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Clinical Trial News

ImmunoPrecise Achieves AI-Driven Breakthrough in Universal Dengue Vaccine Discovery

AIDrug Discovery
  • ImmunoPrecise Antibodies has identified a highly conserved epitope across all four dengue virus serotypes using its proprietary LENSai™ platform powered by patented HYFT® technology.
  • The discovery represents a major milestone toward developing a universal dengue vaccine by targeting a viral component that remains unchanged despite mutations across all dengue serotypes.
  • The company plans to extend its AI-driven vaccine design platform to other infectious diseases including HIV, Norovirus, and RSV, with early assessments underway for oncology applications.
  • The breakthrough was achieved entirely through computational methods, demonstrating the platform's ability to translate complex biological data into actionable vaccine design without laboratory-based inputs.

Cresemba Antifungal Drug Achieves Record Global Sales, Triggers $2.5M Milestone Payment to Basilea

  • Basilea Pharmaceutica received a second $2.5 million milestone payment in 2025 from partner Pfizer following strong Cresemba sales performance in Asia Pacific and China.
  • Global sales of Cresemba reached $562 million in 2024, representing 19% year-over-year growth and making it the world's largest branded antifungal for invasive fungal infections.
  • The antifungal drug is now marketed in more than 70 countries, with particularly robust uptake in China driving continued commercial success.
  • Cresemba is approved for treating invasive aspergillosis and invasive mucormycosis in adult patients across multiple regions including China, Europe, and the United States.

Osivax Completes Phase 2a Booster Trial for Broad-Spectrum Influenza Vaccine OVX836

  • Osivax announced completion of patient visits in its Phase 2a booster trial evaluating OVX836, a broad-spectrum influenza A vaccine candidate targeting the highly conserved nucleoprotein antigen.
  • The randomized, double-blind trial enrolled 117 healthy adults aged 20-64 who previously participated in Phase 2 trials conducted 3-5 years ago, testing booster doses at 180μg or 480μg.
  • OVX836 represents a first-in-class approach using oligoDOM™ nanoparticle technology to target the nucleoprotein, which is less likely to mutate than surface antigens.
  • Final results are expected in the second half of 2025, with the trial uniquely assessing immune response persistence and boostability over an extended timeframe.

Safety and Immune Response of One Dose of OVX836 at Two Dose Levels, in Comparison to Influvac TetraTM, After Intramuscular Administration in Healthy Subjects Aged 18-65 Years

NCT04192500CompletedPhase 2
Osivax
Posted 12/11/2019

Safety and Immunogenicity of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Participants Previously Administered With OVX836

NCT06582277CompletedPhase 2
Osivax
Posted 10/22/2024

Efficacy, Immunogenicity and Safety of OVX836 Influenza Vaccine 480μg

NCT05569239Not Yet RecruitingPhase 2
Osivax
Posted 9/8/2025

Immunogenicity and Safety of the Concomitant Administration of OVX836 and Quadrivalent Influenza Vaccine in Healthy Volunteers.

NCT05284799CompletedPhase 2
Osivax
Posted 5/9/2022

Immunogenicity and Safety of Three Dose Levels of OVX836 Candidate Vaccine Against Influenza in Healthy Volunteers.

NCT05060887CompletedPhase 2
Osivax
Posted 11/15/2021

Cellectar Biosciences Raises $2.5 Million Through Warrant Exercise to Advance Cancer Drug Development

Targeted TherapyOrphan DrugOncology
  • Cellectar Biosciences secured $2.5 million in funding through the exercise of existing warrants at a reduced price of $0.3041 per share, with proceeds designated for general corporate purposes and operating expenses.
  • The company's lead candidate iopofosine I 131 has received FDA Breakthrough Therapy Designation and is being studied in Phase 2b trials for multiple myeloma and CNS lymphoma.
  • Cellectar's proprietary Phospholipid Drug Conjugate platform aims to deliver next-generation cancer treatments with improved efficacy and safety through targeted delivery mechanisms.

