Frank Ahmann is the co-founder, CEO and president at XM Therapeutics. The Providence-based biotech company, which spun out of Brown University and is developing new treatments for chronic heart and respiratory diseases, recently secured $375,000 from the Slater Technology Fund.
PBN: How did the XM Therapeutics team come up with the idea to use extracellular matrix, or ECM, particles to treat chronic diseases?
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AHMANN: The trigger for our idea to use ECM particles came from knowing about an academic group in southern California that was using a heavily processed and denatured animal-sourced ECM hydrogel to treat heart failure.
We knew that using our human stem cell-sourced ECM particles with all of their native components in an undisturbed architecture was very likely a better solution. Once we took a deeper look at the whole field, we realized that using “healthy” human ECM particles produced in a lab to treat various diseases had not been done before.
PBN: In what ways does this treatment differ from traditional methods, and what can it offer that current options can’t address?
AHMANN: Generally speaking, traditional treatment methods have focused on developing small molecules or biologics that affect a single mechanism or cell type implicated in the fibrotic and inflammatory process. This has not been successful because the human body has multiple mechanisms of defense and repair, with built-in redundancies that involve various cells and the ECM. Expecting a single molecule or magic bullet to fix that is extremely optimistic.
Our technology is built on the observation from animal studies that ECM particles are multifactorial and capable of affecting various signals that lead to fibrosis, inflammation and poor oxygen supply. By repairing the abnormal ECM in various chronic disease states, we can correct cell behavior and the tissue as a whole. This has been a significant goal of tissue engineering but thus far, a practical, injectable and fully human product had not been developed. We are doing that.
PBN: Why did the team choose to focus on heart and lung disease for the treatment’s initial applications?
AHMANN: Our scientific, clinical and entrepreneurial founders have deep experience in diseases affecting the heart. Heart disease remains a global challenge with limited and expensive treatment options. It is the most prevalent chronic condition among older people and their risk exposure in surgical or interventional procedures calls for a better treatment option. We are driven by the goal to deliver that option.
Beyond the heart, we look at other organs and indications where we can have a measurable impact and where other pharma or biotech companies may be eager to partner. The respiratory system fits that bill, so we are looking at it, although we remain receptive to other alternatives.
PBN: What research has the team carried out so far to test this treatment, and what were the results?
AHMANN: In the first year since we began operations, we accomplished three significant initial goals. First, we established a production platform that consistently yields uniform extracellular matrix particles from human stem cells.
Second, we carried out proof-of-principle testing and confirmed the ability of our particles to change the composition of the abnormal ECM to reduce scar size and improve muscle contractility and perfusion in a preclinical heart model.
Third, proteomic profiling has identified the mechanisms at work between cells and the ECM particles in the healing process that follows tissue injury. We are proud of our accomplishments but fully aware that this is only the beginning of the development pathway.
PNB: What are the next steps in developing this technology, and do you have a goal for when it will become widely available?
AHMANN: The next phase takes us from the research realm into a more structured development pathway that involves safety testing, scale-up, validation, compliance and a well-defined catalog of requirements to satisfy the Food and Drug Administration to enable human clinical trials.
If everything goes well, we can get to human studies in two more years, provided that we have adequate funding. Beyond that, a few more years of human safety and efficacy testing will be needed before the therapy can become widely available.
Jacquelyn Voghel is a PBN staff writer. You may reach her at Voghel@PBN.com.
