A proprietary protein, delivered subcutaneously, that stimulates heart regeneration after cardiac injury
The devastating impact of myocardial infarction is a result of the inability of the adult human heart to regenerate after injury. Cells in some other tissues, such as skin and bone, will proliferate to rebuild damaged tissue. In the heart, however, once damage occurs, it is permanent...until now.
The founders of Regencor have discovered that a non-glycosylated variant form of FSTL1, which is not normally present in humans, can promote cardiac regeneration. This proprietary protein can drive human cardiac muscle proliferation in vitro, and heart regeneration in adult mammals after myocardial infarction.
The regenerative protein safely promotes:
New cardiac muscle growth
New myocardial blood vessel formation
Significant scar reduction
Significant recovery of cardiac function
We are developing Q-Beads, a subcutaneous depot formulation for the API (non-glycosylated FSTL1). Q-beads are designed to release the API over 30 days, and are administered in a single injection during an outpatient visit.
Proof of concept for the regenerative activity of our API was first demonstrated in mice and adult pigs using a depot collagen patch (EpicaPatch) applied over the surface of the infarct zone. The EpicaPatch was designed to be a back-up formulation compatible with coronary artery bypass surgery (CABG).
The regenerative activity of our API was confirmed in adult pigs using a second developmental depot formulation, PLGA microparticles (MyoBeads) infused through the infarct related artery directly into the infarct zone. The MyoBeads were designed to be a back-up formulation compatible with percutaneous coronary intervention (PCI).
The successful demonstration of regenerative activity using the MyoBeads led to the development of the commercial formulation, the Q-Beads. This Q-Bead clinical formulation was derived from the MyoBeads, and uses similar encapsulation technology but is administered subcutaneously to outpatients. This Q-Bead formulation is superior because it does not require revascularization procedures (CABG or PCI), and it can be used for both the acute MI and the chronic heart failure markets. Q-Beads are easy to administer requiring only a single subcutaneous injection.
Potential to cure heart failure
Our recombinant protein reverses tissue damage, restores cardiac function, and prevents progression to heart failure after MI.
Candidate for accelerated FDA approval
Likely designated as regenerative medicine advanced therapy.
Simple critical path for development
Does not utilize complex biologicals that must be delivered by injected vectors or cells.
Straightforward clinical implementation
Outpatient subcutaneous administration.
Deep market penetration
Our formulation is designed for use in both the acute MI & the chronic heart failure markets.
Established proof of safety & efficay
Demonstrated in both small and large animal studies.
Highlights of this patent family:
Composition of Matter, Pharmaceutical Compositions and Uses of Hypoglycosylated FSTL1 issued in the US, Japan and Australia
Clean ISR & WO by International Search Authority
Entered National Phase: US, Canada, Europe, Australia, Japan, China (Oct 9th, 2017)
Will provide COM protection for the API until at least 2035