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Vera Therapeutics' Atacicept Achieves 46% Proteinuria Reduction in Phase 3 IgA Nephropathy Trial

Drug Approval
  • Vera Therapeutics' Phase 3 ORIGIN trial met its primary endpoint, demonstrating a statistically significant 46% reduction in proteinuria versus baseline and 42% improvement over placebo (p<0.0001) at 36 weeks.
  • The company plans to submit a Biologics License Application for atacicept in Q4 2025, targeting accelerated approval for IgA nephropathy with a potential PDUFA decision by mid-2026.
  • Atacicept has received FDA Breakthrough Therapy Designation and could become a first-in-class therapy for IgAN, addressing a critical unmet need in a market affecting approximately 3 million patients globally.
  • Director Patrick Enright demonstrated strong insider confidence with a $5.28 million stock purchase in June 2025, coinciding with the finalization of Phase 3 data.

Danhong Injection Shows Promise in Reducing Inflammation and Improving Vascular Function in Unstable Angina Patients

  • A comprehensive meta-analysis of 46 randomized controlled trials involving 4,601 patients with unstable angina pectoris demonstrates that Danhong injection significantly reduces key inflammatory markers including high-sensitivity C-reactive protein, tumor necrosis factor-alpha, and interleukin-6.
  • The traditional Chinese medicine injection also improved vascular endothelial function by decreasing endothelin-1 and homocysteine levels while increasing nitric oxide levels, suggesting potential cardiovascular protective effects.
  • Despite promising efficacy results, the overall quality of evidence was rated as low to very low, highlighting the need for larger, higher-quality randomized controlled trials to establish robust clinical evidence.
  • The safety profile appears favorable with adverse event rates comparable between treatment and control groups, though more rigorous safety assessments are needed for definitive conclusions.

Evosep Launches High-Throughput Proteomics Platform Eno and Expands SCIEX Partnership at ASMS 2025

Drug Discovery
  • Evosep unveiled the Evosep Eno, a high-throughput separation platform that can analyze over 500 samples per day and identify close to 7,000 proteins with 40% improved performance.
  • The new platform enables analysis of more than 2,000 proteins per minute while maintaining industry-leading system-to-system and lab-to-lab reproducibility for multi-site studies.
  • Evosep strengthened its strategic partnership with SCIEX through a reseller agreement, allowing SCIEX to offer the Evosep Eno alongside their mass spectrometers to pharmaceutical customers.
  • The collaboration aims to provide end-to-end solutions for drug development pipelines, enabling pharmaceutical companies to analyze a wider range of drug modalities more efficiently.

STEMCELL Technologies Acquires Cellular Highways to Advance Cell Therapy Manufacturing with Revolutionary VACS Technology

  • STEMCELL Technologies, Canada's largest biotechnology company, has acquired UK-based Cellular Highways Ltd from TTP Group to strengthen its cell therapy manufacturing capabilities.
  • The acquisition includes the Highway1 instrument featuring proprietary VACS (Vortex-Actuated Cell Sorting) technology, which enables high-speed cell sorting in a closed, sterile system while maintaining cell integrity.
  • Highway1 has proven to be the fastest GMP-ready cell sorter available since entering the market in 2024, designed under ISO 13485 certification for therapeutic development applications.
  • The technology significantly reduces research and development timelines and costs by avoiding traditional non-sterile sorting methods that can degrade cell health and viability.

4D Path's Digital Biomarker Identifies Treatment Responders in Previously Resistant Breast Cancer Patients

  • 4D Path's QPOR platform demonstrated breakthrough ability to predict neoadjuvant chemotherapy response in breast cancer patients with low tumor-infiltrating lymphocytes, achieving 66% response rates in previously treatment-resistant populations.
  • The study analyzed 88 HER2-negative germline BRCA carriers and found that immune heterogeneity assessment outperformed traditional TIL quantification as a predictive biomarker for treatment response.
  • Triple-negative breast cancer patients with low TILs and low heterogeneity achieved remarkable 74% response rates, surpassing even high-TIL patients at 50% response rates.
  • This research challenges current clinical practice of steering low-TIL patients away from chemotherapy and opens new personalized treatment pathways for previously underserved patient populations.

