MedPath

Clinical Trial News

Abbott Partners with MSD to Expand Distribution of Diabetes Drug Portfolio in India

  • Abbott and MSD Pharmaceuticals have formed a strategic distribution partnership to expand access to MSD's oral anti-diabetic portfolio in India, including sitagliptin and its fixed-dose combinations.
  • The agreement covers the distribution of sitagliptin-based brands Januvia, Janumet, and Janumet XR, which remain category leaders despite patent expiration in July 2022.
  • India's oral anti-diabetic drug market is valued at Rs 12,500 crore, with DPP-4 inhibitors accounting for Rs 4,000 crore, addressing a critical need for over 101 million diabetic patients.
  • The partnership represents a strategic response to post-patent landscapes, allowing multinational firms to maintain market presence through local distribution networks.

NervGen Appoints Randall Kaye as Chief Medical Advisor Following Positive Spinal Cord Injury Trial Results

  • NervGen Pharma has appointed Dr. Randall Kaye as Chief Medical Advisor to guide the clinical and regulatory strategy for NVG-291, following positive topline results from the chronic cohort of their Phase 1b/2a spinal cord injury trial.
  • Dr. Kaye brings extensive CNS therapeutic development experience, having previously served as CMO at Longboard Pharmaceuticals through its $2.6 billion acquisition by H. Lundbeck A/S.
  • The appointment positions NervGen to advance NVG-291, a first-in-class therapeutic peptide with FDA Fast Track designation, toward an anticipated FDA meeting in the second half of 2025.
  • NVG-291 met its primary endpoint in the chronic cohort and demonstrated promising changes in hand function assessment, representing a potential breakthrough in neuroreparative therapeutics.

Curasight Advances uTREAT Brain Cancer Therapy with Phase 1 Trial Submission to EMA

Targeted Therapy
  • Curasight A/S has submitted a Clinical Trial Application to the European Medicines Agency for a Phase 1 trial of uTREAT, a targeted radiopharmaceutical therapy for glioblastoma patients.
  • The therapy targets the uPAR receptor, with recent Phase II data showing 94% of Grade 4 gliomas were uPAR-positive, supporting the treatment's potential in this aggressive brain cancer.
  • Glioblastoma affects approximately 30,000 patients annually in the US and EU, with a devastating prognosis where only 5% of patients survive five years after diagnosis.
  • The company has partnered with Premier Research as the contract research organization to conduct the international Phase 1 trial, with first patient dosing expected in the second half of 2025.

Akari Therapeutics Secures India Patent for Novel Spliceosome-Inhibiting ADC Payload Technology

  • Akari Therapeutics received Patent No. 562,919 from India's Intellectual Property Office for its novel PH1 payload, a spliceosome inhibitor that disrupts RNA splicing to kill cancer cells and activate immune responses.
  • The patent covers the company's immuno-oncology PH1 payload, proprietary linkers, and ADC technology with applications across various cancer targets, strengthening global IP protection.
  • India represents a strategic market with cancer cases projected to reach 2.08 million by 2040, highlighting the growing need for innovative cancer therapies.
  • The company's lead candidate AKTX-101 targets Trop2 receptors and has demonstrated significant tumor-killing activity and prolonged survival in preclinical studies compared to traditional ADC payloads.

Respiratorius Secures FDA Pre-IND Meeting for VAL001 Cancer Treatment Following Positive Physician Survey

Oncology
  • Respiratorius has been granted a pre-IND meeting with the FDA for VAL001, an innovative oral formulation of sodium valproate designed as pre-treatment for cancer therapy, particularly Diffuse Large B-cell Lymphoma.
  • A comprehensive physician survey across the U.S., Europe, and Japan involving 135 treating physicians and key opinion leaders found that over 70% would be willing to prescribe VAL001, citing favorable clinical efficacy and established safety profile.
  • Commercial analysis projects VAL001 could achieve annual sales of USD 190 million at estimated market penetration, with cumulative revenue of USD 2.3 billion over the period of market exclusivity.
  • The company has secured patent protection for VAL001's formulation across key markets including the U.S., Europe, Japan, and Canada, with the European patent recently granted providing at least 20 years of market exclusivity.

