Curi Bio, a leader in developing human stem cell-based platforms for drug discovery, has announced a Memorandum of Understanding (MOU) for scientific collaboration with Genetox and DreamCIS. Genetox specializes in botulinum toxin (BoT) for cosmetic and therapeutic purposes, while DreamCIS provides CRO services supporting clinical development and regulatory affairs. Together, they will work with Curi Bio to utilize its neuromuscular junction (NMJ) model as a non-animal potency assay for advancing Genetox’s BOTAONE (botulinum toxin) through US FDA approval.

Botulinum toxin is valued for its therapeutic applications, from chronic pain management to cosmetic enhancements. Accurate potency assessment is crucial for safe dosing of this potent neurotoxin. Traditionally, the mouse lethality bioassay has been used, but it is slow, costly, and ethically contentious. The recent FDA Modernization Act 2.0 has removed the regulatory mandate for animal testing, allowing for more humane testing methodologies.

Curi Bio, known for its expertise in delivering human functional data, has received a Small Business Innovation Research grant to develop a human stem cell-based neuromuscular junction. This project aims to provide a 3D human neuromuscular junction model for disease modeling and potency assays without animal studies. In collaboration with the University of Washington, Curi Bio is working towards delivering a functional potency assay for BOTAONE research and manufacture.

Through the MOU, Genetox demonstrates its commitment to incorporating Curi Bio’s NMJ-based potency assay into BOTAONE’s manufacturing and quality control processes. The collaboration will seek regulatory approval for BOTAONE from authorities such as the Korean FDA and US FDA. This partnership signifies a shift towards using in vitro human functional data for regulatory approval, reflecting the evolving landscape of non-animal testing methodologies in the biopharmaceutical industry.

Curi Bio, expressed enthusiasm about the collaboration, emphasizing its role in accelerating the approval process for BOTAONE and advancing more ethical and efficient drug testing methodologies. Dr. Jong Deok Ahn, CEO of Genetox, and Dr. Jeounghee Yoo, CEO of DreamCIS, echoed this sentiment, highlighting the potential of this innovative technology to set new standards for botulinum toxin-based therapeutics and contribute to a healthier future for patients worldwide.

 

Source: businesswire.com

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