- 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 85% of patients in this study have avoided a cystectomy to
date
- Breakthrough status for ImmunityBio’s superagonist Anktiva
N-803 in this indication
- Biologics License Application filing anticipated in second half
of 2021
ImmunityBio, Inc., a privately-held immunotherapy company, today
announced positive data from the first cohort of a pivotal Phase
2/3 trial (QUILT 3.032) for non-muscle invasive bladder cancer in
high risk carcinoma in situ (CIS) disease. The data showed 51 out
of 71 evaluable patients (72%) had a complete response (at any
time) to intravesical BCG plus N-803 (Anktiva), with 59%
probability of these patients maintaining a complete response for
at least 12 months, with a median duration of complete response of
19.2 months to date.
With the observed efficacy and only 1% of patients reporting
treatment emergent serious adverse events, but none of which were
treatment-related, 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.
“The high rates of progression and recurrence for NMIBC make it
one of the most expensive cancers to treat. This preliminary data
is heartening and provides additional evidence of the potential for
ImmunityBio’s Anktiva in treating a serious and potentially fatal
cancer, for which the alternative is a highly invasive radical
cystectomy,” said Patrick Soon-Shiong, M.D., Chairman and CEO of
ImmunityBio. “We expect to file a Biologics License Application
following a meeting with the FDA in 2021.”
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 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 ImmunityBio will be successful in improving the
treatment of the novel coronavirus, the timing and results of the
clinical development of had5-COVID -19 oral capsule vaccine, or
whether ImmunityBio will be successful in gaining regulatory
approval of, commercializing or distributing the vaccine. Risks and
uncertainties related to these endeavors include, but are not
limited to the successful completion of the currently contemplated
Phase 1 trials and the currently enrolling Phase 2 trial and
subsequent clinical development and FDA approval of the vaccine on
the currently anticipated timeline, if at all, as well as
manufacturing and distribution challenges., Risks and uncertainties
related to this endeavor include, but are not limited to, the
company’s beliefs regarding the success, cost, and timing of its
development activities and clinical trials.
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
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.
- 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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Investors Sarah Singleton NantKwest 844-696-5235, Option
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Media Amy Jobe LifeSci Advisors 315-879-8192
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