective response rate of 50% in the third of five ascending dose cohorts. The trial has now completed enrollment across all five dose cohorts, positioning the company to provide comprehensive efficacy and safety data from the complete dose range.
"During the third quarter, our team continued to advance our portfolio while winding down activities surrounding the BEACON-IPF trial," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. "Looking ahead, we continue to evaluate a range of opportunities to create shareholder value."
Strategic Refocus Following BEACON-IPF Discontinuation
The company is completing close-out activities for its BEACON-IPF Phase 2b/3 clinical trial of bexotegrast in the fourth quarter of 2025, with full results to be submitted for future publication. The discontinuation of this idiopathic pulmonary fibrosis (搜索) program has allowed Pliant to significantly reduce operating expenses and focus resources on its oncology pipeline.
Financial Impact of Strategic Restructuring
Pliant's third quarter 2025 financial results reflect the strategic shift in focus. Research and development expenses decreased to $17.9 million compared to $47.8 million in the prior-year quarter, primarily driven by the discontinuation of BEACON-IPF. General and administrative expenses also declined to $10.3 million from $14.3 million, due to lower personnel-related costs from workforce restructuring.
The company's net loss improved to $26.3 million compared to $57.8 million in the third quarter of 2024. As of September 30, 2025, Pliant maintained a strong cash position with $243.3 million in cash, cash equivalents, and short-term investments. In October, the company completed voluntary prepayment of all outstanding debt under its loan agreement with Oxford Finance LLC (搜索).
Expanding Integrin-Based Pipeline
Beyond PLN-101095, Pliant has received regulatory clearance for a Phase 1 study of PLN-101325, a monoclonal antibody agonist of integrin α7β1 targeting muscular dystrophies (搜索). The company's early-stage platform includes preclinical research focused on tissue-specific delivery and internalization of drug payloads utilizing integrin receptor-binding molecules.