Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced that the FDA has cleared Sorrento’s internally developed
anti-CD47 monoclonal antibody, STI-6643, which was discovered from
Sorrento's G-MAB™ library, for an initial clinical trial. The
initial clinical trial will be a basket trial entitled “A Phase 1B,
Open-Label, Dose-Escalation Study of the Safety and Efficacy of
STI-6643, an Anti-CD47 Human Monoclonal Antibody, in Patients with
Selected Relapsed or Refractory Malignancies.”
Cluster of differentiation 47 (also known as integrin-associated
protein) (“CD47”) is a ubiquitously-expressed glycoprotein of the
immunoglobulin superfamily that plays a critical role in
self-recognition. Various solid and hematologic cancers exploit
CD47 expression to evade immunological eradication, and its
overexpression is clinically correlated with poor prognoses. One
essential mechanism behind CD47-mediated immune evasion is that it
can interact with signal regulatory protein-alpha (SIRPα) expressed
on myeloid cells, causing phosphorylation of the SIRPα cytoplasmic
immunoreceptor tyrosine-based inhibition motifs and recruitment of
Src homology 2 domain-containing tyrosine phosphatases to
ultimately result in delivering an anti-phagocytic “don’t eat me”
signal. Given its essential role as a negative checkpoint for
innate immunity and subsequent adaptive immunity, the CD47/SIRPα
axis has been explored as a new target for cancer immunotherapy and
its disruption has demonstrated great therapeutic promise.
In preclinical evaluations, STI-6643 displayed decreased red
blood cell binding and hemolysis, while maintaining potent
anti-tumor activity in solid tumor disease models. Clinical trials
with anti-CD47 mAbs have historically experienced limitations due
to significant anemia, hemagglutination, and thrombocytopenia due
to CD47 expression on normal red blood cells, ultimately requiring
employment of complicated clinical dosing regimens. These issues
have not been seen to date with STI-6643 in preclinical studies
conducted head-to-head against synthesized versions of other CD47
mAbs. Additionally, STI-6643 showed minimal T, B or NK cell
depletion as opposed to other synthesized mAb clones, which could
potentially result in improved efficacy by preserving infiltrating
anti-tumor immune cells. STI-6643 has the potential to be a
“best-in-class” product if these preclinical benefits are able to
be reproduced in human trials. Sorrento is also conducting
preclinical studies to compare the safety and efficacy of lymphatic
delivery of STI-6643 to established parenteral routes of
administration using Sorrento’s Sofusa™ technology. This study will
be conducted at the Moffitt Cancer Center in Tampa, FL with Dr.
David A. Sallman as the coordinating lead investigator.
STI-6643 is the second anti-CD47 antibody that has been
developed from the G-MAB library. The other anti-CD47 antibody
(IMC-002) discovered from the G-MAB library was previously cleared
by the FDA, and is currently in Phase 1 human studies sponsored by
ImmuneOncia Therapeutics, LLC, a joint venture company between
Sorrento (35% ownership) and Yuhan Corporation.
Regarding the recent clearance for a clinical trial for STI-6643
by the FDA, Dr. Henry Ji, Chairman and CEO of Sorrento, commented,
“We have seen great performance from STI-6643 in our IND-enabling
studies. Our internal anti-CD47 program has now yielded two
clinical candidates, a signal of our continued commitment to the
development of innovative, safe and efficacious cancer treatments
in addition to our commitment to fighting COVID-19.”
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 initiation of a phase
1B basket trial for STI-6643; the therapeutic efficacy of targeting
the CD47/SIRPα axis for cancer immunotherapy; the potential
therapeutic benefits of STI-6643; the potential for pre-clinical
data and results to be replicated in future clinical trials; the
safety and efficacy of STI-6643; the potential for the safety and
efficacy of STI-6643 to be replicated in future clinical trials;
the potential for clinical trials with STI-6643 to not experience
limitations that other anti-CD47 mAbs clinical trials have
experienced, including anemia, hemagglutination, thrombocytopenia
and complicated dosing regimens; the potential for STI-6643 to be a
“best-in-class” product; regulatory approvals of STI-6643; and the
completion of clinical trials of STI-6643. 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 studies and
seeking regulatory approval for STI-6643, including the timing for
receipt of any such approval; conducting and receiving results of
clinical trials; 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 the company in the execution of its cancer, anti-tumor
and G-MAB antibody therapeutic product candidates 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.
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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