Silviu Itescu, MBBS, FRACP, CEO, Mesoblast Limited.
Silviu Itescu, MBBS, FRACP, is the Chief Executive Officer and Managing Director of Mesoblast Limited. Dr. Itescu has served on Mesoblast’s board of directors since the company’s founding in 2004, was Executive Director from 2007, and became Chief Executive Officer and Managing Director in 2011.
Prior to founding Mesoblast in 2004, he established an international reputation as a physician scientist in the fields of stem cell biology, autoimmune diseases, organ transplantation, and heart failure.
Dr. Itescu has been a faculty member of Columbia University in New York, and the University of Melbourne and Monash University in Australia.
In 2013, Dr. Itescu received the inaugural Key Innovator Award from the Vatican’s Pontifical Council for Culture for his leadership in translational science and clinical medicine in relation to adult stem cell therapy. In 2011, he was named BioSpectrum Asia Person of the Year. He has consulted for various international pharmaceutical companies, has been an adviser to biotechnology and health care investor groups, and has served on the board of directors of several publicly listed life sciences companies.
In this 2,966 word interview, exclusively in the Wall Street Transcript, Dr. Itescu details the current status of Mesoblast Limited (NASDAQ:MESO) allogeneic cell therapy, focusing on life-threatening inflammatory diseases.
“We’ve got several platform technologies around allogeneic cell therapy, focusing on life-threatening inflammatory diseases, with a unique technology that is immunomodulatory that is able to change some pretty substantial outcomes around survivability of pretty bad diseases, disease states. We’re in late-phase development.
Our lead product is before the FDA. We’re aiming to reduce the very high mortality associated with children who’ve got a devastating complication of a bone marrow transplant called acute graft-versus-host disease.
That same product is also being evaluated for reducing mortality in patients with the most severe forms of inflammatory lung disease due to COVID-19. They’re our lead product candidates.
Sitting behind that is a product targeting severe heart failure, again, focusing on reduction in mortality. And a final product looks at severe inflammatory back pain, where we think that we can make an impact on the opioid epidemic.”
The FDA is currently reviewing the lead product for Mesoblast.
“…We had excellent results in Phase 3.
We achieved the pre-specified primary endpoint of Day 28 overall response and achieved a significant outcome around survival benefit in children with steroid-refractory GVHD.
For children under 12, there is no approved therapy. In these children, mortality rate approaches somewhere between 70% to 90%. So it’s a real bad disease, a real unmet need. We’ve demonstrated through the submission process and with a 9-to-1 positive vote by the ODAC panel — there was agreement that we demonstrated both safety and efficacy for these children for whom there is no approved therapy.
Our focus is on demonstrating to a sufficiently high standard to the FDA that if approved, the product maintains lot to lot consistency every time we make it. Obviously, in the Phase 3 trial, the product demonstrated consistency because the results speak for themselves.
We’ve continued to make the product. And we have established new assays that I think continue to even further underline that we understand the mechanism of action and that go to the heart of the mechanism that the cells go through in order to improve the outcomes in these steroid-refractory GVHD patients.
And so we think that we will have alignment with the FDA because the potency assays now are very much in line with the disease process, how we think the cells turn off the disease process. And we think that it’ll allow us to be very confident, and for the agency to be confident, that as the product is hopefully in the marketplace, it will demonstrate that every lot behaves exactly the same way as the lot before.
That’s really what the FDA wants. They want to see that we’ve got a handle on the mechanism, that we have a handle on the production, that there’s no differences in production from every product that goes out the door.”
The same medication was used in COVID 19 treatments by Mesoblast:
“There were a lot of similarities between how the cells work in graft-versus-host disease and how we thought they were likely to work in COVID-19 inflammatory disease of the lung. And so we initiated a compassionate use program, which showed a clinically important survival effect.
We saw a very positive signal with nine out of the first 11 patients treated under an emergency IND at Mount Sinai Hospital were able to come off ventilators and were successfully discharged.
And on that basis, we moved forward with the FDA’s agreement to initiate a randomized, controlled 300-patient study.
What we had not understood at the time is that age was a very, very important factor in outcome. It was very early in the pandemic and wasn’t clear. And in fact, I think something like 10 out of the first 11 patients that we treated in the emergency IND were all under the age of 65, were relatively young patients.
We actually chose to give just two doses, as opposed to eight doses as is currently used in graft-versus-host disease. Two doses to these patients in the first five days to see whether we could improve outcomes. And in patients who are younger, under the age of 65, what we saw was a 46% reduction in mortality through at least 90 days.
And if you’re alive through 90 days, you’re alive and you’re doing well. That is on top of existing standard of care. And that’s a great outcome.
We didn’t see the same benefit in older patients. And the reason for that we believe is that age is really a biomarker of a poor immune system that cannot handle the virus well. And so older people have got much higher levels of virus and much higher levels of inflammation than younger people.
And I think what this says to us is that we picked the right dose to see a survival benefit in younger, healthier patients, where the mortality is still a big problem.
I mean, you still have a 40% to 50% death rate in younger people who end up requiring invasive mechanical ventilation in the ICU. If you can have a reduction of that magnitude in this population, you’ve got something that’s really important.
With respect to the older people, I think, we’re going to need to explore a higher dose range or maybe a more repeated dose regimen. Many other drugs, including vaccines, are being found that they will require repeat dosing or high dosing in older people, whose immune systems are not handling the virus as well.”
Read the entire 2,966 word interview with Dr. Itescu, CEO of Mesoblast Limited (NASDAQ:MESO), exclusively in the Wall Street Transcript.
Dr. Silviu Itescu, CEO & Managing Director
Mesoblast Limited (NASDAQ:MESO)
55 Collins Street, Level 38
Melbourne 3000
Australia
email: info@mesoblast.com
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