Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. and Levena Biopharma, a Sorrento Company, are to Present Positive Clinical Progress of A166, an Anti-HER2 ADC, in Treating Locally Advanced or Metastatic HER2-Positive Breast Cancer Patients at the ASCO 202
June 01 2022 - 9:00AM
Sichuan Kelun-Biotech Biopharmaceutical Co,
Ltd. ("Kelun-Biotech") and Levena Biopharma (“Levena”), a
subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE,
“Sorrento”), today announced the planned presentation of A166 data
(Abstract #1037 and Poster #415) in patients with HER2-expressing
locally advanced or metastatic solid tumors at the 2022 Annual
Meeting of ASCO, the American Society of Clinical Oncology, to be
held on June 3-7 in Chicago, IL. A166 is a HER2 antibody-drug
conjugate (ADC) developed by Kelun-Biotech in a partnership with
Levena Biopharma, which provided the patent-protected technologies
for the generation and production of A166 in relation to (1)
Duostatin-5, a proprietary tubulin inhibitor, (2) K-Lock, a
site-specific conjugation technology, and (3) an enzymatically
cleavable linker.
As previously reported, in Phase 1 of the study,
A166 demonstrated a safety profile that compared favorably to its
commercial competitors and potentially superior efficacy as shown
by the overall response rate (ORR) of 59.1% and 71.4% in the 4.8
mg/kg cohort and 6.0 mg/kg cohort, respectively, in heavily
pretreated patients with HER2-positive breast cancer (data
presented at the 2021 ASCO meeting [NCT05311397; J Clin Oncol 39,
2021 (suppl 15; abstr 1024)].
At the upcoming 2022 ASCO meeting, Kelun-Biotech
will report updated data from this Phase 1 trial (Abstract #1037
and Poster #415). The Phase 1 dose expansion of the study was
conducted in several sites in China and enrolled a total of 58
female patients (n=23 at 4.8 mg/kg and n=35 at 6.0 mg/kg) treated
with A166 in 3-week cycles.
- The best ORR was 73.9% (17/23; 95%
CI, 51.59 to 89.77) in the 4.8 mg/kg cohort and 68.6% (24/35; 95%
CI, 50.71 to 83.15) in the 6.0 mg/kg cohort.
- Median progression free survival
(PFS) was 12.3 months (95% CI, 6.00-not reached) in the 4.8 mg/kg
cohort and 9.4 months (95% CI, 4.00 to 10.40) in the 6.0 mg/kg
cohort.
- Of 23 patients treated in the 4.8
mg/kg cohort, one had a confirmed and sustained CR lasting 7+
months.
- Next generation sequencing was
performed on tissue-derived DNA and blood-derived circulating tumor
DNA.
- The detailed safety data, RECIST
1.1 response rate, and biomarker analyses will be presented in a
poster (#415) at the 2022 ASCO meeting.
About Sichuan Kelun-Biotech Biopharmaceuticals, Co.
Ltd.Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. is a
subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd., founded in
2016. Kelun-biotech is committed to developing, and commercializing
innovative drugs for the treatment of cancer, autoimmune and other
diseases with unmet medical needs.
Kelun-Biotech has developed a fully integrated
multi-functional platform which includes R&D, CMC (Chemistry,
Manufacturing, and Controls), and clinical development
capabilities. Leveraging the platform, the company has built a
robust pipeline, 1 I/O monoclonal antibody asset in NMPA NDA stage,
3 assets (including 1 monoclonal antibody and 2 ADCs) in Phase 3 or
pivotal clinical trials, and an additional 10 molecules in clinical
studies. For more information, please contact: China:
klbio_bd@kelun.com, US: bd@kluspharma.com
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 postherpetic 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 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 A166, an anti-HER2 ADC; the
therapeutic and clinical potential of A166; the potential safety
and efficacy of A166, including A166’s potential efficacy against
HER2-positive breast cancer; and the potential advantages of A166
over its competitors. 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 safety and efficacy
for A166; 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 continuing or 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 and subsequent Quarterly Report 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
RelationsContact: 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™, COVIMARK™ and Fujovee™ are
trademarks of Sorrento Therapeutics, Inc.
SEMDEXA™ (SP-102) is a trademark of Semnur
Pharmaceuticals, Inc. A proprietary name review by the FDA is
planned.
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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