- 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.
WAYNE,
Pa. and TULLINGE, Sweden, July 10,
2024 /PRNewswire/ -- 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.
SmartCella Contact:
Niklas
Prager, CEO, +46 768 117744;niklas.prager@smartcella.com
Nina Nornholm, Head of Corporate
Communication +46 708 550356,
nina.nornholm@smartcella.com
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
This information was brought to you by Cision
http://news.cision.com.
https://news.cision.com/smartcella-holding-ab/r/xylocor-and-smartcella-enter-into-license-agreement-for-use-of-the-extroducer-to-administer-novel-ge,c4013444
The following files are available for download:
https://mb.cision.com/Main/21365/4013444/2909969.pdf
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