Additional Proxy Soliciting Materials (definitive) (defa14a)
19 May 2021 - 1:05AM
Edgar (US Regulatory)
UNITED STATES
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CEL-SCI CORPORATION
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CEL-SCI
CORPORATION
8229 Boone Blvd., Suite 802
Vienna, Virginia 22l82
(703) 506-9460
May 11,
2021
Dear
Fellow Shareholders:
As of
the date of this letter, the final statistical analysis and
resulting data read out of our Phase 3 clinical trial in head and
neck cancer have not yet been completed. This important work is
being conducted by outside experts and then doublechecked by yet
another statistical team. The amount of data being analyzed and
reviewed is monumental since our study is the world’s largest
for this indication. While CEL-SCI remains blinded to the data, we
believe that Multikine will show significant clinical benefit and
help patients with little to no toxicity. Therefore, we are
currently expanding and upgrading our Multikine-dedicated cGMP
manufacturing facility, as well as hiring and training more
personnel. The expansion of the manufacturing facility, which began
in 2020, is expected to be completed in the coming months and will
double the facility’s capacity to accommodate two shifts for
increased production of Multikine.
At
CEL-SCI we are pursuing an idea which could fundamentally alter the
way cancer is treated. Our goal has been to create the first
non-toxic cancer drug and the first cancer immunotherapy to be
given to head and neck cancer patients before the immune system is
damaged by current standard of care therapy, which includes surgery
and radiation or surgery and combined chemoradiotherapy. Multikine
immunotherapy is being developed to treat advanced primary head and
neck cancer as its first indication. This development path was
chosen because advanced primary head and neck cancer is a very
prevalent cancer for which the overall survival rate has not
improved in decades. In addition, the FDA has not approved a new
drug for this disease indication in many decades. It is a dire
unmet medical need.
As far
as we know, Multikine is the only drug being studied in a Phase 3
trial that is given to advanced primary head and neck cancer
patients before standard of care therapy. Under current guidelines,
there is a limited 3-week opportunity to introduce a new treatment
to help these patients between diagnosis and administration of
surgery. Other drugs used to treat this disease must be given for
periods greater than 3 weeks to observe any effect. Consequently,
other drugs developed for head and neck cancer are directed towards
patients who have failed initial treatment, whose disease has
metastasized, or whose tumors are unresectable (i.e., cannot be
removed by surgery).
Another
key consideration for drugs that will be used as a first line
treatment for cancer is that they must have a favorable toxicity
profile. Currently available cancer drugs do not. A favorable
toxicity profile is critical since patients who receive a first
line treatment will subsequently have their tumors removed
surgically and also receive radiation or radiation plus
chemotherapy, and the inherent risks of surgery plus the very
severe toxicities of the follow-on treatments could cause death. If
Multikine added toxicity to the treatment regimen administered to
the patients in our Phase 3 trial we would most likely not have
been allowed to use it as the first treatment following
diagnosis.
Our
Phase 3 trial was undertaken based on safety and potential efficacy
results obtained in published Phase 2 trials which indicated that
Multikine was used safely and patients receiving the Multikine
treatment regimen prior to surgery had an increased rate of overall
survival. Multikine increased overall survival by 33% in a final
Phase 2 study when compared to published data from 55 clinical
trials in the same patient population. In addition, some Multikine
treated patients experienced complete tumor elimination, confirmed
by pathology, in just 3 weeks before surgery in these Phase 2
studies. The Phase 3 study’s primary endpoint is designed to
show that patients treated with the Multikine treatment regimen
followed by standard of care treatments have an improvement in
survival over those treated with standard of care treatments
alone.
It has
taken over 30 years to bring Multikine to this point. We have given
it all we have. If Multikine immunotherapy shows efficacy in head
and neck cancer, then we believe it will have strong potential
against other solid tumors as well. We look forward to the
completion of our Phase 3 data analysis and are eager to share the
results of this analysis as soon as they become
available.
We
thank you for your patience and continued support.
Sincerely,
Geert
Kersten
Chief
Executive Officer
* 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. Moreover, no definitive conclusions can be drawn from the
early-phase, clinical-trials data involving the investigational
therapy Multikine. Further research is required, and early-phase
clinical trial results must be confirmed in the Phase 3 clinical
trial of this investigational therapy that is in
progress.
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