MedPath

Clinical Trial News

Cantargia's Nadunolimab Receives FDA Fast Track Designation for Metastatic Pancreatic Cancer

Monoclonal AntibodyOncology
  • The FDA has granted Fast Track Designation to nadunolimab, Cantargia's anti-IL1RAP antibody, for treating previously untreated metastatic pancreatic ductal adenocarcinoma with high IL1RAP expression levels.
  • The designation follows strong clinical data from the CANFOUR study showing 35% two-year survival, 14.2 months overall survival, and 48% overall response rate in patients with high IL1RAP expression.
  • Fast Track Designation provides benefits including more frequent FDA meetings, eligibility for Accelerated Approval and Priority Review, and rolling review opportunities for the Biologic License Application.
  • The recognition addresses the high unmet medical need in metastatic pancreatic cancer, where current treatment options are limited and overall survival after first-line treatment is typically less than 12 months.

A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors

NCT03267316CompletedPhase 1
Cantargia AB
Posted 9/19/2017

Nadunolimab in Combination with Gemcitabine Plus Carboplatin in Patients with Advanced Triple Negative Breast Cancer.

NCT05181462Active, Not RecruitingPhase 1
Cantargia AB
Posted 1/11/2022

IQVIA and NVIDIA Launch AI Orchestrator Agents to Accelerate Clinical Research and Drug Development

AI
  • IQVIA announced the launch of multiple AI orchestrator agents in collaboration with NVIDIA at GTC Paris, designed to manage and accelerate complex pharmaceutical development workflows for thousands of global customers.
  • The AI agents can reduce clinical trial start-up processes from 200 days and clinical data review from seven weeks to as little as two weeks through automated workflows and specialized sub-agents.
  • The orchestrator agents utilize NVIDIA NIM microservices and IQVIA's petabytes of healthcare data to streamline target identification, clinical site start-up, and drug commercialization processes.
  • The technology enables pharmaceutical companies to focus on decision-making rather than time-consuming administrative tasks while providing comprehensive market analysis in days instead of weeks.

Memo Therapeutics Demonstrates Therapeutic Antibodies Can Cross Kidney Barrier, Supporting BK Virus Treatment Approach

Monoclonal Antibody
  • Memo Therapeutics published research in Frontiers in Pharmacology showing that intravenously administered therapeutic IgG antibodies can cross the kidney endothelial barrier and be detected in urine.
  • The study found that 0.015% (median) of serum rituximab concentration appears in urine, with levels reaching up to 4.2%, challenging previous assumptions about size-exclusion limitations.
  • These findings provide scientific support for the dosing strategy of potravitug, MTx's investigational anti-BK polyomavirus antibody currently in Phase II trials for kidney transplant recipients.
  • BKV nephropathy affects up to 70% of kidney transplant recipients with established BK viremia and is associated with compromised graft function and reduced long-term survival.

Israeli Researchers Develop Bioengineered Skin Graft That Accelerates Burn Healing by 50%

  • Researchers from Tel Aviv University and Sheba Medical Center have developed a bioengineered skin graft using patients' own cells that heals burns in half the time of standard treatments.
  • The innovative graft achieved wound closure in just four days compared to eight days with conventional methods in animal models, while also promoting hair follicle growth.
  • The technology uses FDA-approved nanofiber scaffolds that allow cells to self-organize into natural skin structure without requiring animal-derived materials or causing tissue shrinkage.
  • The breakthrough was driven by urgent clinical needs arising from treating numerous burn victims, including soldiers injured in recent conflicts.

Bayer and Broad Institute Extend Cardiovascular Research Partnership Through 2030

Precision MedicineDrug Discovery
  • Bayer and the Broad Institute have extended their decade-long cardiovascular research collaboration by an additional five years, focusing on precision cardiology target identification and novel therapeutic approaches.
  • The partnership has already yielded clinical progress with Bayer's GIRK4 inhibitor entering Phase I trials in May 2025 for atrial fibrillation treatment.
  • Current research efforts target specific cardiovascular conditions including dilated cardiomyopathy, leveraging genomics expertise and human cardiomyocyte platforms for drug discovery.
  • The collaboration combines Broad Institute's genomics capabilities with Bayer's drug discovery experience to address significant unmet medical needs in cardiovascular diseases.

