Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced it has been working on a novel decoy cellular vaccine for
COVID-19 (STI-6991) and is in active discussions with the FDA’s
Center for Biologics Evaluation and Research under IND#019724
regarding the required IND-enabling studies, CMC (chemistry,
manufacturing and controls), clinical protocol and end-points for
potential accelerated approval. Upon receiving guidance from the
FDA, Sorrento intends to submit a full package for an IND filing
that would enable human clinical trials to start as soon as
possible.
The decoy cell strategy (I-Cell™, which means
immune-training cells) has been conceptualized and developed by
Sorrento scientists utilizing expertise acquired in the fight
against cancer. Sorrento expects to utilize a well-known
replicating cell line (human erythroleukemia, K562) to incorporate
SARS-CoV-2’s spike protein or its S1 domain onto the cellular
membrane so that the viral antigen is presented on a decoy cell
surface to elicit both T cell and B cell immunities. The selected
cell line has been used safely in cancer vaccination programs and
is well characterized (clinical trials using K562 expressing
granulocyte-macrophage colony-stimulating factor have been used as
a tumor vaccine). Upon expression of the viral protein as a surface
marker, the decoy cell “looks like” the virus to a healthy person’s
immune system. After irradiation to prevent the replication of the
cells, the cells can be administered by intramuscular injection as
a vaccine. In the presence of this “look alike” training cell, the
recipient may develop a protective immune response and produce
corresponding neutralizing antibodies against the SARS-CoV-2 virus.
If the vaccinated subject is later exposed to the SARS-CoV-2
coronavirus, his or her T cell immunity and neutralizing antibodies
are expected to block the spike protein from attaching to the ACE2
(angiotensin converting enzyme 2) on the normal human cell surface,
thus potentially attenuating or preventing the SARS-CoV-2 infection
which causes COVID-19 disease.
A short communication explaining this
vaccination approach was accepted for publication by Medicine in
Drug Discovery (an Elsevier peer reviewed open access journal. The
article can be found at
https://www.sciencedirect.com/science/article/pii/S2590098620300130?via%3Dihub).
Per the publication, “the overall strategy to utilize a viral
antigen-expressing, non-replicating cellular system as both a
carrier, and as an immunogenic antigen-presenting platform is
novel. The view is that this platform will be recognized by the
immune system, and a neutralizing antibody response will ensue. The
most important aspect of the platform is that it should allow for
dendritic cells to recruit T lymphocytes and induce Th1 cell
polarization that if feasible will also induce a cytotoxic T cell
response and thus clearance of SARS-CoV-2 virus. The strategy
should be safe as they are using K562 cell line that is HLA
negative. The platform appears to be readily scalable and would
appear to provide uniform cell product. One key aspect is that will
the vaccine prevent engraftment and proliferation after host
implantation; the answer here appears to be yes as the cells will
be irradiated post-expansion in order to abolish their replication
ability and thus no in vivo cell growth. In sum an intriguing
platform is put forth and if viable as it appears to be it could
make an impact on the treatment of COVID-19.”1
Sorrento is currently working to demonstrate
I-Cells’ ability to generate protective T cell and B cell
immunities in an animal model. Sorrento has identified a leading
infectious disease contract research organization to support the
phase 1 clinical trial and accelerated timelines. Sorrento has
begun process development, validation and scaled up manufacturing
testing in its state-of-the-art cGMP cell therapy facilities in San
Diego in anticipation of registrational clinical trials and
commercialization.
Sorrento anticipates all IND requirements will
be fulfilled in the next few months. Depending on government
support and the FDA’s response, Sorrento believes it may be in a
position to initiate human vaccination trials as early as mid-year
2020.
David Epstein, former CEO of Novartis
Pharmaceuticals, a division of Novartis AG, who has been advising
Sorrento, said, “This promising vaccination strategy is uniquely
suited for rapid scale up and advancement into the clinic. I
am hopeful because this novel approach can make a difference in the
lives of so many.”
“We have developed a novel approach to
vaccination that we believe can be a breakthrough in the fight
against COVID-19. We believe using a human cell as a training agent
is unique and likely to be effective for vaccination,” stated Dr
Henry Ji, Chairman and CEO of Sorrento Therapeutics. “By utilizing
an existing cell line that has previously been used to make cancer
vaccines, we know we have a product candidate with a promising
safety profile. We are very confident that, if our product
candidate is approved, we will have the required capacity in place
to produce enough doses to protect millions of people in the near
term. Confirming that I-Cell works in humans is our top priority
and our most immediate focus.”
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 immuno-oncology platforms, including
key assets such as fully human antibodies (“G-MAB™ library”),
clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T”),
intracellular targeting antibodies (“iTAbs”), antibody-drug
conjugates (“ADC”), and clinical stage oncolytic virus
(“Seprehvir®”). Sorrento is also developing potential coronavirus
antiviral therapies, including COVIDTRAP™, ACE-MABTM and
I-CellTM.
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.
Resiniferatoxin 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 expected timing for commencing and completing
registrational studies and for submitting an IND application for
I-CellTM STI-6991 as a vaccine for the SARS-CoV-2 virus; the
therapeutic potential of I-CellTM STI-6991 as a vaccine for
SARS-CoV-2 and COVID-19 disease; I-CellTM STI-6991’s ability to
elicit T cell and B cell immunities against SARS-CoV-2; the ability
of a contract research organization to support the clinical trial
(Phase 1) of I-CellTM STI-6991; the expected timing of a clinical
trial (Phase 1) of I-CellTM STI-6991; the expected timing of
completion of all IND requirements I-CellTM STI-6991; the expected
timing for commencing and completing human vaccination trials of
I-CellTM STI-6991; regulatory approvals of I-CellTM STI-6991; the
development and commercialization of I-CellTM STI-6991 for
SARS-CoV-2 virus and COVID-19; the readiness of Sorrento’s cGMP
facilities for large-scale production of I-CellTM STI-6991 for
commercialization and Sorrento’s expected capacity to produce drug
substance; the expected time needed for Sorrento’s cGMP facilities
to produce doses of I-CellTM STI-6991; the safety and efficacy of
I-CellTM STI-6991; and Sorrento’s potential position in the vaccine
industry. 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 conducting
pre-clinical trials and seeking IND regulatory approval for
I-CellTM STI-6991; conducting and receiving results of clinical
trials for I-CellTM STI-6991; the clinical and commercial success
of a vaccine against SARS-CoV-2 virus infections using I-CellTM
STI-6991; the viability and success of using I-CellTM STI-6991 in
anti-viral therapeutic areas, including coronaviruses; 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 of
manufacturing and supplying drug product; risks related to
leveraging the expertise of its employees, subsidiaries, affiliates
and partners to assist the company in the execution of its I-CellTM
STI-6991 vaccine strategies; risks related to Sorrento’s debt
obligations; 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: 1.858.203.4120
Email: mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered trademarks of
Sorrento Therapeutics, Inc.G-MAB™, COVIDTRAP™, ACE-MABTM and
I-CellTM are trademarks of Sorrento Therapeutics, Inc.ZTlido® is a
trademark owned by Scilex Pharmaceuticals Inc.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. © 2020
Sorrento Therapeutics, Inc. All Rights Reserved.
_____________________
1https://doi.org/10.1016/j.medidd.2020.100026
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