- One vaccine, three routes for activating the entire immune
system and providing T cell, B cell memory, and mucosal
protection
- The first COVID-19 vaccine trials designed to deliver both S
and N SARS-CoV-2 viral proteins via multiple routes—subcutaneous,
sublingual, and oral
- Oral capsule stimulates immunity to both S and N proteins and
could potentially serve as a universal boost to other S-based
(antibody-based) vaccines and reduce transmission
- T-cell vaccine could potentially address escape mutant variants
to S proteins
ImmunityBio, Inc., a privately-held immunotherapy company, and
NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer
cell-based therapeutics company, today announced the first cohorts
of their South Africa and U.S. COVID-19 vaccine trials have
received their initial doses of the company’s T-cell-based COVID-19
vaccine candidate, hAd5. This candidate is unique in targeting both
the spike (S) and nucleocapsid (N) proteins of the SARS-CoV-2
virus. These trials will determine which route combination provides
the strongest immune response and long-term immunity, as well as
the vaccine candidate’s effectiveness against the growing number of
mutated variants of the virus.
In the three trials, the hAd5 vaccine candidate is being
administered in a subcutaneous, oral, or sublingual formulation.
The Phase I trial in Cape Town, South Africa is using subcutaneous
administration and nine participants have been dosed to date. It is
expected to be followed by sublingual delivery and room
temperature-stable oral capsule trials. The two U.S. Phase Ib
trials are studying a combination of subcutaneous/sublingual and
subcutaneous/oral formulations; six participants have been dosed in
each trial to date. In total, 140 participants will be enrolled in
the South African and U.S. trials.
“Current COVID-19 vaccines only target the S protein, the
primary source of virus mutations. These mutations may render
existing vaccines less effective, so we have designed our vaccine
differently and are driving T cells to both S and N. Thus, the
immune system could clear the infected cell rather than merely
block the virus from entering the cell. This novel design could
address the multiple mutations occurring globally today,” said
Patrick Soon-Shiong, M.D., Executive Chairman of ImmunityBio and
NantKwest.
Cape Town, South Africa Trial
The Phase I trial is being conducted at the Wellcome Centre for
Infectious Diseases Research in Africa (CIDRI-Africa) Khayelitsha
Clinical Research Site. Participants will receive two subcutaneous
injections of the vaccine candidate 21 days apart and will be
closely monitored for safety outcomes and immune responses
generated. The evaluation of this novel COVID-19 vaccine, designed
to be formulated in a room-temperature-stable capsule and can be
administered sublingually, is a critical step for South Africa in
the fight against the pandemic. The capsule and sublingual
formulations protocol will be evaluated in a follow-on trial.
U.S. Oral and Sublingual Vaccine Trials
The oral trial is a new study (NCT04732468) and the sublingual
trial is the cohort C expansion to the Phase I subcutaneous trial
(NCT04591717), which was initiated in October 2020. Based on the
findings of these trials, the optimal combination of administration
route and dose will be determined and entered into the Phase II/III
design.
NantKwest Transaction
As previously announced on December 21, 2020, ImmunityBio
entered into an agreement to combine in a stock-for-stock
transaction with NantKwest. The combination, which is expected to
close in the first half of 2021, will create a leading
immunotherapy and cell therapy company focused on oncology and
infectious disease.
About ImmunityBio
ImmunityBio, Inc. is a late-clinical-stage immunotherapy company
developing next-generation therapies that drive immunogenic
mechanisms for defeating cancers and infectious diseases. The
company’s immunotherapy platform activates both the innate (natural
killer cell and macrophage) and adaptive (T cell) immune systems to
create long-term “immunological memory.” This novel approach is
designed to eliminate the need for high-dose chemotherapy, improve
upon the outcomes of current CAR-T-cell therapies, and extend
beyond checkpoint inhibitors.
ImmunityBio’s platform is based on the foundation of three
separate modalities: Antibody cytokine fusion proteins, synthetic
immunomodulators, and second-generation human adenovirus (hAd5)
vaccine technologies.
