Pliant Therapeutics

PLN-101095 Combined with Pembrolizumab Shows Promising Activity in ICI-Refractory Solid Tumors

2 months ago

• Interim data from a Phase 1 trial showed 50% objective response rate in patients receiving PLN-101095 with pembrolizumab at the highest dose tested (1000 mg BID), with confirmed partial responses across multiple tumor types including NSCLC, melanoma, and cholangiocarcinoma. • The integrin αvβ8 and αvβ1 inhibitor PLN-101095 was generally well tolerated across all doses, with rash (33.3%), fatigue (22.2%), and squamous cell carcinoma/keratoacanthoma (22.2%) being the most common treatment-emergent adverse events. • The novel combination targets the TGF-β pathway to potentially overcome immune checkpoint inhibitor resistance by increasing immune cell infiltration into the tumor microenvironment, offering hope for patients with limited treatment options.

Neumora Therapeutics Announces Major Leadership Restructuring as Paul Berns Takes CEO Role

3 months ago

• Neumora Therapeutics undergoes significant leadership changes with Paul L. Berns, co-founder and executive chair, assuming the role of CEO and chairman of the Board effective February 14, 2025. • The clinical-stage biopharmaceutical company is advancing seven neuroscience programs, with three clinical-stage programs expected to deliver data readouts in 2025, including Phase 3 results for navacaprant in depression. • Joshua Pinto, Ph.D., has been appointed as president, while Bill Aurora, Pharm.D., and Michael Milligan take on roles as chief operating and development officer and chief financial officer, respectively.

Pliant Therapeutics Halts IPF Drug Trial Following Safety Concerns, Stock Plummets

3 months ago

• Pliant Therapeutics has suspended enrollment and dosing in their Phase 2b/3 trial of bexotegrast for idiopathic pulmonary fibrosis following safety monitoring board recommendations. • RBC Capital Markets responds by downgrading Pliant Therapeutics stock from Outperform to Sector Perform, dramatically reducing price target from $45 to $4. • The trial suspension could either lead to protocol modifications in consultation with FDA or potentially signal serious safety concerns that might end the program entirely.

Pliant Therapeutics Halts BEACON-IPF Trial Following Safety Board Review

3 months ago

• Pliant Therapeutics has temporarily suspended enrollment and dosing in its Phase IIb/III BEACON-IPF trial of Bexotegrast following recommendations from the independent Data Safety Monitoring Board. • The clinical trial pause impacts the study's original timeline, which aimed to complete Phase IIb enrollment of 360 idiopathic pulmonary fibrosis patients by Q1 2025. • The company's stock experienced significant decline, dropping 34.81% in regular trading and an additional 58% in after-hours trading to $3.27.

Alumis and Acelyrin Announce Merger to Create $737M Clinical-Stage Biopharma Company

4 months ago

• Alumis and Acelyrin have agreed to merge in an all-stock transaction, creating a combined entity with $737 million in cash runway extending into 2027. • The merged company will retain the Alumis name and prioritize development of two TYK2 inhibitors targeting conditions including psoriasis, lupus, and multiple sclerosis. • Acelyrin's thyroid eye disease drug lonigutamab is included in the deal but will undergo strategic review to assess its market differentiation potential.

Advanced Liver Cancer Market to Reach $11.13 Billion by 2035, Driven by Early Detection and Novel Therapies

4 months ago

• The advanced liver cancer market is projected to grow from $2.31 billion in 2024 to $11.13 billion by 2035, exhibiting a CAGR of 15.38%, according to IMARC Group research. • Advancements in early detection technologies, including multi-modal MRI, contrast-enhanced ultrasound, and liquid biopsy, are significantly improving diagnosis and expanding treatment options for patients. • Novel therapeutic approaches, including targeted therapies, immunotherapies, and combination treatments, are transforming patient outcomes, with drugs like Namodenoson showing promising results in clinical trials.

Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments

5 months ago

• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions. • Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways. • These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets. • The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.

Trevi Therapeutics' Haduvio Phase 2b Trial for IPF-Related Chronic Cough Nears Completion

5 months ago

• Trevi Therapeutics' Phase 2b CORAL trial evaluating Haduvio for chronic cough in IPF patients has reached 75% enrollment, indicating strong progress. • The trial, involving 160 patients across 10 countries, is assessing the efficacy of three Haduvio doses versus placebo over six weeks. • Top-line data from the CORAL trial is anticipated in the first half of 2025, offering hope for a potential first-in-class treatment. • A prior Phase 2a trial demonstrated Haduvio's significant reduction in cough frequency in IPF patients, supporting further investigation.

Rusfertide Achieves Primary Endpoint in Phase 3 VERIFY Trial for Polycythemia Vera

5 months ago

• Rusfertide significantly reduced the need for phlebotomies in polycythemia vera (PV) patients, with 77% achieving clinical response compared to 33% on placebo. • The VERIFY trial met all key secondary endpoints, including hematocrit control and improved patient-reported outcomes, demonstrating comprehensive efficacy. • The hepcidin mimetic was well-tolerated, with no new safety concerns, suggesting a favorable risk-benefit profile for PV patients. • Protagonist and Takeda plan to submit detailed results for presentation at upcoming medical conferences and to regulatory agencies for potential approval.

IPF Drug Development Heats Up with Novel Targets and Clinical Advances

6 months ago

• Refoxy Pharma secured $9.58 million to advance its FOXO3-targeting IPF drug, RP-01, aiming to modulate tissue repair mechanisms. • Boehringer Ingelheim plans to submit an NDA for nerandomilast after a successful Phase 3 trial showing improved lung function in IPF patients. • Endeavor BioMedicines' ENV-101 and Insilico Medicine's ISM001-055 demonstrate promising results in improving lung function and reducing fibrosis in Phase 2 trials. • Bristol Myers Squibb's BMS-986278, an LPA1 antagonist, received FDA Breakthrough Therapy Designation after reducing the rate of FVC decline by 69% in a Phase 2 study.

Insilico Medicine's AI-Designed Drug Shows Promise in Phase IIa IPF Trial

8 months ago

• Insilico Medicine's ISM001-055 met its primary safety endpoint and secondary efficacy endpoints in a Phase IIa trial for idiopathic pulmonary fibrosis (IPF). • The AI-designed drug demonstrated a dose-dependent improvement in forced vital capacity (FVC), a key measure of lung function, in IPF patients. • The company plans to engage with regulatory authorities to design a Phase IIb study, exploring extended treatment durations and larger patient cohorts. • ISM001-055 targets TNIK, offering a novel approach to treating IPF by addressing both fibrosis and inflammation, potentially modifying the disease.