Pliant Therapeutics Updates PLN-101095 Clinical Data
Pliant Therapeutics announced the presentation of updated data from its Phase 1 trial of PLN-101095, in combination with pembrolizumab, in patients with immune checkpoint inhibitor-refractory advanced or metastatic solid tumors. The oral presentation was made at the Clinical Trials Mini Symposium of the American Association for Cancer Research (AACR) 2026 Annual Meeting. All responding patients showed large increases in plasma interferon gamma after a 14-day run-in period of monotherapy with PLN-101095. At Week 10, all responders maintained more than a 2-fold increase in IFN-gamma. No non-responders showed meaningful increases in IFN- gamma. In addition to IFN- gamma increases, all responding patients showed elevated plasma PD-L1 levels, known to be induced by increased IFN-gamma and a predictor of an improved ICI response. As increases in IFN-gamma have the potential to serve as a biomarker of TGF-beta inhibition and an early indicator of PLN-101095 anti-tumor activity. Pliant anticipates further study of this biomarker as part of the expansion cohorts in the Phase 1b trial. PLN-101095 was generally well tolerated across all doses evaluated with few discontinuations due to adverse events. Rash was the most common treatment-related adverse event, all Grade 1 or 2, and the majority of events occurred within the first 2 days of the initial pembrolizumab dose. One Grade 3 TRAE was observed.
Trade with 70% Backtested Accuracy
Analyst Views on PLRX
About PLRX
About the author
Pliant Therapeutics Presents Updated Clinical Data for PLN-101095
- Significant Tumor Reduction: In heavily pretreated immune checkpoint inhibitor (ICI)-refractory patients, the combination of PLN-101095 and pembrolizumab demonstrated an average tumor reduction of 89%, with a median treatment duration of 19 months for three confirmed responders, indicating the potential efficacy of this therapy in hard-to-treat tumors.
- Biomarker Exploration: All responders exhibited a significant increase in plasma interferon gamma (IFN-γ) levels, ranging from 4 to 13-fold after a 14-day monotherapy, and maintained over a 2-fold increase at Week 10, suggesting that PLN-101095 may serve as a biomarker for TGF-β inhibition and an early indicator of its anti-tumor activity.
- Trial Expansion: Pliant has initiated a Phase 1b trial enrolling patients with NSCLC and high tumor mutational burden, where they will receive PLN-101095 monotherapy followed by pembrolizumab, with interim data expected in 2027 to further validate the clinical value of this combination therapy.
- Good Safety Profile: PLN-101095 was generally well tolerated across all doses, with only two discontinuations due to adverse events, and most treatment-related adverse events were Grade 1 or 2 rashes, demonstrating the safety and feasibility of this drug in clinical applications.
Pliant Therapeutics Reports Q4 EPS In-Line with Expectations
- Earnings Performance: Pliant Therapeutics reported a Q4 GAAP EPS of -$0.38, aligning with market expectations, which indicates the company's financial stability amidst ongoing challenges.
- Cash Reserves: As of December 31, 2025, the company holds $192.4 million in cash, cash equivalents, and short-term investments, which is projected to fund operations into the second half of 2028, thereby enhancing investor confidence in its operational sustainability.
- Market Opportunity: The expiration of the poison pill plan has created a reverse arbitrage opportunity for Pliant Therapeutics, potentially offering investors new strategic avenues and reflecting market interest in the company's future prospects.
- Industry Engagement: The company presented at the Oppenheimer 36th Annual Healthcare Life Sciences Conference, further elevating its visibility and influence within the industry.
Pliant Therapeutics Shifts Focus to Oncology, Showcases Early PLN-101095 Data
- Strategic Shift: Pliant Therapeutics has pivoted from fibrosis to oncology, focusing on its integrin small-molecule platform while evaluating external assets for potential in-licensing or acquisition, indicating a proactive approach in a new therapeutic area.
- Clinical Data Highlights: Early Phase I data for oral PLN-101095 showed activity at doses of ≥1,000 mg BID with four clinical responders and an average tumor reduction of approximately 71%, suggesting significant potential efficacy across multiple tumor types and laying the groundwork for future studies.
