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Clinical Trial News

ImmunoPrecise's AI-Designed GLP-1 Peptides Outperform Semaglutide in Receptor Activation Studies

AIDrug Discovery
  • ImmunoPrecise Antibodies announced that its AI-designed GLP-1 receptor agonist peptides achieved comparable or superior receptor activation to Semaglutide in independent third-party in vitro studies.
  • Two lead peptide candidates outperformed or matched Semaglutide under controlled assay conditions, with sequences rationally engineered using the company's proprietary HYFT technology for improved stability and peptidase resistance.
  • The breakthrough validates IPA's LENSai platform and demonstrates that AI can generate functionally validated peptide drugs with potential for rapid expansion into adjacent therapeutic areas.
  • The company is now considering two preclinical development paths including injectable delivery studies and non-invasive delivery strategies such as transdermal patches and nucleic acid-based delivery systems.

MiNA Therapeutics Reports Breakthrough Pre-Clinical Results for RNA-Based Sickle Cell Disease Treatment

  • MiNA Therapeutics' MTL-HBG drug candidate achieved 62% fetal hemoglobin levels in patient-derived cells, representing a 45% absolute increase over controls in pre-clinical studies.
  • The small activating RNA therapy demonstrated pancellular activity with 82% of erythroid progenitor cells expressing fetal hemoglobin, offering potential protection from sickle cell disease symptoms.
  • MTL-HBG is administered in vivo without harmful pre-conditioning or complex cell engineering, currently advancing through IND-enabling studies toward clinical trials.
  • The breakthrough data will be presented at the European Hematology Association 2025 Congress, highlighting the transformational therapeutic potential of RNA activation technology.

Comprehensive Analysis Reveals 943 Autoimmune Collaboration and Licensing Deals Across 30 Diseases from 2016-2025

  • A new comprehensive report analyzes 943 autoimmune collaboration and licensing deals from 2016-2025, covering over 30 diseases including multiple sclerosis, rheumatoid arthritis, lupus, and Crohn's disease.
  • The analysis provides unprecedented access to deal payment terms, financial structures, and actual SEC contract documents from leading biopharma companies worldwide.
  • The report offers critical insights into upfront payments, milestone structures, royalty rates, and negotiation patterns that can inform strategic planning and due diligence for autoimmune R&D partnerships.

BioNTech to Acquire CureVac for $1.25 Billion to Strengthen mRNA Cancer Immunotherapy Pipeline

CAR-T
  • BioNTech announced a $1.25 billion all-stock acquisition of CureVac through a public exchange offer, offering $5.46 per CureVac share representing a 55% premium to strengthen its mRNA-based cancer immunotherapy capabilities.
  • The strategic transaction will combine complementary mRNA technologies in design, delivery formulations, and manufacturing to accelerate development of transformative cancer treatments and establish new standards of care.
  • The deal has secured support from shareholders representing 50.08% of CureVac shares and is expected to close in 2025, marking a key milestone in BioNTech's oncology strategy focused on pan-tumor programs and bispecific antibody candidates.

Sensible Biotechnologies Achieves 90% Reduction in mRNA Optimization Time Using AI-Powered Platform

AI
  • Sensible Biotechnologies has reduced mRNA optimization cycles from 15 days to just one day using NVIDIA-powered AI technology, representing a more than 90% time reduction.
  • The company's cell-based platform produces mRNA therapeutics within living cells, creating pure and low-immunogenicity drug products that could unlock new therapeutic areas including cancer and rare diseases.
  • The AI-driven platform achieves over 11,000 simulation steps per second and reduces simulation runtimes from overnight to under an hour per sequence.
  • This breakthrough enables faster development of next-generation mRNA medicines by allowing rapid screening of multiple RNA candidates in parallel.

Cytiva Completes $1.6 Billion Global Manufacturing Expansion to Boost Biopharmaceutical Supply Chain

  • Cytiva has completed major expansion projects across the United States, Europe, and Asia as part of a $1.6 billion investment plan running through 2028 to enhance biopharmaceutical manufacturing capacity.
  • The company has doubled chromatography resins production capacity in Uppsala, Sweden, and is establishing new manufacturing sites in Michigan and expanding filtration capabilities across multiple locations.
  • These expansions follow an "in-region for-region" manufacturing strategy designed to provide faster delivery of critical supplies including chromatography resins, filtration systems, and cell culture media to biopharmaceutical customers worldwide.

KAIST Researchers Develop Antibody Treatment to Restore Vision in Retinitis Pigmentosa

  • Researchers at KAIST have developed a breakthrough antibody treatment that blocks the PROX1 protein, allowing damaged retinal cells to regenerate and restore vision in mice with retinitis pigmentosa for over six months.
  • The treatment targets Müller glia cells, which naturally regenerate retinal damage in fish but are inhibited by PROX1 protein in mammals, preventing natural retinal repair.
  • Human clinical trials are planned to begin in 2028 through KAIST spinout Cellia Inc., offering hope for the 1.5 million people worldwide affected by retinitis pigmentosa.
  • The antibody injection represents a potential cure for the leading cause of inherited retinal degeneration-associated blindness, which currently has no known treatment.

Merck Launches Phase 3 Trial for Single-Dose Dengue Vaccine V181 Targeting Global Public Health Crisis

  • Merck has initiated the MOBILIZE-1 Phase 3 clinical trial evaluating V181, a single-dose quadrivalent vaccine designed to prevent dengue disease caused by all four virus serotypes regardless of prior exposure.
  • The randomized, double-blind, placebo-controlled study aims to enroll approximately 12,000 healthy individuals aged 2 to 17 years across more than 30 trial sites in dengue-endemic areas of the Asia-Pacific region.
  • With approximately four billion people at risk globally and around 105 million dengue infections occurring annually, V181 represents a potential breakthrough in addressing one of the world's fastest-growing mosquito-borne diseases.
  • The trial marks the first Phase 3 study in Merck's clinical development program for V181, with recruitment beginning in Singapore and expansion planned across Indonesia, Malaysia, Philippines, Thailand, and Vietnam.

A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)

NCT07013487RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 6/11/2025

Novel Antimicrobial Strategies Show Promise Against Drug-Resistant Pathogens

  • Researchers have identified multiple innovative approaches to combat antimicrobial resistance, including novel bacteriocins, enzyme inhibitors, and repurposed drugs targeting resistant pathogens.
  • A new compound called s-Phen demonstrates potential to synergistically reduce colistin resistance in Acinetobacter baumannii with no observed toxicity.
  • Scientists have developed a chimeric endolysin that significantly improves survival rates in animal models of streptococcal infection.
  • The research highlights diverse therapeutic strategies ranging from antimicrobial peptides derived from animal sources to metabolic pathway targeting approaches.

Mezzion Secures $20 Million to Advance Phase 3 Trial of Udenafil for Rare Congenital Heart Disease

Rare Disease
  • Mezzion Pharma secured approximately $20 million in strategic funding led by Midas-Meritz New Technology Finance Association to support the ongoing global Phase 3 FUEL-2 trial of udenafil for Fontan circulation patients.
  • The investment represents strong institutional confidence in Mezzion's late-stage pipeline, with lead investor Midas PE citing positive FUEL-1 results and expressing belief in udenafil's potential for successful Phase 3 completion and regulatory approval.
  • The financing follows growing clinical momentum, including the introduction of dedicated ICD-10 codes for Fontan-associated conditions, marking progress in addressing this long-overlooked rare congenital heart disease population.
  • Mezzion reports accelerating enrollment and growing engagement across clinical sites for the FUEL-2 trial, with plans to continue seeking additional investments to support global development efforts.

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