- Dr. Sam S. Chang, Professor of Urology at Vanderbilt Cancer
Program, to host the program “A Deep Dive with Patrick Soon-Shiong:
Next-Generation Immunotherapy for NMBIC”
- Discussion about the basis for ANKTIVA’s Breakthrough Therapy
designation and the novel mechanism of how the IL-15 superagonist
achieves durable complete responses in BCG unresponsive NMIBC
The Executive Chairman and Global Chief Scientific and Medical
Officer of ImmunityBio, Inc. (NASDAQ: IBRX), a next-generation
immunotherapy company, will discuss the implications of the recent
FDA approval of ANKTIVA® (nogapendekin alfa inbakicept-pmln) for
use in combination with bacillus Calmette-Guerin (BCG) for
non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ
(CIS) with or without papillary tumors at the American Urological
Association Annual Meeting (AUA 2024) this week in San Antonio,
Texas.
Patrick Soon-Shiong, M.D., will discuss the company’s novel
FDA-designated Breakthrough Therapy ANKTIVA, and its potential as
an alternative therapy to radical surgery for patients with
advanced cases of bladder cancer that have failed to respond to the
current standard of care of BCG adminstered alone. Dr. Soon-Shiong
will describe how the tumor evades BCG therapy and how ANKTIVA
rescues BCG when combined with ANKTIVA, revealing details of
ImmunityBio’s Cancer Moonshot strategy of transforming “MHC
Negative” (cold) bladder cancer cells as a mechanism of tumor
evasion from BCG, to “MHC Positive” (hot) tumors via ANKTIVA’s
activation of NK and T cells, resulting in complete durable
response.
“The realization that this transformation of MHC- to MHC+ could
rescue exhausted or immune-evaded T cells was the basis of our
Cancer Moonshot announced in 2016. Our QUILT program provided
insight that this strategy of transforming MHC- to MHC+ applies to
all tumor types that have entered the escape phase, and the
approval of ANKTIVA marks our first step to the next evolution of
immunotherapy by orchestrating both the innate and adaptive immune
system. I very much look forward to elaborating on the details with
Dr. Sam Chang at the AUA conference,” said Dr. Patrick
Soon-Shiong.
Hosting Dr. Soon-Shiong will be Dr. Sam S. Chang, M.D.,
Professor of Urology and Chief Surgical Officer of the Vanderbilt
Ingram Cancer Center. Dr. Chang was a principal investigator for
ImmunityBio’s QUILT 3.032 study, which produced the data on which
the FDA approval was based. The fireside chat, titled “A Deep Dive
with Patrick Soon-Shiong: Next Generation Immunotherapy for NMIBC,”
will take place Friday, May 3, 2024 at 3:15 CDT in the Learning
Lab, located in the AUA Square, in front of the Science &
Technology Hall of the Henry B. González Convention Center in San
Antonio, Texas.
In addition, at the AUA Annual Meeting, ImmunityBio’s Chief
Medical Officer Sandeep “Bobby” Reddy, M.D., will present the
latest findings from the Company’s QUILT 3.032 and QUILT 2.005
studies.
- MP16-03: N-803 plus BCG Complete Response rate in NMIBC CIS
subjects: BCG refractory, relapsed, checkpoint failure, and
chemotherapy failure; updated results (QUILT 3.032). Friday, May 3, 2024 from 1:00 to 3:00 in Room
221B
- QUILT 2.005: A comparison of intravesical Bacillus
Calmette-Guerin (BCG) in combination with the IL-15 superagonist
N-803 to BCG alone in patients with BCG-naïve NMIBC. Sunday, May 5, 2024 from 10:32 to 10:40 am in the
Learning Lab.
About ImmunityBio
ImmunityBio is a vertically-integrated biotechnology company
developing next-generation therapies and vaccines that bolster the
natural immune system to defeat cancers and infectious diseases.
