Sorrento Therapeutics, Inc. (NASDAQ: SRNE; “Sorrento”), a clinical
stage biopharmaceutical company developing new therapies to treat
cancer, pain and COVID-19, and Dyadic International, Inc. (NASDAQ:
DYAI; “Dyadic”), a global biotechnology company focused on further
improving, applying and deploying its proprietary C1-cell protein
production platform to accelerate development, lower production
costs and improve access to biologic vaccines and drugs at flexible
commercial scales, today announced the signing of a binding term
sheet to enter into an exclusive license agreement to develop and
commercialize vaccines, therapeutics, and diagnostics for
coronaviruses, including Dyadic’s lead COVID-19 vaccine candidate,
DYAI-100, produced using Dyadic's proprietary and patented C1-cell
protein production platform. The final terms of the license will be
set forth in a definitive agreement to be entered into between the
parties.
Sorrento Chairman and CEO, Dr. Henry Ji,
commented, “We look forward to continuing our collaboration with
Dyadic, which began last year, initially with a goal of developing
and commercializing a protein-based COVID-19 vaccine that can be
rapidly manufactured in large quantities in our existing cGMP
facilities, and stored and transported at room temperature, in
order to increase access and affordability to underserved
populations globally.” Dr Ji. continued, “Over the past six months
we have carried out several promising preclinical animal studies
using the C1-produced RBD antigen in Dyadic’s lead COVID-19 vaccine
candidate, DYAI-100. Our goal is to manufacture a COVID-19 vaccine
that will provide protection across the variants of concern,
including Delta, and in addition, apply the C1 protein production
platform broadly across our current and future coronavirus
programs.”
Mark Emalfarb, Dyadic’s President and Chief
Executive Officer noted, “We are delighted to have executed a
binding term sheet with Sorrento Therapeutics to license the C1
technology for the development and commercialization of coronavirus
vaccines, therapeutics, and diagnostics, including COVID-19. This
marks a significant milestone in our corporate development efforts
as we expect the license agreement we will enter into to enable us
to monetize our internal COVID-19 development efforts with a
partner that has the resources and expertise to advance vaccines,
therapeutics, and diagnostics both clinically and
commercially.”
“The license agreement, when executed,
contemplates an up-front payment of $10 million in cash and stock,
up to $4 million in reimbursements for preclinical and clinical
development costs incurred by Dyadic for the development and
advancement of our proprietary DYAI-100 vaccine, up to $33 million
in milestone payments and ongoing royalties following
commercialization. All future development costs related to this
license will be incurred by Sorrento,” concluded Mr. Emalfarb.
Mr. Michael Tarnok, Dyadic’s Board Chairman
noted, “This is a significant event for Dyadic and humankind
globally, having achieved our goal of creating a pathway that
potentially addresses the COVID-19 vaccine production gap for mass
scale immunizations and treatments across the globe, quickly and
efficiently. The Sorrento license will cover all other territories
not already covered by Dyadic’s existing COVID-19 agreements with
Medytox, Syngene and the Rubic Consortium.”
About Dyadic International, Inc.
Dyadic International, Inc. is a global
biotechnology company developing what it believes will be a
potentially significant biopharmaceutical gene expression platform
based on the fungus Thermothelomyces heterothallica (formerly
Myceliophthora thermophila), named C1. The C1 microorganism, which
enables the development and large-scale manufacture of low-cost
proteins, has the potential to be further developed into a safe and
efficient expression system that may help speed up the development,
lower production costs and improve the performance of biologic
vaccines and drugs at flexible commercial scales. Dyadic is using
the C1 technology and other technologies to conduct research,
development and commercial activities for the development and
manufacturing of human and animal vaccines and drugs, such as virus
like particles (VLPs) and antigens, monoclonal antibodies, Fab
antibody fragments, Fc-Fusion proteins, biosimilars and/or
biobetters, and other therapeutic proteins. Certain other research
activities are ongoing, which include the exploration of using C1
to develop and produce certain metabolites and other biologic
products. Dyadic pursues research and development collaborations,
licensing arrangements and other commercial opportunities with its
partners and collaborators to leverage the value and benefits of
these technologies in development and manufacture of
biopharmaceuticals. As the aging population grows in developed and
undeveloped countries, Dyadic believes the C1 technology may help
bring biologic vaccines, drugs, and other biologic products to
market faster, in greater volumes, at lower cost, and with new
properties to drug developers and manufacturers, and improve access
and cost to patients and the healthcare system, but most
importantly save lives.
