Next-generation IgG protease candidate Xork to
be licensed for development with AT845, an investigational Astellas
Gene Therapies' product, for the treatment of Pompe Disease
Selecta to receive a $10M upfront payment and eligible to receive up
to $340M for certain additional
development and commercial milestones plus royalties on commercial
sales
WATERTOWN, Mass. and TOKYO, Jan. 9, 2023
/PRNewswire/ -- Selecta Biosciences, Inc. (NASDAQ: SELB,
President and CEO: Carsten Brunn,
Ph.D., "Selecta"), and Astellas Pharma Inc. (TSE: 4503, President
and CEO: Kenji Yasukawa, Ph.D.,
"Astellas" or "Astellas Gene Therapies") today announced an
exclusive licensing and development agreement for IdeXork (Xork).
Xork is being studied as a potential next generation immunoglobulin
G (IgG) protease that will be developed by Astellas for use with
AT845, an investigational, adeno-associated virus (AAV)-based
treatment for Late-Onset Pompe disease (LOPD) in adults.
"Currently many patients are ineligible for clinical trials with
investigational AAV gene therapy products due to the presence of
naturally occurring antibodies against AAV gene therapy capsids,"
said Carsten Brunn, Ph.D., President
and Chief Executive Officer of Selecta. "Xork has the potential to
expand access to life-changing gene therapies by addressing
pre-existing immunity to AAV. Most other IgG proteases in
development are derived from common human pathogens, and as a
result there is a high prevalence of pre-existing antibodies
against these proteases that can restrict their use. Xork is
differentiated by its low cross-reactivity to pre-existing
antibodies in human serum. We are thrilled to partner with Astellas
as they advance their robust gene therapy portfolio through the
clinic."
Naoki Okamura, Chief Strategy
Officer of Astellas added, "We are looking forward to partnering
with Selecta as we strive to expand our therapies to a broader
range of patients living with debilitating diseases, who have
limited treatment options. This agreement provides an opportunity
to deliver potentially transformative gene therapy treatments to a
specific population of LOPD adult patients who might otherwise be
ineligible for clinical trials or treatment with Astellas'
investigational product."
Under the terms of the agreement, Selecta will receive a
$10M upfront payment and is eligible
to receive up to $340M for certain
additional development and commercial milestones plus royalties on
any potential commercial sales where Xork is used as a
pre-treatment for AT845. Selecta is responsible for the development
and manufacturing of Xork and will maintain the rights for the
development of additional indications beyond Pompe disease.
Astellas would have the sole and exclusive right to commercialize
Xork for use in Pompe disease with an Astellas gene therapy
investigational or authorized product, with a current focus on
AT845.
About Selecta Biosciences, Inc.
Selecta Biosciences Inc. (NASDAQ: SELB) is a clinical stage
biotechnology company leveraging its ImmTOR™ platform to develop
tolerogenic therapies that selectively mitigate unwanted immune
responses. With a proven ability to induce tolerance to highly
immunogenic proteins, ImmTOR has the potential to amplify the
efficacy of biologic therapies, including redosing of life-saving
gene therapies, as well as restore the body's natural
self-tolerance in autoimmune diseases. Selecta has
several proprietary and partnered programs in its pipeline focused
on enzyme therapies, gene therapies, and autoimmune
diseases. Selecta Biosciences is headquartered in
the Greater Boston area. For more information, please
visit www.selectabio.com.
About AT845 for the treatment of Late-Onset Pompe Disease
(LOPD)
Astellas is developing AT845, a novel gene replacement therapy
using an AAV8 vector under a muscle-specific promotor to deliver a
functional copy of the GAA gene, for the treatment of adult
LOPD. AT845 is being investigated to determine whether it can
deliver a functional GAA gene that is efficiently transduced
to express GAA directly in tissues affected by the disease,
including skeletal and cardiac muscle.
About Astellas
Astellas Pharma Inc. is a
pharmaceutical company conducting business in more than 70
countries around the world. We are promoting the Focus Area
Approach that is designed to identify opportunities for the
continuous creation of new drugs to address diseases with high
unmet medical needs by focusing on Biology and Modality.
Furthermore, we are also looking beyond our foundational Rx focus
to create Rx+® healthcare solutions that combine our
expertise and knowledge with cutting-edge technology in different
fields of external partners. Through these efforts, Astellas stands
on the forefront of healthcare change to turn innovative science
into VALUE for patients. For more information, please visit our
website at https://www.astellas.com/en.
About Astellas Gene Therapies
Astellas Gene Therapies
is an Astellas Center of Excellence developing genetic medicines
with the potential to deliver transformative value for patients.
