Exclusive use of Selecta’s Synthetic Vaccine
Particles (SVP™) platform technology provided to Spark Therapeutics
for co-administration with up to five gene therapy targets,
including FVIII for hemophilia A
Spark Therapeutics (NASDAQ:ONCE) and Selecta Biosciences, Inc.
(NASDAQ:SELB) today announced a license agreement that provides
Spark Therapeutics with exclusive worldwide rights to Selecta’s
proprietary Synthetic Vaccine Particles (SVP™) platform technology
for co-administration with gene therapy targets, including FVIII
for hemophilia A, as well as exclusive options for up to four
additional undisclosed genetic targets.
Selecta’s immune tolerance SVP, including SVP-Rapamycin, is an
investigational technology intended to suppress the formation of
neutralizing antibodies to an adeno-associated virus (AAV) capsid
when used in combination with gene therapies, without altering the
therapeutic profile of the gene therapy. Neutralizing antibodies
form in response to an initial administration of an AAV gene
therapy and prevent effective subsequent usage. The potential
ability to re-dose a gene therapy may be beneficial where a patient
has not achieved a sufficient therapeutic expression of the
transferred gene in the initial dose.
“Selecta’s nanoparticle technology, which is undergoing
preclinical testing in gene therapy, may prevent formation of
neutralizing antibodies, and thus potentially enable re-dosing up
to an optimal therapeutic profile by extending the reach of gene
therapy to diseases that require higher doses or more extensive
transduction of target cells than may be achieved through one-time
dosing,” said Jeffrey D. Marrazzo, chief executive officer of Spark
Therapeutics. “Importantly, if proven successful, the
co-administration of Selecta’s technology with a gene therapy may
enable repeat dosing of AAV gene therapies in both adults and
pediatric patients, potentially minimizing the risk of a T-cell
immune response to the capsid.”
“Gene therapy is a core area of focus for Selecta; one that we
believe could benefit profoundly from our immune tolerance SVP
technology platform,” said Werner Cautreels, Ph.D., president, CEO
and chairman of Selecta. “We are excited about this license
agreement with Spark Therapeutics, a recognized gene therapy
leader, which accelerates the application of our SVP platform in
gene therapy. Our preclinical studies in this field, together with
the clinical data we have generated with SEL-212 in gout showing
prevention of anti-drug antibodies, suggest that the application of
our immune tolerance SVP technology to biologic therapies may
greatly benefit patients with life-threatening diseases who
currently lack adequate treatment options due to the occurrence of
undesired immune responses.”
Subject to the terms of the agreement, Spark Therapeutics will
make an initial $10 million cash payment to Selecta and purchase $5
million of Selecta’s common stock. Within 12 months of the
agreement’s signing, Spark Therapeutics has agreed to pay Selecta
an additional $5 million in cash and to purchase $10 million of
Selecta’s common stock. Selecta will be eligible for up to $430
million in milestone payments for each target, with up to $65
million being based on Spark Therapeutics’ achievement of specified
development and regulatory milestones and up to $365 million for
specified commercial milestones. In addition, Spark Therapeutics
will pay Selecta tiered mid-single to low-double-digit royalties on
worldwide annual net sales of any resulting commercialized gene
therapy.
The terms of this agreement do not apply to Spark Therapeutics’
ongoing investigational development programs in inherited retinal
diseases (IRDs), including voretigene neparvovec for the treatment
of RPE65-mediated IRD and SPK-7001 for choroideremia. This
agreement does not impact Spark Therapeutics’ ongoing Phase 1/2
trial of SPK-9001 in hemophilia B in collaboration with
Pfizer or its planned Phase 1/2 trial of SPK-8011 in
hemophilia A.
Selecta independently is applying its SVP technology to its own
proprietary gene therapy programs. Selecta has obtained an
exclusive license from Massachusetts Eye and Ear to Anc80, an in
silico-designed gene therapy vector, for Methylmalonic Acidemia and
has options for additional pre-defined indications. Additionally,
Selecta is advancing a proprietary gene therapy program for
Ornithine Transcarbamylase Deficiency.
