Sorrento Receives US FDA Clearance to Proceed With Phase 1 Clinical Trials for STI-2020 (COVI-AMG) in Healthy Volunteers and ...
December 09 2020 - 9:00AM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”)
announced today FDA acceptance of its Investigational New Drug
(IND) application for its Phase 1 clinical trials for intravenous
(IV) STI-2020 (COVI-AMG). The trials will evaluate the safety,
pharmacokinetics and efficacy of a single injection of STI-2020 in
healthy volunteers and outpatient COVID-19 patients with mild
symptoms.
Sorrento previously announced that STI-2020
demonstrated a complete neutralizing effect at a very low dose in
preclinical studies and high potency that may potentially enable
rapid deployment and availability to patients. Sorrento has
initiated cGMP manufacturing to produce up to 100,000 doses in
anticipation of a potential EUA.
The FDA has been requesting that IND sponsors
evaluate SARS-CoV-2 neutralizing antibodies in development for
activity against antibody drug-resistant SARS-CoV-2 variants,
including the E484K, F490S, Q493R and S494P mutations. Sorrento has
evaluated the binding activity of STI-2020 against all of these
variants in preclinical studies and the binding affinity of
STI-2020 against each of the variants is similar to or better than
that observed for wild-type SARS-CoV-2. In addition, STI-2020
demonstrated similarly strong binding affinities to the currently
dominant D614G variant and the mink-associated N439K variant as
compared to that for wild-type SARS-CoV-2.
To expedite development toward a potential EUA
submission, Sorrento is planning on initiating dosing in a healthy
population. “Since COVI-AMG comes in a small volume IV-push
formulation, made possible by the high potency of this unique
antibody, we expect trials to enroll very quickly. This combination
potentially makes STI-2020 an ideal candidate for the early
treatment of SARS-CoV-2 infection in an outpatient setting,” stated
Mike Royal, MD, Chief Medical Officer of Sorrento.
More information about the Phase 1 clinical
trials can be found at www.clinicaltrials.gov (NCT#:
NCT04584697).
About Sorrento Therapeutics,
Inc.
Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to treat
cancers. 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 COVI-GUARD™, COVI-AMG™, COVI-SHIELD™, Gene-MAb™,
COVI-MSC™ and COVI-DROPS™; and diagnostic test solutions, including
COVI-TRACK™, COVI-STIX™ and COVI-TRACE™.
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 StatementsThis
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 potency and potential neutralizing profile of STI-2020 and the
impact on SARS-CoV-2; the preclinical and clinical testing of
STI-2020; the safety, pharmacokinetics and efficacy of STI-2020;
the expected speed and timing for enrolling patients in the phase 1
trials; the expectation of the commencement of any pivotal trials
for STI-2020; the expected timing of any EUA submission; the
potential receipt of an EUA for STI-2020 and expected timing for
any receipt thereof; the expected availability of doses of STI-2020
and the timing thereof; the predictive value of the animal model
used in preclinical studies; the potential potency of STI-2020; the
binding affinity of STI-2020 against antibody drug-resistant
SARS-CoV-2 variants; the expected effective dose of STI-2020 in
humans; the potentially faster manufacturing speed, availability
and/or potential lower cost for STI-2020; the potential for rapid
scaling up of manufacturing operations for STI-2020; the potential
for STI-2020 to be used as an early treatment of SARS-CoV-2
infection in an outpatient setting; and Sorrento's potential
position in the antiviral 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 and receiving results of clinical
trials for STI-2020; the clinical and commercial success of
STI-2020 against preventing and treating SARS-CoV-2 virus
infections; the viability and success of STI-2020 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 that prior
test 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 COVID-19
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,
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.
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™, COVI-GUARD™,
COVI-AMG™, COVI-SHIELD™, Gene-MAb™, COVI-DROPS™, COVI-MSC™,
COVI-TRACK™, COVI-TRACE™ and COVI-STIX™ 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.©2020 Sorrento Therapeutics, Inc. All
Rights Reserved.
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