Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento") announces
today that its Chairman and CEO, Dr. Henry Ji will be discussing
the progress made, including innovative higher potency Dimeric
Antigen Receptor (“DAR”) technology and allogeneic
knock-out/knock-in (“KOKI”) cell therapy manufacturing advances
related to its CD38 immunotherapies at upcoming industry
conferences, investor conferences and investor meetings. The
reference presentation in support of those update discussions has
been uploaded to the Sorrento investor relations website and was
filed today with the Securities and Exchange Commission (“SEC”) on
a Current Report on Form 8-K.
Key progress update areas that will be discussed include:
Clinical Proof-of-concept Study for Anti-CD38 Autologous
CAR-T Cell Therapy
The Sorrento suite of anti-CD38 immunotherapies is based on a
fully human anti-CD38 antibody mined from the Sorrento G-MAB™
antibody library. This antibody has demonstrated unique functional
binding properties, which make it a promising candidate for
therapeutic applications.
Dr. Evren Alici’s research team at the Karolinska Institutet and
Hospital in Stockholm, Sweden, has generated preclinical data
demonstrating that this anti-CD38 antibody can be effectively used
in chimeric antigen receptors (“CAR-T”) and antibody-drug
conjugates (“ADC”) retaining its anti-tumor activity against
multiple myeloma cells obtained from patients who had previously
failed anti-CD38 therapy with daratumumab (Darzalex®).
The current anti-CD38 CAR construct has also enabled successful
manufacturing of autologous CAR-T cells using retrovirus-based cGMP
manufacturing processes. The CAR-T cells obtained in this
traditional approach have been successfully administered to
multiple myeloma patients. Patient recruitment is currently ongoing
at two clinical sites and additional sites will be opened in the
second half of 2019.
“Our CD38 CAR-T program remains an active clinical stage trial
with relapsed or refractory multiple myeloma (“RRMM”) patients
being dosed and recruitment proceeding as expected. We are
particularly proud of our production site at Sorrento in San Diego
producing the clinical CD38-CAR-T cells used in our study,” stated
Dr. Jerome Zeldis, Chief Medical Officer of Sorrento. “Given the
high level of interest in our program, we look forward to publicly
discussing our study data later this year.”
Next-Generation Anti-CD38 Non-viral KOKI Allogeneic
DAR-T Cell Therapy
The key components/steps of current state-of-the-art CAR-T cell
therapy programs are: a) CAR architecture; b) viral-based
transduction of the CAR construct into the T cells; and c) using
the patients as their own source for these autologous T cells.
Sorrento has developed disruptive next-gen technology platforms to
address each of these components/steps. The research and
development team at Sorrento has pioneered an allogeneic
(“off-the-shelf”) cell therapy technology (KOKI DAR-T) that
utilizes healthy donor T cells and genetically (“non-virally”)
modifies them with a novel DAR construct (see the public
presentation accompanying this press release).
Our proprietary design of the dimeric antigen receptor (“DAR”)
is based on utilizing the complete antigen-binding fragment (Fab)
of the parental antibody. It is generally accepted that Fabs more
closely mimic the functional and biophysical properties of natural
antibodies. Utilizing the same antibody binding domain sequence, we
have compared CAR constructs to their corresponding DAR constructs.
Our data showed that the DAR-T cells exhibited a higher
cytotoxicity against target-expressing tumor cells as compared to
CAR-T cells. In preclinical mouse models, the DAR-T cells
demonstrated increased anti-tumor potency as well.
Our non-viral KOKI technology may offer several potential
benefits over existing virus-based technology, such as
transgene-encoding lentiviruses or retrovirus, to introduce antigen
receptor constructs into pre-screened healthy donor (allogeneic) T
cells. These potential advantages of our non-viral KOKI technology
include: a) site-specific integration of transgenes into a
pre-selected locus in the T cell genome; b) enhanced clonal
expansion of the DAR-T cells; and c) streamlined method for
transgene construct production without need for laborious and
time-consuming virus production, release and validation processes,
resulting in a shorter research and development timelines for
IND-enabling activities.
Another major drawback of current CAR-T therapy is the reliance
on patients’ own T cells (autologous therapy). This leads to delays
in treatment (vein-to-vein time of several weeks) and substantial
manufacturing costs due to the individual processing of each
patient sample. By utilizing healthy donor T cells as the starting
point in our KOKI DAR-T cell technology these concerns can be
effectively addressed.
