- FDA authorized the expansion of the active Phase 1 COVID-19
vaccine trial and a second trial to test a novel combination of
T-cell-based hAd5 subcutaneous prime vaccine with a
room-temperature oral or sublingual boost, to induce comprehensive
immune protection through CD4+ and CD8+ T cells to both Spike (S)
and Nucleocapsid (N) antigens, as well as generate systemic and
mucosal antibodies
- The first COVID-19 trials conducted to deliver both S and N
proteins via multiple routes (skin, gut, or under the tongue) to
activate the entire immune system and drive T-cell and B-cell
memory, which are required for long-term immune protection
- Oral, room-temperature boost that stimulates immunity to both S
and N proteins could potentially serve as a universal boost to
other S-based vaccines while also targeting escape mutants
- Testing of novel combination of oral boost to subcutaneous
prime is based on positive NIH/BARDA-sponsored non-human primate
data showing potent T-cell and antibody response to hAd5 after oral
boost, with rapid inhibition of virus replication to undetectable
levels following SARS-CoV-2 challenge
ImmunityBio, Inc., a privately-held immunotherapy company, and
NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer
cell-based therapeutics company, today announced they have received
FDA authorization to expand Phase I testing of a bivalent hAd5
T-cell COVID-19 vaccine. The FDA authorized the expansion of a
currently active multi-cohort trial of the subcutaneous version of
the vaccine in order to study the addition of sublingual boosts.
The FDA also authorized a second Phase I study that will examine
the addition of an oral boost to the subcutaneous prime
administration. As a result, the companies will enroll another 105
participants in the U.S. trials of their vaccine candidate, which
is unique in targeting both the spike (S) and nucleocapsid (N)
proteins of the SARS-CoV-2 virus.
The expectations of inducing protective immune responses in
healthy volunteers – with this novel combination of an oral boost
with a subcutaneous prime – are based on the positive findings
reported in the NIH/BARDA-sponsored Non-Human Primate (NHP) study.
This recent data showed that when administered with an oral boost,
the bivalent vaccine resulted in potent stimulation of S- and
N-specific T cells with potent antibody release from memory B cells
following viral challenge. Additionally, activation of the full
immune system by S and N proteins resulted in complete viral
clearance of SARS-CoV-2 in lung and nasal passages following the
challenge. On the basis of these findings, ImmunityBio has expanded
the current Phase 1 study of subcutaneous prime with oral or
sublingual boost to explore the potential of this second-generation
vaccine to reduce disease and transmission of the virus.
The oral trial is a new study (NCT04732468) and the sublingual
trial is the cohort C expansion to the Phase 1 subcutaneous trial
(NCT04591717), which was initiated last Fall. Both oral and
sublingual trials are anticipated to begin this month and will be
conducted at two sites in California. Based on the findings of
these trials involving over 100 participants, the optimal
combination of route of administration and dose will be determined
and entered into the Phase 2 / 3 design.
“The NHP study findings reinforce our hypothesis that a
T-cell-based vaccine could be protective, not only in preventing
mild, moderate, and severe disease, but also in potentially
limiting transmission of the virus,” said Patrick Soon-Shiong, MD,
Chairman and CEO of ImmunityBio. “We believe that the key to
creating long-term immunity to the SARS-CoV-2 virus and overcoming
the variants that are rapidly developing around the world is to
create a vaccine that activates not only antibodies but also memory
B and T cells to multiple antigens. Furthermore, room-temperature
stable formulations for oral delivery have the potential to solve
the cold-chain challenges of distribution and the ability to
generate mucosal IgA antibody barriers to the virus in the upper
respiratory tract where it first enters the body.”
One Vaccine, Two Trials, Three Routes of Immune
Protection
The first two cohorts of the Phase Ib, open label, dose-ranging
study (NCT04591717) of the vaccine received two different dose
levels (.5 and 1ml). Participants received two subcutaneous
injections 21 days apart. No grade three or four AEs and no SAEs
were observed at either dose level and, in the intermediate (1ml)
dose group, immunogenicity was observed as early as 14 days after
the prime. An additional group of 40 subjects will be enrolled to
evaluate safety, reactogenicity, and immunogenicity of the
combination of hAd5 in four different cohorts receiving sublingual
and subcutaneous formulations to select an optimal combination dose
for future studies.
The second Phase 1b trial (NCT04732468) is designed to assess
the safety, reactogenicity, and immunogenicity of the combination
of hAd5 in oral capsule and subcutaneous formulations; and to
select an optimal combination dose for future studies. Up to 65
subjects will be enrolled in the four-cohort study, which is
anticipated to begin in Q1.
About the T-Cell-Based Vaccine Candidate
Developed by ImmunityBio and manufactured by NantKwest, this
second generation hAd5 vectored vaccine is unique in targeting both
spike (S) and nucleocapsid (N) SARS-CoV-2 proteins to generate B
and T cell memory to these antigens and long-term immunity to the
virus. Most of the COVID-19 vaccines approved by the FDA or in
late-stage clinical trials deliver only the spike protein, which
has already mutated several times. Another unique characteristic of
the hAd5 design is its use of a second-generation hAd5 platform
that was developed to elicit anti-SARS-CoV-2 immune responses even
in Ad-immune individuals, meaning subjects can receive the vaccine
multiple times, if necessary. The stimulation of anti-hAd5 immune
responses is attenuated with the second-generation platform in
comparison with the first-generation platforms, due to additional
genetic deletions. The hAd5 room temperature-stable oral capsules
were developed in partnership with UK-based biotechnology company
iosBio.
Phase I trials have been initiated in the U.S. and recruitment
is set to begin in February in Cape Town, South Africa for a trial
(NCT04710303) of subcutaneous administration to be followed by
additional trials using sublingual delivery and room
temperature-stable oral capsules.
NantKwest Transaction
As previously announced, on December 21, 2020, ImmunityBio
entered into an agreement to combine in a stock-for-stock
transaction with NantKwest (NASDAQ: NK). 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 2 or
3 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/20210211005960/en/
Investors Sarah Singleton 844-696-5235, Option 5
Media Andrew Siegel / Greg Klassen Joele Frank, Wilkinson
Brimmer Katcher 212-355-4449
Amy Jobe, Ph.D. LifeSci Communications 315-879-8192
ajobe@lifescicomms.com
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