NantKwest Announces FDA Authorization of IND Application for Mesenchymal Stem Cell Product for the Treatment of Severe COVID-...
18 5월 2020 - 9:30PM
Business Wire
- Preliminary data from NantKwest collaborators suggests
mesenchymal stem cell treatments may benefit COVID-19 patients with
acute respiratory distress syndrome and cytokine storm
- Trial anticipated to initiate in Los Angeles area hospitals
in Q2
- Proprietary automated “GMP-in-a-Box”, an in-house
manufacturing apparatus, enables rapidly scalable, off-the-shelf
allogeneic mesenchymal stem cell product BM-Allo.MSC
NantKwest, Inc. (NASDAQ: NK) today announced it has received
authorization from the U.S. Food and Drug Administration (FDA) for
an Investigational New Drug application to treat patients with
acute respiratory distress syndrome (ARDS) caused by COVID-19 with
BM-Allo.MSC, an allogeneic mesenchymal stem cell (MSC) product
derived from human bone marrow. NantKwest has entered into an
agreement with the National Marrow Donor Program (Be the Match) to
provide donor material and has developed automated proprietary
methods to expand and generate multiple dose forms utilizing a
modular, closed system (GMP-in-a-box) from NantKwest affiliate
ImmunityBio, Inc., to expand BM-Allo.MSCs, enabling the scalable
manufacture and immediate distribution of cryopreserved BM-Allo.MSC
product.
“There is an urgent need to develop broadly accessible treatment
options for the devastating outcomes seen in the thousands of
COVID-19 patients who are facing severe disease with ARDS and
‘cytopathic storm’,” said Patrick Soon-Shiong, M.D., Chairman and
Chief Executive Officer of NantKwest and ImmunityBio. “While
MSC-derived treatments have shown promise in treating patients with
ARDS, including those with COVID-19, the ability to scale
production to support the overwhelming patient need has been a
challenge. Our proprietary GMP-in-a-Box enables the rapid and
scalable manufacture of our fully human BM-Allo.MSC product,
overcoming this previous limitation to advance a promising new
treatment to those patients who are most in need. Due to our
proprietary methods, we are well positioned to rapidly advance
BM-Allo.MSC during the current wave of COVID-19, with an
anticipated trial initiation in Q2.”
BM-Allo.MSC is a bone marrow-derived allogenic MSC product being
developed to attenuate the inflammatory processes that drive ARDS
in severe COVID-19 patients. MSCs are multipotent progenitor cells
that give rise to cell types responsible for tissue repair and may
restore effective immune function and contribute to viral
clearance. Prior work with allogeneic MSC products in patients with
ARDS has shown that such treatment is safe and may reduce key
markers of inflammatory processes.
Trial Design
The Phase 1b, randomized, double-blind, placebo-controlled study
will evaluate the safety and efficacy of BM-Allo.MSC versus current
supporting care in treating patients with severe disease and
requiring ventilator support (IND 019735). The therapeutic will be
administered to a total of 45 patients receiving care in the
critical care or ICU setting. The primary objectives of the study
include overall safety and reduction in time on ventilator. The
secondary objective will focus on the efficacy of BM-Allo.MSC in
reducing the number of days patients require oxygen, duration of
hospitalization, and mortality.
About NantKwest
NantKwest (NASDAQ: NK) is an innovative, clinical-stage
immunotherapy company focused on harnessing the power of the innate
immune system to treat cancer and virally-induced infectious
diseases. NantKwest is the leading producer of clinical dose forms
of off-the-shelf natural killer (NK) cell therapies. The activated
NK cell platform is designed to destroy cancer and virally-infected
cells. The safety of these optimized activated NK cells—as well as
their activity against a broad range of cancers—has been tested in
Phase I clinical trials in Canada and Europe, as well as in
multiple Phase I and II clinical trials in the United States. By
leveraging an integrated and extensive genomics and transcriptomics
discovery and development engine, together with a pipeline of
multiple, clinical-stage, immuno-oncology programs, NantKwest’s
goal is to transform medicine by delivering off-the-shelf living
drugs-in-a-bag and bringing novel NK cell-based therapies to
routine clinical care. NantKwest is a member of the NantWorks
ecosystem of companies. For more information, please visit
www.nantkwest.com
haNK is a registered trademark of NantKwest, Inc.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements include statements concerning or
implying that NantKwest will be successful in improving the
treatment of cancer and/or Covid-19. Risks and uncertainties
related to this endeavor include, but are not limited to, obtaining
FDA approval of NantKwest’s NK cells, as well as other
therapeutics, as part of the NANT Cancer Vaccine platform as a
cancer treatment and/or Covid-19 treatment.
Forward-looking statements are based on management’s current
expectations and are subject to various risks and uncertainties
that could cause actual results to differ materially and adversely
from those expressed or implied by such forward-looking statements.
Accordingly, these forward-looking statements do not constitute
guarantees of future performance, and you are cautioned not to
place undue reliance on these forward-looking statements.
These and other risks regarding NantKwest’s business are
described in detail in its Securities and Exchange Commission
filings, including in NantKwest’s Quarterly Report on Form 10-Q for
the Quarter ended March 31, 2020. These forward-looking statements
speak only as of the date hereof, and we disclaim any obligation to
update these statements except as may be required by law.
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Jen Hodson Jen@nant.com 562-397-3639
NantKwest (NASDAQ:NK)
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