MedPath

Tagged News

Lantern Pharma Receives FDA Guidance for Pediatric CNS Cancer Trial Targeting ATRT

Orphan DrugAIRare Disease
  • Lantern Pharma completed a Type C meeting with the FDA, receiving critical guidance on the regulatory pathway and trial design for a planned pediatric CNS cancer trial targeting Atypical Teratoid Rhabdoid Tumor (ATRT).
  • The FDA confirmed the potential incorporation of spironolactone as a combination agent with LP-184/STAR-001 to assess synergistic effects in enhancing efficacy against CNS cancers.
  • The company's ATRT program has received both Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA, highlighting the urgent unmet medical need.
  • Lantern plans to submit an IND application amendment based on FDA guidance, with trial initiation targeted for Q1 2026.

ArcaScience Secures $7M to Accelerate AI-Driven Drug Safety Evaluation Platform

AI
  • ArcaScience raised $7 million in seed funding to expand its AI platform that transforms drug benefit-risk assessments from months-long processes to seconds-long computations.
  • The French healthtech startup's platform integrates over 100 billion biomedical data points and is already being used by major pharmaceutical companies including Sanofi, AstraZeneca, GSK, and Takeda.
  • The funding will support US and UK expansion and launch of patient-facing solutions for pediatric brain cancer and dermatological diseases.
  • The global benefit-risk evaluation market is valued at $13 billion annually, with experts predicting 80% of pharmaceutical companies will rely on AI solutions by 2026.

BostonGene's AI Model Identifies Five Novel Subtypes to Predict Immunotherapy Response in Kidney Cancer

AITargeted TherapyPrecision MedicineOncology
  • BostonGene published a study in Cell Reports Medicine introducing the largest harmonized transcriptomic and clinical dataset in kidney cancer, analyzing over 3,600 patient samples.
  • Researchers developed a multimodal AI foundation model that identified five novel Harmonized Immune Tumor Microenvironment (HiTME) subtypes in clear cell renal cell carcinoma.
  • The AI model generated clinically interpretable responder scores that correlated with survival outcomes for both immune checkpoint inhibitors and VEGF inhibitors across independent cohorts.
  • The framework revealed a therapy-resistant subgroup characterized by immune-desert phenotypes and angiogenic signaling, highlighting new therapeutic opportunities.

SeqOne Acquires Congenica to Create Global Leader in AI-Powered Genomic Medicine

AI
  • SeqOne has acquired UK-based Congenica from the Wellcome Sanger Institute, creating one of the most significant global pure-play software companies in genomics serving over 160 laboratories across 30+ countries.
  • The combined entity aims to achieve over 200,000 patient genomic analyses by 2025, leveraging AI-powered platforms for rapid diagnosis of rare diseases and personalized cancer therapies.
  • This strategic acquisition follows SeqOne's impressive growth trajectory, doubling revenue and expanding from three to over 30 countries in a single year while maintaining continuity of service for existing customers.

Biotech Veterans Launch Corsera Health with Annual RNAi Drug to Prevent Cardiovascular Disease

AI
  • Biotech leaders John Maraganore and Clive Meanwell have launched Corsera Health with the ambitious goal of creating a world without cardiovascular disease.
  • The company is developing a once-annual RNAi drug targeting PCSK9 and angiotensinogen to lower cardiovascular disease risk, with human trials planned by year-end.
  • Corsera has created an AI tool called Klotho Health to predict cardiovascular disease likelihood and has raised $50 million from founders and insider investors.
  • The startup plans to offer both direct-to-consumer and physician-based approaches for their preventive cardiovascular medicine platform.

Medical Horizons Partners with Bowhead Health to Expand AI-Powered Clinical Trial Matching Across Italy, Turkey, and Cyprus

AI
  • Medical Horizons S.r.l. has secured an exclusive distribution agreement with Canadian company Bowhead Health Inc. to bring AI-powered clinical trial matching technology to Italy, Turkey, and Cyprus.
  • Bowhead Health's platform addresses the inefficiencies of manual clinical trial matching by enabling hospitals to instantly scan global and local trial databases, particularly capturing genomic details that are often missed.
  • The AI-driven technology aims to reduce time spent on manual searches while accelerating progress toward personalized medicine by connecting patients with appropriate therapies more efficiently.

Charm Therapeutics Raises $80M to Advance AI-Designed Menin Inhibitor for AML Treatment

AI
  • UK-based Charm Therapeutics secured $80 million in Series B funding to advance its next-generation menin inhibitor for acute myeloid leukemia into Phase I clinical trials starting Q1 2026.
  • The company's AI-driven DragonFold platform designed a menin inhibitor that maintains potency against all known clinical resistance mutations, addressing key limitations of first-generation therapies.
  • The funding round was co-led by New Enterprise Associates and SR One, with participation from NVIDIA, OrbiMed, F-Prime, and Khosla Ventures.
  • Charm's candidate is designed to be efficacious at low doses while avoiding cardiac arrhythmia and drug-drug interactions associated with existing menin inhibitors.

Hemex Expands Global Clinical Network Alliance to Strengthen End-to-End CRO Capabilities

OncologyAI
  • Hemex AG announced the expansion of its global footprint through a Clinical Network Alliance with international partners, combining specialized expertise in oncology, regulatory operations, digital health, and site management.
  • The alliance provides comprehensive access to international trial networks across the United States, Europe, and India, supported by over 130 experienced professionals and a Quality Assurance team with successful regulatory inspections from major authorities worldwide.
  • Key partners include Kitsa USA with AI-driven platform capabilities, Shankus Hospitals with 13 oncology centers managing over 33,000 outpatients annually, and specialized CROs offering bioavailability/bioequivalence studies and regulatory compliance services.
  • The collaboration aims to deliver faster patient recruitment, stronger regulatory alignment, and efficient cross-border execution for pharmaceutical, biotech, and medtech companies conducting clinical trials.

Oxford University Launches £118M AI-Powered Vaccine Research Program Against Antibiotic-Resistant Bacteria

AI
  • Oxford University's Vaccine Group has launched the CoI-AI program with £118 million funding from Larry Ellison's Ellison Institute of Technology to develop AI-powered vaccines against antibiotic-resistant bacterial infections.
  • The research will target deadly pathogens including Streptococcus pneumoniae, Staphylococcus aureus, and E. coli using human challenge models combined with artificial intelligence to identify protective immune responses.
  • Led by Professor Sir Andrew Pollard, who previously ran COVID-19 vaccine trials, the program represents a new frontier in vaccine science aimed at addressing one of the most urgent problems in infectious disease.
  • The collaboration combines Oxford's expertise in immunology and human challenge studies with EIT's AI technology, supported by Oracle's computational resources and scheduled to operate from EIT's Oxford campus opening in 2027.

Raina Biosciences Publishes Breakthrough AI Platform for mRNA Therapeutics in Science

AICAR-TDrug Discovery
  • Raina Biosciences announced publication of its GEMORNA platform data in Science, marking the world's first generative AI platform purpose-built for mRNA design and optimization.
  • GEMORNA-generated mRNAs demonstrated up to 150-fold increase in human erythropoietin expression and nearly 100% anti-tumor efficacy in primary human T cells compared to benchmarks.
  • The MIT spinout company closed a $5.7 million angel round and is collaborating with leading pharmaceutical and biotech companies to accelerate mRNA therapeutic development.
  • The platform addresses key limitations in mRNA therapeutics by designing sequences with enhanced expression levels and durability across diverse therapeutic applications.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.