SEATTLE--(BUSINESS WIRE)--Curi Bio, the industry leader in developing human stem cell-based platforms for drug discovery, today announced the signing of a Memorandum of Understanding (MOU) for scientific and strategic collaboration with Genetox and DreamCIS. Genetox, an emerging biopharmaceutical company specializing in the sale and manufacture of botulinum toxin (BoT) for cosmetic and therapeutic purposes, and DreamCIS, a leading provider of CRO services supporting clinical development and regulatory affairs, will collaborate with Curi Bio to use the company’s cutting-edge neuromuscular junction (NMJ) model as a non-animal potency assay for advancing Genetox’s BOTAONE (botulinum toxin) through US FDA approval.
BoT is renowned for its therapeutic applications, including the treatment of chronic pain, autonomic disorders, congenital neuromuscular conditions, and cosmetic enhancements. Accurate potency assessment of manufactured lots is essential for safe and effective dosing of the potent neurotoxin. Current standards utilize the mouse lethality bioassay, which is slow, costly, and controversial. US lawmakers recently passed the FDA Modernization Act 2.0 which removed the animal testing regulatory mandate for new investigational drug applications. As an industry leader in delivering human functional data using its advanced platforms for global pharmaceutical and biotechnology companies, Curi Bio has already completed multiple projects that have displaced the use of many animal studies for the discovery of next-generation medicines.
Shortly after the bill’s passage, Curi Bio was awarded a Small Business Innovation Research grant to develop a novel human stem-cell based neuromuscular junction. The project has supported Curi Bio’s development of a next-generation 3D human neuromuscular junction model used for disease modeling, for pharmaceutical and cosmetics potency assays, and for testing broad pathogenicity. The project is currently underway in collaboration with Dr. Alec Smith and Dr. David Mack at the University of Washington and has the goal of delivering human data for animal-free functional potency assays. The project will deliver a functional potency assay for botox research and manufacture in a turnkey, scalable format. Once developed, the assay could be further extended towards a variety of devastating human neuromuscular diseases such as amyotrophic lateral sclerosis (ALS) and Charcot-Marie-Tooth disease (CMT). The project was awarded to Curi Bio by the National Institutes of Health (NIH) and National Center for Advancing Translational Sciences (NCATS) in conjunction with the Food and Drug Administration (FDA).
With this MOU, Genetox shows its commitment to making Curi Bio’s NMJ-based potency assay a key part of BOTAONE’s manufacturing, quality control, and product release processes. Genetox will seek approval for its BOTAONE product from regulatory authorities, including the Korean FDA and United States FDA. This MOU represents an innovative advancement in the field of botox production and regulatory acceptance and marks the first steps of a paradigm shift where in vitro human functional data are used for regulatory approval. As the biopharmaceutical industry shifts towards non-animal testing methodologies, this joint effort underscores the commitment of the three companies to innovation and to ethical research practices.
“This collaboration represents a significant step forward in our mission to revolutionize drug discovery and development,” said Dr. Nicholas A. Geisse, CEO of Curi Bio. “As we continually refine our 3D neuromuscular junction model to develop a clinically-relevant potency assay utilizing human data, we are excited to collaborate with industry leaders and forward thinkers like Genetox and DreamCIS to accelerate the approval process for BOTAONE in the US. This endeavor paves the way for more ethical and efficient drug testing methodologies in the future.”
“We at Genetox are thrilled to embark on this strategic partnership with Curi Bio and DreamCIS,” said Dr. Jong Deok Ahn, CEO of Genetox. “We are confident that this innovative technology will not only facilitate the FDA approval process for BOTAONE, but also set a new standard for the development of botulinum toxin-based therapeutics across the industry.”
“This initiative not only aligns with our dedication to employing cutting-edge science, but also to our responsibility towards more humane and sustainable research practices,” said Dr. Jeounghee Yoo, CEO of DreamCIS. “We look forward to achieving remarkable milestones together and contributing to a healthier future for patients worldwide.”
About Curi Bio
Curi Bio unlocks novel workflows and delivers functional human data to inform biopharmaceutical R&D decision-making. Through an integrated platform featuring advanced 3D tissue models of disease, biosystems enabling clinically relevant functional analyses and AI/ML-enabled insights, Curi Bio melds functional and analytical assessments for drug safety, efficacy, and potency. By offering leading global pharmaceutical end users an integrated preclinical platform along with highly predictive human stem cell tissue models to generate clinically-relevant data, Curi Bio is bridging the gap between preclinical R&D and clinical outcomes, accelerating the discovery and development of safer, more effective medicines.
For more information, please visit www.curibio.com.
About Genetox
Genetox is a biopharmaceutical company specializing in botulinum toxin, fillers, medicines, and cosmetic solutions. The company leverages cutting-edge research and development to create innovative and effective products that meet the highest quality standards. Genetox is committed to providing patients with safe and reliable solutions to improve their health and well-being.
For more information, please visit http://genetox.co.kr/.
About DreamCIS
Established in April 2000, DreamCIS is a Korean Contract Research Organization (CRO) providing comprehensive R&D services to biopharmaceutical companies, including clinical trial operations, post-marketing surveillance, and data management. Since listing on the KOSDAQ in 2020, DreamCIS has expanded its business through strategic acquisitions, including MediTip, a leading Korean regulatory affairs consulting company, and LCS, a preclinical consulting company. In collaboration with its parent company Tigermed, DreamCIS offers a one-stop, full-scope suite of clinical trial services spanning the entire duration of new drug development.
For more information, please visit https://www.dreamcis.com/home/.