The company’s range of immunotherapy and cell therapy platforms,
alone and together, act to drive and sustain an immune response
with the goal of creating durable and safe protection against
disease. Designated an FDA Breakthrough Therapy, ANKTIVA® is the
first FDA-approved immunotherapy for non-muscle invasive bladder
cancer that activates natural killer cells, T cells, and memory T
cells for a long duration response. The company is applying its
science and platforms to treating cancers, including the
development of potential cancer vaccines, as well as developing
immunotherapies and cell therapies that we believe sharply reduce
or eliminate the need for standard high-dose chemotherapy. These
platforms and their associated product candidates are designed to
be more effective, accessible, and easily administered than current
standards of care in oncology and infectious diseases.
For more information, please visit: www.immunitybio.com
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, such as statements regarding confirmation, participation and
timing, as well as data and results from clinical trials and
potential implications therefrom, commercialization plans and
timelines, including product availability and shipments, potential
regulatory pathways and approval requests and submissions, FDA
meetings, timelines and potential results therefrom, the regulatory
review process and timing thereof, market and prevalence data,
potential benefits to patients, potential treatment outcomes for
patients, the described mechanism of action and results and
contributions therefrom, information regarding potential benefit to
patients, information regarding ongoing pre-clinical studies and
clinical trials, potential future uses and applications of ANKTIVA
and use in cancer vaccines and across multiple tumor types,
methods, conference call and webcast timing, and ImmunityBio’s
approved product and investigational agents as compared to existing
treatment options, among others. Statements in this press release
that are not statements of historical fact are considered
forward-looking statements, which are usually identified by the use
of words such as “anticipates,” “believes,” “continues,” “goal,”
“could,” “estimates,” “scheduled,” “expects,” “intends,” “may,”
“plans,” “potential,” “predicts,” “indicate,” “projects,” “seeks,”
“should,” “will,” “strategy,” and variations of such words or
similar expressions. Statements of past performance, efforts, or
results of our preclinical and clinical trials, about which
inferences or assumptions may be made, can also be forward-looking
statements and are not indicative of future performance or results.
Forward-looking statements are neither forecasts, promises nor
guarantees, and are based on the current beliefs of ImmunityBio’s
management as well as assumptions made by and information currently
available to ImmunityBio. Such information may be limited or
incomplete, and ImmunityBio’s statements should not be read to
indicate that it has conducted a thorough inquiry into, or review
of, all potentially available relevant information. Such statements
reflect the current views of 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 ImmunityBio,
including, without limitation, (i) the risks and uncertainties
associated with commercial launch execution, success and timing,
(ii) risks and uncertainties related to the regulatory submission
and review process, (iii) the ability of ImmunityBio to continue
its planned preclinical and clinical development of its development
programs through itself and/or its investigators, and the timing
and success of any such continued preclinical and clinical
development, patient enrollment and planned regulatory submissions,
(iv) the timing and funding of the incremental $100 million of
non-dilutive financing following ImmunityBio’s receipt of FDA
approval of the BLA, (v) ImmunityBio’s ability to retain and hire
key personnel, (vi) ImmunityBio’s ability to obtain additional
financing to fund its operations and complete the development and
commercialization of its various product candidates, (vii)
potential product shortages or manufacturing disruptions that may
impact the availability and timing of product, (viii) ImmunityBio’s
ability to successfully commercialize its product candidates and
uncertainties around regulatory reviews and approvals, (ix)
ImmunityBio’s ability to scale its manufacturing and commercial
supply operations for its product candidates and future approved
products, and (x) ImmunityBio’s ability to obtain, maintain,
protect and enforce patent protection and other proprietary rights
for its product candidates and technologies. More details about
these and other risks that may impact ImmunityBio’s business are
described under the heading “Risk Factors” in the Company’s Form
10-K filed with the U.S. Securities and Exchange Commission (“SEC”)
on March 19, 2024 and in subsequent filings made by ImmunityBio
with the SEC, which are available on the SEC’s website at
www.sec.gov. ImmunityBio cautions you not to place undue reliance
on any forward-looking statements, which speak only as of the date
hereof. ImmunityBio does not undertake any duty to update any
forward-looking statement or other information in this press
release, except to the extent required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240430306875/en/
Investors Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc. +1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
Media Greg Tenor Salutem +1 717-919-6794
Gregory.Tenor@Salutemcomms.com
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