WATERTOWN, Mass., and
Research Triangle Park, N.C.,
Feb. 17, 2021 /PRNewswire/
-- Selecta Biosciences, Inc. (NASDAQ: SELB) and Asklepios
BioPharmaceutical, Inc. (AskBio), a wholly owned and independently
operated subsidiary of Bayer AG, today announced the initiation of
a Phase 1 dose-escalation trial of SEL-399, an adeno-associated
viral serotype 8 (AAV8) empty vector capsid (EMC-101) containing no
DNA combined with ImmTOR™. The trial aims to determine the optimal
dose of ImmTOR to mitigate the formation of antibodies to AAV8
capsids used in gene therapies.
"We are pleased to further evaluate ImmTOR's ability to reduce
the formation of antibodies to AAV capsids and potentially enable
gene therapy redosing by having initiated this dose-escalation
study of SEL-399," said Carsten
Brunn, Ph.D., president and chief executive officer of
Selecta. "This trial builds upon our strong preclinical data in
non-human primates and marks the first time that ImmTOR in
conjunction with an AAV capsid has been dosed in humans, which is a
significant milestone. Data from this study will inform the design
of future clinical trials in patients as we seek to unlock the full
potential of gene therapy."
The dose-escalation trial of SEL-399 is designed to evaluate the
safety and preliminary efficacy of ImmTOR in gene therapy. The
study, being conducted in healthy volunteers at the SGS Life
Sciences Clinical Pharmacology Unit in Antwerp, Belgium, plans to enroll up to 45
subjects to investigate increasing doses of ImmTOR and EMC-101.
Subjects will be randomized in a 3:1 ratio of ImmTOR plus empty
AAV8 capsid to empty capsid alone. Preliminary efficacy will be
measured by assessing levels of AAV8-specific neutralizing
antibodies.
Jude Samulski, Ph.D., chief
scientific officer and co-founder of AskBio said, "By determining
the dose at which ImmTOR is able to inhibit the formation of
AAV-specific antibodies, this study could be a significant
first step toward overcoming some of the unwanted immune responses
associated with gene therapies. We look forward to using these
findings to inform future studies as we work to develop strategies
for repetitive dosing of AAV, thus extending durability of
expression."
Selecta and AskBio expect to report initial results from this
clinical trial in the fourth quarter of 2021.
About Selecta Biosciences, Inc.
Selecta
Biosciences Inc. (NASDAQ: SELB) is leveraging its clinically
validated 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.
The company's first program aimed at addressing immunogenicity to
AAV gene therapies is expected to enter clinical trials in early
2021 in partnership with AskBio for the treatment of methylmalonic
acidemia (MMA), a rare metabolic disorder. A wholly-owned program
focused on addressing IgA nephropathy driven by ImmTOR and a
therapeutic enzyme is also in development among additional product
candidates. Selecta recently licensed its Phase 3 clinical product
candidate, SEL-212, in chronic refractory gout to Sobi. For more
information, please visit www.selectabio.com.
About AskBio
Asklepios BioPharmaceutical, Inc.
(AskBio), a wholly owned and independently operated subsidiary of
Bayer AG acquired in 2020, is a fully integrated AAV gene
therapy company dedicated to developing life-saving medicines that
cure genetic diseases. The company maintains a portfolio of
clinical programs across a range of neuromuscular, central nervous
system, cardiovascular and metabolic disease indications with a
clinical-stage pipeline that includes therapeutics for Pompe
disease, Parkinson's disease and congestive heart failure, as well
as out-licensed clinical indications for hemophilia and Duchenne
muscular dystrophy. AskBio's gene therapy platform includes Pro10™,
an industry-leading proprietary cell line manufacturing process,
and an extensive AAV capsid and promoter library. With global
headquarters in Research Triangle Park,
North Carolina, and European headquarters in Edinburgh, UK, the company has generated
hundreds of proprietary third-generation AAV capsids and promoters,
several of which have entered clinical testing. Founded in 2001 and
an early innovator in the gene therapy field, the company holds
more than 500 patents in areas such as AAV production and chimeric
and self-complementary capsids. Learn more
at www.askbio.com or follow us on LinkedIn.
About Bayer
Bayer is a global enterprise with core
competencies in the life science fields of health care and
nutrition. Its products and services are designed to benefit people
by supporting efforts to overcome the major challenges presented by
a growing and aging global population. At the same time, the Group
aims to increase its earning power and create value through
innovation and growth. Bayer is committed to the principles of
sustainable development, and the Bayer brand stands for trust,
reliability and quality throughout the world. In fiscal 2019, the
Group employed around 104,000 people and had sales of 43.5
billion euros. Capital expenditures amounted to 2.9 billion
euros, R&D expenses to 5.3 billion euros. For more
information, visit www.bayer.com.
AskBio Forward-Looking Statements
This press
release contains "forward-looking statements." Any statements
contained in this press release that are not statements of
historical fact may be deemed to be forward-looking statements.
Words such as "believes," "anticipates," "plans," "expects,"
"will," "intends," "potential," "possible" and similar expressions
are intended to identify forward-looking statements. These
forward-looking statements include without limitation statements
regarding AskBio's pipeline of development candidates; AskBio's
collaboration with Selecta; AskBio's clinical trials, including its
ability to enroll subjects, the timing of any such trials and any
potential side effects; whether ImmTOR will be able to reduce the
formation of antibodies to AAV capsids and potentially enable gene
therapy redosing; the timing of and results from the SEL-399/101
trial; whether the SEL-399/101 study could be a significant first
step in overcoming the immunogenicity concerns associated with gene
therapies; AskBio's strategies for repetitive dosing of AAV,
extending durability of expression; AskBio's goal of developing
life-saving medicines aimed at curing genetic diseases; and the
potential benefits of AskBio's development candidates to patients.
These forward-looking statements involve risks and uncertainties,
many of which are beyond AskBio's control. Known risks include,
among others: AskBio may not be able to execute on its business
plans and goals, including meeting its expected or planned
regulatory milestones and timelines, clinical development plans and
bringing its product candidates to market, due to a variety of
reasons, including the ongoing COVID-19 pandemic, possible
limitations of company financial and other resources, manufacturing
limitations that may not be anticipated or resolved in a timely
manner, potential disagreements or other issues with our
third-party collaborators and partners, and regulatory, court or
agency feedback or decisions, such as feedback and decisions from
the United States Food and Drug Administration or the United States
Patent and Trademark Office. Any of the foregoing risks could
materially and adversely affect AskBio's business and results of
operations. You should not place undue reliance on the
forward-looking statements contained in this press release. AskBio
does not undertake any obligation to publicly update its
forward-looking statements based on events or circumstances after
the date hereof.
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 the unique
proprietary platform of its partners, the potential of ImmTOR to
enable re-dosing of AAV gene therapy, the potential treatment
applications of product candidates utilizing the ImmTOR platform in
areas such as gene therapy, the ability of the Company and AskBio
to develop gene therapy products using ImmTOR and AskBio's
technology, the novelty of treatment paradigms that the Company is
able to develop, whether the observations made in non-human primate
study subjects will translate to studies performed with human
beings, the potential of any therapies developed by the company and
AskBio 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
intellectual property 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 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 or 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 primates, 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 from operations raise substantial doubt
regarding its ability to continue as a going concern, substantial
fluctuation in the price of its common stock, and other important
factors discussed in the "Risk Factors" section of the company's
most recent Quarterly Report 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.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/selecta-biosciences-and-askbio-initiate-first-in-human-dose-escalation-study-to-evaluate-immtor-in-gene-therapy-301229448.html
SOURCE Asklepios BioPharmaceutical, Inc.