Provides updated data on prolonged duration of
complete response in BCG-Unresponsive and BCG-Naïve NMIBC
patients
- Following the Type A Meeting with the FDA, ImmunityBio has
completed the BLA resubmission addressing the issues in the
Complete Response Letter.
- As part of this resubmission, ImmunityBio provided an update on
the Duration of Complete Response (CR) in BCG-unresponsive NMIBC
patients with CIS ± Ta/T1 disease (QUILT-3.032) demonstrating a
prolonged duration of remission with a median duration of CR not
yet reached with a follow-up in responders exceeding 28
months.
- In the responding BCG-unresponsive NMIBC patients updated
efficacy data demonstrated a probability of avoiding a cystectomy
at ≥ 24 months of over 90%.
- ImmunityBio also provided an update on the long-term follow-up
(QUILT-205) in BCG Naïve NMIBC patients demonstrating a prolonged
duration of complete remission in 6 out of 6 patients available for
follow-up with a median survival of 8.8 years with ongoing bladder
preservation to date.
- These findings in both BCG-unresponsive and BCG-naïve patients
demonstrate a prolonged duration of complete remission exceeding
over 2 years in the unresponsive cohort and over 8 years in the
BCG-naïve cohort.
ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy
company, today announced it has completed the resubmission of its
Biologics License Application (BLA) to the U.S. Food and Drug
Administration (FDA) for N-803 (Anktiva®), a first-in-class IL-15
superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment
of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in
situ (CIS) with or without Ta or T1 disease.
The BLA is supported by the results of ImmunityBio’s studies in
bladder cancer including the pivotal QUILT-3.032 study
(NCT03022825), published in NEJM Evidence1 in November 2022. An
update of the duration of response regarding the responders
identified by the FDA in the efficacy population for BCG
unresponsive subjects with high-risk CIS disease was provided in
the BLA resubmission. This update demonstrated a prolonged duration
of remission in responding subjects, with a median duration of CR
not yet reached with a follow-up in responders exceeding 28 months,
and a safety profile as reported previously. The updated duration
of CR in these responding BCG-unresponsive subjects showed that the
probability of maintaining a CR for ≥ 24 months was 60%, with a
cystectomy free rate at ≥ 24 months of over 90%.
In addition, ImmunityBio provided an update on the long-term
follow-up (QUILT-205) of subjects receiving N-803 plus BCG for CIS
± Ta/T1 in the Phase 1b (QUILT-2.005) trial, examining the survival
of the nine subjects entering the trial since 2014. All 9 subjects
(100%) achieved a complete remission and the results are published
in Oncoimmunology2-5. Of the nine subjects, two were deceased from
causes other than bladder cancer and one was lost to follow-up. Of
the 6 subjects available for follow-up (QUILT-205), 6 out of 6
subjects (100%) demonstrated long-term complete remission with
bladder preservation over a median survival period of 8.8 years and
all 6 subjects have avoided a cystectomy to date.
ImmunityBio’s IL-15 superagonist N-803 (Anktiva)
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
investigational IL-15 superagonist complex consisting of an IL-15
mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion
protein. Its proposed mechanism of action is direct specific
stimulation of CD8+ T cells and NK cells through beta gamma T-cell
receptor binding with generation of memory T-cells while avoiding
T-reg stimulation. N-803 is designed to have 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 in 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 CIS and Papillary Disease.
N-803 is investigational. Safety and efficacy have not been
established by any Health Authority or Agency, including the
FDA.
Selected Publications:
- Chamie, K., Chang, S. S., Kramolowsky, E., Gonzalgo, M. L.,
Agarwal, P. K., Bassett, J. C., Bjurlin, M., Cher, M. L., Clark,
W., Cowan, B. E., David, R., Goldfischer, E., Guru, K., Jalkut, M.
W., Kaffenberger, S. D., Kaminetsky, J., Katz, A. E., Koo, A. S.,
Sexton, W. J., … Soon-Shiong, P. (2023). IL-15 Superagonist NAI in
BCG-Unresponsive Non–Muscle-Invasive Bladder Cancer. In NEJM
Evidence (Vol. 2, Issue 1). Massachusetts Medical Society.
https://doi.org/10.1056/evidoa2200167
- Rosser CJ, Tikhonenkov S, Nix JW, Chan OTM, Ianculescu I, Reddy
S, Soon-Shiong P. Safety, Tolerability, and Long-Term Clinical
Outcomes of an IL-15 analogue (N-803) Admixed with Bacillus
Calmette-Guérin (BCG) for the Treatment of Bladder Cancer.
