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Clinical Trial News

First-in-Human HIV Vaccine Trial Begins in Africa Using Novel Gorilla Adenovirus Vector Platform

  • The first doses of the investigational GRAdHIVNE1 HIV vaccine candidate were administered on July 28, 2025, at the Mutala Trust clinical trial site in Harare, Zimbabwe.
  • The Phase 1 trial will enroll approximately 120 healthy adults aged 18-50 years, including 48 people living with HIV who are virally suppressed on antiretroviral therapy.
  • The vaccine utilizes ReiThera's proprietary gorilla adenovirus vector platform, which encounters minimal pre-existing immunity in humans compared to human adenoviral vectors.
  • The immunogen design specifically targets highly conserved HIV epitopes to combat the virus's rapid mutation and immune evasion capabilities.

TearCare System Demonstrates Cost Savings and Superior Outcomes Compared to Cyclosporine in Dry Eye Treatment

  • A cost-utility analysis published in Expert Review of Pharmacoeconomics and Outcomes Research shows TearCare System reduces per-patient annual costs by $903 compared to cyclosporine 0.05% for treating moderate to severe meibomian gland disease-associated dry eye.
  • The analysis revealed TearCare resulted in lower annual costs of $4,916 and higher quality-adjusted life years of 0.76, compared to cyclosporine's $5,819 costs and 0.74 QALYs over a one-year period.
  • TearCare patients experienced an incremental QALY gain of 0.014 while receiving two procedures annually, demonstrating both clinical and economic advantages over traditional cyclosporine therapy.
  • The study was conducted from a US healthcare payer perspective and confirmed TearCare's cost-saving advantage through robust scenario analyses that validated results across different clinical assumptions.

Rapid Dose Therapeutics Submits QuickStrip Nicotine Oral Film for Health Canada Approval

  • Rapid Dose Therapeutics has submitted a product application to Health Canada for approval of its QuickStrip Nicotine products in four dose strengths (1-4 mg), marking a significant regulatory milestone for the innovative oral nicotine delivery system.
  • The fast-dissolving oral thin film technology delivers nicotine through oral mucosa and is designed to mimic cigarette nicotine absorption without harmful combustion byproducts, offering a safer alternative for smokers.
  • The company has conducted a pharmacokinetic clinical trial comparing QuickStrip Nicotine to traditional cigarettes and worked with a global cigarette manufacturer over 30 months to optimize the product.
  • The Canadian nicotine pouches market was valued at USD 112.2 million in 2024 with projected 4.7% annual growth through 2030, driven by increased adoption of smoke-free alternatives.

BMI OrganBank Receives FDA Breakthrough Device Designation for Room Temperature Kidney Preservation Technology

  • BMI OrganBank has secured FDA Breakthrough Device Designation for its revolutionary room temperature machine perfusion platform designed to preserve kidneys for transplantation.
  • The company's technology aims to address the critical issue that a large proportion of donated kidneys remain unused due to limitations in current cold storage preservation methods.
  • Clinical studies for the portable OrganBank kidney device are planned to begin early next year, with the potential to significantly reduce kidney transplant waitlist times.
  • The breakthrough designation provides expedited FDA engagement and underscores the transformative potential of the technology to improve transplant patient outcomes.

Roche Receives FDA Clearance for First TAGS-Powered Respiratory Test Detecting Four Major Viruses

  • Roche's cobas Respiratory 4-flex becomes the first FDA-cleared assay utilizing innovative TAGS technology, simultaneously detecting SARS-CoV-2, influenza A, influenza B, and RSV in a single test.
  • The new diagnostic platform offers customizable testing menus and digital reflex capabilities, allowing laboratories to tailor testing based on physician orders and obtain additional results from the same sample.
  • TAGS technology uses multiplex PCR testing combined with color, temperature and data processing to detect multiple targets within a single optical channel, streamlining laboratory workflows.
  • The test integrates with Roche's cobas 5800, 6800 and 8800 molecular lab instruments, providing laboratories with flexibility to address evolving respiratory testing demands.

