Core Insights - Pliant Therapeutics, Inc. announced promising interim results from its Phase 1 clinical trial of PLN-101095, showing a 50% objective response rate in patients with advanced or metastatic solid tumors who are refractory to immune checkpoint inhibitors [2][5][6] Group 1: Clinical Trial Details - The trial is evaluating PLN-101095, an integrin αvβ8 and αvβ1 inhibitor, in combination with pembrolizumab in patients with ICI-refractory tumors [2][7] - Three partial responses were observed in cohort three at the highest tested dose of 1000 mg administered orally twice daily [2][5] - The trial has enrolled nine patients across three cohorts, with treatment durations of 14 days followed by combination therapy [3][5] Group 2: Efficacy Observations - Among the six patients treated at the 1000 mg BID dose, three confirmed partial responses were noted, with significant reductions in tumor sizes: 74% for NSCLC, 48% for cholangiocarcinoma, and 42% for melanoma [5][6] - Initial partial responses were observed at Week 10 for NSCLC, Week 34 for cholangiocarcinoma, and Week 18 for melanoma [5] Group 3: Safety and Tolerability - PLN-101095 was generally well tolerated across all doses tested, indicating a favorable safety profile [2][5][6] - The ongoing trial is currently enrolling the fourth cohort, which will evaluate PLN-101095 at a different dosing schedule of 1000 mg three times daily [6] Group 4: Company Background - Pliant Therapeutics is focused on developing novel therapeutics for fibrotic diseases, with PLN-101095 being a key candidate for treating solid tumors [8] - The company has received regulatory designations for its lead product candidate, bexotegrast, indicating its commitment to advancing innovative treatments [8]

32 sites are currently contracted in the INVINCIBLE-3 Study, and 25 patients have been screened Eight Swiss sites are activated in the INVINCIBLE-4 Study, and several patients have been screened Final sarcoma data from our first metastatic study and our INVINCIBLE-3 Study design was presented at the annual Connective Tissue Oncology Society Meeting in November 2024 Final data from our first neoadjuvant breast cancer study and our INVINCIBLE-4 Study design was presented at the annual San Antonio Breast Canc ...

Puma Biotechnology (PBYI) Q4 2024 Earnings Call February 27, 2025 04:30 PM ET Company Participants Mariann Ohanesian - Senior Director of Investor RelationsAlan Auerbach - Founder, Chairman, President, CEO & SecretaryJeffrey Ludwig - Chief Commercial OfficerMaximo F. Nougues - CFO & Principal Accounting OfficerHang Hu - AVP - Biotech Equity Research Conference Call Participants Edward White - MD & Senior Biotechnology AnalystMarc Frahm - Biotechnology Equity Research Analyst Operator Good afternoon. My name ...