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Clinical Trial News

Exceptional Responders: 14 Pancreatic Cancer Patients Show Remarkable Immunotherapy Outcomes in Multi-Institutional Study

  • A multi-institutional study of 14 pancreatic cancer patients revealed exceptional responses to immunotherapy, with 82% achieving partial tumor shrinkage and median progression-free survival of 12 months.
  • The research challenges conventional assumptions about immunotherapy effectiveness in pancreatic cancer, showing survival rates of 80% at one year and 70% at two years among exceptional responders.
  • More than half of the responding patients did not have high microsatellite instability (MSI-high), suggesting alternative biological mechanisms may drive immunotherapy success in pancreatic cancer.
  • The findings support redesigning clinical trials with broader eligibility criteria and personalized molecular profiling to identify more patients who could benefit from immune-based treatments.

Celltrio Secures $15 Million to Accelerate Global Expansion of Cell Therapy Automation Platform

  • Celltrio, a Fremont-based life sciences company, raised $15 million in funding led by Premier Partners to accelerate global commercialization of its RoboCell automation platform.
  • The investment will scale manufacturing capabilities and expand commercial operations across North America, Europe, and Asia for the company's cell culturing and cell therapy automation solutions.
  • RoboCell is a flagship modular platform that fully automates sterile cell culturing and cell therapy manufacturing processes for biopharma, regenerative medicine, and research laboratories.
  • Premier Partners, which has managed approximately $2.9 billion in assets, cited Celltrio's customer traction and differentiated intellectual property as key factors in their investment decision.

BioAge Labs Partners with Norwegian Biobank to Accelerate Aging-Related Drug Discovery

Drug Discovery
  • BioAge Labs announced a collaboration with Age Labs AS to analyze over 17,000 samples from Norway's HUNT Biobank, generating millions of molecular readouts to identify novel therapeutic targets for aging-related diseases.
  • The partnership will profile samples from 6,000+ participants collected over decades, focusing on those who transitioned from health to cardiometabolic disease, cognitive decline, or other chronic conditions.
  • The molecular profiling data will integrate with BioAge's existing discovery platform containing over 50 million molecular measurements collected over five decades to accelerate drug target identification.
  • BioAge's lead candidate BGE-102, an NLRP3 inhibitor for obesity, is planned for IND submission and Phase 1 trials in mid-2025.

Skyhawk Therapeutics Initiates Phase 2/3 Trial of SKY-0515 for Huntington's Disease

  • Skyhawk Therapeutics has dosed the first patient in its Phase 2/3 FALCON-HD trial evaluating SKY-0515, an oral RNA splicing modulator for Huntington's disease treatment.
  • SKY-0515 demonstrated promising Phase 1 results with up to 72% reduction in huntingtin mRNA in healthy volunteers and was generally well tolerated across all doses.
  • The investigational drug uniquely targets both huntingtin and PMS1 proteins, two key drivers of Huntington's disease pathology, potentially offering enhanced therapeutic impact.
  • The randomized, placebo-controlled trial will enroll 120 participants across 10 sites in Australia and New Zealand, representing a significant milestone for disease-modifying HD therapies.

Study of SKY-0515 for Safety, Efficacy, and Pharmacodynamics in Participants With Huntington's Disease

NCT06873334RecruitingPhase 2
Skyhawk Therapeutics, Inc.
Posted 5/27/2025

Ashvattha Therapeutics Unveils Novel Nanomedicine Radiotracers for Neuroinflammation and Cancer Imaging at SNMMI 2025

Precision MedicineOncology
  • Ashvattha Therapeutics will present data on two breakthrough nanomedicine radiotracers at the SNMMI Annual Meeting, demonstrating selective targeting capabilities in neuroinflammation and cancer.
  • The company's flurimedrimer radiotracer selectively targets activated microglia in the human brain, supporting development of precision imaging tools for neurological conditions.
  • A second radiotracer designed to target tumor-associated macrophages shows potential for advancing precision imaging in oncology applications.
  • The data demonstrates the versatility of Ashvattha's hydroxyl dendrimer platform to achieve selective uptake in different inflammatory environments across therapeutic areas.