Anktiva™ (ImmunityBio’s lead cytokine infusion protein) is a
novel interleukin-15 (IL-15) superagonist complex and has received
Breakthrough Therapy and Fast Track Designations from the U.S. Food
and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle
invasive bladder cancer (NMIBC). The company is also in Phase I or
III trials for indications such as first- and second-line lung
cancer, triple-negative breast cancer, metastatic pancreatic
cancer, recurrent glioblastoma, and soft tissue sarcoma in
combination with the company’s synthetic immune modulator
(Aldoxorubicin).
ImmunityBio is also developing therapies, including vaccines,
for the prevention and treatment of HIV, influenza, and the
coronavirus SARS-CoV-2 with its second-generation human adenovirus
(hAd5) vaccine technologies.
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 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 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.
Forward-Looking Statements
This communication contains forward-looking statements relating
to the proposed transaction involving NantKwest, Inc. (“NantKwest”)
and ImmunityBio, Inc. (“ImmunityBio”), including financial
estimates and statements as to the expected timing, completion and
effects of the proposed transaction and statements relating to
NantKwest and ImmunityBio’s future success in improving the
treatment of various diseases and illnesses, including, but not
limited to COVID-19 and cancer. Statements in this communication
that are not statements of historical fact are considered
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended (the “Securities Act”), and
Section 21E of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), which are usually identified by the use of words
such as “anticipates,” “believes,” “continues”, “could”,
“estimates,” “expects,” “intends,” “may,” “plans,” “potential”,
“predicts”, “projects,” “seeks,” “should,” “will,” and variations
of such words or similar expressions. These forward-looking
statements are neither forecasts, promises nor guarantees, and are
based on the current beliefs of NantKwest’s management and
ImmunityBio’s management as well as assumptions made by and
information currently available to NantKwest and ImmunityBio. Such
statements reflect the current views of NantKwest and ImmunityBio
with respect to future events and are subject to known and unknown
risks, including business, regulatory, economic and competitive
risks, uncertainties, contingencies and assumptions about NantKwest
and ImmunityBio, including, without limitation, (i) inability to
complete the proposed transaction because, among other reasons,
conditions to the closing of the proposed transaction may not be
satisfied or waived, (ii) uncertainty as to the timing of
completion of the proposed transaction, (iii) potential adverse
effects or changes to relationships with employees, suppliers or
other parties resulting from the announcement or completion of the
proposed transaction, (iv) the outcome of any legal proceedings
that may be instituted against the parties and others related to
the potential transaction between NantKwest and ImmunityBio, (v)
possible disruptions from the proposed transaction that could harm
NantKwest’s or ImmunityBio’s respective business, including current
plans and operations, (vi) unexpected costs, charges or expenses
resulting from the proposed transaction, (vii) uncertainty of the
expected financial performance of the combined company following
completion of the proposed transaction, including the possibility
that the expected synergies and value creation from the proposed
transaction will not be realized or will not be realized within the
expected time period, (viii) the ability of each of NantKwest or
ImmunityBio to continue its planned preclinical and clinical
development of its respective development programs, and the timing
and success of any such continued preclinical and clinical
development and planned regulatory submissions, (ix) inability to
retain and hire key personnel, and (x) the unknown future impact of
the COVID-19 pandemic delay on certain clinical trial milestones
and/or NantKwest’s or ImmunityBio’s operations or operating
expenses. More details about these and other risks that may impact
NantKwest’s business are described under the heading “Risk Factors”
in NantKwest’s most recent Quarterly Report on Form 10-Q and Annual
Report on Form 10-K filed with the U.S. Securities and Exchange
Commission (“SEC”) and in subsequent filings made by NantKwest with
the SEC, which are available on the SEC’s website at www.sec.gov.
