Full Press Release Details
FDA Authorizes ImmunityBio Study of Anktiva and PD-L1 t-haNK to Increase Effectiveness of Trodelvy in
Triple-Negative Breast Cancer
CULVER CITY, Calif., June 15, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced it has
received FDA authorization to conduct a Phase 1b/2 open-label study to evaluate the safety and preliminary efficacy of its superagonist Anktiva (N-803, an IL-15
superagonist) and PD-L1 targeted high-affinity natural killer (t-haNK) cells in combination with standard chemo and Trodelvy (sacituzumab govitecan-hziy), in subjects
with advanced triple-negative breast cancer (TNBC). The study may provide data indicating whether this combination can increase the effectiveness of Trodelvy in patients who have failed to respond to other treatments.
Triple-negative breast cancer is a serious, aggressive cancer with a high mortality rate. While Trodelvy displayed efficacy against TNBC in phase 3 testing, only a
third of third-line patients respond to it, and less than 17% of them continue to respond after a year. ImmunityBio proposed this new study based on data from a Phase 1 trial (NCT03387085) with Anktiva and the company s haNK cells that elicited
a significant response rate in refractory TNBC. Anktiva and PD-L1 t-haNK when used in combination with Trodelvy may show additive or even synergistic effects, greatly increasing the response rate and,
importantly, durability of responses.
Antibody-drug conjugates like Trodelvy have made tremendous progress in giving patients with TNBC more and
higher-quality time, but we believe Anktiva could potentially fill remaining treatment gaps and offer patients additional hope, said Patrick Soon-Shiong, M.D., Founder and Executive Chairman of ImmunityBio. We re conducting multiple
studies with Anktiva across different tumor types, in some cases in combination with our NK cell line, that are designed to determine if they can enhance the activity of therapeutic monoclonal antibodies like Trodelvy and, ultimately, provide
patients with longer, progression-free survival.
The strategy behind this approach is to attack the tumor in two distinct, complementary ways with
Trodelvy delivering the initial blow by targeting the protein Trop-2 displayed by many TNBC cells and delivering a chemotherapy payload while Anktiva recruits key cells of the immune system, including NK and T
cells, to continue fighting the tumor. To further unleash the power of the immune system, PD-L1 t-haNK will be introduced.
If Trodelvy is a missile that delivers a chemo payload to a tumor target, a superagonist like
Anktiva is the army that follows to finish the job and keep the target in check, said Adam Brufsky, M.D., Ph.D., Professor of Medicine in the Division of Hematology/Oncology at the University of Pittsburgh and a member of ImmunityBio s
scientific advisory board. Anktiva s role in using the body s immune system in the battle is a key part of the broader strategy to provide a long-term cure to breast and other types of cancer.
QUILT 3.058 Study Details
This phase 1b/2 open-label study will evaluate the
safety and efficacy of sacituzumab govitecan-hziy in combination with chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1
t-haNK) in subjects with TNBC after at least two prior treatments for metastatic disease.
The study consists of two phases and the maximum total enrollment for
this study is 79 subjects.
An estimated 2.3 million
women globally were diagnosed with breast cancer last year and 685,000 died from it. Triple negative breast cancer is an especially aggressive form of the disease and accounts for 10% to 15% of breast cancers, according to the American Cancer
Society. TNBC tests negative for estrogen receptors (ER), progesterone receptors (PR) and human epidermal growth factor receptor 2 (HER2) protein. Therefore, TNBC does not respond to hormonal therapy or medicines that target ER, PR, or HER2
and other treatment options are limited, particularly after initial lines of therapy have failed. Innovative treatment approaches, such as the combination of Trodelvy, Anktiva, and PD-L1 t-haNK with
chemotherapy described here may offer new hope to these advanced TNBC patients.
ImmunityBio is a leading 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.
ImmunityBio has a comprehensive immunotherapy pipeline with more than 40 clinical trials (company sponsored or investigator initiated) of which 25 are at Phase II
and III stage of development across 19 indications in solid and liquid cancers and infectious diseases. Currently 17 first-in-human immunotherapy agents are in
clinical testing and, to date, over 1,800 patients have been studied with our antibody cytokine fusion proteins, albumin chemo immunomodulators, Adeno and yeast vaccines and our
off-the-shelf natural killer cell products. 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 s platforms are based on the foundation of four separate modalities: Antibody cytokine fusion
proteins, synthetic immunomodulators, second-generation human adenovirus (hAd5) and yeast vaccine technologies, and
state-of-the-art, off-the-shelf natural killer
cells, including autologous and allogenic cytokine-enhanced memory NK cells. ImmunityBio is currently developing a dual construct COVID-19 vaccine candidate using its hAd5 platform.
ImmunityBio is a leading producer of cryopreserved and clinical dose forms of
off-the-shelf natural killer (NK) cell therapies. The company has established GMP manufacturing capacity at scale with cutting-edge cell manufacturing expertise and ready-to-scale facilities, as well as extensive and seasoned R&D, clinical trial, and regulatory operations and development teams. For more information, please visit:
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(iii) uncertainty of the expected financial performance and successful integration of the combined company following completion of the recent merger of ImmunityBio with NantCell (the Merger ), including the possibility that the
expected synergies and value creation from the Merger will not be realized or will not be realized within the expected time period, (iv) whether interim, initial, top-line and preliminary data
from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data, (v) our
ability to obtain additional financing to fund our operations and complete the development and commercialization of our various product candidates, and (vi) the unknown future impact of the COVID-19
pandemic delay on certain clinical trials or their milestones and/or ImmunityBio s operations or operating expenses. 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 8-K filed with the U.S. Securities and Exchange Commission ( SEC ) on March 10, 2021, Form 10-Q filed with the
SEC on May 14, 2021 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.
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