Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced it has entered into an exclusive license agreement with
Mayo Clinic for a potential breakthrough technology platform that
is capable of generating a great diversity of stable
antibody-drug-nanoparticle albumin-bound (nab) immune complexes
(ADNICs) targeting many types of human diseases including various
solid and liquid tumors. The ADNIC is the next generation in
antibody drug conjugate (ADC) technology that potentially addresses
limitations of current ADC technology, such as complex
manufacturing processes (e.g., antibody-chemotherapy linkers),
which can affect drug half-life, stability and tumor accessibility,
and result in high cost of goods (COGs). The ADNIC platform is
currently generating clinical data at Mayo Clinic through clinical
trials with multiple investigational products in a variety of
cancers including ovarian, endometrial, and multiple lymphoma
sub-types. These trials will continue and are expected to be
expanded.
The ADNIC technology, developed at Mayo Clinic,
offers many potential advantages:
- Optimizes the likelihood that a
chemotherapeutic payload will be preferentially delivered to the
specific, targeted cancer cell type (supported by existing
preclinical pharmacokinetic (PK) data);
- Potentially more efficient and
effective than traditional ADCs because ADNICs allow for the entire
ADNIC complex to be absorbed into the targeted cancer cell rather
than just the chemotherapeutic payload; and
- Uses non-covalent binding to
external albumin sites to potentially facilitate delivery of both a
monoclonal antibody and chemotherapeutic payload directly to the
tumor and its microenvironment.
The ADNIC technology potentially eliminates the
need to use covalent linker technology by incorporating
therapeutically or immunologically active antibodies in a
reversible manner with a nanoparticle composed of albumin and a
payload of one or more drugs.
The platform has indicated clinical benefits in
an FDA-cleared investigator-sponsored trial at Mayo Clinic under
the supervision of Svetomir Markovic, M.D., Ph.D., a medical
oncologist and hematologist. Preliminary results suggest that
patients have experienced clinical benefit from receiving prototype
product candidates that utilize the ADNIC technology developed by
Dr. Markovic and Wendy Navalo at Mayo Clinic, including objective
responses in heavily pre-treated patients with advanced
cancers.
The technology platform is protected by a rich
intellectual property portfolio comprised of 17 patent families, 32
patents granted to date with life through at least 2035 and another
135 patents pending.
“This stable complex potentially allows for the
delivery of higher doses of active drug directly into the tumor as
demonstrated in animal studies and in preliminary trials in cancer
patients,“ according to Dr. Markovic, the inventor of the ADNIC
technology at Mayo Clinic. The reversibility of complex formation
may allow for deeper tumor penetration, thereby potentially
enabling a better anti-tumor effect. The exclusive license to the
ADNIC platform also includes access to a proprietary and scalable
manufacturing process that is expected to enable high product yield
and low COGs.
“The Mayo Clinic-developed ADNIC platform is a
perfect fit for our extensive G-MAB antibody products including but
not limited to our anti-PD-L1, anti-CD38, anti-BCMA and anti-ROR1
antibodies. We will accelerate the development and
commercialization of this amazing technology by generating and
developing multiple next-generation ADNIC product candidates for
the potential treatment of cancer, COVID-19 and other human
diseases,” stated Henry Ji, Ph.D., Chairman and CEO of Sorrento
Therapeutics. “Teaming with Mayo Clinic, this license expands
Sorrento’s mission of developing innovative life-saving medicines
for unmet medical needs,” continued Dr. Ji. Sorrento will continue
to execute on the clinical development strategy developed by Mayo
Clinic for multiple ADNIC lead product candidates in COVID-19 and
multiple solid and hematologic malignancies.
Mayo Clinic, Dr. Markovic and Ms. Navalo have
financial interests in the technology referenced in this release.
Mayo Clinic will use any revenue it receives to support its
not-for-profit mission in patient care, education and research.
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™; and diagnostic test
solutions, including COVI-TRACK™ and COVI-TRACE™.
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 potential applications for the ADNIC technology; the
ability for the ADNIC technology to address issues with current ADC
technology, including complex manufacturing processes associated
with ADC technology; the potential for ADNIC technology to allow
for preferential delivery of a chemotherapeutic payload to
specific, targeted cancer cell types; the potential for ADNIC
technology to allow for more efficient and/or effective absorption
of the ADNIC complex into the targeted cancer cell; the potential
for ADNIC technology to facilitate delivery of antibody(ies) and/or
chemotherapeutic drug(s) directly to its target; the potential for
ADNIC technology to eliminate the need to use covalent linker
technology; the potential for ADNIC technology to allow for
delivery of higher doses of active drug; any anti-tumor effects of
the ADNIC technology; the continuation and expansion of clinical
trials at Mayo Clinic for investigational products in a variety of
cancers; and Sorrento’s research, clinical and commercial plans
with respect to the ADNIC technology. 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 and its
subsidiaries', affiliates’ and partners’ technologies and prospects
and collaborations with partners, including, but not limited to
risks related to seeking regulatory approval for any antibody
product candidates utilizing the ADNIC technology; 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 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
cancer, anti-tumor and G-MAB antibody 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: Alexis Nahama, DVM (SVP Corporate
Development)Telephone: 1.858.203.4120Email:
mediarelations@sorrentotherapeutics.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™, and COVI-TRACE™ 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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