Resolving Cardiometabolic Dysfunction With Transient Gene Therapy
Foment Bio’s platform of off-the-shelf gene therapy constructs activate in vivo regenerative exosome production to resolve inflammation and repair injured tissue.
Our Approach…
The field of regenerative medicine has made enormous strides in its understanding of the biology of healing over the last few decades. Focus has evolved from stem cells to secreted paracrine factors & exosomes as being the key regulators of tissue remodeling in response to injury and inflammation.
Foment Bio is a clinical-stage biotechnology company developing non-viral, off-the-shelf, gene based products that activate natural healing cascades to repair tissue and restore organ function. Our pipeline consists of products that drive transient in vivo production of regenerative exosomes able to promote new blood vessel growth, prevent cell death, reduce scar formation, and resolve tissue inflammation.
This treatment approach captures the benefit of cell & exosome-based therapy while transferring the therapy production from a complex and expensive ex vivo process to an inexpensive, evolutionarily optimized in vivo process. Foment’s transient gene therapy constructs possess substantial benefits over alternative treatment modalities, including: a strong safety profile, efficient & scalable manufacturing, robust product stability, and repeat dosing.
Translation
Early studies in a rat model of myocardial infarction demonstrated the therapeutic potential of the Foment constructs (below). In a study testing the therapeutic effects of conditioned media samples (left), the secretome from cells transfected with the Foment constructs exhibited enhanced recovery of heart function. A subsequent study showed that administration of the plasmids constructs (right) resulted in function recovery that was maintained, suggesting lasting tissue remodeling.
The potential of this approach has been translated into the clinic. To date, 203 patients have been treated with Foment Bio constructs with no drug related serious adverse events (SAEs). Efficacy signals have been observed across multiple indications.
In a Phase I study of dermal scarring, treatment arms reported meaningful improvement in scar cosmesis or appearance as assessed by both patients and physicians.
In a Phase II heart failure study (below), the 30mg dose exhibited a significant ejection fraction improvement over placebo in a cohort of the most severe heart failure patients. Further, a clear dose response was observed (below, right).