Please visit Dyadic's website
at http://www.dyadic.com for additional information,
including details regarding Dyadic's plans for its
biopharmaceutical business.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to treat cancers
and COVID-19. Sorrento's multimodal, multipronged approach to
fighting cancer is made possible by its extensive immuno-oncology
platforms, including key assets such as fully human antibodies
(“G-MAB™ library”), clinical stage immuno-cellular therapies
(“CAR-T”, “DAR-T™”), antibody-drug conjugates (“ADCs”), and
clinical stage oncolytic virus (“Seprehvir™”). Sorrento is also
developing potential antiviral therapies and vaccines against
coronaviruses, including COVIGUARD™, COVI-AMG™, COVISHIELD™,
Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions,
including COVITRACK™, COVISTIX™ and COVITRACE™.
Sorrento's commitment to life-enhancing
therapies for patients is also demonstrated by our effort to
advance a first-in-class (TRPV1 agonist) non-opioid pain management
small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg,
dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel,
viscous gel formulation of a widely used corticosteroid for
epidural injections to treat lumbosacral radicular pain, or
sciatica, and to commercialize ZTlido® (lidocaine topical system)
1.8% for the treatment of post-herpetic neuralgia. RTX has
completed a Phase IB trial for intractable pain associated with
cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is
in a pivotal Phase 3 trial for the treatment of lumbosacral
radicular pain, or sciatica. ZTlido® was approved by the FDA on
February 28, 2018.
For more information visit
www.sorrentotherapeutics.com.
Forward-Looking Statements
This press release and any statements made for
and during any presentation or meeting contain forward-looking
statements related to Sorrento Therapeutics, Inc., under the safe
harbor provisions of Section 21E of the Private Securities
Litigation Reform Act of 1995 and subject to risks and
uncertainties that could cause actual results to differ materially
from those projected. Forward-looking statements include statements
regarding the C1-cell protein production platform and DYAI-100; the
expected collaboration between Sorrento and Dyadic, including but
not limited to, the development and commercialization of COVID-19
vaccines, including DYAI-100 and Sorrento’s MultiValent COVID-19
vaccine, and therapeutic antibodies, protein therapeutics and
diagnostics for coronaviruses; the properties of DYAI-100,
including its induction of high-titer neutralization activity
against SARS-CoV-2 and its variants of concern; the capability to
manufacture protein-based vaccines in large quantities; Sorrento’s
resources and expertise in developing and commercializing vaccines,
therapeutics and diagnostics; the potential for such protein-based
vaccines to be stored and transported at room temperature; the
expectation that such vaccines would be effective against
SARS-CoV-2 and its variants of concern; the plan to utilize the C-1
cell protein production platform in connection with other existing
and new coronavirus programs; and the expected entry into a
definitive license agreement between the parties and the terms
thereof. Risks and uncertainties that could cause our actual
results to differ materially and adversely from those expressed in
our forward-looking statements, include, but are not limited to:
risks related to Sorrento's technologies and prospects, including,
but not limited to risks related to seeking regulatory approval for
DYAI-100 and other vaccine and therapeutic candidates produced by
the C1-cell protein production platform; clinical development
risks, including risks in the progress, timing, cost, and results
of clinical trials and product development programs; risk of
difficulties or delays in obtaining regulatory approvals; risks
that clinical study results may not meet any or all endpoints of a
clinical study and that any data generated from such studies may
not support a regulatory submission or approval; risks that prior
test, study and trial results may not be replicated in future
studies and trials; risks of manufacturing and supplying drug
product; risks related to leveraging the expertise of its
employees, subsidiaries, affiliates and partners to assist Sorrento
in the execution of its therapeutic antibody product candidate
strategies; risks related to the global impact of COVID-19; and
other risks that are described in Sorrento's most recent periodic
reports filed with the Securities and Exchange Commission,
including Sorrento's Annual Report on Form 10-K for the year ended
December 31, 2020, and subsequent Quarterly Reports on Form 10-Q
filed with the Securities and Exchange Commission, including the
risk factors set forth in those filings. Investors are cautioned
not to place undue reliance on these forward-looking statements,
which speak only as of the date of this release and we undertake no
obligation to update any forward-looking statement in this press
release except as required by law.
Media and Investor Relations
Contacts
Dyadic International, Inc.Ping W. RawsonChief
Financial OfficerPhone: (561) 743-8333Email: prawson@dyadic.com
Sorrento Therapeutics, Inc.
Alexis Nahama, DVMSVP, Corporate DevelopmentEmail:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, SOFUSA™, COVIGUARD™, COVI-AMG™,
COVISHIELD™, Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™,
COVITRACE™ and COVISTIX™ are trademarks of Sorrento Therapeutics,
Inc.
SEMDEXA™ is a trademark of Semnur
Pharmaceuticals, Inc.
ZTlido® is a registered trademark owned by
Scilex Pharmaceuticals Inc.
All other trademarks are the property of their
respective owners.
©2021 Sorrento Therapeutics, Inc. All Rights
Reserved.
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