Xylyx Bio wins orphan status and $2.99M NIH grant for bioengineered transplant lungs

Xylyx Bio has received Orphan Drug Designation from the FDA for Inspirex Lung, its lead candidate for patients with lung failure who need a transplant. In the same announcement on 20 October, the company said it had won a $2.99 million Small Business Innovation Research (SBIR) grant from the National Heart, Lung, and Blood Institute at the NIH.

The problem it is trying to solve

Lung transplant is limited by supply. Xylyx says more than 75% of donor lungs go unused, often because of injury that is acute and could be reversed. Inspirex Lung is an investigational bioengineered whole human lung graft. The idea is to take donor lungs that would otherwise be turned down and bring them up to standard transplant criteria.

It does this with the company's XC Platform, which uses xenogeneic cross-circulation to support injured lungs outside the body. Xylyx points to preclinical work published in *Nature Medicine* and *The Journal of Heart and Lung Transplantation* describing the approach.

"Patients with lung failure often die waiting for a transplant, while most donated lungs are not used." Andrea Nye, MPH, MBA, President and CEO, Xylyx Bio

The numbers

The grant is a Direct-to-Phase II SBIR award worth $2,999,266 over two years (award number R44HL182545). It will pay for safety and feasibility studies, including the first transplants in humans. It is non-dilutive, so Xylyx does not have to give up equity for it.

Orphan designation applies to products for conditions affecting fewer than 200,000 people in the US. Subject to the usual requirements, it can bring tax credits on qualifying trial costs, an exemption from marketing application user fees and up to seven years of market exclusivity after approval. Inspirex Lung has not been approved by the FDA or any other regulator.

Who's behind it

Andrea Nye is President and CEO, and John O'Neill, PhD, is Chief Scientific Officer. Alongside the transplant programme, Xylyx sells disease-modelling and drug-testing products and services through its InMatrico and InOrgano programmes.

The bigger picture

Organ bioengineering is a small corner of regenerative medicine. What makes this week's news useful is the pairing: orphan status gives Xylyx incentives that pay off later, while the NIH grant pays for the human studies it needs now. For a company at this stage, that is a way to reach the clinic without leaning entirely on venture money.