About Spark TherapeuticsSpark Therapeutics, a
fully integrated company, is striving to challenge the
inevitability of genetic disease by discovering, developing, and
delivering gene therapies that address inherited retinal
diseases (IRDs), liver-mediated diseases such as hemophilia, and
neurodegenerative diseases. Our validated platform successfully has
delivered proof-of-concept data with investigational gene therapies
in the retina and liver. Our most advanced investigational
candidate, voretigene neparvovec, in development for the treatment
of RPE65-mediated IRD, has received orphan designations in the U.S.
and European Union, and breakthrough therapy designation in the
U.S. The pipeline also includes SPK-7001, in a Phase 1/2 trial for
choroideremia, and two hemophilia development programs: SPK-9001 in
a Phase 1/2 trial for hemophilia B being developed in collaboration
with Pfizer (which also has received both breakthrough therapy and
orphan product designations) and SPK-8011, a preclinical candidate
for hemophilia A to which Spark Therapeutics retains global
commercialization rights. To learn more about us and our growing
pipeline, visit www.sparktx.com.
Spark Cautionary Note on Forward-looking
StatementsThis release contains "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995, including statements regarding the company's
SPK-FIX program. Any forward-looking statements are based on
management's current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in,
or implied by, such forward-looking statements. These risks and
uncertainties include, but are not limited to, the risk that the
SVP nanoparticle technology used in connection with gene therapies
will not produce results in humans that are similar to the
preclinical results observed to date. For a discussion of other
risks and uncertainties, and other important factors, any of which
could cause our actual results to differ from those contained in
the forward-looking statements, see the "Risk Factors" section, as
well as discussions of potential risks, uncertainties and other
important factors, in our Annual Report on Form 10-K, our Quarterly
Reports on Form 10-Q and other filings we make with the Securities
and Exchange Commission. All information in this press release is
as of the date of the release, and Spark undertakes no duty to
update this information unless required by law.
About Selecta Biosciences, Inc.Selecta
Biosciences, Inc. is a clinical-stage biopharmaceutical company
developing targeted therapies that use immunomodulators
encapsulated in nanoparticles to induce antigen-specific immune
responses to prevent and treat disease. Selecta’s proprietary
Synthetic Vaccine Particles (SVP™) technology is a highly flexible
nanoparticle platform capable of incorporating a wide range of
antigens and immunomodulators, allowing SVP-based products to
either induce antigen-specific tolerance or activate the immune
system. Selecta’s focus and strategy is to leverage its SVP immune
modulating platform to develop and commercialize highly
differentiated life-sustaining biologic drugs that are uniquely
capable of mitigating the formation of anti-drug antibodies (ADAs).
Proprietary programs that use SVP-Rapamycin to enhance efficacy and
safety of therapy include SEL-212, Selecta’s lead Phase 2 clinical
program in chronic refractory gout, and two gene therapies programs
for genetic metabolic diseases. Tolerance-inducing SVP biological
products also have potential applications in the treatment of
allergies and autoimmune diseases. Selecta is also developing SVP
product candidates that activate the immune system to prevent and
treat cancer, infections and other diseases. Selecta is based in
Watertown, Massachusetts, USA. For more information, please visit
http://selectabio.com.
Selecta Biosciences 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 company’s
expectation about receiving payments from Spark Therapeutics under
the license agreement, the progress of the Phase 1/2 clinical
program of SEL-212 including the number of centers in the Phase 2
clinical trial of SEL-212 and the announcement of data, conference
presentations, the ability of the company’s SVP platform, including
SVP-Rapamycin, to mitigate immune response and create better
therapeutic outcomes, the potential treatment applications for
products utilizing the SVP platform including repeat dosing for
gene therapy, any future development of the company’s discovery
programs in peanut allergy and celiac disease, the sufficiency of
the company’s cash, cash equivalents, investments, and restricted
cash 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 their
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 unproven approach of the company’s SVP
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 or licenses, 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, substantial
fluctuation in the price of its common stock, a significant portion
of the company’s total outstanding shares are eligible to be sold
into the market in the near future, and other important factors
discussed in the “Risk Factors” section of the company’s Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission, or SEC, on November 10, 2016, and in other filings that
the company makes with the SEC. In addition, any forward-looking
statements included in this press release represent the company’s
views only as of the date of this release and should not be relied
upon as representing its views as of any subsequent date. The
company specifically disclaims any obligation to update any
forward-looking statements included in this press release.
Spark Therapeutics Corporate Contact:Daniel
Faga, Chief Business Officer(855) SPARKTX (1-855-772-7589)
Spark Therapeutics Media Contact:Dan QuinnTen
Bridge Communications(781) 475-7974
dan@tenbridgecommunications.com
Selecta Biosciences Contact:Jason
Fredette617-231-8078jfredette@selectabio.com
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