Minovia Therapeutics is a clinical-stage biotech developing mitochondria-based cell therapies—using its Mitochondrial Augmentation Technology (MAT) to transplant healthy mitochondria into cells to treat diseases driven by mitochondrial dysfunction, including rare genetic mitochondrial disorders. Pulse 2.0 interviewed Minovia Therapeutics co-founder and CEO Dr. Natalie Yivgi-Ohana to gain a deeper understanding of the company.
Dr. Natalie Yivgi-Ohana’s Background
Could you tell me more about your background? Dr. Yivgi-Ohana said:
“I have a PhD in Biochemistry, and throughout my academic training, I have focused on different aspects of mitochondrial research such as the role of mitochondria in reproductive organs, embryogenesis, hormonal regulation, and, of course, energy production for cellular health. One of the organs I studied was the placenta – a young and healthy organ that is full of highly functional mitochondria. Back then, I thought I should identify a clinical purpose for the highly abundant placenta that is usually discarded. A few years later, I founded Minovia – aiming to use placental mitochondria to treat patients who suffer from mitochondrial dysfunction.”
Formation Of The Company
How did you come up with the idea for the company? Dr. Yivgi-Ohana shared:
“Following my postdoctoral fellowship, I decided to take a sabbatical to think about how I could utilize my academic knowledge to create translational research. For several months, I was at home, reading, drafting new ideas, and thinking. One day, while reading about the selfish gene theory by Richard Dawkins, I realized that mitochondria, which reside within our evolutionary cells, are simply bacteria that have entered cells and transferred most of their DNA to the host to protect their genetic material. In that moment, I thought: what if mitochondria can still enter cells? If we were to isolate functional mitochondria from the placenta and incubate them with diseased cells, would they enter cells just like they did during evolution? Or put another way, can we restore mitochondrial function in diseased cells by transplanting healthy, functional mitochondria into the patient? With this idea, I went to the first investors who became my partners, and with the initial funding they had invested, we conducted the first experiments demonstrating that indeed mitochondria can re-enter cells and rescue their function. With that, the Minovia journey began.”
Core Programs
What are Minovia’s core programs? Dr. Yivgi-Ohana explained:
“Our lead product is MNV-201, a first-in-class cell therapy that uses Minovia’s proprietary Mitochondrial Augmentation Technology (MAT) to add healthy, energy-producing mitochondria into a patient’s own stem cells — aiming to restore organ function and improve health. MNV-201 is currently in two clinical programs: a phase 2 clinical study in Pearson Syndrome, which is a rare pediatric disease, and a phase 1b study in low-risk Myelodysplastic Syndrome, also known as MDS, in adults, both of which have mitochondrial dysfunction at their core.”
“The preliminary safety and multi-systemic effect of the therapy led us to explore potential partnerships with longevity and regenerative medicine clinics aiming to reverse age-related mitochondrial dysfunction.”
Challenges Faced
Have you faced any challenges recently? Dr. Yivgi-Ohana acknowledged:
“We are located in Israel, so in addition to general global biotech funding challenges, we have had to deal with residing in a state that’s at war. I have an amazing team, who are all true fighters for the cause of treating these difficult diseases, and we all agreed that rather than waiting for the war to end and save the funds we had, we should accelerate our clinical programs to generate real and worthwhile clinical data. I am grateful for this brave decision and the strength of our team as it has allowed us to raise money from our investors, extend the clinical runway for our therapies, and generate real interest from the public market.”
Evolution Of The Company’s Technology
How has the company’s technology evolved since launching? Dr. Yivgi-Ohana noted:
“In the early days of Minovia, it wasn’t always clear what our lead drug product would be and how we would apply the isolated mitochondria to patients. We initially studied the effect of direct mitochondria injection into muscle with ischemic conditions in preclinical models, targeting critical limb ischemia as first indication. Due to regulatory concerns from the direct injection of mitochondria, we eventually developed an ex-vivo cell therapy approach, where for MNV-201, hematopoietic stem cells are collected from the patient’s blood, enriched with placental mitochondria and infused back into the patient’s blood stream. We also decided to focus on rare genetic mitochondrial diseases to demonstrate safety and multi-organ improvement in an unmet medical need. This, we believed, would pave the path forward to treat other, more common diseases.”
Significant Milestones
What have been some of the company’s most significant milestones? Dr. Yivgi-Ohana cited:
“Dosing the first patient with mitochondrial augmentation technology and demonstrating safety and efficacy has been the most significant milestone. So far, 24 patients have been treated with our therapy, and the results have been incredibly encouraging. In fact, we have recently announced interim data from our phase 2 trial in Pearson Syndrome that has demonstrated no treatment-related serious adverse events, as well as preliminary signals of efficacy.”
Differentiation From The Competition
What differentiates the company from its competition? Dr. Yivgi-Ohana affirmed:
“Minovia is the only company in the mitochondrial transplantation space that uses a stem cell therapy approach to deliver healthy mitochondria systemically and unlike many other companies in this space, we are a clinical stage biotech, with 2 INDs already approved. We have tens of patents and applications protecting our products and the therapeutic field in general. In terms of treating mitochondrial dysfunction through this delivery platform, we believe we are the leaders of this industry.”
Future Company Goals
What are some of the company’s future goals? Dr. Yivgi-Ohana concluded:
“In the near future, Minovia plans to expand into the U.S. market, opening clinical sites for both Pearson Syndrome and Myelodysplastic Syndrome, as well as conducting our pivotal study for Pearson Syndrome to approve the first ever mitochondrial-based therapy by the FDA.”
“In parallel to this disease-focused track, we plan to partner with longevity and regenerative medicine clinics globally and deliver mitochondrial augmentation therapies in such a fast-growing industry.”