Infinity Bio Secures $8M Series A to Advance Antibody Reactome Profiling Technology

  • Infinity Bio closed an $8 million Series A financing round led by Illumina Ventures to expand its proprietary MIPSA™ antibody reactome profiling platform.
  • The biotechnology company acquired assets from Serimmune, Inc. to broaden its immune profiling service offerings and plans to launch new services in 2025.
  • The platform enables high-resolution analysis of antibody responses against viruses, human proteins, and allergens, supporting biomarker discovery and therapeutic development.
  • Founded in 2023, Infinity Bio operates a 9,000 square-foot laboratory in Baltimore capable of processing thousands of samples per week for academic, government, and biopharma customers.

Climb Bio Strengthens Leadership Team with Key Executive Appointments to Advance Immune-Mediated Disease Pipeline

Monoclonal Antibody
  • Climb Bio appointed Edgar D. Charles, M.D., MSc as Chief Medical Officer, bringing over 20 years of immunology-focused pharmaceutical development experience from Bristol Myers Squibb and Merck & Co.
  • The company also hired Cindy J. Driscoll, MBA as Senior Vice President, Finance, a seasoned executive with over two decades of biotechnology industry experience.
  • Dr. Charles will lead clinical development of budoprutug, an anti-CD19 monoclonal antibody, and CLYM116, an anti-APRIL monoclonal antibody for immune-mediated diseases.
  • The appointments come at a pivotal time as Climb Bio prepares to execute clinical studies for both therapeutic programs targeting B-cell mediated diseases.

Pattern Computer Advances AI-Discovered Drug for Multiple Hard-to-Treat Cancers to Testing Phase

Precision Medicine
  • Pattern Computer has developed a novel AI-discovered drug using CRISPR technology that targets a protein not expressed in healthy adult tissue but present in aggressive early-onset colorectal cancer patients.
  • The company's Pattern Discovery Engine identified a genetic signature that increases colorectal cancer risk by 200% in individuals under 45 years old, leading to both a new diagnostic tool and therapeutic target.
  • Initial testing will focus on early-onset colorectal cancer, with potential applications across multiple hard-to-treat cancers including ovarian, lung, breast, pancreatic, and brain cancers.
  • The drug is designed with genome-wide specificity for a single target and aims to block metastasis while reducing tumor growth with minimal toxicity.

Fareva Opens New GMP Sterile Pilot Unit in France to Support Biotech Drug Manufacturing

Monoclonal Antibody
  • Fareva has launched a new GMP sterile pilot unit at its Pau site in France, designed to produce liquid and lyophilized injectable forms for biotechnology-derived medicines.
  • The facility features advanced isolator technology compliant with revised Annex 1 requirements and can handle products ranging from small molecules to highly potent substances up to OEB 5 classification.
  • The unit supports flexible batch production from 200 to 8,000 vials and enables manufacturing of monoclonal antibodies, mRNA in LNP form, proteins, peptides, and ADCs for clinical trials and small commercial batches.
  • The new capability strengthens Fareva's position in sterile Fill & Finish services and supports pharmaceutical development from Phase 1 studies through commercialization via the company's network of five sterile production sites.

SandboxAQ Releases 5.2 Million Synthetic Molecules Dataset to Accelerate AI-Driven Drug Discovery

AIDrug Discovery
  • SandboxAQ, an AI startup spun out from Google and backed by Nvidia, has released a dataset of 5.2 million synthetic three-dimensional molecules to accelerate drug discovery processes.
  • The synthetic molecules were generated using Nvidia's chips and are designed to help scientists predict drug-protein binding interactions, a critical step in pharmaceutical development.
  • The publicly available dataset combines traditional scientific computing with AI advancements to train models that can virtually replicate lab experiments and predict molecular binding in a fraction of the time.
  • SandboxAQ plans to commercialize AI models developed with this data, aiming to provide results that rival actual laboratory experiments but through virtual simulation.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.