Sorrento has developed a robust manufacturing process in which
these donor-derived KOKI DAR-T cells are expanded and purified
resulting in the production of hundreds of KOKI allogeneic DAR-T
cell doses per manufacturing run from a single healthy donor in
about 2 weeks. This has the potential to substantially reduce cost
of goods sold (“COGS”) and expand access to cell therapy to
patients. This KOKI DAR-T manufacturing process will enable
Sorrento with its current manufacturing staff to produce in its
existing San Diego cGMP facilities the non-viral CD38 DAR-T cells
for “off-the-shelf” treatments for thousands of cancer patients per
year. Notably, allogeneic cell therapies will enable the execution
of global trials and potential commercialization as the shipping
logistics and distribution will be simplified. In addition, certain
countries’ restrictions on patient cell shipping and processing
currently hampering CAR-T cell therapy studies will not prevent
patients from receiving KOKI DAR-T cell treatments.
“Our first clinical program will be KOKI allogeneic CD38 DAR-T
cell therapy. Preclinical data and clinical trial designs will be
shared and discussed with the clinical and scientific community as
well as investors once the IND has been accepted and the clinical
study initiated”, said Dr. Henry Ji, Chairman and CEO of Sorrento.
“We are currently applying our KOKI allogeneic DAR technology to
our cell therapy program pipeline for multiple hematological and
solid tumor indications, including: multiple myeloma, lymphoma,
liver cancer, sarcoma, pancreatic cancer and glioma.”
Anti-CD38 Antibody-Drug Conjugate STI-6129
In keeping with off-the-shelf immunotherapy strategy, Sorrento
is developing STI-6129 (or LNDS1001 for China), an anti-CD38 ADC,
for which we plan the IND submission in the second half of 2019.
Preclinical studies have demonstrated strong anti-tumor activity.
Notably, the toxin payload of the ADC is based on our proprietary
tubulin inhibitor Duostatin5. The required toxicology studies of
the ADC showed a promising safety profile. The manufacturing of the
GMP drug substance of the ADC was successfully completed at our
facility in Suzhou, China. The clinical drug product will be
manufactured at Bioserv, our wholly-owned San Diego-based
fill/finish service provider. We anticipate initiation of clinical
studies in hematological malignancies and potentially non-oncology
indications by the end of 2019.
“In total, all of our anti-CD38 immunotherapies have been
discovered, developed and manufactured in-house by our outstanding
R&D and manufacturing team members. This demonstrates the
unique and efficient “turn-key” approach as we are able to perform
with our immunotherapy R&D teams utilizing internal expertise
and capabilities without being dependent on external service
providers,” said Dr. Henry Ji, Chairman and CEO of Sorrento. “We
believe that this anti-CD38 therapy suite illustrates the depth and
breadth of the disruptive technology platforms we have to attack
diseases with high unmet medical need from different angles. Each
modality has its unique strengths but when properly sequenced in
the clinic by our outstanding clinical development team, we believe
substantial benefit potential can be provided to patients, their
caretakers and the medical community. We see our CD38 Therapeutics
business unit as a model for our vision and will apply this
approach to a variety of therapeutic targets, including CD19, BCMA,
and CEA.”
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to turn
malignant cancers into manageable and possibly curable diseases.
Sorrento's multimodal multipronged approach to fighting cancer is
made possible by its extensive array of immuno-oncology platforms,
including key assets such as fully human antibodies (“G-MAB™
library”), clinical-stage immuno-cellular therapies (“CAR-T”),
antibody-drug conjugates (“ADC”), and clinical-stage oncolytic
virus (“Seprehvir®”).
Sorrento's commitment to life-enhancing therapies for cancer
patients is also demonstrated by our effort to advance a
first-in-class (TRPV1 agonist) non-opioid pain management small
molecule in Resiniferatoxin (“RTX”) and ZTlido®. Resiniferatoxin is
completing a Phase 1b trial in terminal cancer patients. ZTlido was
approved by US FDA on 02/28/18.
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 and its subsidiaries' technologies and product
candidates, including the Company’s anti-CD38 cell therapy and CAR,
CAR-T, DAR-T and KOKI DAR-T programs and drug products, expected
timing for clinical studies and trials and the timing for
submitting an IND. 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'
technologies and prospects, including Sorrento’s anti-CD38 cell
therapy and CAR, CAR-T, DAR-T and KOKI DAR-T programs and drug
products; risks related to seeking regulatory approvals and
conducting clinical trials; 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, 2018, 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, SVP Corporate Development
Telephone: 1.858.203.4120
Email: mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered trademarks of
Sorrento Therapeutics, Inc.
ZTlido® and G-MAB™ are trademarks owned by Scilex
Pharmaceuticals Inc. and Sorrento, respectively.
Seprehvir®, is a registered trademark of Virttu Biologics
Limited, a wholly-owned subsidiary of TNK Therapeutics, Inc. and
part of the group of companies owned by Sorrento Therapeutics,
Inc.
All other trademarks are the property of their respective
owners.
© 2019 Sorrento Therapeutics, Inc. All Rights Reserved.
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