Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced that the FDA has authorized Sorrento’s IND application
for the Phase 1 clinical testing of its allogeneic anti-CD38
Dimeric Antigen Receptor (DAR) - T Cell therapy for relapsed or
refractory multiple myeloma. The proprietary CD38 DAR-T cell
therapy candidate demonstrated strong cytotoxic activity in
preclinical studies. DAR-T product candidates are produced using
Sorrento’s proprietary, non-viral knockout-knockin (KOKI)
technology, which potentially allows for improved specificity,
stability and potency, and enables an off-the-shelf treatment
approach, thereby eliminating the need for patients to undergo
leukapheresis and undesirable treatment delays to perform cell
harvesting, manufacturing and release prior to treatment for each
individual cancer patient.
Sorrento’s KOKI-enabled DAR-T platform uses
DAR-modified T cells from a normal healthy donor which are
engineered to be specific to the cell surface marker of interest,
in this case CD38, a clinically validated antigen in myeloma, to
target tumor cells. The combination of KOKI and DAR-T technologies
offers potential advantages over conventional CAR-T therapies,
including removing the ability for DAR-expressing T cells to
illicit undesired immune reaction to the cancer patient, thereby
reducing or eliminating the possibility of graft versus host
disease (GvHD) following treatment. Additionally, once DAR-T cells
are manufactured, they can be stored at the clinic site, allowing
patients to be screened and treated within days. This is compared
to existing approved CAR-T therapies, which typically require 6-8
weeks of screening, cell production and qualification before a
patient can receive treatment. Because of this timeframe, it is not
unusual for cancer patients to no longer be eligible for CAR-T
treatment due to disease progression. Also, autologous CAR-T cells
pose several manufacturing challenges, including issues that relate
to quality control and single-lot-release, and often do not meet
the release criteria following the manufacturing process. DAR-T
technology is designed to potentially provide a significant
advancement to the timeliness and potency of treatments for patient
populations who have already undergone multiple rounds of
chemotherapy and are suffering from persistent disease.
DAR-T technology is readily adaptable to dozens
of cancer targets and Sorrento has developed a preclinical product
pipeline with specific fully human antibodies discovered from
Sorrento’s G-MAB™ library. Sorrento expects to file additional IND
applications now that the first DAR-T Phase 1 trial has been
cleared to proceed by the FDA.
“This FDA clearance of our first allogeneic
DAR-T cell therapy is a seminal event for our cutting-edge KOKI and
DAR-T technologies,” said Henry Ji, Ph.D., Chairman and CEO of
Sorrento. “We foresee the first “Off-the-Shelf" DAR-T trial will
open the door to numerous other DAR-T cell therapies for other
indications to follow.”
About the DAR-T™ Platform
Sorrento’s DAR-T technology is a proprietary, next-generation
cell therapy platform that offers potential advantages over
conventional Chimeric Antigen Receptor (CAR) T cell therapy:
- The proprietary DAR construct
utilizes a natural antibody Fab (antigen-binding fragment)
structure instead of an artificial scFv (single-chain variable
fragment) sequence.
- Preclinical in vitro and in vivo
studies have demonstrated that DAR-T cells provide better target
specificity and functionality, due to higher inherent stability of
the Fab and stronger affinity of DAR vs. CAR receptors on the T
cell surface.
- DAR-T cells may reduce potential
undesirable side effects, such as CAR-T induced cytokine release
syndrome (CRS) and graft-versus-host disease (GvHD).
About KOKI™ Technology
Sorrento’s proprietary, non-viral knockout-knockin (KOKI)
technology provides DAR-T cells with several potential benefits
over virus-based transduction currently used for CAR-T
therapies:
- “Off-the-Shelf": DAR-T cells are
cryo-preserved engineered T cells designed to be delivered to
patients on-demand without delays in treatment due to the lengthy
and individualized manufacturing process for CAR-T.
- “Allogeneic”: DAR-T cells are
produced from pre-screened healthy volunteers; while autologous
CAR-T cells are patient-specific and made from and for individual
cancer patients.
- “Mass Production”: DAR-T cell
manufacturing is scalable (potentially hundreds to thousands of
doses per manufacturing run) and can meet high demand while
autologous CAR-T cell therapy requires a single-lot-release process
that can only be performed one patient at a time.
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 expectations for Sorrento's technologies and product
candidates, including, but, not limited to, Sorrento’s anti-CD38
DAR-T clinical candidate; the clinical potential of DAR-T;
potential advantages of Sorrento’s DAR-T and KOKI technologies,
including allogeneic and off-the-shelf capabilities, and scalable
production of DAR-T cells; potential benefits of the KOKI
manufacturing approach; potential advantages of allogeneic DAR-T
products over current autologous CAR-T therapy, including the
reduction of potential undesirable side effects; potential
applications for the DAR-T platform; the development of additional
DAR-T programs based on antibodies from Sorrento’s G-MAB antibody
library; and Sorrento’s expected timing for filing new IND
applications for DAR-T product candidates. 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 its CD38 DAR-T
therapeutic candidate; 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™, KOKI™, 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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