Sorrento Enters Into Binding Term Sheet to Acquire Exclusive Rights to Abivertinib with Completed Registrational Trial Data i...
May 21 2020 - 7:00AM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) and ACEA
Therapeutics, Inc. (“ACEA”) have entered into a binding term sheet
for an exclusive license to ACEA’s Abivertinib across all
indications for all territories outside of China. The final terms
of the license will be set forth in a definitive agreement to be
entered into between the parties.
Abivertinib is a novel small molecule tyrosine kinase inhibitor
(TKI) that selectively targets both mutant forms of the epidermal
growth factor receptor (EGFR) and Bruton’s tyrosine kinase
(BTK).
More than 600 patients have been treated with Abivertinib at
different oral doses up to 300 mg bid in multiple trials through
registration trial (NCT03856697) in patients with non-small cell
lung cancer (NSCLC) and B cell malignancies (Phase 1) conducted in
China. Favorable safety, tolerability and efficacy in patients with
NSCLC or relapsed/refractory B-cell malignancies were demonstrated
in separate studies.
At the American Society of Clinical Oncology (ASCO) meeting in
2019, the results of an interim analysis of 209 response-evaluable
patients (n=227 total) with NSCLC was presented. Of the 209
patients, the investigators determined that 90% (188/209) had tumor
size reduction, with 52% of the patients (109/209) demonstrating a
confirmed partial response, 5% (11/209) of the patients
demonstrating an unconfirmed partial response, 30% of the patients
(64/209) demonstrating stable disease and 12% of the patients
(25/209) demonstrating progressive disease. The progression free
survival (Kaplan-Meier) was 7.5 months at the time. An estimate of
the median overall survival was 25 months at the time of the
presentation with the study still ongoing. All patients (n=227)
experienced at least one adverse event (AE). Grade 3/4 (in
severity) AEs were reported in 46% of the patients (104/227), of
which treatment related grade 3/4 AEs were reported in 30% of the
patients (67/227). None of the grade 5 AEs (4%, 9/227) were deemed
treatment-related. Most treatment-related AEs were grade 1 or 2,
the most common of which were transaminase elevations and diarrhea,
which are generally considered common for TKIs. Other common
treatment-related AEs included anemia, neutropenia and
thrombocytopenia, and all generally considered typical AEs with
long-term use of TKIs. No unexpected AEs were reported.
Promptly following the execution of the definitive license
agreement, Sorrento expects to meet with the FDA to discuss the
data and the path forward to seek approval for oncologic
indications.
About ACEA TherapeuticsACEA Therapeutics is
committed to developing and delivering innovative treatments to
improve the lives of patients with life-threatening diseases. ACEA
has expanded drug discovery efforts to encompass development in
both targeted and immunotherapy areas. Alongside a robust R&D
organization, ACEA has established drug manufacturing and
commercial capabilities in China to support its long-term growth.
This infrastructure provides ACEA greater control over drug supply
chain to make sure products are delivered to patients on-time and
at the highest quality. ACEA is well positioned to deliver on its
promise to bring innovative treatments to patients living with
life-threatening diseases while creating value for shareholders,
employees, and society.
For more information visit www.aceatherapeutics.com
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 (“ADCs”), and clinical stage oncolytic virus
(“Seprehvir®”). Sorrento is also developing potential antiviral
therapies and vaccines against coronaviruses, including COVIDTRAP™,
ACE-MAB™, COVI-MAB™, COVI-GUARD™, COVI-SHIELD™ and
COVI-KILLER™. 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. RTX 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 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 Abivertinib, including the
safety, tolerability and demonstrated efficacy thereof, the
expected entry into a definitive license agreement between the
parties and expected meetings and discussions with the FDA. 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 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
therapeutic product candidates 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.
ContactAlexis Nahama, DVM (SVP
Corporate Development)Email:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.G-MAB™, COVI-MAB™,
COVI-GUARD™, COVI-SHIELD™, COVIDTRAP™, ACE-MAB™, COVI-KILLER™ and
COVI-CELL™ 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.
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