Bristol Myers Squibb Subsidiary RayzeBio Acquires OncoACP3 Radiopharmaceutical for Prostate Cancer in $1.35 Billion Deal

  • RayzeBio, a Bristol Myers Squibb subsidiary, has licensed exclusive worldwide rights to OncoACP3, a novel radiopharmaceutical targeting prostate cancer, from Philochem AG for up to $1.35 billion.
  • OncoACP3 is a small molecule ligand with high affinity for Acid Phosphatase 3 (ACP3), currently in Phase I trials showing promising selective tumor uptake and minimal healthy tissue uptake.
  • The deal includes a $350 million upfront payment, up to $1 billion in development milestones, and mid-single to low double-digit royalties on global net sales.
  • The agreement strengthens RayzeBio's position in radiopharmaceutical therapeutics and provides Bristol Myers Squibb entry into the prostate cancer treatment arena through actinium-based therapy development.

A Study to Evaluate the Safety and Dosimetry of 68Ga-OncoACP3 in Patients With Prostate Cancer

NCT06840535RecruitingPhase 1
Philogen S.p.A.
Posted 4/8/2025

SpliceBio Raises $135 Million Series B to Advance First Dual AAV Gene Therapy for Stargardt Disease

Orphan Drug
  • SpliceBio secured $135 million in Series B funding co-led by EQT Life Sciences and Sanofi Ventures to advance SB-007, the first dual AAV gene therapy cleared by FDA for Stargardt disease treatment.
  • The company's proprietary Protein Splicing platform addresses a fundamental limitation of AAV vectors by enabling delivery of large genes that exceed the 4.7 kilobase packaging capacity through engineered inteins.
  • SB-007 has received Orphan Drug Designation from both FDA and European Commission, with the first patient dosed in the Phase 1/2 ASTRA study in March 2025.
  • The platform technology has transformative potential across ophthalmology and neurology by unlocking treatment possibilities for genetic disorders previously considered untreatable due to large gene size limitations.

China Approves First-in-Class Influenza Drug Onradivir Targeting Novel PB2 Protein

Drug Approval
  • China's National Medical Products Administration has approved onradivir, the world's first anti-influenza drug targeting the PB2 protein of the virus's RNA polymerase, marking a breakthrough in influenza treatment.
  • The novel drug demonstrates rapid efficacy by suppressing viral load to very low levels within 24 hours and shows low resistance development compared to existing treatments.
  • Clinical studies indicate onradivir acts faster than commonly used flu treatments oseltamivir and baloxavir marboxil in reducing symptoms and viral load in patients.
  • The approval provides a new therapeutic option for adult patients with uncomplicated influenza A, addressing a global health challenge that causes 290,000 to 650,000 deaths annually.

SpliceBio Raises $135 Million Series B to Advance Gene Therapy for Stargardt Disease Using Novel Protein Splicing Platform

Rare Disease
  • SpliceBio secured $135 million in Series B funding co-led by EQT Life Sciences and Sanofi Ventures to advance its lead gene therapy candidate SB-007 for Stargardt disease.
  • The company's innovative Protein Splicing platform overcomes the challenge of delivering large genes by splitting them into smaller pieces that reassemble into full-length proteins.
  • SB-007 targets Stargardt disease, the most common inherited macular degeneration affecting 1 in 8,000-10,000 people with no approved treatments currently available.
  • The technology has potential to address over 1,200 known mutations causing Stargardt disease and could unlock treatments for other genetic disorders involving large genes.

MaxCyte and Ori Biotech Partner to Enhance CAR-T Cell Manufacturing Through Platform Integration

CAR-TGene Editing
  • MaxCyte and Ori Biotech announced a strategic collaboration integrating their ExPERT™ and IRO® platforms to improve gene-edited T cell yields and reduce manufacturing timelines.
  • The partnership will evaluate CD19 CAR expression via CRISPR knock-in in activated T cells as the initial test system to optimize manufacturing processes.
  • MaxCyte's Flow Electroporation® technology, used in over 19 active clinical and commercial programs, will be combined with Ori's automated manufacturing platform.
  • The collaboration aims to provide therapy developers with enhanced tools to achieve clinically relevant quantities of gene-edited T cells more rapidly and efficiently.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.