NantKwest and ImmunityBio caution you not to place undue reliance
on any forward-looking statements, which speak only as of the date
hereof. NantKwest and ImmunityBio do not undertake any duty to
update any forward-looking statement or other information in this
communication, except to the extent required by law. No
representation is made as to the safety or effectiveness of these
product candidates for the therapeutic use for which such product
candidates are being studied.
Certain information contained in this communication relates to
or is based on studies, publications, surveys and other data
obtained from third-party sources and NantKwest’s and ImmunityBio’s
own internal estimates and research. While NantKwest and
ImmunityBio believe these third-party sources to be reliable as of
the date of this communication, it has not independently verified,
and makes no representation as to the adequacy, fairness, accuracy
or completeness of, any information obtained from third-party
sources. In addition, all of the market data included in this
communication involves a number of assumptions and limitations, and
there can be no guarantee as to the accuracy or reliability of such
assumptions. Finally, while NantKwest and ImmunityBio each believes
its own internal research is reliable, such research has not
verified by any independent source.
No Offer or Solicitation
This communication is not intended to and does not constitute an
offer to sell or the solicitation of an offer to buy, sell or
solicit any securities or any proxy, vote or approval in any
jurisdiction pursuant to or in connection with the proposed
transaction or otherwise, nor shall there be any sale of securities
in any jurisdiction in which such offer, solicitation or sale would
be unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offer of securities
shall be deemed to be made except by means of a prospectus meeting
the requirements of Section 10 of the Securities Act.
Additional Information and Where to Find It
In connection with the proposed transaction, NantKwest filed
with the SEC a registration statement on Form S-4, which included a
prospectus and joint proxy / solicitation statement of NantKwest
and ImmunityBio (the “solicitation statement/prospectus”). The
registration statement was declared effective on February 1, 2021
and the solicitation statement/prospectus was first mailed to
stockholders of NantKwest on or about February 5, 2021. NantKwest
may also file other documents regarding the proposed transaction
with the SEC. This communication does not constitute an offer to
sell or the solicitation of an offer to buy any securities or a
solicitation of any vote or approval. This communication is not
intended to be, and is not, a substitute for such filings or for
any other document that NantKwest may file with the SEC in
connection with the proposed transaction. BEFORE MAKING ANY VOTING
OR INVESTMENT DECISION, INVESTORS AND SECURITY HOLDERS ARE URGED TO
CAREFULLY READ THE ENTIRE REGISTRATION STATEMENT AND SOLICITATION
STATEMENT / PROSPECTUS, AND ANY OTHER RELEVANT DOCUMENTS FILED WITH
THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE
DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR
WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION.
Investors and security holders are able to obtain free copies of
the registration statement and solicitation statement/prospectus
and other documents once they are filed with the SEC by NantKwest
through the website maintained by the SEC at www.sec.gov. In
addition, investors and security holders are able to obtain free
copies of the prospectus and other documents filed with the SEC on
NantKwest’s website at www.ir.nantkwest.com.
Participants in the Solicitation
NantKwest and certain of its respective directors and executive
officers may be deemed to be participants in the solicitation of
proxies from stockholders of NantKwest in connection with the
proposed transaction under the rules of the SEC. Investors may
obtain information regarding the names, affiliations and interests
of directors and executive officers of NantKwest in NantKwest’s
proxy statement for its 2020 annual meeting of stockholders, which
was filed with the SEC on April 24, 2020, as well as its other
filings with the SEC. Other information regarding the participants
in the proxy solicitation and a description of their direct and
indirect interests, by security holdings or otherwise, are included
in the registration statement, solicitation statement / prospectus
and other relevant materials to be filed with the SEC by NantKwest
regarding the proposed transaction (if and when they become
available). You may obtain free copies of these documents at the
SEC’s website at www.sec.gov. Copies of documents filed with the
SEC will also be available free of charge from NantKwest using the
sources indicated above.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210308005285/en/
Investors Sarah Singleton NantKwest, Inc. 844-696-5235,
Option 5
Media Amy Jobe, Ph.D. LifeSci Communications 315-879-8192
ajobe@lifescicomms.com
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