As it awaits FDA feedback on its pivotal trial for its leading med, Minovia Therapeutics has hired Alan Jacobs, M.D., Ph.D., to help boost it over the line.
The U.S.-Israel biotech, which uses a platform to augment disease caused by mitochondrial dysfunction, will now tap Jacobs’ 20 years’ experience at companies including Aspire Health Science, Hemostemix and PerceptiMed.
As CMO, he will now lead Minovia’s clinical operations and regulatory affairs, including speeding up the development plans for Pearson Syndrome and other “primary and secondary mitochondrial diseases,” the biotech said in a statement.
Currently, Minovia is working on an IND-enabled phase 1/2 test in Pearson syndrome, a fatal pediatric disease. It hopes that by harnessing the power of mitochondria, membrane-bound cell organelles that generate most of the chemical energy needed to power the cell's biochemical reactions, it can help address this unmet medical need and hit other diseases.
Minovia said it is currently “awaiting feedback from FDA” on pivotal study design for Pearson syndrome for the next stage of development.
The biotech’s approach is based on cell therapies to treat patients affected with mitochondrial diseases using its so-called Mitochondrial Augmentation Therapy (MAT) platform. MAT is being developed as a scalable therapeutic platform targeting the root cause of diseases caused by mitochondrial dysfunction. In MAT, patients’ hematopoietic stem and progenitor cells are enriched with healthy mitochondria in the hope this can stop or reverse certain diseases.
“Mitochondrial diseases are often fatal with no approved therapies in the U.S., something we are working tirelessly to change,” said Natalie Yivgi-Ohana, CEO and co-founder of Minovia.
“Twelve patients have been dosed so far in Israel with our Mitochondrial Augmentation Therapy (MAT) through compassionate use programs, as well as part of a phase 1/2 trial under IND, and we have our sights on potential FDA approval in an ultra-rare indication over the next several years. We are honored and excited to have Dr. Jacobs as CMO, which will enable us to draw on his considerable scientific and business expertise in bringing successful cell therapy treatments to patients with these rare diseases.”