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Clinical Trial News

Sentinel BioTherapeutics Launches with Novel IL-2 Immunotherapy Platform for Solid Tumors

  • RBL LLC announced the launch of Sentinel BioTherapeutics, a clinical-stage company developing innovative immune-priming therapies for solid tumors that typically respond poorly to checkpoint inhibitors.
  • The company's platform enables sustained local delivery of interleukin-2 (IL-2) through an allogeneic encapsulated cell-based system to enhance checkpoint inhibitor effectiveness against cancers like ovarian cancer and mesothelioma.
  • Phase 1 clinical data presented at the 2025 ASCO Annual Meeting demonstrate dose-dependent increases in CTLA-4 expression on T cells, supporting the therapy's potential as a priming agent for checkpoint inhibition.
  • Sentinel's lead program SENT001 holds fast-track designation for PROC and orphan disease designation for mesothelioma, with plans to initiate immune priming clinical trials for peritoneal solid tumors.

Cerus Corporation Reports Positive Phase 3 Results for INTERCEPT Blood System at ISBT Congress

FDA Approval
  • Cerus Corporation will present positive Phase 3 ReCePI study results for its INTERCEPT Blood System red blood cell treatment at the 35th ISBT Congress in Milan.
  • The presentations demonstrate broad clinical applicability of the INTERCEPT system across multiple blood components including platelets, plasma, and red blood cells.
  • Clinical data showcases reduced hemoglobin use in complex cardiac surgery and effective pathogen inactivation capabilities including California encephalitis virus.
  • The INTERCEPT system represents the only FDA-approved pathogen reduction technology for platelets and plasma globally.

Ludwig Enterprises Develops Non-Invasive Breast Cancer Screening Test Using Buccal Cell mRNA Analysis

  • Ludwig Enterprises published ASCO abstract detailing a novel non-invasive breast cancer screening test that analyzes mRNA from buccal cheek swab samples collected across 40 U.S. clinical centers.
  • The study identified six-biomarker combinations using machine learning algorithms that achieved excellent performance metrics with F-scores ≥0.85 for breast cancer detection.
  • Two top-performing biomarker systems demonstrated high precision (0.888-0.892) and recall (0.902-0.913) values, suggesting potential clinical utility for early breast cancer detection.
  • The research focuses on mRNA-based cytokine biomarkers associated with inflammatory pathways and cancer development, offering complementary insights to traditional DNA genetic testing.

Dx&Vx Advances Universal COVID-19 Vaccine to Phase 2 Trials Using Virus-Like Particle Platform

  • Dx&Vx has accelerated development of a universal COVID-19 vaccine using virus-like particle (VLP) technology that offers greater stability than mRNA vaccines and theoretically provides immunity against all known and future variants.
  • The company has successfully completed Phase 1 trials in the U.S. and South Africa and is preparing Investigational New Drug applications for global Phase 2 studies across South Korea, the U.S., and Southeast Asia.
  • Beyond the universal vaccine, Dx&Vx is developing a diverse pipeline including a room-temperature stable mRNA vaccine platform, an oral obesity treatment, and the OVM-200 cancer vaccine targeting solid tumors.
  • The company has also acquired universal COVID-19 treatment technology from LUCA AI Cell with efficacy data against dozens of lethal viruses, positioning itself for comprehensive pandemic preparedness.

Cocrystal Pharma's CC-42344 Shows 1,000-Fold Greater Potency Than Tamiflu Against H5N1 Avian Influenza

  • Cocrystal Pharma's investigational drug CC-42344 demonstrated exceptional antiviral activity against the highly pathogenic 2024 Texas H5N1 avian influenza strain with an EC50 of 0.003 µM.
  • The novel PB2 inhibitor showed approximately 1,000-fold greater potency compared to Tamiflu (EC50 2.69 µM) in virology studies using the A/Texas/37/2024 strain.
  • The compound targets a highly conserved active site of the PB2 protein and is being developed as an oral treatment for pandemic and seasonal influenza infections.
  • With favorable Phase 1 safety data already established, CC-42344 represents a potential breakthrough in addressing the multibillion-dollar influenza market and pandemic preparedness concerns.