- Strong Financial Position: Pliant reported approximately $211 million in cash, expected to sustain operations into at least the second half of 2028, demonstrating the company's financial stability while advancing its oncology initiatives.
- Future Plans: The company plans to initiate a Phase Ib expansion study of PLN-101095 in combination with pembrolizumab in Q2, focusing on specific indications like non-small cell lung cancer, which is anticipated to yield more data and development opportunities in oncology.
Combination of Pliant Cancer Drug and Merck's Keytruda Enhances Treatment Responses in Challenging Tumors
Pliant Therapeutics' Trial Results: Pliant Therapeutics released promising interim data from its Phase 1 trial of PLN-101095, showing antitumor activity in combination with Merck's Keytruda in patients with advanced solid tumors that are refractory to immune checkpoint inhibitors.
Clinical Responses Observed: Among the heavily pretreated patient population, there were four responders, including one complete response and three partial responses, with clinical responses noted in various cancer types such as cholangiocarcinoma and melanoma.
IFN-γ Levels and Tolerability: Responding patients exhibited significant increases in plasma interferon gamma levels, while PLN-101095 was generally well tolerated, demonstrating a dose-dependent pharmacokinetic profile.
Stock Performance and Future Plans: Despite the positive trial results, Pliant's stock fell by over 20%, trading near its 52-week low, while the company plans to initiate a Phase 1b trial in 2026 to further explore PLN-101095's efficacy in non-small cell lung cancer and other tumor types.
JP Morgan Lowers Pliant Therapeutics Rating to Underweight
Real-time Intelligence: Benzinga Pro offers traders the fastest news alerts to help them make informed decisions in the stock market.
Exclusive Community: Joining Benzinga Pro connects users with over 10,000 serious traders and provides access to exclusive stories and insights from Benzinga reporters.
Biotech Stocks Surge in After-Hours Trading Following Trial News, Insider Purchases, and Conference Excitement
Biotech Stock Movements: Several small- and mid-cap biotech stocks experienced significant gains in after-hours trading on September 9, 2025, driven by clinical updates, insider buying, and upcoming investor conferences, with notable performances from Immutep, Nautilus Biotechnology, and Pliant Therapeutics.
Immutep's Clinical Trial Update: Immutep's shares rose 4.37% after announcing that data from its Phase II trial for eftilagimod alpha will be presented at the CTOS 2025 conference, focusing on a rare cancer with high unmet need.
Nautilus Biotechnology Insider Buying: Nautilus Biotechnology's stock surged 12.25% following CEO Sujal M. Patel's significant insider purchases, indicating confidence in the company's future, alongside participation in an upcoming investor conference.
Kura Oncology's Regulatory Milestones: Kura Oncology's shares increased 6.12% after presenting at the H.C. Wainwright conference, highlighting key developments and upcoming regulatory milestones for its menin inhibitor targeting acute myeloid leukemia.
Pliant Therapeutics Presents Updated Clinical Data for PLN-101095
- Significant Tumor Reduction: In heavily pretreated immune checkpoint inhibitor (ICI)-refractory patients, the combination of PLN-101095 and pembrolizumab demonstrated an average tumor reduction of 89%, with a median treatment duration of 19 months for three confirmed responders, indicating the potential efficacy of this therapy in hard-to-treat tumors.
- Biomarker Exploration: All responders exhibited a significant increase in plasma interferon gamma (IFN-γ) levels, ranging from 4 to 13-fold after a 14-day monotherapy, and maintained over a 2-fold increase at Week 10, suggesting that PLN-101095 may serve as a biomarker for TGF-β inhibition and an early indicator of its anti-tumor activity.
- Trial Expansion: Pliant has initiated a Phase 1b trial enrolling patients with NSCLC and high tumor mutational burden, where they will receive PLN-101095 monotherapy followed by pembrolizumab, with interim data expected in 2027 to further validate the clinical value of this combination therapy.
- Good Safety Profile: PLN-101095 was generally well tolerated across all doses, with only two discontinuations due to adverse events, and most treatment-related adverse events were Grade 1 or 2 rashes, demonstrating the safety and feasibility of this drug in clinical applications.
