- ANKTIVA® Drug Substance completed and released with two-year
storage stability data sufficient for 170,000 doses of ANKTIVA
product
- ImmunityBio’s 400,000 square foot GMP fill-finish facility in
Dunkirk, New York on track to be completed in 12-18 months with
capacity to produce a million vials annually
- Coupled with a recent announcement of BCG availability in
partnership with the Serum Institute of India (SII), ImmunityBio
has large-scale inventory and capacity for BCG
ImmunityBio, Inc. (NASDAQ: IBRX) announced today that the drug
substance (DS) has been completed and successfully qualified for
“fill finish” (filling vials and finishing packaging), sufficient
for 170,000 doses of 400mcg ANKTIVA (nogapendekin alfa
inbakicept-pmln). Coupled with the recent announcement of a
partnership with the Serum Institute of India (SII) for BCG
availability, this provides the Company with a significant initial
supply of ANKTIVA for commercial and clinical trial use in advance
of the full operation of the Company’s own drug substance and
fill-finish manufacturing plants in California and New York.
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the full release here:
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ImmunityBio’s state-of-the-art GMP
biological manufacturing facility in Dunkirk, New York (Photo:
Business Wire)
Since the Company’s merger with NantKwest in 2021, ImmunityBio
has made significant capital investments in personnel, plants, and
equipment to ensure global capacity of ANKTIVA drug product for
both the commercial launch, as well as clinical trials in bladder
cancer and other tumor types in its pipeline. Both drug substance
(DS) and drug product (DP) facilities are nearing completion to
ensure sufficient capacity and multiple GMP manufacturing sites for
ANKTIVA in its approved indication, as well as for clinical trials
and future indications.
“When we began the development of ANKTIVA and enlisted our
contract manufacturer, we believed that the manufacture of a
biologic as complicated as ANKTIVA was best served by having
multiple sites of manufacturing, including in-house capacity and
external partners,” said Patrick Soon-Shiong, M.D., Executive
Chairman and Global Chief Scientific and Medical Officer at
ImmunityBio. “Our investment since 2021 in our facilities, together
with the agreement entered into with the Serum Institute of India
(SII) ensures that both ANKTIVA and BCG could be available at scale
on a global basis.”
In 2020, the company began construction of a state-of-the-art
biological manufacturing plant in California with large-scale
bioreactors for ANKTIVA drug substance and it is anticipated to be
completed in the next 12-18 months. The large-scale equipment
needed for GMP biological manufacture, with long-lead times, are on
site and will be installed in the next 12 months. Upon completion,
this 100,000 square foot manufacturing site will have the capacity
to manufacture drug substance sufficient for a million doses of
ANKTIVA a year.
The drug product will be filled at the Dunkirk, New York
facility, a 400,000 square foot state-of-the-art GMP facility in
which the fill-finish equipment has been purchased and is in the
process of being installed.
These infrastructure capacity plans were initiated in
anticipation of the approval of ANKTIVA in combination with BCG for
non-muscle invasive bladder cancer, carcinoma in situ (CIS), to
ensure that ImmunityBio has sufficient drug product supply, not
only for the first commercial launch of ANKTIVA but for other
clinical trials and indications.
“Our belief in the importance of this molecule and its potential
to evolve immunotherapy to the next level, guided our strategic
plan to invest for the future with anticipation of ANKTIVA’s
approval,” said Rich Adcock, CEO & President ImmunityBio. “I’m
grateful for our employees and our investors who have supported and
believed in our commitment to invest for our long-term vision and
future.”
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 the scale of production capacity
for the manufacturing facilities referenced herein, the anticipated
uses of such facilities, anticipated timelines for completion of
such facilities and operational status of such facilities, the
collaboration between ImmunityBio and the Serum Institute of India
and expected results therefrom, clinical trials and potential
implications therefrom, commercialization plans and timelines, the
regulatory review process and timing thereof, potential future uses
and applications of ANKTIVA in additional indications, 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) potential delays in product
availability and regulatory approvals, (ii) whether the BCG
manufactured by Serum will receive regulatory approval in the U.S.
and/or other regions, (iii) the risks and uncertainties associated
with commercial launch execution, success and timing, (v)
additional risks and uncertainties related to the regulatory
submission and review process, (vi) 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, (vii) the ability of ImmunityBio and/or its
contractors to complete the construction or address construction
needs at ImmunityBio’s manufacturing facilities on the anticipated
timelines, or at all, (viii) ImmunityBio’s ability to comply with
the covenants and obligations under the Dunkirk facility lease
agreement and related agreements and potential implications
thereof, (ix) the risks and uncertainties associated with third
party collaborations and agreements, (x) ImmunityBio’s ability to
obtain additional financing to fund its operations and complete the
development and commercialization of its various product
candidates, (xi) potential product shortages or manufacturing
disruptions that may impact the availability and timing of product,
(xii) ImmunityBio’s ability to scale its manufacturing and
commercial supply operations for its product candidates and future
approved products, and (xiii) 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/20240507050323/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
ImmunityBio (NASDAQ:IBRX)
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