Medical Device Network

XyloCor taps SmartWise’s infusion device for gene therapy administration

XyloCor will pay approximately $130m in upfront and milestone-based payments to SmartCella for the supply of Extroducer infusion system.

XyloCor Therapeutics has signed a licensing agreement with SmartWise, a subunit of SmartCella Holding, to use the latter’s Extroducer infusion catheter system to administer gene therapies directly into the heart and other hard-to-reach tissues.

XyloCor will pay approximately $130m in upfront and milestone-based payments to SmartCella for the supply of Extroducer for clinical trials and commercial use. SmartCella will also be entitled to ‘mid-single digit’ royalties.

XyloCor plans to use the Extroducer system to administer its cardiovascular gene therapy XC001 (encoberminogene rezmadenovec). The use of the system allows for the direct administration of XC001 into the heart without the need for invasive surgical interventions.

XC001 is adenovirus-based gene therapy, which is designed to reduce ischaemic burden by creating new blood vessels in the heart through the local expression of multiple isoforms of vascular endothelial growth factor (VEGF).

The company is investigating the gene therapy as a treatment for refractory angina. In May, XyloCOr reported positive results from the Phase II EXACT trial (NCT04125732). XC001 significantly increased exercise duration and decreased the frequency of angina episodes. Angina class also improved in 81% of participants at six months.

There were no treatment-related severe adverse events. However, the 20 expected severe adverse events were related to the surgical procedure.

“We welcome the Extroducer delivery of XC001 as it offers a more efficient method for gene therapy administration for patients with refractory angina,” said Timothy D Henry MD, interventional cardiologist and director of the Lindner Center, The Christ Hospital, Cincinnati, Ohio.

“Preclinical models provide strong evidence that this approach will maintain, or even improve the efficacy when compared to surgical delivery and it should lower the risk of complications that may arise from surgical administration. I am looking forward to initiating the Phase IIb trial of XC001 in patients with refractory angina using this innovative administration approach.”

Extroducer is designed to allow direct tissue or organ infusions through the vessel wall into organs and tumours. The system was cleared by the US Food and Drug Administration (FDA) to direct organ or tissue transfer in 2022. Last week, SmartCella raised approximately €50m ($54m) to expedite its growth and bolster the commercialisation of Extroducer.