CEL-SCI Corporation Completes Commercial-Scale Buildout of Multikine Manufacturing Facility
October 22 2021 - 8:00AM
Business Wire
CEL-SCI Corporation (NYSE American: CVM) today announced
it has completed the expansion of its existing dedicated Multikine*
(Leukocyte Interleukin, Injection) cGMP manufacturing facility. The
expansion was undertaken in anticipation of filing a Biologics
License Application (BLA) which, if approved, will allow Multikine
produced in the facility to be commercially distributed. The
construction, which began in 2020, expanded the facility and added
various upgrades to ensure it will be in compliance with all
requirements of the FDA’s Current Good Manufacturing Practice (GMP)
regulations. The facility’s production capacity has been doubled to
meet anticipated market demand for Multikine once it is licensed.
The renovations also anticipate that additional personnel will be
required to staff a second manufacturing shift to meet the eventual
market demand for Multikine. Following an $11 million investment to
increase production, CEL-SCI staff recently moved back into the
renovated facility.
“We are now validating the facility and will begin preparing our
facility license application for Multikine. We continue to hire and
train additional personnel required to efficiently operate the
manufacturing facility in compliance with all federal and state
requirements,” stated CEL-SCI CEO, Geert Kersten.
CEL-SCI reported topline results in June 2021 from its landmark
pivotal Phase 3 study of Multikine as a neoadjuvant treatment of
advanced primary previously untreated head and neck cancer, which
is believed to be the largest study in the world for this
indication.
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system while
it is still intact should provide the greatest possible impact on
survival. Therefore, in the Phase 3 study CEL-SCI treated patients
who are newly diagnosed with advanced primary squamous cell
carcinoma of the head and neck with the investigational product
Multikine first, BEFORE they received surgery and radiotherapy or
surgery plus concurrent radiotherapy and chemotherapy (the current
standard of care for these patients). This approach is unique. Most
other cancer immunotherapies are administered only after
conventional therapies have been tried and/or failed. Multikine
(Leukocyte Interleukin, Injection), received Orphan Drug
designation from the FDA for neoadjuvant therapy in patients with
squamous cell carcinoma (cancer) of the head and neck. CEL-SCI
believes that this Phase 3 study is the largest Phase 3 study in
the world for the treatment of advanced primary head and neck
cancer.
Multikine is designed to help the immune system “see” the tumor
at a time when the immune system is still relatively intact and
thereby thought to be better able to mount an attack on the tumor.
The Phase 3 study was started in early 2011 and was fully enrolled
with 928 patients in September 2016. To prove an overall survival
benefit, the study required CEL-SCI to wait until at least 298
(deaths) events had occurred among the two main comparator groups.
This study milestone occurred in late April 2020 and database lock
occurred in December 2020. The study results announced in June 2021
showed excellent survival benefit for those patients who received
Multikine plus surgery and radiation. In the other treatment arm,
when chemotherapy was added to the radiotherapy, the survival
benefit was negated.
The Company’s LEAPS technology is being developed for rheumatoid
arthritis. The Company has operations in Vienna, Virginia, and
near/in Baltimore, Maryland.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. When used in this press release, the words "intends,"
"believes," "anticipated," "plans" and "expects," and similar
expressions, are intended to identify forward-looking statements.
Such statements are subject to risks and uncertainties that could
cause actual results to differ materially from those projected.
Such statements include, but are not limited to, statements about
the terms, expected proceeds, use of proceeds and closing of the
offering. Factors that could cause or contribute to such
differences include, an inability to duplicate the clinical results
demonstrated in clinical studies, timely development of any
potential products that can be shown to be safe and effective,
receiving necessary regulatory approvals, difficulties in
manufacturing any of the Company's potential products, inability to
raise the necessary capital and the risk factors set forth from
time to time in CEL-SCI's filings with the Securities and Exchange
Commission, including but not limited to its report on Form 10-K
for the year ended September 30, 2020. The Company undertakes no
obligation to publicly release the result of any revision to these
forward-looking statements which may be made to reflect the events
or circumstances after the date hereof or to reflect the occurrence
of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark
that CEL-SCI has registered for this investigational therapy, and
this proprietary name is subject to FDA review in connection with
the Company's future anticipated regulatory submission for
approval. Multikine has not been licensed or approved for sale,
barter or exchange by the FDA or any other regulatory agency.
Similarly, its safety or efficacy has not been established for any
use.
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version on businesswire.com: https://www.businesswire.com/news/home/20211022005045/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
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