MedPath

Tagged News

UK Launches £18.8 Million Initiative to Transform Nuclear Waste into Precision Cancer Therapies

  • The UK has announced a £18.8 million investment to develop targeted alpha therapies using lead-212 extracted from recycled nuclear fuel for precision cancer treatment.
  • The project, co-led by UK National Nuclear Laboratory and Medicines Discovery Catapult, aims to create an "evergreen" supply of radiopharmaceuticals that directly attack cancer cells while sparing healthy tissue.
  • A tiny amount of processed material equivalent to a single drop of water in an Olympic-sized swimming pool could potentially treat thousands of cancer patients.
  • The initiative positions the UK to provide these innovative treatments both domestically and globally, targeting previously untreatable cancers with sustainable nuclear waste utilization.

Solve Therapeutics Secures $120 Million to Advance Next-Generation ADC Platform for Solid Tumors

  • Solve Therapeutics raised $120 million in an oversubscribed financing round led by Yosemite to accelerate development of its clinical-stage ADC pipeline featuring proprietary CloakLink™ linker technology.
  • The company's lead programs SLV-154 and SLV-324 are currently in Phase 1 clinical trials for solid tumors, with funding supporting completion of Phase 1b studies and operational expansion.
  • Solve's CloakLink™ platform addresses traditional ADC limitations by increasing stability and decreasing hydrophobicity, potentially enabling improved therapeutic indices and reduced toxicity.
  • The financing brings Solve's total capital raised to $321 million, following a $75 million round completed in December 2024.

Third Arc Bio Partners with Adagene to Develop Masked CD3 T Cell Engagers for Solid Tumor Treatment

  • Third Arc Bio has entered a licensing agreement with Adagene to develop two masked CD3 T cell engagers using Adagene's SAFEbody precision masking technology platform.
  • The partnership aims to address precision challenges in solid tumor immunotherapy by combining Third Arc Bio's ARCStim Platform with Adagene's tumor-specific activation capabilities.
  • Adagene will receive $5 million upfront and is eligible for up to $840 million in development and commercial milestones, plus royalties on sales.
  • The collaboration expands Third Arc Bio's portfolio of novel CD3- and CD28-targeting T cell engagers while allowing Adagene to retain development rights in Greater China, Singapore, and South Korea.
NCT06672185RecruitingPhase 1
Third Arc Bio
Posted 2/5/2025

FDA Approves Five Breakthrough Therapies for Gastrointestinal Cancers in First Half of 2025

  • The FDA granted five landmark approvals for GI cancers in early 2025, including the first targeted therapy for KRAS G12C-mutated colorectal cancer with sotorasib plus panitumumab.
  • Pembrolizumab received full approval for HER2-positive gastric cancer, while nivolumab plus ipilimumab gained approvals for MSI-H/dMMR colorectal cancer and hepatocellular carcinoma.
  • Retifanlimab became the first new treatment option for anal canal carcinoma in years, addressing a significant unmet medical need in this rare malignancy.
  • These approvals reflect accelerating momentum in precision medicine and immunotherapy combinations, reshaping treatment paradigms across multiple GI cancer types.

Diamyd Medical's Phase 3 Type 1 Diabetes Trial Clears Final Safety Review Ahead of March 2026 Readout

  • The independent Data Safety Monitoring Board completed its sixth scheduled safety review of Diamyd Medical's Phase 3 DIAGNODE-3 trial, identifying no safety concerns and recommending continuation as planned.
  • The precision medicine immunotherapy Diamyd® is being evaluated in 285 enrolled patients, with more than 70 completing full 24-month follow-up and over 135 completing 15-month visits.
  • An early efficacy readout planned for March 2026 may serve as the basis for a Biologics License Application under the FDA's accelerated approval pathway.
  • The trial operates under Fast Track and Orphan Drug Designations from the FDA, targeting patients with the HLA DR3-DQ2 genotype who represent approximately 40% of Type 1 Diabetes patients.

Beacon Biosignals Secures $86M Series B to Advance AI-Driven Brain Health Diagnostics

  • Beacon Biosignals raised an oversubscribed $86 million Series B funding round to build the world's largest neurodiagnostic dataset and advance AI-driven biomarkers for brain health.
  • The company's FDA-cleared Waveband device directly measures brain electrical activity through EEG during sleep and wake, bringing gold-standard neurophysiology from lab to home settings.
  • Beacon's technology now supports research programs with more than half of the world's top ten biopharmaceutical companies, leveraging AI-derived biomarkers to accelerate CNS drug development.
  • The funding will scale operations to accelerate neurobiomarker discovery across neurological and psychiatric conditions including depression, Parkinson's disease, Alzheimer's disease, and sleep apnea.

Mursla Bio Partners with Global Pharma to Develop AI-Driven Biomarkers for MASH Precision Medicine

  • Mursla Bio has announced a collaboration with a leading global pharmaceutical company to advance biomarker-guided precision medicine in metabolic dysfunction-associated steatohepatitis (MASH).
  • The partnership will utilize Mursla Bio's AI Precision Medicine Platform to generate hepatocyte-specific extracellular vesicle profiles from blood samples to identify patients most likely to benefit from investigational MASH therapies.
  • The collaboration leverages the same infrastructure that enabled Mursla Bio's EvoLiver product to achieve FDA Breakthrough Device Designation, expanding the company's reach in hepatology beyond liver cancer surveillance.
  • MASH affects 5-7% of the world's adult population and represents an emerging therapeutic focus as the GLP-1 revolution reshapes obesity management.

Indivi Secures CHF 15 Million to Advance Alzheimer's Biomarker Discovery Platform

  • Indivi, a Basel-based precision medicine company, closed a CHF 15 million funding round led by Ava Investors to advance biomarker discovery in neuroscience drug development.
  • The company plans to launch a proof-of-concept trial in 2026 targeting functional and electrophysiological biomarkers for β-amyloid-depleting therapies in Alzheimer's disease.
  • Indivi's platform combines electrophysiology and sensor-derived assessments to deliver earlier Proof-of-Biology and Proof-of-Concept signals in neuroscience research.
  • The funding aims to improve clinical trial success rates by enhancing signal-to-noise ratios of early-stage endpoints where conventional measures lack sensitivity.

BostonGene and Kyoto University Partner to Develop AI-Powered Biomarkers for Esophageal Cancer Treatment

  • BostonGene and Kyoto University have announced a research collaboration to develop advanced biological signatures for targeted treatment strategies in esophageal squamous cell carcinoma (ESCC) patients.
  • The partnership will leverage BostonGene's AI-powered platform to analyze tumor molecular profiles and assess their correlation with response to immune checkpoint inhibitor and chemoradiotherapy combination therapy.
  • The research builds on the NOBEL Phase II trial led by Dr. Manabu Muto, integrating genomic and transcriptomic profiling to identify immune-related biomarkers for improved patient stratification and clinical trial optimization.

Cogent Biosciences Raises $475.3 Million to Advance Bezuclastinib for Systemic Mastocytosis

  • Cogent Biosciences successfully priced concurrent public offerings totaling approximately $475.3 million in net proceeds to fund development of bezuclastinib and other precision therapies.
  • The company's lead candidate bezuclastinib is a selective tyrosine kinase inhibitor designed to target the KIT D816V mutation driving systemic mastocytosis and advanced gastrointestinal stromal tumors.
  • Proceeds will support bezuclastinib's development and anticipated commercial launch, while also funding the company's broader pipeline targeting genetically defined diseases.
  • The financing includes $300 million in common stock and $200 million in convertible notes, providing substantial capital runway for the biotechnology company's clinical programs.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.