Humacyte to File IND Application to Support FIH Study of Small-Diameter ATEV in CABG

January 21, 2025—Humacyte, Inc. announced that it plans to file an investigational new drug (IND) application with the FDA to allow first-in-human (FIH) clinical evaluation of the company’s small-diameter (3.5-mm) acellular tissue-engineered vessel (sdATEV) in coronary artery bypass graft (CABG) surgery.

Humacyte’s ATEV is a bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair. To date, only the 6-mm configuration of ATEV has been studied in human trials, specifically in studies conducted in vascular trauma repair, arteriovenous access for hemodialysis, and peripheral artery disease, noted the company.

Humacyte stated that its current plans for filing an IND are based on the outcome of a recent meeting held with the FDA, including agreements reached with the agency.

According to the company, the sdATEV has been studied in multiple preclinical CABG models to enable the IND filing.

The results of a 6-month preclinical study in primates were presented at the American Heart Association’s Scientific Sessions 2024 held November 16-18 in Chicago, Illinois.

In the preclinical CABG model, the sdATEV was observed to sustain patency, recellularized with the animals’ host cells, and remodeled to effectively reduce the initial size mismatch between the sdATEV and the animals’ native artery, reported Humacyte.

As the company noted in the press release, harvesting vein from a CABG patient may lead to complications and may not be feasible because of missing or diseased veins. ATEV is designed to be available off the shelf and does not require further injuring the patient to obtain arterial replacement material.

“CABG surgery can be lifesaving in appropriately selected patients with coronary artery disease,” commented John H. Alexander, MD, Professor of Medicine, Department of Medicine, Division of Cardiology, Senior Investigator at the Duke Clinical Research Institute at Duke University in Durham, North Carolina, in the company’s press release. “A long-standing, major limitation of CABG surgery has been the availability of ideal conduits to use as bypass grafts. If clinical trials are successful, this tissue-engineered graft could have the potential to transform CABG surgery by providing an unlimited supply of an off-the-shelf conduit to use in patients undergoing CABG surgery. We look forward to helping to advance this technology into human studies.”

Laura Niklason, MD, Founder and Chief Executive Officer of Humacyte, added, “We are very pleased to be moving closer to human clinical studies of the sdATEV in CABG, and our planned IND filing and initiation of FIH study after the FDA clearance will be a major milestone for Humacyte. Our preclinical results suggest that the sdATEV may be a promising off-the-shelf alternative to native vessel grafts in CABG, and we look forward to evaluating this possibility in human clinical studies.”

On December 19, 2024, the company announced that the FDA granted full approval for the ATEV (Symvess) for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein graft is not feasible. For uses other than the FDA approval, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency, advised the company.