- QUILT 3.032 study completes planned enrollment of BCG
unresponsive non-muscle invasive bladder cancer CIS cohort with 59%
probability of patients maintaining complete response for at least
12 months
- Over 87.5% of patients in this study have avoided a cystectomy
to date
- FDA Breakthrough Therapy designation and Accelerated Approval
for ImmunityBio’s superagonist Anktiva™ N-803 in this
indication
ImmunityBio, Inc., a privately-held immunotherapy company, today
announced the oral presentation of “Phase II/III clinical results
of IL-15RαFc superagonist N-803 with BCG in BCG-unresponsive
non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS)
patients (Cohort A)” during a session at the Genitourinary Cancers
Symposium sponsored by the American Society of Clinical Oncology
(ASCO).
The data showed 51 out of 72 evaluable patients (71%), with 10.7
months median follow-up, had a complete response at any time to
intravesical BCG plus N-803, also called Anktiva™ (95% confidence
interval), meeting the primary endpoint of the study. In addition,
the study showed 59% probability of these patients maintaining a
complete response for at least 12 months, with an estimated median
duration of complete response of 19.2 months to date using
Kaplan-Meier methods.
“The high rates of complete response without serious adverse
events indicates that the combination of BCG plus N-803 is a
promising alternative to existing therapies and compares favorably
to the other approved options valrubicin and pembrolizumab,” said
presenting author Karim Chamie, M.D., Associate Professor of
Urology, David Geffen School of Medicine at UCLA.
No immune-related adverse events were seen in any patients, and
only 1% of patients reported treatment emergent serious adverse
events, but none of which were treatment-related. Additionally, 24%
of patients received additional chemotherapy and other therapies
(excluding BCG) between last dose of BCG and study entry, and 100%
of patients received prior BCG, thus the data support the potential
for Anktiva plus BCG as a novel option for BCG unresponsive CIS, a
therapeutically challenging disease. Patients with BCG unresponsive
CIS disease face surgical removal of the bladder, a procedure
fraught with high morbidity and mortality.
Bladder cancer has a high incidence worldwide; it caused 212,536
deaths and an estimated 573,278 new cases were diagnosed in 20201.
In the United States, bladder cancer is the fourth most commonly
diagnosed solid malignancy in men and the twelfth for women; The
American Cancer Society estimates 80,470 new cases and 17,670
deaths in 20192. Approximately 75-85% of all newly diagnosed cases
of bladder cancer are non-muscle invasive bladder cancer
(NMIBC)3.
The open-label, three cohort multicenter Phase 2/3 study of
intravesical BCG plus Anktiva (N-803) in patients with
BCG-unresponsive high-grade NMIBC (NCT03022825) was opened in 2017.
The primary endpoint for Cohort A of this Phase 2/3 study is
incidence of complete response (CR) of CIS at any time. The FDA had
granted Fast Track Designation to the pivotal trial based on Phase
I data. In December 2019, the FDA granted ImmunityBio Breakthrough
Therapy Designation based on interim Phase 2 data indicating the
primary endpoint of the trial was already met.
ImmunityBio’s IL-15 superagonist Anktiva (N-803)
The cytokine interleukin-15 (IL-15) plays a crucial role in the
immune system by affecting the development, maintenance, and
function of the natural killer (NK) and T cells. N-803 is a novel
IL-15 superagonist complex consisting of an IL-15 mutant
(IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein.
N-803 has improved pharmacokinetic properties, longer persistence
in lymphoid tissues and enhanced anti-tumor activity compared to
native, non-complexed IL-15 in vivo.
N-803 is currently being evaluated for adult patients in two
clinical NMIBC trials. QUILT 2.005 is investigating use of N-803 in
combination with BCG for patients with BCG-naïve NMIBC; QUILT 3.032
is studying N-803 in combination with BCG in patients with
BCG-unresponsive NMIBC.
The Urgent, Unmet Need to Treat NMIBC and Avoid
Cystectomy
For the last 30 years, BCG immunotherapy has been the standard
for treating NMIBC. However, disease recurrence and progression
rates remain unacceptably high. Standard of care recommendations
for these patients include lifetime invasive surveillance and rapid
treatment of recurrences, creating a substantial financial burden
and drastic impact on quality of life. Of those patients who
experience recurrence, approximately 30% will progress and succumb
to their disease over a 15-year period, and another 50% will
undergo radical cystectomy of the bladder in an attempt to control
their disease4.
For high-risk NMIBC patients who are BCG-unresponsive with
persistent or recurrent disease, treatment guidelines recommend a
surgical procedure called radical cystectomy, a surgery to remove
the entire bladder that may require removal of other surrounding
organs. In men, removal of the prostate may be necessary, and in
women, surgeons may also remove the uterus, fallopian tubes,
ovaries and cervix, and occasionally a portion of the vagina.
Despite the advent of minimally invasive procedures and robotic
techniques, the 90-day mortality and morbidity rates in patients
who undergo cystectomy remain unacceptably high at 5.1-8.1% and
28-64%, respectively5. Based on this urgent need, FDA published
guidance in February 2018 to address BCG unresponsive non-muscle
invasive bladder cancer (NMIBC), stating that the goal of therapy
in patients with BCG-unresponsive NMIBC is to avoid cystectomy.
NantKwest Transaction
ImmunityBio separately announced today that it has entered into
an agreement to combine in a stock-for-stock transaction with
NantKwest, Inc. (NASDAQ: NK). The combination will create a leading
immunotherapy and cell therapy companies 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.
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 https://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.
- Global cancer statistics: GLOBOCAN estimates of incidence and
mortality worldwide for 36 cancers in 185 countries:
https://gco.iarc.fr/
-
https://www.cancer.org/cancer/bladder-cancer/about/key-statistics.html
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3263923/
- https://doi.org/10.1016/j.eururo.2018.09.028
- https://doi.org/10.1016/j.eururo.2013.12.018
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version on businesswire.com: https://www.businesswire.com/news/home/20210216005447/en/
Investors Sarah Singleton NantKwest 844-696-5235, Option
5
Media Amy Jobe, Ph.D. LifeSci Communications 315-879-8192
ajobe@lifescicomms.com
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