View the letter:
https://cel-sci.com/wp-content/uploads/2023/10/CEL-SCI_shareholder_letter_from_CEO_Oct2023.pdf
CEL-SCI Corporation (NYSE American: CVM) today released a
letter to shareholders from the Company’s CEO, Geert Kersten. The
very comprehensive letter details the data reported on the efficacy
of Multikine (Leukocyte Interleukin, Injection)* in the head and
neck cancer target patient population as well as CEL-SCI’s plan to
file for immediate regulatory approval. The shareholder letter can
be read in full on the Company’s website (https://cel-sci.com/) or
by clicking HERE.
Below is the letter’s introduction:
Dear Shareholders
This shareholder letter will be longer and much more detailed
than prior letters. My goal is to show you the clinical data
supporting Multikine’s survival benefits, explain how we identified
the target population of head and neck cancer patients who should
receive Multikine, and describe our efforts with the world’s
leading regulatory bodies to bring Multikine to market as quickly
as possible.
Why are we confident that Multikine should be approved as soon
as possible? First, we can clearly identify patients who should get
Multikine. Second, Multikine definitely benefits patients by
causing pre-surgical responses. Third, the Multikine survival
benefit in the target population is outstanding. Fourth, as a
statistical matter, another trial is more than 95% likely to be
successful and therefore should not be necessary for approval.
Fifth, there are regulatory pathways specifically designed for our
situation where the target population is selected from the larger
Phase 3 study population. We believe that we meet these factors
with strong evidentiary support and are eager to move forward.
A Well-Defined Target Population
Last week at the European Society for Medical Oncology (ESMO)
conference—the most important annual European cancer conference—we
presented new data on Multikine’s efficacy that is far superior to
the results we presented last year. We accomplished this by
focusing our target population on patients mostly to have
pre-surgical responses to Multikine. We identified these patients
based on the clinical data, cellular analysis, and advice from
regulators and top consultants, including two of the most respected
head and neck immuno-oncologists in the world. This is a huge achievement, because it means
Multikine patients can be identified upon
diagnosis with tests that physicians routinely use in cancer
screenings. In addition, we can now meet a critical regulatory
requirement: the writing of an approval label for Multikine.
Multikine Undeniably Helps Patients, Period.
Certain facts about Multikine cannot be denied. First, Multikine
leads to pre-surgical responses, meaning that Multikine’s benefits
become immediately apparent for many within just a few weeks of
treatment. Second, if you have a pre-surgical response, then your
survival is greatly improved. Therefore, we know that Multikine improves survival for those with
pre-surgical responses. I
will show you the data that proves this to be true.
The Clinical Data Is Outstanding
By way of summary, Phase 3 patients in the finalized target
population saw the following:
- risk of death cut in half at five
years versus the control;
- 28.6% absolute 5-year overall survival benefit versus control
(p=0.0015);
- 0.349 hazard ratio vs control (95% CIs [0.18, 0.66], Wald
p=0.0012);
- >35% rate of pre-surgery tumor reductions and/or downstages
(p<0.01); and
- low PD-L1 tumor expression (vs high PD-L1 where Keytruda and
Opdivo work best).
CEL-SCI Has All The Ingredients For Approval
We can identify at diagnosis the
patients most likely to have pre-surgical responses to Multikine.
The survival statistics in this target population are so good that
it is hard to imagine how they could be challenged or ignored.
Multikine’s safety profile is very favorable compared to other
oncology agents. And, we have a manufacturing plant that can make
an estimated $2 billion worth of Multikine annually.
CEL-SCI is ready—and we believe
patients and doctors are, too. A new drug for our targeted disease
(previously-untreated locally advanced primary resectable squamous
cell carcinoma of the head and neck) has not been approved by FDA
in decades. The current standard of care provides only a 50-50
chance of living past five years. Large companies have tried and
failed to improve this figure. Patients desperately need better
treatments.
We now have the ingredients for delivering results to investors
as well. While the biotech stock market always has its ups and
downs, and has been dismal lately, the
clinical data will stand firm
and drive the final success for CEL-SCI. We have
presented our new data to regulators in Europe and the UK. Canada
and the United States (FDA) have not yet seen these data, and we
plan to present to them in the next quarter.
CEL-SCI plans to seek approval for immediate patient access to
Multikine without waiting on the results
of a new trial wherever possible. There are regulatory
pathways specifically designed for such approvals that CEL-SCI is
pursuing worldwide. These pathways are called “conditional
approvals” (or, in the U.S., accelerated approval) which means you
can be approved first while a confirmatory study is ongoing and
before that study is completed. Our situation—where we have
selected a portion of the Phase 3 study for our target
population—is precisely why these regulatory pathways were adopted
by regulatory bodies, so that patients do not need to wait many
years before gaining access to promising drugs that have already
been shown to provide clinical benefit.
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 studied patients
who were newly diagnosed with locally 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 called neo-adjuvant. 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.
Multikine is designed to help the immune system “target” 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. CEL-SCI has completed a 928 patient Phase 3 clinical trial
in locally advanced primary head and neck cancer patients.
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, 2022. 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. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231030743158/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
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