Sorrento Announces FDA Authorization to Proceed With Phase 2 Study of Abivertinib (Fujovee™) to Treat Metastatic Castrate Resistant Prostate Cancer (MAVERICK Trial)
17 May 2022 - 11:00PM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced that it has received clearance from the FDA for its
investigational new drug application (IND) for Abivertinib
(Fujovee™) for the Phase 2 MAVERICK study to be conducted in
participants with metastatic castrate resistant prostate cancer
(mCRPC) at multiple centers in the United States. The MAVERICK
study will be conducted in a partnership with the Prostate Cancer
Clinical Trials Consortium and will enroll participants with both
abiraterone-naïve and abiraterone-progressing mCRPC. The MAVERICK
trial will be conducted as an open-label study of Abivertinib with
abiraterone in up to 100 participants harboring the
adrenal-permissive HSD3β1 allele (heterozygous or homozygous). The
primary objective of the study is to evaluate the efficacy of
Abivertinib with abiraterone via an assessment of 6-month
radiographic progression-free survival (rPFS) and the primary
endpoint is the 6-month rPFS defined as a percent of subjects alive
and without progression by Response Evaluation Criteria in Solid
Tumors (RECIST) version 1.1 for measurable disease and Prostate
Cancer Working Group 3 (PCWG3) criteria for bone metastases.
Participants will remain on treatment until radiographic
progression, unacceptable toxicity, intercurrent illness or other
reasons (such as subject withdrawal).
Extragonadal androgen production requires the
activity of 3β-hydroxysteroid dehydrogenase isoenzyme-1 (3β-HSD1)
encoded by the HSD3β1 allele and an identified single nucleotide
polymorphism (SNP) can create an adrenal-permissive phenotype that
allows for more rapid development of mCRPC resulting in earlier
castration resistance and shortened overall survival. Increased BTK
expression has been observed in various solid tumors, including
prostate cancer, and it is believed that the interplay between BTK
inhibition and 3βHSD is responsible. BTK inhibition has been shown
to inhibit androgen production, particularly from extragonadal
precursor steroids, in preclinical models. In addition to
selectively targeting both mutant forms of EGFR (T790M and exon 19
and 21 mutations), Abivertinib irreversibly binds to the BTK
receptor, preventing phosphorylation of the receptor.
Abivertinib is an oral capsule taken twice daily and has been well
tolerated across multiple cancer types in doses up to 300 mg twice
daily.
The global market for CRPC for 2021 was $2.7
billion, with the U.S. accounting for 67% ($1.83 billion), and a
CAGR of 4.15%, projected to reach $4.56 billion, with the U.S.
projected to account for 68% ($3.08 billion) by 2031(1).
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 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 Abivertinib (Fujovee™); the therapeutic and clinical
potential of Abivertinib; the potential safety and efficacy of
Abivertinib, including Abivertinib’s potential efficacy against
castrate resistant prostate cancer (CRPC); the global market for
CRPC in 2021 and the amount accounted for in the U.S., the
projected CAGR for the CRPC global market and the amount of the
CRPC global market that the U.S. will account for by 2031; the
expected number of participants in the Phase 2 MAVERICK study and
the expected time that trial participants will remain on study.
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
Abivertinib; 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
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™, 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.
References
(1) Datamonitor
and Sorrento Internal Research.
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