Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) is
pleased to announce the results of a Phase II NK/T-cell lymphoma
study of IMC-001, a PD-L1 monoclonal antibody licensed to
ImmuneOncia Therapeutics, LLC (“ImmuneOncia”) (Seongnam, South
Korea). ImmuneOncia is a biotechnology company specializing in
immuno-oncology drug development, jointly established by Yuhan
Corporation of Korea and Sorrento. In addition to IMC-001,
ImmuneOncia has a wide range of new products in the pipeline, such
as IMC-002, a CD47 antibody, and IMC-201, a bispecific antibody.
The Phase II NK/T-cell lymphoma study was selected for an oral
presentation at the Asian Congress of the European Society for
Medical Oncology (ESMO Asia 2022) in Singapore on December
4th, 2022. The clinical data demonstrated that in patients with
heavily treated NK/T-cell lymphoma, 6 of 10 evaluable patients
(60%) not only achieved an objective response, but all 6 patients
with an objective response also achieved a complete remission with
IMC-001. Additionally, 4 of these 6 patients stayed on treatment
for over a year, which provides encouraging indication of long-term
IMC-001 treatment safety and durable efficacy.
NK/T-cell lymphoma is a rare cancer that is most prevalent in
Asian countries, including China and Korea, and is typically
treated with a regimen of radiation and chemotherapy. NK/T-cell
lymphoma has a high recurrence rate of 75% within two years. Due to
the absence of standard-of-care treatment for relapsed/refractory
cases, NK/T lymphoma represents a high unmet medical need and
significant market opportunity. To date, no single immuno-oncology
drug has obtained approval in this indication.
Professor Won Seog Kim of Samsung Medical Center, the presenter
and Principal Investigator of the IMC-001 study, commented, “The
complete remission and response rate of 60% of IMC-001
significantly outperformed currently available drugs for the
treatment, and very rare adverse events of grade 3 or higher also
limit concerns over the side effects, making it a leader among
PD-L1 drugs. We expect these results to satisfy the criteria for
approval.”
Heung Tae Kim, Chief Executive Officer of ImmuneOncia said,
“This achievement sets a new standard for the second-line treatment
of NK/T-cell lymphoma, which has high unmet needs. ImmuneOncia is
preparing additional clinical trials to expand its indications in
solid cancer.”
Henry Ji, Ph.D., Chief Executive Officer of Sorrento commented,
“We expect to leverage these data to create momentum to secure
additional partnership and co-development opportunities for IMC-001
in regions with a high incidence of NK/T-cell lymphoma, such as
China, as well as in other indications.”
IMC-001 is a PD-L1 antibody, a fully human immune checkpoint
inhibitor, that serves as the basis of the current immuno-oncology
market. This antibody activates the anticancer functions of T cells
by strongly inhibiting the binding between PD-1 expressed on T
cells and PD-L1 expressed on the surface of cancer cells. Moreover,
it can mediate ADCC (antibody-dependent cellular cytotoxicity)
against tumor cells, as it maintains the Fc effector function using
human IgG1.
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 next-generation tyrosine kinase inhibitors (“TKIs”),
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 STI-1558, COVISHIELD™ and COVIDROPS™, 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 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 the development of and prospects of IMC-001 (PD-L1
antibody); the potential for IMC-001 to become a leader among PD-L1
drugs; the expectation of Phase II results to satisfy criteria for
approval; potential side effects, tolerability, long-term toxicity,
safety and durability of response of IMC-001; ImmuneOncia’s plans
for additional clinical trials and plans for any future partnership
and co-development opportunities for IMC-001, including in other
regions or indications. 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
of IMC-001 and seeking regulatory approval for IMC-001; clinical
development risks, including risks in the progress, timing, cost,
and results of clinical trials and product development programs;
risks 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, including those for IMC-001
and any topline or preliminary 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 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.
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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