XyloCor Therapeutics and SmartCella Enter into License Agreement for Use of the Extroducer Infusion Catheter System to Administer Novel Gene Therapy XC001 to the Heart
2024年7月10日 - 9:00PM
ビジネスワイヤ(英語)
- The Extroducer® Infusion Catheter System ® enables local
delivery of XC001 to the heart without the need for surgery.
- XC001 has achieved positive Phase 1/2 results in the EXACT
Trial validating its transformative potential for treatment of
refractory angina in patients who have exhausted available
treatment options and have a debilitating quality-of-life.
XyloCor Therapeutics, Inc. (“XyloCor”), a clinical‑stage
biopharmaceutical company developing novel gene therapies for
cardiovascular disease, and SmartWise, a unit of SmartCella Holding
AB (“SmartCella”), have entered into a licensing agreement
under which XyloCor has rights to the Extroducer® Infusion Catheter
System ®, a first-in-class endovascular device designed to deliver
advanced therapies directly into the heart [and hard-to-reach
tissues] . 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.
“This agreement with SmartCella will enable XyloCor to build
upon its robust foundation of efficacy and safety data for XC001 by
offering the potential for improved safety and ease of delivery
without surgery via this novel catheter,” said Al Gianchetti,
President and CEO of XyloCor. “Teaming up with SmartCella will help
in our effort to optimize patient safety and tolerability while
maintaining accurate delivery of XC001 to target areas in the heart
for patients with refractory angina. It also opens up the potential
to develop XC001 earlier in the coronary artery disease progression
for even larger patient groups.”
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 (VEGF). With the use
of the Extroducer catheter, XyloCor can offer patients a better
delivery option for local administration of XC001 directly to the
heart, that is less invasive and eliminates potential risks
associated with surgical administration.
“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 2b trial of XC001 in
patients with refractory angina using this innovative
administration approach.”
The recently published EXACT Phase 1/2 trial assessed the use of
one-time gene therapy with XC001 as a new therapeutic approach in
refractory angina – a debilitating and chronic condition that
impacts over one million people in the United States and is growing
in prevalence. In the EXACT trial, 42 patients with class II-IV
angina were treated with XC001 directly administered to the heart
following 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, due to a decrease in ischemic burden, as measured
by Positron Emission Tomography (PET) imaging. Notably, six 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. XC001 was well tolerated in the patient population and
there were no serious adverse events related to the drug. 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.
“The collaboration underscores the transformative potential of
the Extroducer in delivering XC001 therapy for patients with
refractory angina. A great example of a powerful combination of
delivery system and drug therapy representing a substantial
advancement in treatment options. The collaboration with such a
distinguished partner as XyloCor marks a significant milestone for
our global expansion efforts and will also enable us to further
explore and harness the future capabilities of the Extroducer,
ultimately expanding the benefits to a greater number of patients
in need,“ said Niklas Prager, CEO of SmartCella.
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. Total
deal value amounts to approximately USD 130 million and mid-single
digit royalties.
About XC001
XC001 is designed to promote new blood vessels in the heart that
will bypass diseased blood vessels and improve blood flow. By
restoring blood flow, chest pain associated with refractory angina
may decrease, potentially improving patients’ quality of life by
enabling them to engage in daily physical activities that would
otherwise cause pain. XC001 is designed to avoid toxicity issues
observed with other gene therapies through a strategy of one‑time,
local administration. This approach allows XC001 to achieve higher
gene expression in the heart while minimizing systemic vector
circulation and associated side effects.
About Extroducer® Infusion Catheter System
The Extroducer® Infusion Catheter System is a first-in-class
endovascular delivery device which enables direct-to-tissue drug
delivery. The Extroducer® addresses a significant unmet need in the
field of novel therapies, enabling targeted delivery of a wide
range of modalities for solid tumor treatment, genetic disorders
and tissue repair, to name but a few. Using standard equipment and
routine interventional radiology approaches, the Extroducer
provides access to hard-to-reach tissues by safely penetrating the
vessel wall and delivering payload directly to the target location.
SmartWise received U.S. Food and Drug Administration (FDA)
clearance under 510(k) for the Extroducer® delivery catheter in
June 2022.
About XyloCor
XyloCor Therapeutics, Inc. is a private, clinical‑stage
biopharmaceutical company developing potential best‑in‑class gene
therapies to transform outcomes for patients with cardiovascular
disease. The Company’s lead product candidate, XC001, is in
clinical development to investigate use for patients with
refractory angina for whom there are no treatment options. XyloCor
has a second preclinical investigational product, XC002, in
discovery stage, being developed for the treatment of patients with
cardiac tissue damage from heart attacks. The company, which was
co‑founded by Ronald Crystal, M.D., and Todd Rosengart, M.D., has
an exclusive license from Cornell University. For more information,
visit www.xylocor.com.
About SmartCella
SmartCella, founded in 2014, is an innovative biotechnology
company based in Stockholm, Sweden. SmartCella’s vision is to
combine first-in-class delivery platforms with cutting-edge cell
and mRNA therapies to unleash the full potential of targeted
therapies. The company has three main business units, Smartwise,
SmartCella Solutions and ProCella. For more information, visit
www.smartcella.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20240708015082/en/
Corporate and Investor Relations: A. Brian Davis, XyloCor
Therapeutics, Inc. brian.davis@xylocor.com 610-541-2056 Media
Contact: Mike Beyer Sam Brown Inc. Healthcare Communications
mikebeyer@sambrown.com 312-961-2502 SmartCella Contact:
Niklas Prager, CEO, +46 768 117744;
niklas.prager@smartcella.com