Bachem Expands Global Manufacturing Network to Meet Surging Demand for Peptide and Oligonucleotide Therapeutics

  • Bachem announces major investments across four manufacturing sites in Switzerland, US, and UK to expand peptide and oligonucleotide production capabilities.
  • The expansion responds to growing therapeutic demand, with the global obesity drug market expected to increase more than 15-fold by 2030.
  • Key upgrades include a new state-of-the-art Building K facility at Bubendorf and increased annual peptide production capacity to nearly one metric ton at the Vista site.
  • Infrastructure improvements at the St Helens site have doubled output for research chemicals, while a new Sisseln facility is under development in northwestern Switzerland.

Real-World Evidence Guides Extended Dosing Strategies for Next-Generation Anti-VEGF Therapies in Retinal Disease

Real World Evidence
  • Retinal specialists are successfully extending treatment intervals beyond traditional 12-week limits with newer anti-VEGF agents like faricimab and aflibercept 8 mg, with some physicians comfortable reaching 16-20 weeks in appropriate patients.
  • Real-world data reveals that switching from aflibercept 2 mg to 8 mg typically allows 2-4 week extensions in treatment intervals, with benefits improving over time rather than immediately after switching.
  • Patient compliance drops significantly beyond 4-month intervals, leading physicians to identify a "sweet spot" of 3-4 month treatment cycles that balance disease control with patient convenience.
  • Loading dose strategies differ between treatment-naive and previously treated patients, with complete reloading often unnecessary when switching to newer agents in experienced patients.

Biohaven Initiates Pivotal Phase II/III Trial of Brain-Penetrant TYK2/JAK1 Inhibitor BHV-8000 for Early Parkinson's Disease

  • Biohaven has launched a global Phase II/III trial of BHV-8000, a first-in-clinic brain-penetrant TYK2/JAK1 inhibitor targeting neuroinflammation in early Parkinson's disease.
  • The randomized, placebo-controlled trial will enroll 550 patients across 185 sites in 13 countries to evaluate 10mg and 20mg doses against placebo.
  • BHV-8000 demonstrated good safety profile in Phase I studies with no serious adverse events and showed target engagement with significant reductions in inflammatory biomarkers.
  • The trial addresses a critical unmet need as no disease-modifying therapies currently exist for Parkinson's disease, which affects over 10 million people globally.

A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease

NCT06976268RecruitingPhase 2
Biohaven Therapeutics Ltd.
Posted 5/28/2025

Ochre Bio Strengthens Leadership with Former Eli Lilly and AstraZeneca Executive as RNA Therapeutics Company Expands

AIDrug Discovery
  • Oxford-based Ochre Bio has appointed Dr. Elaine Sullivan, former VP at Eli Lilly and AstraZeneca, as Senior Independent Non-Executive Director to support the company's RNA therapeutics development for chronic liver disease.
  • The company has expanded its scientific team with key hires including Dr. Julian Maller as Head of In Silico Biology and Dr. Sarah Batey as Head of Portfolio Development & Scientific Operations.
  • Ochre Bio combines AI with human data to discover RNA therapeutics and operates across Oxford, New York, and Taipei with multi-million-pound partnerships with GSK and Boehringer Ingelheim.

Rona Therapeutics Reports 99% Lipoprotein(a) Reduction with Annual-Dose RNAi Therapy RN026

  • Rona Therapeutics announced preclinical data for RN026, an RNAi therapy targeting lipoprotein(a), achieving 99% reduction in non-human primate studies with potential annual dosing.
  • A single 2mg/kg subcutaneous injection maintained 95% Lp(a) reduction at 98 days and sustained ~80% reduction through 154 days in non-human primates.
  • The therapy demonstrated dual cardiovascular benefits with 25% LDL-C reduction and showed no adverse findings in repeated dose toxicity studies.
  • RN026 targets an estimated 10-20% of the global population with elevated Lp(a) levels, addressing multiple cardiovascular diseases including ASCVD and aortic stenosis.

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