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Humacyte’s First Preclinical Results of HAV™ in Coronary Artery Bypass Grafting to be Presented at Advanced Therapies Week – A Further Development in their HAV Portfolio

Anna Osborne
5 January 2022
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Humacyte, a clinical-stage biotechnological company, has announced that they are to present the first preclinical results of their Human Acellular Vessels™ (HAV) for use in coronary artery bypass grafting (CABG) surgery, at Phacilitates Advanced Therapies Week in Miami this January.  

The presentation, “Bioengineering and the Future of Cardiac Surgery”, will be delivered by cardiac surgery expert, Alan Kypson, a cardiothoracic surgeon at the University of North Carolina Rex Hospital in Raleigh.   

CABG surgery restores blood flow to the heart muscle through treating blockages of the coronary arteries. During the presentation, Alan will discuss the six month results from the preclinical use of HAV in a primate CABG model and evaluate what this means for the potential of HAV in human CABG use.  

“The preclinical results to be presented this month represent a key milestone in the development of small-diameter HAVs for potential use in CABG,” commented Laura Niklason, Founder, President and CEO of Humacyte. 

According to a recent press release, Humacyte aims to transform the practice of medicine through commercially producing bioengineered human tissue for universal implantation to treat vascular conditions and improve the lives of patients.  

The team has focused its scalable technology platform on the bioengineered product candidate HAV – a regenerative vascular construct – for vascular replacement, reconstruction and repair. HAV was the first product to receive RMAT designation from the FDA. 

More than 765,000 global CABG procedures take place a year, however Laura Niklason notes: “It is estimated that as many as 45% of CABG patients do not have suitable autologous vein for their needed bypass procedures”. This creates an urgency for off-the-shelf bioengineered therapies.  

The HAV preclinical program has developed a small-diameter HAV to be used as an alternative to the existing patient harvested vasculature. In particular, it aims to have an application for use in obese and diabetic patients, where the risks of saphenous vein harvesting are great.  

The preclinical results for HAV in CABG use will join an ongoing Humacyte HAV portfolio of clinical trials for HAV use in various vascular diseases, which includes Phase III trials conducted for the 6mm HAV in vascular trauma and AV access for haemodialysis, as well as the long-term follow ups for Phase II PAD studies.  

Most notably, in mid-December Humacyte announced the successful results of a case study in which an infected synthetic iliofemoral bypass graft was replaced with a bioengineered HAV, in what was the first use of HAV for this procedure.  

As an investigational product candidate, HAV was implanted under an expanded access programme authorised by the FDA in April 2019. At 22 months post-implantation, the patient – a 42-year-old female who had a history of right external iliac artery endofibrosis – had shown significant clinical improvements, with no signs of implant infection observed.  

The potential of the investigational HAV to populate with the patient’s own cells and become a part of the patient’s own DNA and own tissue, and thereby be durable over time and free from complications that threaten other types of conduits, warrants further evaluation as a replacement for infected synthetic vascular grafts,” explained Thomas Naslund of Vanderbilt University Medical Center and co-author on the case study. 

Following on from the case study success, in October the Mayo Clinic filed an investigational new drug application with FDA to potentially allow their surgeons to use the investigational HAV for severe PAD treatment in up to 25 patients. 

The positive outcomes of this case study mimic the robust clinical efficacy and safety data collected from over 430 patients across the clinical trials of HAV for use in different vascular conditions. Clinical evidence highlights its potential to be non-immunogenic and infection-resistant. HAV’s bioengineered nature eliminates the need for vessel harvesting from patients, enables HAV to be produced on a commercial scale, and allows it to also become durable living tissue, overcoming many current limitations in vessel tissue repair and replacement.

The clinical results of HAV use in vascular applications Humacyte CEO Laura comments shows “the potential of our bioengineered tissue platform to redefine what’s possible in regenerative medicine.” 

We will have to wait and see what implications the preclinical results to be presented at Advanced Therapies Week could have towards HAV’s future use in CABG surgery and the impact this could have on the progression of the advanced therapies industry.  

 You can join Humacyte’s presentation at 9:20am EST on January 28th, 2022 at Advanced Therapies Week in Miami >> 

 Sources: Humacyte Press releases (03/01/22) and (15/12/21)