November 23, 2020
– BioSpherix collaboration enables cost-efficient, highly-scalable cell therapy manufacturing at Minovia’s new US manufacturing site –
– O’Donnell to bring extensive cell therapy operational and CMC experience to Minovia –
– Expansion of leadership team and cGMP manufacturing capability advances Minovia’s mission to deliver novel cell therapies to patients with mitochondrial diseases –
CAMBRIDGE, Mass. & HAIFA, Israel–(BUSINESS WIRE)–Minovia Therapeutics, a clinical-stage company focused on the development of cell-based Mitochondrial Augmentation Therapy (MAT) to treat mitochondrial diseases, announced today a major expansion of its physical and organizational cGMP US manufacturing capability through a collaboration with BioSpherix, a specialized cell therapy equipment manufacturer. The Company also announced the appointment of David O’Donnell as its new Global Head of Manufacturing and Supply Chain. These developments will enable Minovia to continue its rapid development of MAT, including the initiation of the first US site to support its long-term clinical development plans in multiple primary mtDNA diseases.
The relationship with BioSpherix will allow Minovia to deliver end-to-end cell processing capability by configuring BioSpherix’s cytocentric, modular isolator technology to fit Minovia’s needs in a highly-regulated, cGMP environment, and provides flexibility and scalability for the future. The BioSpherix technology will be an integral component of Minovia’s US manufacturing site, a 4,600 square foot facility in the growing biotech cluster in Woburn, Massachusetts.
Bethany Sensenig, CFO & Head of US Operations, said, “We see BioSpherix’s innovative technology as being fit-for-purpose to our highly personalized, cell-based process, and we look forward to our manufacturing site being fully operational by the end of the year. Our collaboration further advances our efforts to build capacity for delivering Mitochondrial Augmentation Therapy to the US market in a robust, scalable, and cost-effective way.”
Randy Yerden, CEO of BioSpherix, commented, “BioSpherix’s technology, in comparison to a traditionally-engineered, stick-built clean-room approach, is a more cost-effective option with a shorter time from design to a validated site, and can also be easily customized to Minovia’s requirements. Our Cytocentric® process control is also likely to result in a higher potency product.”
To guide its manufacturing expansion, Minovia has appointed David O’Donnell as its new Global Head of Manufacturing and Supply Chain. David is a former Director of Technology Operations and CMC at Unum Therapeutics and former Director of Cell Processing and Manufacturing Operations at OvaScience.
Natalie Yivgi-Ohana, PhD, Co-founder & CEO of Minovia, stated, “David brings a wealth of experience in cell processing for mitochondrial cell-based products. His leadership, along with our strategic collaboration with BioSpherix, will be critical to advancing our clinical development plans towards commercialization. We are developing MAT to treat the root cause of diseases generated by mitochondrial dysfunction. Our commitment to bring therapies to mitochondrial disease patients remains stronger than ever, and we look forward to the launch of our US manufacturing site and dosing of patients at US sites through our future clinical trials.”
About Minovia Therapeutics
Minovia Therapeutics is a clinical stage company and the first to use a cell therapy approach to treat people affected with mitochondrial diseases through its Mitochondrial Augmentation Therapy (MAT) platform. MAT is being developed as a robust and scalable therapeutic platform targeting the root cause of diseases generated by mitochondrial dysfunction. MAT enriches patients’ hematopoietic stem and progenitor cells with healthy mitochondria isolated from an allogeneic or syngeneic source. Minovia’s initial clinical focus is on rare mitochondrial diseases for which there are no approved treatments in the United States and the unmet medical need is immense. Minovia is now conducting an IND enabled phase I/II clinical trial in Pearson Syndrome, a fatal pediatric disease. Harnessing the power of mitochondria, Minovia is committed to exploring the full potential of its proprietary platform to address mitochondrial diseases ranging from orphan indications to more common diseases.Download this news article