SAN DIEGO and BOSTON, July 24,
2020 /PRNewswire/ -- Sorrento Therapeutics, Inc.
(Nasdaq: SRNE, "Sorrento") and SmartPharm Therapeutics, Inc.
("SmartPharm") announced today the signing of a letter of intent
for Sorrento to acquire SmartPharm, a gene-encoded therapeutics
company developing non-viral DNA and RNA gene delivery platforms
for COVID-19 and rare diseases, with broad potential for
application in enhancing antibody-centric therapeutics, including
against COVID-19. The transaction is expected to close in
August 2020. Financial terms of the
deal were not disclosed.
Sorrento and SmartPharm previously announced a research and
development collaboration to encode and express in vivo
Sorrento's proprietary SARS-CoV-2 neutralizing monoclonal
antibodies utilizing SmartPharm's Gene Mab plasmid nanoparticle
platform.
Sorrento plans to accelerate the development of multiple
candidates for in vivo gene-encoded expression of Sorrento's
antibodies, starting with Sorrento's previously announced STI-1499,
or COVI-GUARD™, which is currently moving through preclinical and
manufacturing requirements with an IND submission targeted for
August 2020. The initial clinical
trial for STI-1499 is expected to be in ICU patients to ensure
safety and potentially allow a preliminary look at efficacy. In
vitro results so far have demonstrated STI-1499's ability to
completely neutralize SARS-CoV-2 infection at low doses, making
STI-1499 Sorrento's lead candidate for potential cost-effective
passive protection against COVID-19.
SmartPharm's Gene Mab™ platform delivers to muscles a novel
low-immunogenic DNA plasmid encoded with a therapeutic antibody for
long-lasting expression in vivo. If clinical trials are
successful, a single administration of STI-1499dpi (DNA plasmid
injection) could allow the recipient's own muscle cells to produce
the antibody for a prolonged period of time after a single
injection, potentially providing extended protection against
COVID-19 for periods of time that might provide an alternative to
vaccines. Manufacturing of DNA plasmids (in bacterial fermenters)
can be done with Sorrento's in-house cGMP capabilities for a
fraction of the cost associated with traditional antibody
manufacturing.
"We are very encouraged by the preclinical data generated thus
far by our STI-1499 neutralizing antibody against COVID-19," said
Henry Ji, Ph.D., CEO of Sorrento
Therapeutics. "We are excited about the prospect of leveraging
SmartPharm's Gene Mab platform in combination with our G-MAB
library to produce next-generation gene-encoded antibody candidates
against a host of pathogens and cancer cell types. Being able to
stimulate the body to produce in vivo our most potent
antibodies at optimized manufacturing costs will offer an
additional competitive advantage as Sorrento transitions from
product development to full scale manufacturing and
commercialization."
About SmartPharm Therapeutics
SmartPharm Therapeutics, Inc. is a privately held, development
stage biopharmaceutical company focused on developing
next-generation, non-viral gene therapies for the treatment of
serious or rare diseases with the vision of creating "Biologics
from Within." SmartPharm is currently developing a novel pipeline
of non-viral, gene-encoded proteins for the treatment of conditions
that require biologic therapy such enzyme replacement and tissue
restoration. SmartPharm commenced operations in 2018 and is
headquartered in Cambridge, MA,
USA. For more information, please visit www.smartpharmtx.com.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to treat
cancers. 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™", "Seprehvec™"). Sorrento is also
developing potential antiviral therapies and vaccines against
coronaviruses, including COVIDTRAP™, ACE-MAB™, COVI-MAB™,
COVI-GUARD™, COVI-SHIELD™ and T-VIVA-19™.
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 ZTlido® (lidocaine topical system)
1.8% for the treatment of post-herpetic neuralgia. RTX is
completing a phase IB trial for intractable pain associated with
cancer and a phase 1B trial in
osteoarthritis patients. 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 proposed acquisition of SmartPharm; the potential effects that
the acquisition of SmartPharm may have on Sorrento's business and
product candidate pipeline; the expected timing for the closing of
the transaction; the initiation and completion of ongoing studies
for COVID-19 using antibodies and gene-encoded antibodies, and data
read-outs related thereto; the potency and potential blocking
capabilities of STI-1499 and STI-1499dpi and their respective
impact on SARS-CoV-2; the expected length of any antiviral
protection provided by STI-1499 and STI-1499dpi; the potential
administration and applications of STI-1499 and STI-1499dpi, alone
or in combination; the timeline and status of preclinical testing
for STI-1499 and STI-1499dpi; the expected timing of an IND
submission for STI-1499; expectations regarding the initial
clinical trial for STI-1499; the potential safety and efficacy of
STI-1499 and STI-1499dpi; the therapeutic potential of STI-1499 and
STI-1499dpi for SARS-CoV-2 and COVID-19; the potential costs
associated with manufacturing STI-1499dpi and other DNA plasmids;
Sorrento's ability to produce antibody candidates against pathogens
and cancer cells; Sorrento's ability to transition from product
development to full scale manufacturing and commercialization; and
Sorrento's potential position in the anti-viral immunity industry.
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 with newly
acquired technologies, including the proposed acquisition of
SmartPharm and the utilization of SmartPharm's Gene-Encoded
Therapeutics (GET) platforms for the treatment and prevention of
coronavirus infections and other pathogens and cancer cells; risks
related to seeking regulatory approvals and conducting clinical
trials; the clinical and commercial success of the treatment and
prevention of coronavirus infections using monoclonal antibodies
and gene-encoded antibodies; the viability and success of using
monoclonal antibodies and gene-encoded antibodies for treatments in
anti-viral therapeutic areas, including coronavirus; 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 prior study and trial results may not be replicated in
future studies and trials; 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 related to seeking regulatory approvals and
conducting clinical trials; risks of manufacturing drug product;
risks related to leveraging the expertise of its employees,
subsidiaries, affiliates and partners to assist the company in the
execution of its 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, 2019, 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
Contact: Dani Frank
Email: sorrento@factorypr.com
Sorrento® and the Sorrento logo are registered trademarks of
Sorrento Therapeutics, Inc.
G-MAB™, COVI-GUARD™, COVI-SHIELD™, COVIDTRAP™, T-VIVA-19™,
COVI-MAB™, ACE-MAB™, COVI-TRACK™, Saving-Life™ and Improving-Life™
are trademarks of Sorrento Therapeutics, Inc.
ZTlido® is a trademark owned by Scilex Pharmaceuticals Inc.
All other trademarks are the property of their respective
owners.
© 2020 Sorrento Therapeutics, Inc. All Rights Reserved.
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SOURCE Sorrento Therapeutics, Inc.