CancerVax Achieves Breakthrough in Targeted Nanoparticle Development for Universal Cancer Treatment

Targeted Therapy
  • CancerVax successfully created cell-targeting nanoparticles that can latch onto cancer cell surface proteins with high efficiency, completing a critical component of their two-step cancer detection platform.
  • The company's innovative approach uses Smart mRNA technology to disguise cancer cells as viruses like measles, tricking the immune system into attacking malignant cells while leaving healthy tissue unharmed.
  • Recent laboratory confirmation demonstrated strong conjugation efficiency, indicating the nanoparticles can be manufactured at scale for potential clinical-grade production.
  • The next phase involves combining the targeting nanoparticles with Smart mRNA payloads for in-vitro optimization and in-vivo animal testing to evaluate efficacy and toxicity.

Biocytogen Secures Japan Patent for RenMab Platform, Strengthening Global IP Portfolio for Fully Human Antibody Discovery

Monoclonal AntibodyGene Editing
  • Biocytogen Pharmaceuticals has received a Japan Patent Office invention patent for its RenMab fully human antibody mouse platform technology, marking a significant milestone in global intellectual property expansion.
  • The RenMab platform uses proprietary SUPCE technology to replace murine immunoglobulin genes with human counterparts, enabling generation of fully human antibodies without additional humanization steps.
  • The company has established licensing agreements with over 20 companies including Merck KGaA, Janssen/Johnson & Johnson, and BeiGene, generating over 1,000,000 fully human antibody sequences against more than 1,000 therapeutic targets.
  • Biocytogen's RenMice platform has secured patent grants in nearly 10 countries with nearly 40 patent applications under examination across 15 countries and regions.

Harmony Biosciences Secures Patent Protection for WAKIX Through 2030 Settlement with Lupin

Orphan Drug
  • Harmony Biosciences reached a settlement agreement with Lupin Limited that prevents generic competition for WAKIX until January 2030, strengthening the company's intellectual property position for its narcolepsy treatment.
  • The settlement resolves patent infringement litigation related to Lupin's generic application and reinforces the validity of Harmony's patent portfolio protecting pitolisant hydrochloride formulations.
  • Harmony is advancing next-generation pitolisant formulations with utility patents potentially extending exclusivity to 2044, while continuing to defend against other generic challengers seeking WAKIX approval.

Mitochondrial DNA Variant Predicts Immunotherapy Resistance in Metastatic Melanoma

  • Researchers analyzed genetic material from 1,225 metastatic melanoma patients and identified that those with mitochondrial haplogroup T (HG-T) were 3.46 times less likely to respond to checkpoint inhibitor therapy.
  • The HG-T variant, present in approximately 12% of metastatic melanoma patients, is inherited only from mothers and represents the first genetic biomarker to predict immunotherapy resistance in this deadly skin cancer.
  • Validation studies across 13 cancer centers confirmed the findings, with HG-T patients showing only 18% response rates compared to over 50% in patients without this genetic variant.
  • The discovery could enable pre-treatment genetic testing to identify non-responders and guide alternative treatment strategies for the nearly 10,000 Americans who die annually from metastatic melanoma.

Mediar Therapeutics Initiates Phase 2 Trial of First-in-Class Anti-WISP1 Antibody for Idiopathic Pulmonary Fibrosis

Monoclonal AntibodyRare Disease
  • Mediar Therapeutics has dosed the first patient in its Phase 2 WISPer trial evaluating MTX-463, a first-in-class anti-WISP1 antibody for idiopathic pulmonary fibrosis treatment.
  • The randomized, double-blind, placebo-controlled study will measure changes in forced vital capacity at 24 weeks as its primary endpoint in IPF patients.
  • MTX-463 targets the myofibroblast, the key pathogenic cell driving fibrosis progression, representing a novel therapeutic approach for this devastating disease.
  • The company has entered a global licensing agreement with Eli Lilly to advance MTX-463 through the Phase 2 trial, while independently developing two additional fibrosis programs.

WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

NCT06967805RecruitingPhase 2
Mediar Therapeutics
Posted 5/5/2025

Kiniksa Pharmaceuticals Advances KPL-387 Phase 2/3 Trial for Recurrent Pericarditis

Monoclonal Antibody
  • Kiniksa Pharmaceuticals announced the trial design for its Phase 2/3 clinical study of KPL-387, a monoclonal antibody targeting IL-1R1, in recurrent pericarditis patients.
  • The trial will enroll up to 165 participants across dose-focusing and pivotal portions, with initiation planned for mid-2025 and Phase 2 data expected in the second half of 2026.
  • KPL-387 offers a potential monthly subcutaneous dosing profile, which could expand treatment options for recurrent pericarditis patients currently facing limited therapeutic alternatives.

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