Our gene therapy drug discovery engine is built around innovative
science, a validated AAV platform, and industry leading internal
manufacturing capability with a particular focus on rare diseases
of the eye, CNS and neuromuscular system. Astellas Gene Therapies
will also be advancing additional Astellas gene therapy programs
toward clinical investigation. Astellas Gene Therapies is based in
San Francisco, with manufacturing
and laboratory facilities in South San
Francisco, Calif., Sanford,
N.C. and Tsukuba, Japan.
Astellas Cautionary Notes
In this press release,
statements made with respect to current plans, estimates,
strategies and beliefs and other statements that are not historical
facts are forward-looking statements about the future performance
of Astellas. These statements are based on management's current
assumptions and beliefs in light of the information currently
available to it and involve known and unknown risks and
uncertainties. A number of factors could cause actual results to
differ materially from those discussed in the forward-looking
statements. Such factors include, but are not limited to: (i)
changes in general economic conditions and in laws and regulations,
relating to pharmaceutical markets, (ii) currency exchange rate
fluctuations, (iii) delays in new product launches, (iv) the
inability of Astellas to market existing and new products
effectively, (v) the inability of Astellas to continue to
effectively research and develop products accepted by customers in
highly competitive markets, and (vi) infringements of Astellas'
intellectual property rights by third parties. Information about
pharmaceutical products (including products currently in
development) which is included in this press release is not
intended to constitute an advertisement or medical advice.
Selecta Forward-Looking Statements
Any statements in this press release about the future
expectations, plans and prospects of Selecta Biosciences, Inc. (the
"Company"), including without limitation, statements
regarding the unique proprietary technology platform of the
Company and its partners,the anticipated benefits of the
Company's licensing and development agreement with Astellas related
to Xork, the potential of ImmTOR to enable re-dosing of AAV
gene therapy and to mitigate immunogenicity, the potential of
ImmTOR and the Company's product pipeline to treat chronic
refractory gout, MMA, IgAN, other autoimmune diseases, lysosomal
storage disorders, or any other disease, the anticipated timing or
the outcome of ongoing and planned clinical trials, studies and
data readouts, the anticipated timing or the outcome of the FDA's
review of the Company's regulatory filings, the Company's and its
partners' ability to conduct its and their clinical trials and
preclinical studies, the timing or making of any regulatory
filings, the anticipated timing or outcome of selection of
developmental product candidates, the potential treatment
applications of product candidates utilizing the ImmTOR platform in
areas such as gene therapy, gout and autoimmune disease, the
ability of the Company and its partners where applicable to develop
gene therapy products using ImmTOR, the novelty of treatment
paradigms that the Company is able to develop, whether the
observations made in non-human study subjects will translate to
studies performed with human beings, the potential of any therapies
developed by the Company to fulfill unmet medical needs, the
Company's plan to apply its ImmTOR technology platform to a range
of biologics for rare and orphan genetic diseases, the potential of
the Company's technology to enable repeat administration in gene
therapy product candidates and products, the ability to re-dose
patients and the potential of ImmTOR to allow for re-dosing, the
potential to safely re-dose AAV, the ability to restore transgene
expression, the potential of the ImmTOR technology platform
generally and the Company's ability to grow its strategic
partnerships and enrollment in the Company's clinical trials and
other statements containing the words "anticipate," "believe,"
"continue," "could," "estimate," "expect," "hypothesize," "intend,"
"may," "plan," "potential," "predict," "project," "should,"
"target," "would," and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including, but not
limited to, the following: the uncertainties inherent in the
initiation, completion and cost of clinical trials including proof
of concept trials, including the uncertain outcomes, the
availability and timing of data from ongoing and future clinical
trials and the results of such trials, whether preliminary results
from a particular clinical trial will be predictive of the final
results of that trial and whether results of early clinical trials
will be indicative of the results of later clinical trials, the
ability to predict results of studies performed on human beings
based on results of studies performed on non-human subjects, the
unproven approach of the Company's ImmTOR technology, potential
delays in enrollment of patients, undesirable side effects of the
Company's product candidates, its reliance on third parties to
manufacture its product candidates and to conduct its clinical
trials, the Company's inability to maintain its existing or future
collaborations, licenses or contractual relationships, its
inability to protect its proprietary technology and intellectual
property, potential delays in regulatory approvals, the
availability of funding sufficient for its foreseeable and
unforeseeable operating expenses and capital expenditure
requirements, the Company's recurring losses from operations and
negative cash flows, substantial fluctuation in the price of the
Company's common stock, risks related to geopolitical conflicts and
pandemics and other important factors discussed in the "Risk
Factors" section of the Company's most recent Annual Report on Form
10-K and subsequent Quarterly Reports on Form 10-Q, and in other
filings that the Company makes with the Securities and Exchange
Commission. In addition, any forward-looking statements included in
this press release represent the Company's views only as of the
date of its publication and should not be relied upon as
representing its views as of any subsequent date. The Company
specifically disclaims any intention to update any forward-looking
statements included in this press release, except as required by
law.
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SOURCE Astellas Pharma Inc.