Levena Biopharma, A Sorrento Company, Announces Positive Clinical Data for Its Out-Licensed A166 Product Candidate, A Third-Generation Anti-HER2-ADC, In Treating Heavily Pretreated HER2-Positive Breast Cancer Patients
May 03 2022 - 9:15AM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced that its license and development partner, Sichuan
Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun”), presented
at this year’s Chinese Society of Clinical
Oncology (CSCO) Guideline Conference (April 23-24, 2022) Phase
1 data for its anti-HER2-ADC, A166. To generate this site-specific
third generation ADC, Kelun partnered with Levena Biopharma, a
Sorrento company, which provided the proprietary ADC technologies
for the generation and production of A166, including (1) a
proprietary small molecule toxin, Duostatin-5, a tubulin inhibitor,
(2) K-Lock, a site-specific conjugation chemistry and (3) an
enzymatically cleavable linker. Compared to Kadcyla®, the first
Antibody-Drug Conjugate approved for the treatment of HER2-positive
metastatic breast cancer, A166 demonstrated potentially better
efficacy, as shown in the overall response rate (ORR) of 73.9% with
A166 at 4.8mg/kg versus Kadcyla®, which had an ORR of 31.3%, as
well as the progression-free survival (PFS) of 12.3 months with
A166 versus 6 months with Kadcyla®.
About Sorrento Therapeutics,
Inc.
Sorrento is a clinical and commercial stage
biopharmaceutical company developing new therapies to treat cancer,
pain (non-opioid treatments), autoimmune disease 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”),
immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates
(“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also
developing potential antiviral therapies and vaccines against
coronaviruses, including Abivertinib, COVISHIELD™ and COVI-MSC™;
and diagnostic test solutions, including COVIMARK™.
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 (PHN). RTX has
been cleared for a Phase II trial for intractable pain associated
with cancer and a Phase II trial in osteoarthritis patients.
Positive final results from the Phase III Pivotal Trial C.L.E.A.R.
Program for SEMDEXA™, its novel, non-opioid product for the
treatment of lumbosacral radicular pain (sciatica), were announced
in March 2022. 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 A166 (Anti-HER@-ADC); the therapeutic and clinical
potential of A166, including its antitumor activity; the potential
safety and efficacy of A166 and the clinical testing of A166. 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 clinical development risks for
A166, 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 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, 2021 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: Brian CooleyEmail:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, Seprehvec™, SOFUSA™,
COVISHIELD™, COVIDROPS™, COVI-MSC™, and COVIMARK™ 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.
©2022 Sorrento Therapeutics, Inc. All Rights
Reserved.
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