Acceptance into the FDA’s Innovative Science and Technology Approaches for New Drugs (ISTAND) Program marks a key regulatory milestone toward replacing the legacy mouse bioassay with Curi Bio’s human iPSC-derived 3D NMJ platform.
SEATTLE--(BUSINESS WIRE)--#BioTech--Curi Bio, a world leader in human-relevant 3D tissue technology and biosystems for drug discovery and safety testing, today announced that the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has accepted the company's Letter of Intent (LOI) into the Innovative Science and Technology Approaches for New Drugs (ISTAND) program. The acceptance marks a significant regulatory milestone toward qualifying Curi Bio's human iPSC-derived 3D Neuromuscular Junction (NMJ) assay as a formally recognized Drug Development Tool (DDT) based on a non-animal method (NAM) alternative to the mouse bioassay used for botulinum neurotoxin (BoNT) potency testing.
Potency and lot-release testing for BoNT therapeutics spans a multi-billion-dollar global market across aesthetic and therapeutic indications. The industry has historically depended on the “gold standard” Mouse Lethality Bioassay (MLB) to assess BoNT potency. Curi Bio's human cell-derived 3D NMJ platform offers a highly reproducible in vitro alternative that measures neuromuscular contractility in direct response to toxin activity, advancing the broader regulatory momentum generated by the FDA Modernization Act 2.0 and the FDA's NAM initiative. Because Curi Bio’s assay generates physiologically-relevant muscle contractility driven by neuronal stimulation, it provides an identical Mechanism of Action (MoA) that is assessed with in vivo platforms as opposed to proxy measurements of protein degradation.
Having successfully completed an initial Q&A exchange with the FDA, Curi Bio is now advancing to the Qualification Plan phase within ISTAND. While the platform is commercially available now and is being used to de-risk development, streamline batch-release testing, and eliminate animal use in routine BoNT potency assessments, once fully qualified the platform will provide biopharmaceutical developers with a DDT to streamline regulatory submissions.
"Acceptance of our LOI into the FDA's ISTAND program validates both the scientific rigor and regulatory readiness of our 3D neuromuscular platform," said Dr. Nicholas A. Geisse, CEO and Principal Investigator of this project for Curi Bio. "The industry has long needed scalable, human-relevant alternatives to legacy animal models for complex functional testing. By advancing our NMJ assay through the ISTAND framework, we are creating a clear, regulatory-supported path for our biopharma partners to generate faster, more predictive data on our turnkey platform while moving away from costly and imprecise animal testing."
"This acceptance signals a meaningful shift in how regulatory agencies are approaching human-relevant functional data," added Elliot Fisher, Chief Business Officer and Co-Founder of Curi Bio. "Potency testing for botulinum toxins is one of the largest single drivers of batch-release animal testing in pharmaceutical manufacturing. Qualifying our NMJ assay on the Mantarray™ ecosystem gives our commercial partners an off-the-shelf, regulatory-supported pathway to replace the mouse bioassay while capturing significant operational and commercial efficiencies in the process."
Key Highlights
Regulatory Qualification Target: Qualification of Curi Bio's human iPSC-derived 3D NMJ contractility assay as an officially recognized Drug Development Tool (DDT) for BoNT potency and safety assessment under the ISTAND Program.
Replacing Animal Bioassays: Direct replacement of the legacy mouse LD50 bioassay, advancing the 3Rs (Replacement, Reduction, and Refinement) in routine biopharmaceutical quality control and batch-release testing.
Next Steps: Curi Bio will work closely with FDA CDER to finalize the Qualification Plan, detailing experimental protocols, cross-laboratory validation, and context of use (COU) parameters within the ISTAND framework.
About Curi Bio
Curi Bio is accelerating the discovery of next-generation medicines through the Curiverse™, the industry's first closed-loop ecosystem unifying assay-ready iPSC-derived cells, automated high-throughput biosystems, and cloud-based data analytics for industrial-scale, human-relevant drug discovery. Built on three integrated pillars of Cells, Systems, and Data, the Curiverse brings together disease-specific cell models, the Mantarray™ and Nautilai Plus™ biosystem platforms, and the Pulse™ analytics engine to deliver human functional data across cardiac, skeletal muscle, and neuromuscular research. Our mission is to give researchers the transformative tools they need to discover safer, more effective medicines, helping patients live longer, healthier lives. For more information, please visit www.curibio.com.
Contacts
Media Contact:
Jacqueline De Rose Director of Marketing, Curi Bio jacqueline@curibio.com
Corporate & General Contact:
contact@curibio.com
