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Clinical Trial News

Hanmi Pharmaceutical to Present Phase 1 Results of Next-Generation Obesity Drugs at ADA 2025

  • Hanmi Pharmaceutical will present six studies on its next-generation obesity drug candidates HM15275 and HM17321 at the American Diabetes Association 2025 annual meeting in Chicago.
  • HM15275, a triple agonist targeting GLP-1, GIP, and glucagon receptors, has demonstrated potential for more than 25% total body weight loss while minimizing lean mass loss in preclinical studies.
  • HM17321 represents the world's first UCN2-based obesity therapy designed to simultaneously reduce fat mass and increase muscle mass, offering a fundamentally different mechanism from current GLP-1 therapies.
  • Both drug candidates are positioned to initiate Phase 2 and Phase 1 clinical trials respectively in the second half of 2025, potentially addressing key limitations of existing obesity treatments.

Nordic Capital Invests in Minerva Imaging to Build Global Radiopharmaceutical Platform

Targeted TherapyPrecision MedicineOncology
  • Nordic Capital has announced a strategic investment in Minerva Imaging, a Denmark-based contract research organization specializing in targeted radioligand therapies for cancer treatment.
  • The partnership aims to accelerate Minerva's international expansion and strengthen its integrated platform serving pharmaceutical and biotechnology companies in radiopharmaceutical development.
  • Minerva reported revenue of more than DKK 225 million ($35 million) in 2024 and employs over 150 professionals, including PhD-level scientists at its Copenhagen headquarters.
  • The global radiopharmaceuticals market is positioned for significant growth driven by increasing cancer incidence and growing demand for precision medicines.

Walmart Launches Healthcare Research Institute to Expand Clinical Trial Access and Diversity

  • Walmart has launched the Walmart Healthcare Research Institute (WHRI) to connect patients visiting its nationwide health centers with clinical trial opportunities, following similar moves by CVS and Walgreens.
  • The initiative aims to improve recruitment of under-represented groups including African-American, Asian, Hispanic, and Latino populations, addressing the current disparity where 75% of US clinical trial participants are white.
  • WHRI will focus on therapies for older adults, rural residents, women, and minority populations, particularly targeting chronic healthcare conditions.
  • Walmart's existing clinical trial activities have already achieved a threefold improvement in patient referrals compared to industry benchmarks, leveraging the company's reach to 90% of Americans within 10 miles of a Walmart outlet.

Resonant Clinical Solutions Names Christophe Berthoux as CEO to Drive Global Expansion

  • Resonant Clinical Solutions, a global provider of clinical trial services, has appointed Dr. Christophe Berthoux as Chief Executive Officer effective immediately.
  • Berthoux brings over three decades of pharmaceutical services leadership experience, including CEO roles at NAMSA, Synexus, and CitoxLab.
  • The appointment follows Audax Private Equity's acquisition of Resonant from Avantor in 2024, marking a strategic milestone in the company's evolution.
  • Resonant operates with over 850 employees across the US, UK, and Europe, providing clinical trial kitting, equipment services, and biorepository management.

Glycovax Pharma Launches Commercial Production of Affordable CRM197 Protein for Conjugate Vaccines

  • Glycovax Pharma has begun large-scale biomanufacturing of CRM197 protein, addressing a key cost barrier in conjugate vaccine development.
  • The company partnered with Canada's National Research Council to develop a unique and highly efficient production system that meets regulatory standards.
  • CRM197 will be marketed through subsidiary Espoir Therapeutics to vaccine developers, offering GMP-compliant manufacturing with regulatory support.
  • The initiative aims to make conjugate vaccines more accessible by reducing production costs of this essential protein component.

Jaguar Health Reports Statistically Significant Results in Breast Cancer Subgroup from Phase 3 OnTarget Trial

  • Jaguar Health announced statistically significant responder analysis results for a breast cancer patient subgroup in its recently completed Phase 3 OnTarget trial of crofelemer.
  • The company is scheduled to meet with the FDA in May 2025 to review these positive results and discuss the regulatory pathway forward.
  • The estimated US metastatic breast cancer population potentially qualifies as an orphan population, aligning with Jaguar's focus on rare diseases.
  • Jaguar plans to pursue authorization for an expanded access program for breast cancer patients who may not be eligible for a potential pivotal treatment trial.

FDA Agrees VivaVision's Phase 2 Trial Can Serve as Pivotal Study for VVN461LD Eye Drop

  • VivaVision received positive FDA comments allowing its completed Phase 2 trial of VVN461LD to count as one of two pivotal studies required for NDA filing.
  • The dual JAK1/TYK2 inhibitor VVN461LD is being developed as a safer alternative to corticosteroid eye drops for post-operative inflammation following cataract surgery.
  • The FDA agreement significantly reduces development timeline by requiring only one additional Phase 3 trial before NDA submission.
  • VVN461LD aims to provide similar anti-inflammatory efficacy to corticosteroids while minimizing side effects like increased intraocular pressure and delayed wound healing.

Phase 2: VVN461 Ophthalmic Solution for Post -Operative Ocular Inflammation After Cataract Surgery

NCT06164743CompletedPhase 2
VivaVision Biotech, Inc
Posted 1/11/2024

Eluminex Biosciences Reports Positive Phase 1b Results for Novel Pentavalent Antibody EB-105 in Diabetic Macular Edema

  • Eluminex Biosciences announced positive Phase 1b results for EB-105, a novel pentavalent trispecific fusion antibody targeting multiple pathways in diabetic macular edema patients.
  • The LOTUS study demonstrated significant improvements in visual acuity and retinal edema reduction across all dose levels with no safety concerns following single intravitreal injection.
  • EB-105 targets five key components (VEGF-A, VEGF-B, PlGF, Ang-2, and IL-6R) and showed maximal visual acuity gains of +12 to +21 letters at three months.
  • The company plans to initiate Part 2 of the LOTUS study in Q3 2025, evaluating multiple ascending doses to potentially advance to Phase 2/3 trials.

Tang Capital's Concentra Biosciences Acquires Elevation Oncology for $0.36 Per Share in Latest Biotech Liquidation

Oncology
  • Elevation Oncology has agreed to be acquired by Concentra Biosciences, controlled by hedge fund Tang Capital Partners, for $0.36 per share in cash with additional contingent value rights.
  • The acquisition represents the latest example of investment firms targeting struggling biotech "zombies" worth less than their cash reserves for liquidation rather than strategic repositioning.
  • Elevation's lead cancer drug disappointed in clinical testing, forcing the company to shelve its program, lay off most staff, and trade below $1 per share for nearly a year.
  • The deal follows Tang Capital's previous acquisitions of struggling biotechs including Allakos, Jounce Therapeutics, and Kronos Bio through its liquidation-focused investment strategy.

CollPlant Expands STEMCELL Technologies Partnership to Include Clinical and Commercial Applications of Plant-Derived Collagen

  • CollPlant Biotechnologies has expanded its collaboration with STEMCELL Technologies to include clinical development and commercial-scale manufacturing of its plant-derived recombinant human collagen (rhCollagen).
  • The amended agreement extends beyond research applications, positioning CollPlant's rhCollagen as a viable alternative to animal-sourced materials for biomanufacturing applications.
  • STEMCELL Technologies, which supports life sciences research with over 2,500 specialized reagents and tools, will now utilize CollPlant's proprietary rhCollagen technology in clinical and commercial domains.
  • The partnership reflects growing industry priorities around safety, consistency, and ethical sourcing in regenerative medicine and biotechnology applications.

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