University of Bath Develops Oral Delivery System for Injectable Protein Drugs

  • Researchers at the University of Bath have developed a breakthrough technology that enables oral delivery of protein-based drugs like growth hormone and monoclonal antibodies that traditionally require injection.
  • The system uses a bacterial-derived carrier molecule that exploits natural intestinal transport mechanisms to deliver therapeutic proteins across the gut wall with 5-10% bioavailability.
  • The technology could transform treatment for chronic conditions requiring frequent injections, with human testing projected to begin within two years.
  • The platform safely transports various protein therapeutics including hormones and cancer treatments without damaging intestinal tissue or causing inflammation.

OneMedNet Expands Real-World Data Network by 25%, Adding 5 Billion Administrative Records

AIRare Disease
  • OneMedNet Corporation announced a greater than 25% expansion of its proprietary iRWD™ network, adding over 5 billion administrative records to support health economics research and social determinants of health insights.
  • The expanded network now encompasses 1,750+ healthcare system and provider partner sites, covering 34 million patients and 136 million clinical exams across rare diseases, oncology, and cardiology.
  • The expansion positions OneMedNet for significant revenue growth through increased data licensing and enterprise partnerships in the $60 billion real-world evidence industry.

Sonnet BioTherapeutics Expands SON-1010 Trial After Promising Response Rate in Platinum-Resistant Ovarian Cancer

  • Sonnet BioTherapeutics reported a 66% response rate (2 of 3 patients) with SON-1010 plus atezolizumab at the E6 dose in platinum-resistant ovarian cancer patients.
  • The company has added a new E7 cohort testing a 25% higher maintenance dose of 1500 ng/kg based on strong safety profile and efficacy signals.
  • The Phase 1b/2a SB221 study combines SON-1010's IL-12-FHAB technology with Genentech's atezolizumab to turn immunologically 'cold' tumors 'hot'.
  • Topline readouts from the combination study are expected in the fourth quarter of 2025, with potential to advance to randomized Phase 2a portion.

Combination of SON-1010 (IL12-FHAB) and Atezolizumab in Patients With Platinum-resistant Ovarian Cancer

NCT05756907RecruitingPhase 1
Sonnet BioTherapeutics
Posted 9/15/2023

Pulsecare Medical's NxPFA™ Receives NMPA Approval as World's First Nanosecond Pulsed Field Ablation System

Drug Approval
  • Pulsecare Medical's NxPFA™ system has received marketing approval from China's NMPA, becoming the world's first commercially available nanosecond pulsed field ablation system for atrial fibrillation treatment.
  • The SCENA-AF multicenter trial demonstrated 100% acute pulmonary vein isolation success rate and 88.27% one-year treatment success rate with no device-related serious adverse events.
  • The nanosecond technology significantly reduces neuromuscular stimulation, enabling over 92.8% of procedures to be completed under conscious sedation rather than general anesthesia.
  • This third-generation PFA system addresses key limitations of microsecond PFA technologies, including reduced gas formation risk and minimized erythrocytic damage.

Freya Pharma Launches Phase II Study of Lybrido for Female Sexual Dysfunction Using Novel Blood Flow Measurement

  • Freya Pharma Solutions has initiated a Phase II clinical study evaluating Lybrido, a dual-action therapy combining sublingual testosterone and oral sildenafil for Female Sexual Interest/Arousal Disorder.
  • The study will use innovative Clitoral Doppler Duplex Ultrasound imaging to objectively measure clitoral blood flow parameters as a biomarker of genital arousal response.
  • The company is simultaneously preparing for the ALETTA pivotal study, with enrollment planned to begin in late 2025 across 20 European research sites in five countries.
  • Lybrido has already been tested in over 20 Phase I and Phase IIa trials, plus large-scale Phase IIb trials across 17 US research sites.

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