Visby Medical Secures $65 Million to Launch FDA-Authorized At-Home STI Test

  • Visby Medical raised approximately $55 million with potential to reach $65 million in funding led by Catalio Capital Management to accelerate launch of its FDA-authorized at-home Women's Sexual Health Test.
  • The company's diagnostic platform delivers laboratory-grade PCR results within 30 minutes through a single-use, disposable test that connects to a smartphone app for seamless telemedicine consultation.
  • Industry veterans Isaac Ro and Chuck Alpuche joined the board to enhance operational capabilities and manufacturing scale-up as the product launches in July 2025 through direct-to-consumer channels.

Pelage Pharmaceuticals' PP405 Shows Hair Regeneration Potential in Phase 2a Trial

  • PP405 demonstrated significant hair density improvements in men with advanced hair loss, with 31% showing greater than 20% increase at 8 weeks compared to 0% in placebo group.
  • The topical therapy targets hair follicle stem cells directly, offering a novel regenerative approach that induced new hair growth from previously inactive follicles.
  • The treatment showed a robust safety profile with no systemic absorption detected and met primary safety endpoints in the 78-patient randomized controlled trial.
  • Pelage Pharmaceuticals plans to initiate Phase 3 studies in 2026 to further evaluate this potential first-in-class therapy for androgenetic alopecia.

Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

NCT06393452Active, Not RecruitingPhase 2
Pelage Pharmaceuticals, Inc.
Posted 6/5/2024

Clinical Trial Launches in Florida to Test Investigational Oral Medication for Severe Thunderstorm Aversion in Dogs

FDA Approval
  • A clinical study is evaluating an investigational oral medication given twice-daily during storm season for dogs with severe thunderstorm aversion, with the goal of achieving FDA approval.
  • The study is recruiting dogs in Florida who display intense fear behaviors during thunderstorms, including hiding, trembling, destructiveness, and self-harm.
  • Nearly 50% of dog owners report their dogs show fear when exposed to noises, highlighting the significant prevalence of this veterinary behavioral condition.
  • Qualifying dogs receive all study-related care including evaluations, diagnostic testing, and medication at no cost during Florida's storm season.

Quilt Health Secures $6M Seed Funding to Modernize Clinical Trial Access for Complex Diseases

AIRare Disease
  • Quilt Health, a digital health company focused on bridging treatment access gaps for complex diseases, successfully closed a $6 million seed funding round, bringing total funding to $8 million.
  • The company addresses critical clinical trial recruitment challenges, with more than 70% of trials failing to meet enrollment thresholds, particularly in rare disease research where patient pools are small and hard to reach.
  • Quilt Health's AI-powered platform integrates multiple data sources to surface key patient characteristics and outcomes, supporting clinical workflows and improving trial efficiency for pharmaceutical sponsors, research sites, and patients.
  • The company recently partnered with the National Alliance of Sickle Cell Centers (NASCC), providing access to a national network of more than 115 sickle cell centers to combine research and patient care.

Nature Study Validates Non-Invasive Fat Reduction Technology for Abdominal Obesity Treatment

  • A peer-reviewed study published in Nature Scientific Reports demonstrates statistically significant abdominal fat reduction using Alma's Accent Prime ultrasound and radiofrequency technology in Korean women with abdominal obesity.
  • The clinical trial conducted at Ewha Womans University Seoul Hospital showed measurable fat layer thickness reduction through ultrasound imaging and waist circumference assessments, with high patient satisfaction and no adverse events.
  • The research addresses the growing global obesity crisis, with over 1 billion people worldwide living with obesity according to the World Health Organization, highlighting the need for safe, non-surgical treatment alternatives.
  • Accent Prime's CE-marked platform combines proprietary ultrasound and radiofrequency technologies for personalized body contouring treatments without surgery or downtime.

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