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Clinical Trial News

US Aid Cuts Halt HIV Vaccine Research in South Africa, Threatening Global Progress

  • The Trump administration's withdrawal of $46 million in funding forced South African researchers to halt the BRILLIANT HIV vaccine clinical trials just one week before they were scheduled to begin.
  • South Africa's loss of $400 million annually in USAID and PEPFAR funding has resulted in the layoff of 100 HIV researchers and 8,000 health workers, severely impacting the country's HIV research capabilities.
  • The funding cuts threaten South Africa's role as a global leader in HIV research, where scientists conduct trials "better, faster and cheaper than anywhere else in the world" according to program director Glenda Grey.
  • Universities and science councils in South Africa could lose approximately $107 million in U.S. research funding over the next five years, affecting both HIV and tuberculosis research programs.

Elegen and Nutcracker Therapeutics Launch Industry's First Fully Cell-Free Manufacturing Platform for RNA-Based Personalized Cancer Therapeutics

  • Elegen and Nutcracker Therapeutics announced a pilot program to demonstrate the industry's first fully synthetic, cell-free manufacturing platform for RNA-based personalized cancer therapeutics.
  • The combined platform reduces manufacturing turnaround time to three weeks from RNA sequence design to drug product, cutting traditional timelines in half.
  • The cell-free approach eliminates bioburden and endotoxin contamination risks while enabling faster synthesis of complex neo-antigen sequences.
  • The collaboration aims to democratize personalized cancer therapeutics by making them more accessible, timely, and scalable for developers worldwide.

Regeneron and BioNTech Advance Phase 2 Trial Combining Cancer Vaccine BNT116 with Cemiplimab for Advanced NSCLC

  • Regeneron Pharmaceuticals and BioNTech SE are conducting a Phase 2 clinical trial evaluating the combination of investigational cancer vaccine BNT116 with cemiplimab versus cemiplimab monotherapy in advanced non-small cell lung cancer patients with PD-L1 expression ≥50%.
  • The randomized trial began recruiting participants on April 21, 2023, and employs a parallel assignment model to assess safety, tolerability, and effectiveness of the combination therapy administered via IV injection and infusion every three weeks.
  • Positive results from this ongoing study could significantly influence both companies' stock performance and position them favorably against competitors in the oncology market.
  • The trial is expected to continue until July 10, 2025, with updates crucial for tracking progress and potential impact on future treatment options for advanced NSCLC patients.

UCLA Researchers Receive $950,000 Grant to Launch Multi-Institutional Trial of Zipalertinib for EGFR-Mutated Cancers

Targeted TherapyOncology
  • UCLA's Arjan Gower received a $950,000 grant from the National Comprehensive Cancer Network and Taiho Oncology Inc. to launch a multi-institutional clinical trial testing zipalertinib.
  • The investigational drug targets specific EGFR mutations, including Exon 20 insertions, which drive cancer growth and resist standard treatments.
  • This funding represents a significant investment in developing targeted therapies for previously difficult-to-treat EGFR-mutated cancers.
  • The multi-institutional approach suggests broad clinical collaboration to evaluate this novel targeted therapy's potential.

CEL-SCI Raises $5.7M to Fund Pivotal Multikine Trial for Head and Neck Cancer

Orphan Drug
  • CEL-SCI Corporation completed a $5.7 million stock offering to fund its confirmatory Phase 3 trial for Multikine, a neoadjuvant immunotherapy targeting head and neck cancer patients with low PD-L1 expression.
  • The company faces severe liquidity constraints with only $1.93 million in cash as of Q1 2025 and quarterly burn rate of approximately $7 million, creating an urgent need for additional funding.
  • Multikine previously demonstrated a 73% five-year survival rate versus 45% for standard care in a specific patient subset, earning FDA Orphan Drug designation.
  • The confirmatory trial will enroll 212 patients and represents CEL-SCI's final opportunity to validate decades of research in neoadjuvant immunotherapy for head and neck cancer.

Profusa Goes Public on Nasdaq with Tissue-Integrating Biosensor Platform for Chronic Disease Management

  • Profusa, Inc. completed its business combination with NorthView Acquisition Corp. and began trading on Nasdaq under ticker "PFSA" on July 14, 2025.
  • The Berkeley-based company has developed tissue-integrating biosensors that can function for months and continuously monitor body chemistry for diabetes, critical limb ischemia, and peripheral arterial disease management.
  • The company raised $9 million through a secured convertible promissory note with up to $20 million available to support transaction costs and working capital needs.

Real-World Study Reveals Persistent Gaps in Molecular Testing and Targeted Therapy Implementation for AML and MDS

Targeted TherapyReal World Evidence
  • A five-year retrospective analysis of over 16,000 patients with AML and MDS found significant gaps in molecular testing implementation, with mean turnaround times of 14-16 days exceeding recommended guidelines.
  • Despite mutations being detected in 68% of AML patients and 72% of MDS patients, transition rates to targeted therapies remained suboptimal, particularly in older AML patients and across all MDS patient groups.
  • The study highlighted the need for streamlined approaches, including ultra-rapid NGS platforms, to improve guideline adherence and enhance patient outcomes in hematological malignancies.

SimBioSys Receives Third FDA Clearance for AI-Powered Breast Cancer Surgery Platform TumorSight Viz

AI
  • SimBioSys secured its third FDA 510(k) clearance for TumorSight Viz 1.3, an AI-powered platform that converts standard breast MRI into 3D visualizations for surgical planning in breast cancer care.
  • The latest version introduces industry-leading AI-driven segmentation accuracy, faster case processing that produces results in minutes, and streamlined workflow integration with PACS connectivity.
  • Clinical validation demonstrates strong concordance with radiologist annotations and consistent performance across more than 1,600 retrospective cases from over nine institutions.
  • The platform addresses the critical need for precision in breast cancer surgery, where re-excision rates remain above 20 percent and significant variability exists in surgical decisions among experienced providers.

CMS Proposes Medicare Coverage for Renal Denervation Devices to Treat Uncontrolled Hypertension

  • The Centers for Medicare and Medicaid Services has proposed national coverage for renal denervation procedures, marking a significant step toward expanding access to this innovative hypertension treatment.
  • Medtronic and Recor Medical received FDA approval for their renal denervation devices in late 2023, with Medtronic's Symplicity Spyral using radiofrequency energy and Recor's Paradise system utilizing ultrasound technology.
  • The proposed coverage could benefit over 18 million Americans with poorly controlled hypertension, potentially making renal denervation one of the largest growth drivers in recent medical device history.
  • The CMS proposal opens a second 30-day public comment period, with the majority of initial comments from physicians speaking positively about the treatment's clinical value.

Indian Regulators Reject Troikaa's Rapid IV Paracetamol Bolus Over Safety and Efficacy Concerns

Drug Approval
  • India's Subject Expert Committee (SEC) has rejected Troikaa Pharmaceuticals' proposal for a rapid intravenous paracetamol bolus formulation due to insufficient safety and efficacy data.
  • The proposed formulation would deliver paracetamol 1000 mg/4 ml as a 2-minute IV bolus, significantly faster than the standard 15-minute infusion currently used.
  • Regulators flagged the absence of commonly expected adverse events in Phase III trial data and questioned the clinical support for proposed indications.
  • The committee has requested additional studies and data before reconsidering approval for the concentrated paracetamol formulation.

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