Pfizer and BioNTech Submit EMA Application for Updated COVID-19 Vaccine Targeting LP.8.1 Strain for 2025-2026 Season

  • Pfizer and BioNTech have submitted a regulatory application to the European Medicines Agency for approval of their updated COMIRNATY COVID-19 vaccine targeting the LP.8.1 strain for the 2025-2026 season.
  • The submission follows the EMA's Emergency Task Force recommendation to update COVID-19 vaccine composition to target the LP.8.1 strain for the upcoming season.
  • The companies have not disclosed information regarding target age groups or whether clinical studies will be conducted for the updated vaccine formulation.
  • COMIRNATY currently holds standard marketing authorization in the EU for individuals from 6 months of age, with multiple adapted vaccines already approved for various SARS-CoV-2 variants.

A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Adults, Including Those at Higher Risk of Severe COVID-19

NCT07069309RecruitingNot Applicable
BioNTech SE
Posted 7/8/2025

Ibudilast Fails to Show Efficacy for Alcohol Use Disorder in Phase 2 Trial, But Shows Promise for Women

  • A UCLA clinical trial found that ibudilast, an asthma drug approved in Japan, was no more effective than placebo for treating alcohol use disorder in most patients.
  • Women taking ibudilast showed significantly greater reductions in drinks per drinking day compared to placebo, suggesting potential gender-specific therapeutic benefits.
  • Participants with higher baseline depression levels responded better to placebo than ibudilast, indicating that mood disorders may influence treatment outcomes.
  • The study highlights the complex role of inflammation and immune responses in alcohol use disorder treatment, supporting continued research into personalized approaches.

Ibudilast for the Treatment of Alcohol Use Disorder

NCT03594435CompletedPhase 2
University of California, Los Angeles
Posted 10/1/2018

Vistagen Advances Fasedienol Phase 3 Program for Social Anxiety Disorder with Q4 2025 Data Readout

  • Vistagen's PALISADE-3 Phase 3 trial evaluating fasedienol nasal spray for acute treatment of social anxiety disorder remains on track for topline data in Q4 2025.
  • The investigational pherine nasal spray represents a potential first-in-class treatment with a novel mechanism targeting olfactory-amygdala neural circuits without systemic absorption.
  • Social anxiety disorder affects over 30 million adults in the U.S., with a mean duration of about 20 years and significant impact on daily functioning and quality of life.
  • Successful results from either PALISADE-3 or PALISADE-4, combined with positive PALISADE-2 data, could support a New Drug Application submission to the FDA.

Breakthrough Immunotherapy Response in Rare Lung Adenosquamous Carcinoma with Multiple Driver Mutations

Precision Medicine
  • A 63-year-old patient with advanced lung adenosquamous carcinoma harboring concurrent KRAS G12C, BRAF, PIK3CA, and FLT1 mutations achieved complete remission with tislelizumab plus chemotherapy, maintaining progression-free survival exceeding 46.5 months.
  • This represents the first documented case of such exceptional response in molecularly complex adenosquamous carcinoma, challenging conventional assumptions about multiple driver mutations and immune resistance.
  • The patient's tumor demonstrated PD-L1 positivity (18.11%) and low tumor mutational burden (3.7 muts/Mb), suggesting that biomarker-guided immunotherapy may overcome therapeutic limitations in this aggressive malignancy.
  • Literature review reveals that adenosquamous carcinoma patients typically achieve median progression-free survival of 5.7-14 months with conventional therapy, making this 46.5-month response unprecedented in the field.

Ferroptosis Emerges as Novel Therapeutic Target in Cancer Treatment and Immunotherapy

  • Ferroptosis, a novel form of programmed cell death discovered in 2012, is characterized by iron-dependent lipid peroxidation and shows significant potential as a cancer therapeutic target, particularly in tumors with RAS mutations.
  • Key regulatory pathways include the GPX4 pathway, FSP1-CoQ10 pathway, and complex interactions between iron metabolism, lipid metabolism, and amino acid metabolism that control ferroptosis sensitivity in cancer cells.
  • Ferroptosis demonstrates promising synergistic effects with cancer immunotherapy by enhancing tumor immunogenicity and promoting immune cell infiltration, with several drugs already showing dual ferroptosis-inducing and immunomodulatory properties.
  • Novel nanomedicines and combination therapies targeting ferroptosis pathways are emerging as innovative treatment strategies, though clinical translation remains challenging and requires further investigation.

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