XyloCor and SmartCella Sign Licensing Agreement for Catheter-Delivered Gene Therapy to the Heart

July 15, 2024—XyloCor Therapeutics, Inc., a clinical stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, and SmartWise, a unit of SmartCella Holding AB, recently announced they have entered into a licensing agreement under which XyloCor has rights to the SmartWise’s Extroducer infusion catheter system.

According to the companies, XyloCor plans to deploy the Extroducer to support catheter-based endocardial delivery of its lead gene therapy candidate—XC001 (encoberminogene rezmadenovec)—in future clinical studies and commercial use.

The Extroducer endovascular device is designed to deliver advanced therapies directly into the heart, including hard-to-reach tissues. SmartWise received FDA 510(k) clearance for the Extroducer delivery catheter in June 2022, noted the press release.

Terms of the agreement include a global license to XyloCor for use of the Extroducer for the administration of XC001 and provide for SmartCella to supply catheters to XyloCor in clinical trials and commercial use in exchange for an upfront payment; clinical, regulatory, and commercial milestones; and a royalty on sales. The value of the deal is approximately $130 million with single-digit royalties, stated the companies.

As outlined in the press release, XC001 is designed to reduce ischemic burden by creating new blood vessels in the heart through the local expression of multiple isoforms of vascular endothelial growth factor. With the use of the Extroducer catheter, XyloCor can offer a less-invasive delivery option for local administration of XC001 directly to the heart, eliminating potential risks associated with surgical administration, stated the companies.

“We welcome the Extroducer delivery of XC001 as it offers a more efficient method for gene therapy administration for patients with refractory angina,” commented Timothy D. Henry, MD, in the press release.

Dr. Henry, who is an interventional cardiologist and Director of the Lindner Center, The Christ Hospital, Cincinnati, Ohio, continued, “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 2b trial of XC001 in patients with refractory angina using this innovative administration approach.”

The companies advised that the phase 2b trial will be a randomized double-blinded study assessing the safety and efficacy of XC001 administered via the Extroducer delivery catheter in coronary artery disease patients with refractory angina.

Results of the EXACT phase 1/2 trial assessing the use of one-time gene therapy with XC001 as a new therapeutic approach in refractory angina were recently published Kenta Nakamura, MD, et al online in Circulation: Cardiovascular Interventions.

As summarized in the press release, the EXACT trial included 42 patients with class II-IV angina who were treated with XC001 directly administered to the heart after minimally invasive surgical access. The results demonstrated that treatment with XC001 can be safely administered and achieve durable clinical improvements of exercise duration, and angina frequency, because of a decrease in ischemic burden, as measured by positron emission tomography.

At 6 months after treatment, 43% of patients had no chest pain with ordinary activities and 58% reported no angina episodes at 12-month clinical follow-up, reported the companies.