In this episode of Sunny Ray's show, host Sunny Ray talks with Abdulkader Rahmo of SMSbiotech about the next generation of regenerative cell therapy. Rahmo traces his path from a childhood fascination with science and Darwin to the discovery of small mobile stem cells around 2009 to 2010, when it took him a year and a half to convince himself the unusual cells were human and not a contamination. He explains targeted multi-gene activity modulation, in which the cells bind to other cells and change gene expression. The conversation covers affordability, why off-the-shelf therapies beat patient-specific ones, and why the company began with chronic obstructive pulmonary disease after an earlier focus on COVID. Rahmo describes the FDA's study may proceed notice, the company's manufacturing scale and eight patents, and a Phase 1B trial of five COPD patients planned for Florida. He also discusses compassionate use cases abroad, including approval in Australia for an ALS patient, the planned orthopedic IND, funding plans, and his personal motivation tied to his mother's death from Alzheimer's disease.
A scientist who spent 18 months doubting his own discovery explains how small mobile stem cells could make regenerative therapy affordable and off the shelf.
What made you go all in on the discovery of SMS cells?
My fascination with science began at 12 when I read Darwin. The small mobile stem cells journey started around 2009 to 2010 with a lot of doubt, because they look nothing like a textbook human cell. It took me a year and a half to convince myself they were human cells and not a contamination. Since then it has been continuous progress.
How do SMS cells work, and what is the software analogy?
Biology relies on information, much like software. We found that small mobile stem cells can physically bind to other cells and change how they process information, meaning they change gene expression. We coined this targeted multi-gene activity modulation, and it is unique to these cells.
What does democratizing stem cell therapy look like for a patient?
Affordability in cell therapy does not exist today. Some treatments cost hundreds of thousands of dollars, even millions. I want very efficient therapies that the wide majority of people can access without undue burden on the economy. For widespread chronic diseases, the solution has to be economically sustainable.
Why does off the shelf matter compared with making cells for one patient at a time?
Autologous treatments are costly and logistically difficult, and they rely on a patient's cells, which are often exhausted by prior treatment. Off-the-shelf cells come from healthy donors, so quality is controlled and fixed. You call the provider, receive cells within a week or two, and treatment starts. It is the industry's gold standard.
Why start with chronic obstructive pulmonary disease?
During COVID we targeted treatments that save the lungs, so we studied how SMS cells interact with lung cells. We were not fast enough to get human results then, so we moved to COPD, a widespread disease lingering for decades without solutions. Still, the cells show benefits in multiple tissues, since they circulate in peripheral blood.
What did the FDA's study may proceed notice mean, and why did it come?
It is a great achievement. We investigated the cells for over a decade to confirm safety and understand how they work. Unlike many stem cells, ours have a clear mechanism of action. We also showed manufacturing, or CMC, scaling to trillions of cells, and obtained eight patents. We did our homework.
What do the next 90 days look like for SMSbiotech?
We are aiming for our first in-human study in the United States, a Phase 1B with five COPD patients at a site in Florida, starting within a few weeks. We will finish the first two sentinel patients, then treat the rest. We are also pursuing compassionate use through right to try or expanded access.
Which disease are you most eager to take the platform into next?
My mother died of Alzheimer's disease, so I feel personal pressure to bring improvement for neurodegenerative patients. However, the company decided the second step will be orthopedics, so our second IND will be in that area. There are a huge number of people suffering from orthopedic disease, and I understand that decision.
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