The assay will provide a quantitative technique to evaluate RVT-802 and is a key step in ongoing efforts to support an FDA filing.

RVT-802 is an investigational, thymic-tissue based regenerative therapy intended to treat the primary immune deficiency resulting from congenital athymia associated with complete DiGeorge Anomaly (cDGA).

It has not been approved for commercial use by the FDA or other health regulators at this time. It was developed in Duke University by Dr. Markert. In 2016, Enzyvant partnered with Duke University and Markert.

Complete DiGeorge Anomaly (cDGA) is a rare disease that affects about 1 in 300,000 infants or about 10-20 infants born each year in the US. Children with cDGA are born without thymus gland that results in severe immunodeficiency due to the inability to produce normally functioning T cells, which defend against infection and regulate essential processes in the immune system.

It is fatal if untreated and death can typicall occur in the first 24 months of life due to susceptibility to infection.

Enzyvant is planning to start the rolling Biologics License Application submission for RVT-802 to the US Food and Drug Administration (FDA) later this year.

The company has already received Breakthrough Therapy designation, Regenerative Medicine Advanced Therapy designation, rare pediatric disease designation, and orphan drug designation from the FDA.

Enzyvant CEO Alvin Shih said: “Today’s announcement of the partnership with Visikol is a key component to enable development of a medicine to treat complete DiGeorge Anomaly.

“Rare disease drug development requires collaboration and creativity, and we are pleased to commence work with Visikol to incorporate an innovative digital pathology approach into the RVT-802 development process.”

Visikol chief science officer Thomas Villani said: “We are excited to work with Enzyvant as they develop RVT-802 into an approvable therapy with the requisite data and CMC procedures.

“We are especially keen to work on this project because it is an ideal opportunity to apply our digital imaging technologies and machine learning capabilities to develop a potentially life-saving therapy.”