Oncoimmunology. 2021 May 3;10(1):1912885. doi:
10.1080/2162402X.2021.1912885. PMID: 33996264; PMCID:
PMC8096327.
- Chamie K, Chang SS, Gonzalgo M, Kramolowsky EV, Sexton WJ, Bhar
P, et al.. Final clinical Results of Pivotal Trial of IL-15rαfc
Superagonist N-803 with BCG in BCG-Unresponsive CIS and Papillary
Non-Muscle Invasive Bladder Cancer (NMIBC). J Clin Oncol (2022)
40(16_suppl):4508. doi: 10.1200/JCO.2022.40.16_suppl.4508
- Chamie K, Chang SS, Gonzalgo M, Kramolowsky EV, Sexton WJ, Bhar
P, et al.. 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. J Clin Oncol
(2021) 39(suppl 6):510. doi: 10.1200/JCO.2021.39.6_suppl.510
- Huang J, Shiao SL, Furuya H, Rosser CJ. Immunogenomic Analysis
of Exceptional Responder to ALT-803 (IL-15 Analogue) in BCG
Unresponsive Nonmuscle Invasive Bladder Cancer: A Case Series and
Review of the Literature. J Immunother. 2019 Nov/Dec;42(9):354-358.
doi: 10.1097/CJI.0000000000000269. PMID: 31107371; PMCID:
PMC6783344.
About ImmunityBio
ImmunityBio is a vertically-integrated, clinical-stage
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. We are applying our 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 ImmunityBio’s resubmission of
its BLA, ImmunityBio’s belief that the BLA resubmission addresses
the issues in the Complete Response Letter, ImmunityBio’s beliefs
about the comprehensive nature of its BLA resubmission and
expectations regarding the acceptance by the FDA and a decision by
the FDA on its BLA, including the timing thereof, the development
of therapeutics for cancer indications and related business
strategies, potential regulatory pathway for certain of
ImmunityBio’s product candidates and target indications, and
ImmunityBio’s investigational agents as compared to existing
treatment options, among others. While ImmunityBio believes the BLA
resubmission addresses the issues identified in the CRL, there is
no guarantee that the FDA will agree, and it remains to be
determined whether the FDA will accept the BLA, as resubmitted, for
review. Further, even if accepted for review, the classification of
the resubmission and timeline for review remains uncertain at this
time. 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 the regulatory review process, (ii)
whether or not the FDA will determine that the BLA resubmission is
complete and acceptable for review, (iii) uncertainties regarding
the timeline of FDA review of the resubmitted BLA, if accepted for
review, (iv) any inability to successfully work with the FDA to
find a satisfactory solution to address any concerns in a timely
manner or at all during the review process for the BLA, including
any inability to provide the FDA with data, analysis or other
information sufficient to support an approval of the BLA, (v) the
ability of ImmunityBio and its third party contract manufacturing
organizations to adequately address the issues raised in the CRL,
(vi) any potential facility re-inspection that may be required
regarding ImmunityBio’s third party contract manufacturing
organizations or otherwise, (vii) whether the FDA accepts the data
and results as included in the BLA resubmission at levels
consistent with the published results, or at all, (viii) the
ability of ImmunityBio to execute a partnering relationship with a
large biopharmaceutical company for commercialization of N-803 plus
BCG for intravesical administration on acceptable terms, if at all,
(ix) the ability of ImmunityBio to continue its planned preclinical
and clinical development of its development programs, and the
timing and success of any such continued preclinical and clinical
development and planned regulatory submissions, (x) ImmunityBio’s
ability to retain and hire key personnel, (xi) ImmunityBio’s
ability to obtain additional financing to fund its operations and
complete the development and commercialization of its various
product candidates, (xii) ImmunityBio’s ability to successfully
commercialize its product candidates and uncertainties around
regulatory reviews and approvals, (xiii) ImmunityBio’s ability to
scale its manufacturing and commercial supply operations for its
product candidates and future approved products, and (xiv)
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 1,
2023 and the Company’s Form 10-Q filed with the SEC on August 8,
2023, 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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version on businesswire.com: https://www.businesswire.com/news/home/20231023256922/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@Salutem.com
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