Clinical Trial News
ENV-101 Shows Promising Results in Idiopathic Pulmonary Fibrosis Treatment, Reducing Pulmonary Vessel Volume
• Endeavor BioMedicines' ENV-101 demonstrated significant reduction in pulmonary vessel volume and increase in lung volume in IPF patients during a Phase 2a clinical trial, with results presented at ATS 2025.
• The post-hoc analysis utilized Qureight's deep learning-based CT analytics, showing ENV-101 is the first therapeutic to reduce pulmonary vessel volume in IPF patients, a marker correlated with improved mortality.
• Endeavor has initiated the Phase 2b WHISTLE-PF trial to further evaluate ENV-101's efficacy across multiple doses in IPF, a devastating disease affecting over 150,000 Americans with limited treatment options.
Highlighted Clinical Trials:
Endeavor Biomedicines, Inc.
Posted 8/26/2021
Endeavor Biomedicines, Inc.
Posted 11/15/2024
FDA Advisory Committee Votes 6-2 in Favor of Daratumumab for High-Risk Smoldering Multiple Myeloma
• The FDA's Oncologic Drug Advisory Committee (ODAC) voted 6-2 that daratumumab (Darzalex Faspro) demonstrates a favorable benefit-risk profile for patients with high-risk smoldering multiple myeloma, potentially offering the first approved therapy for this precursor condition.
• The phase 3 AQUILA trial showed daratumumab significantly delayed progression to active multiple myeloma with a 51% reduction in risk of progression or death compared to active monitoring, with 5-year PFS rates of 63.1% versus 40.8%.
• Committee members expressed concerns about risk classification accuracy and potential overtreatment, but ultimately determined the benefits outweighed risks for this malignant condition that has an 80% five-year progression risk to symptomatic multiple myeloma.
Highlighted Clinical Trials:
Janssen Research & Development, LLC
Posted 11/7/2017
FDA Advisory Committee Rejects New Indications for Genentech's Columvi and Pfizer's Talzenna Combination
• The FDA's Oncologic Drugs Advisory Committee voted 8-1 against approving Genentech's Columvi for a new indication, citing concerns about the pivotal trial's applicability to US patients.
• In a separate decision, the same committee unanimously rejected (8-0) Pfizer's application for Talzenna in combination with Xtandi for first-line treatment in adults with prostate cancer.
• These negative recommendations highlight the FDA's increasing scrutiny of oncology drug applications and may signal stricter requirements for clinical trial design and population representation.
EMPOWER CAD Study Confirms Benefits of IVL-First Strategy in Female Patients with Calcified Coronary Lesions
• The EMPOWER CAD study, the first prospective real-world PCI trial focused exclusively on female patients with complex calcified coronary artery disease, demonstrated high procedural success rates with Shockwave's intravascular lithotripsy.
• Women with coronary artery calcification have historically experienced poorer outcomes than men and are typically underrepresented in clinical trials, making this study particularly significant for addressing gender disparities in cardiovascular care.
• The 30-day results showed 86.9% procedural success with minimal complications, offering a promising alternative to traditional calcium modification treatments like rotational or orbital atherectomy that carry higher complication risks in female patients.
VantAI and Blueprint Medicines Expand Collaboration to Tackle "Undruggable" Targets with AI-Powered Proximity Therapeutics
• VantAI and Blueprint Medicines have expanded their strategic collaboration for the second time since 2022, incorporating additional drug programs focused on targets previously considered undruggable.
• The expanded agreement makes VantAI eligible for up to $1.67 billion in milestone payments plus royalties, highlighting significant industry validation for their AI-driven approach to induced proximity therapeutics.
• The collaboration will leverage VantAI's recently announced Neo-1 foundation model, the first AI system capable of generating molecular glues and other protein-protein interaction modifiers to address complex therapeutic challenges.
Fresenius Kabi Launches 30 mg/30 mL Epinephrine Injection for Emergency Care and Septic Shock
• Fresenius Kabi has introduced Epinephrine Injection, USP, in 30 mg per 30 mL multi-dose vials in the United States, expanding its emergency medicine portfolio.
• The new formulation is indicated for emergency treatment of Type 1 allergic reactions including anaphylaxis in both adults and pediatric patients, as well as for increasing blood pressure in adults with septic shock.
• This launch follows Fresenius Kabi's December 2024 introduction of the first generic 1 mg/mL epinephrine vial, reinforcing the company's commitment to domestic pharmaceutical production and essential medicines.
StemRIM Expands Global Patent Portfolio for Redasemtide Cartilage Regeneration Therapy
• StemRIM Inc. has secured European and Chinese patents for its peptide drug Redasemtide, designed to treat various cartilage disorders including osteoarthritis and osteochondritis dissecans.
• The patent approvals strategically position StemRIM to expand its innovative 'Regeneration-Inducing Medicine™' technology in the world's second-largest pharmaceutical market (Europe) and the rapidly growing Chinese market.
• Redasemtide works by mobilizing mesenchymal stem cells to promote tissue repair and regeneration without using living cells or tissues, potentially offering a novel approach to cartilage disorders.
Poolbeg Pharma Secures £4.1 Million Fundraising to Advance Clinical Programs in Oncology and Obesity
• Poolbeg Pharma has announced a £4.1 million conditional fundraising to advance its POLB 001 Phase 2a trial for cancer immunotherapy-induced Cytokine Release Syndrome and oral GLP-1 proof of concept trial for obesity.
• The fundraising comprises a £2.655 million placing, £1.345 million in direct subscriptions, and up to £100,000 from a retail offer, with shares issued at 2.5 pence each, representing a 12% discount to the previous closing price.
• The proceeds will extend Poolbeg's cash runway into 2027, supporting multiple near-term clinical data catalysts including first patient dosing for POLB 001 in H2 2025 and topline data expected in H2 2026.
Poolbeg Pharma Launches £4 Million Equity Raise to Advance Cancer and Obesity Drug Candidates
• Poolbeg Pharma has launched a £4.1 million equity raise to fund key clinical trials, including its lead program POLB 001 for cancer immunotherapy-induced Cytokine Release Syndrome.
• The London-based biopharmaceutical company reported a widened pretax loss of £5.9 million in 2024, up from £4.5 million in 2023, with administrative expenses increasing by 56%.
• Proceeds from the equity raise will support advancement of both the POLB 001 Phase 2a trial and an oral GLP-1 proof of concept trial targeting the obesity market, extending the company's financial runway into 2027.
CCM Biosciences to Present Breakthrough 4th-Generation EGFR Inhibitors for NSCLC at ASCO 2025
• CCM Biosciences will present data on novel 4th-generation EGFR inhibitors (CCM-205, CCM-245, and CCM-308) that overcome both mutational and non-mutational resistance to 3rd-generation inhibitors in NSCLC at ASCO 2025.
• The company's compounds significantly outperform other investigational 4th-generation inhibitors in various drug resistance models and show efficacy as both monotherapies and in combination with existing treatments.
• CCM Biosciences plans to file an Investigational New Drug (IND) application this year to advance clinical candidates from its EGFR inhibitor program into clinical trials.