Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today
announced the formation of ADNAB, Inc., a subsidiary Company, that
will develop and commercialize a Mayo Clinic-developed technology
platform for the manufacture of antibody-drug conjugates (ADC),
each called an ADNAB™.
An ADNAB™ is an immune complex of nanoparticle
albumin-bound drug products e.g., nab-paclitaxel, which are
non-covalently conjugated with tumor-targeting monoclonal
antibodies (mAb’s). The ADNAB™ platform was developed by Svetomir
Markovic, M.D., Ph.D., and his research team at Mayo Clinic. To
date, Dr. Markovic’s team have successfully formed nine (9)
potential ADNAB™ candidates, including two (2) that are currently
enrolling in an FDA supervised, investigator-initiated human
trial.
Utilizing Sorrento’s G-MAB™ library of fully
humanized monoclonal antibodies, the ADNAB™ platform will generate
a broad portfolio of product candidates targeting liquid and solid
tumors. “We believe this platform has broad potential.” said Henry
Ji, Ph.D., Chairman and CEO of the newly formed ADNAB, Inc. “Our
Vision, is to extend the reach of this platform to therapeutic
areas beyond oncology; we have already begun work on an ADNAB™ for
auto-immune diseases.”
Mayo Clinic physician Tom Habermann, M.D.,
serves as the Principal Investigator for Study LS1681, which is
evaluating a rituximab-ADNAB™ in relapsed/refractory B-cell
lymphomas. Relapsed-Refractory Diffuse Large B Cell Lymphoma (RR
DLBCL), which accounts for approximately one-third of patients with
DLBCL, remains a major cause of morbidity and mortality.
“I think this technology has the potential to be
impactful” said Bradley J. Monk, M.D., Professor of Gynecologic
Oncology at the University of Arizona College of Medicine. “I’m
especially excited by the flexibility of this platform and I’m
anxious to see what we might be able to do with a product that
targets CA-125,” added Dr. Monk.
“The Mayo team has spent years fine-tuning this technology and
now we have a collaborator that can provide the resources necessary
to accelerate and scale this program,” said Svetomir Markovic,
M.D., Ph.D., who discovered and developed the ADNAB™ platform
technology.
“The published clinical studies testing this platform technology
are encouraging and we are looking forward to working with the Mayo
team on both the ongoing and future clinical studies.
Unquestionably, Sorrento and Mayo share the common goal of
utilizing this technology to develop multiple therapies for the
possible benefit of cancer patients,” noted Ji.
ADNAB, Inc. plans to file multiple INDs this
year; and to request Breakthrough Therapy designation from the FDA
in both ovarian and endometrial cancers.
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 COVI-GUARD™, COVI-AMG™, COVI-SHIELD™,
Gene-MAb™, COVI-MSC™ and COVI-DROPS™; and diagnostic test
solutions, including COVI-TRACK™, COVI-STIX™ 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 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
Financial information
Mayo Clinic and Dr. Markovic have a financial interest in the
technology referenced in this news release. Mayo Clinic will use
any revenue it receives to support its not-for-profit mission in
patient care, education and research.
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 plans and timing for the development and
commercialization of the ADNAB technology for multiple therapies,
including endometrial cancer, ovarian cancer, angiosarcoma and
B-Cell lymphomas; the preliminary proof-of-concept results of
Investigator-Initiated Trials to date; the ability for the ADNAB
technology to potentially generate a broad portfolio of product
candidates targeting liquid and solid tumors; plans to expand the
ADNAB platform to other therapeutic areas, including auto-immune
diseases; the continuation of ongoing clinical trials and
initiation of future trials at Mayo Clinic; the planned filing of
multiple IND applications and plans to seek breakthrough therapy
designation for STI-0201 in ovarian and endometrial cancers; and
Sorrento’s research, clinical and commercial plans with respect to
the ADNAB 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 ADNAB 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 RelationsContact: 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™, DAR-T™, ANDAB™, COVI-GUARD™, COVI-AMG™,
COVI-SHIELD™, Gene-MAb™, COVI-DROPS™, COVI-MSC™, COVI-TRACK™,
COVI-TRACE™ and COVI-STIX™ are trademarks of Sorrento
Therapeutics, Inc.
SEMDEXA™ is a trademark of Semnur
Pharmaceuticals, Inc.
ZTlido® is a trademark owned by Scilex
Pharmaceuticals Inc.
All other trademarks are the property of their
respective owners.
© 2021 Sorrento Therapeutics, Inc. All
Rights Reserved.
1
https://clinicaltrials.gov/ct2/show/NCT03003546?term=Ls1681&draw=2&rank=12
https://clinicaltrials.gov/ct2/show/NCT02020707?term=mc1371&draw=2&rank=13
DOI: 10.1200/JCO.2020.38.15_suppl.e18097 Journal of Clinical
Oncology 38, no. 15_suppl
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