Over the last several months, Sorrento Therapeutics, Inc. (Nasdaq:
SRNE, "Sorrento") and its development partners have advanced into
clinical development (Phase 1b through Phase 3 clinical trials) a
number of fully human monoclonal antibodies (mAbs) for the
treatment of COVID-19 and various cancers. This demonstrates the
potential of the deep pipeline generated from Sorrento’s
proprietary G-MAB™ library, invented by Dr. Henry Ji, the Chairman
and CEO of Sorrento. This G-MAB library is based on the use of RNA
transcription for amplification of the antibody variable domains
from over 600 donors. These donors were from both sexes and
of multiple ethnicities, leading to a broad diversity of
antibodies. In-depth analysis of deep sequencing DNA data showed
that the G-MAB library contains more than 20 quadrillion (1016)
distinct antibody sequences. The G-MAB library has fostered
the development of several early and late-stage oncology programs
that are currently in Phase 2 and Phase 3 clinical trials and
neutralizing mAbs currently in a Phase 2 clinical trial directed
against the spike protein of COVID-19 viruses.
Two independent anti-PD-L1 mAbs are now in Phase
2 and Phase 3 clinical studies. A PD-L1 mAb (STI-3031, also known
as IMC-001) was licensed to ImmuneOncia Therapeutics, Inc.
(“ImmuneOncia”), a joint venture between Sorrento and Seoul-based
Yuhan Corporation. IMC-001 has completed a Phase 1b study in
patients with metastatic or locally-advanced solid tumors and is
nearing completion of a Phase 2, open-label, “Neo-Chance” study in
patients with resectable gastric cancer, esophageal cancer and
liver cancer. ImmuneOncia has also started to enroll patients in a
Phase 2 study in relapsed or refractory extranodal NK/T cell
lymphoma, nasal type. Sorrento has filed an IND in the U.S. and
received clearance from the FDA to proceed with a Phase 2a study
for STI-3031 for advanced urothelial carcinoma.
A second antibody, Socazolimab, is licensed to
Lee’s Pharmaceutical Holdings Limited in the Greater China
territory, and has been cleared to begin a multicenter Phase 3
trial as a potential first-line treatment for patients with
extensive-stage small-cell lung cancer. Professor Shun Lu (Shanghai
Chest Hospital) is the Principal Investigator. Additionally, Phase
1b studies in several other indications have been completed for
this product candidate, including: recurrent metastatic cervical
cancer, advanced urothelial carcinoma, and high-grade osteosarcoma
after adjuvant chemotherapy for maintenance. In addition, a Phase
1b/2 study has been initiated as a potential neoadjuvant treatment
option for esophageal carcinoma. For cervical cancer, a pivotal
study has been completed with a breakthrough therapy designation
granted by the National Medical Products Administration (NMPA) in
China. Sorrento intends to open an IND in the U.S. with the intent
to have an end-of-phase 3 meeting or pre-NDA discussion with the
FDA for various cancer indications.
Sorrento previously announced FDA clearance to
commence a Phase 1b study in various relapsed or refractory solid
tumors with an anti-CD47 antibody (STI-6643) (a CD-47 checkpoint
inhibitor interacting with SIRPα). In preclinical studies, STI-6643
appears to have a beneficial toxicity profile (e.g., reduced
hemolysis) without a priming mechanism while maintaining potent
anti-tumor activity. Additionally, Sorrento licensed a separate
promising anti-CD47 antibody (IMC-002) to ImmuneOncia, which has
initiated a Phase 1b study in patients with metastatic or
locally-advanced solid tumors and relapsed or refractory
lymphomas.
Sorrento previously announced the formation of
its subsidiary company - Adnab, Inc.,– which is focused on
developing and commercializing ADNAB™ platform products for
hematological malignancies and solid tumors based on an exclusive
license from the Mayo Clinic. Sorrento intends to combine a variety
of its proprietary mAbs in conjunction with the ADNAB technology
platform, which was developed by Dr. Svetomir Markovic, M.D.,
Ph.D., and his research team at Mayo Clinic. This effort will
potentially result in multiple next-generation ADNAB products.
Since ADNABs can be designed to have one or two mAbs on the
external surface, in addition to a chemotherapeutic payload, the
cytotoxic payload can potentially be delivered preferentially to
targeted cancer cell types. Sorrento expects to develop a number of
innovative ADNABs in anticipation of filing INDs for clinical
trials later in 2021.
“These are very exciting times for Sorrento,”
said Dr. Ji. “These therapeutic antibody examples demonstrate that
we are leveraging the G-MAB library to bring product candidates
rapidly from preclinical development through the IND process and
into clinic trials.”
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 potential for any clinical and pre-clinical G-MAB
antibodies to be the foundation for developing potent ADC or ADNAB
product candidates; the potential for G-MAB antibodies to be used
in the generation and production of future CAR-T or DAR-T cells for
treating hematological cancer and solid tumors; the ability of the
G-MAB library to continue fostering the development of oncology
programs and neutralizing mAbs; the initiation of a Phase 2a study
for STI-3031; the potential therapeutic benefits of STI-3031,
Socazolimab, STI-6643 and IMC-002; the potential for pre-clinical
data and results to be replicated in future clinical trials; the
safety and efficacy of STI-3031, Socazolimab, STI-6643 and IMC-002;
the potential for the safety and efficacy of STI-3031, Socazolimab,
STI-6643 and IMC-002 to be replicated in future clinical trials;
regulatory approvals of STI-3031, Socazolimab, STI-6643 and
IMC-002; the completion of clinical trials of STI-3031,
Socazolimab, STI-6643 and IMC-002; the filing of an IND in the US
for Socazolimab; Sorrento’s ability to combine proprietary mAbs in
conjunction with the ADNAB technology platform to create
next-generation ADNAB products; the potential for ADNABs to deliver
cytotoxic payloads to targeted cancer cell types; the potential for
Sorrento to file INDs for clinical trials for ADNAB; the expected
timing of any IND filings for ADNABs; Sorrento’s intention to open
an IND for Socazolimab and have an end-of-phase 3 meeting or
pre-NDA discussion with the FDA for various cancer indications; or
Sorrento’s ability to continue leveraging the G-MAB library to
bring product candidates from preclinical development, through the
IND process and into clinical trials. 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 STI-3031, Socazolimab, STI-6643,
IMC-002 or any ADNAB product candidates; 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
ContactAlexis Nahama, DVM (SVP Corporate
Development)Email: 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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