Pliant Therapeutics Reports Q4 EPS In-Line with Expectations
- Earnings Performance: Pliant Therapeutics reported a Q4 GAAP EPS of -$0.38, aligning with market expectations, which indicates the company's financial stability amidst ongoing challenges.
- Cash Reserves: As of December 31, 2025, the company holds $192.4 million in cash, cash equivalents, and short-term investments, which is projected to fund operations into the second half of 2028, thereby enhancing investor confidence in its operational sustainability.
- Market Opportunity: The expiration of the poison pill plan has created a reverse arbitrage opportunity for Pliant Therapeutics, potentially offering investors new strategic avenues and reflecting market interest in the company's future prospects.
- Industry Engagement: The company presented at the Oppenheimer 36th Annual Healthcare Life Sciences Conference, further elevating its visibility and influence within the industry.
Pliant Therapeutics Shifts Focus to Oncology, Showcases Early PLN-101095 Data
- Strategic Shift: Pliant Therapeutics has pivoted from fibrosis to oncology, focusing on its integrin small-molecule platform while evaluating external assets for potential in-licensing or acquisition, indicating a proactive approach in a new therapeutic area.
- Clinical Data Highlights: Early Phase I data for oral PLN-101095 showed activity at doses of ≥1,000 mg BID with four clinical responders and an average tumor reduction of approximately 71%, suggesting significant potential efficacy across multiple tumor types and laying the groundwork for future studies.
- Strong Financial Position: Pliant reported approximately $211 million in cash, expected to sustain operations into at least the second half of 2028, demonstrating the company's financial stability while advancing its oncology initiatives.
- Future Plans: The company plans to initiate a Phase Ib expansion study of PLN-101095 in combination with pembrolizumab in Q2, focusing on specific indications like non-small cell lung cancer, which is anticipated to yield more data and development opportunities in oncology.
Combination of Pliant Cancer Drug and Merck's Keytruda Enhances Treatment Responses in Challenging Tumors
Pliant Therapeutics' Trial Results: Pliant Therapeutics released promising interim data from its Phase 1 trial of PLN-101095, showing antitumor activity in combination with Merck's Keytruda in patients with advanced solid tumors that are refractory to immune checkpoint inhibitors.
Clinical Responses Observed: Among the heavily pretreated patient population, there were four responders, including one complete response and three partial responses, with clinical responses noted in various cancer types such as cholangiocarcinoma and melanoma.
IFN-γ Levels and Tolerability: Responding patients exhibited significant increases in plasma interferon gamma levels, while PLN-101095 was generally well tolerated, demonstrating a dose-dependent pharmacokinetic profile.
Stock Performance and Future Plans: Despite the positive trial results, Pliant's stock fell by over 20%, trading near its 52-week low, while the company plans to initiate a Phase 1b trial in 2026 to further explore PLN-101095's efficacy in non-small cell lung cancer and other tumor types.
JP Morgan Lowers Pliant Therapeutics Rating to Underweight
Real-time Intelligence: Benzinga Pro offers traders the fastest news alerts to help them make informed decisions in the stock market.
Exclusive Community: Joining Benzinga Pro connects users with over 10,000 serious traders and provides access to exclusive stories and insights from Benzinga reporters.
Biotech Stocks Surge in After-Hours Trading Following Trial News, Insider Purchases, and Conference Excitement
Biotech Stock Movements: Several small- and mid-cap biotech stocks experienced significant gains in after-hours trading on September 9, 2025, driven by clinical updates, insider buying, and upcoming investor conferences, with notable performances from Immutep, Nautilus Biotechnology, and Pliant Therapeutics.
Immutep's Clinical Trial Update: Immutep's shares rose 4.37% after announcing that data from its Phase II trial for eftilagimod alpha will be presented at the CTOS 2025 conference, focusing on a rare cancer with high unmet need.
Nautilus Biotechnology Insider Buying: Nautilus Biotechnology's stock surged 12.25% following CEO Sujal M. Patel's significant insider purchases, indicating confidence in the company's future, alongside participation in an upcoming investor conference.
Kura Oncology's Regulatory Milestones: Kura Oncology's shares increased 6.12% after presenting at the H.C. Wainwright conference, highlighting key developments and upcoming regulatory milestones for its menin inhibitor targeting acute myeloid leukemia.
