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CEL-SCI CORPORATION
8229 Boone Blvd., Suite 802
Vienna, Virginia 22l82
(703) 506-9460
February
2020
Dear
Fellow Shareholders:
A long
time ago we set out to create a cancer drug that addresses the
following concerns:
●
has little to no
toxicity,
●
extends life, or
better yet, aims to cure cancer patients and
●
is not
prohibitively expensive.
Even in
those days, when the so-called experts ridiculed our efforts and
goals saying ‘it could not be done’, we believed that
the immune system held the key to our health and ability to
effectively fight cancer. The challenge we faced was how to develop
a medicine that can harness the immune system’s power to
fight cancer. Now the application of immunotherapy in the treatment
of cancer has gone from “it can/will not work” to
“this is the future.” Today’s cancer
immunotherapies are generally being developed for patients who have
already had surgery, radiation and/or chemotherapy or for patients
for whom surgery is not an option. These patients usually also have
compromised immune systems. The Phase 3 trial of our
investigational cancer immunotherapy, Multikine* (Leukocyte
Interleukin Injection) is designed to demonstrate that we can be
even more successful in increasing the overall survival (OS) of
cancer patients when we stimulate their immune systems before they are ravaged by the
effects of surgery, radiation, and/or chemotherapy.
The
global pivotal Phase 3 clinical trial, which we started nine years
ago for our Multikine immunotherapy in advanced primary head and
neck cancer patients, tests the hypothesis that giving the
Multikine treatment regimen right after cancer diagnosis, BEFORE
surgery, radiation or radiochemotherapy, will increase the OS of
patients beyond the OS achieved with the current “intent to
cure” standard of care (SOC) therapies. In short, we seek to
make the current “intent to cure” SOC treatment more
successful. And we hope to do so with little to no toxicity added
by our Multikine immunotherapy. Our first goal is to prove this
concept in the treatment of newly diagnosed patients with advanced
primary head and neck cancer, about 4% of all cancers. This is an
indication in dire need of a new and effective treatment because
the last drug approved by the U.S. FDA for this indication was
about 60 years ago, and just about everyone agrees that the current
treatments are horrible and fail to properly address this unmet
medical need. We hope to extend this concept to other solid tumors
as well should our Phase 3 trial be successful.
We
started accruing patients to our Phase 3 study in early 2011 and
completed enrollment of 928 cancer patients in September 2016. Per
the study protocol, 298 deaths (events) will have to occur in the
two comparator groups (Multikine treatment regimen plus SOC vs. SOC
alone) in order to determine whether the study’s primary
endpoint, a 10% increase in overall survival in favor of the
Multikine regimen treatment group, has been achieved.
Based
on the known survival statistics available for the patient
population in our study when we initiated our Phase 3 trial, we had
expected to have reached the required 298 events some time ago.
Clearly, it is a good thing when these very sick stage 3 and 4
cancer patients live longer and/or do not die. In fact, that is the
goal of the study. Since we are blinded to the details of the study
results, we cannot know definitively whether it is our
investigational immunotherapy Multikine treatment regimen or
something else that is responsible for patients living longer.
Nevertheless, it would not come as a surprise for us to see a
survival benefit from our Multikine treatment regimen in the Phase
3 trial because we saw an approximate 33% survival benefit in our
final Phase 2 study. In that final Phase 2 study, the Multikine
treatment regimen was administered to patients just as it is in the
Phase 3 study. Also, the final Phase 2 study showed, by pathology,
that in just three weeks of administering our Multikine treatment
regimen, 100% of the tumor was eliminated in some patients and
approximately 50% of the tumor was eliminated in many of the other
patients. Twenty-four regulators, including the U.S. FDA, gave us
permission to run our pivotal Phase 3 clinical trial based on these
clinical results and other data.
We have
discussed at great length, internally and with outside experts,
what factors, other than the Multikine treatment regimen, might be
contributing to what appears to be a better than expected survival
in this Phase 3 study. The most obvious factors to consider are 1)
the treatments that patients are receiving, either as the first
line treatment (SOC) for newly diagnosed cancer or as treatment of
a tumor that has recurred, have improved during our Phase 3 trial
or 2) the apparent increased survival of the patients in our study
is related to the dropout rate of patients since that would reduce
the sample size from which events can be collected.
To help
us evaluate these factors we engaged an independent statistical
group and asked them to determine if the survival of patients with
squamous cell carcinoma (cancer) of the oral cavity and soft palate
(the same patient population as we enrolled in our Phase 3 study)
treated in the U.S. presumably with the same SOC and in the same
manner as the patients in our Phase 3 study, had changed during the
time patients were enrolled and treated in our Phase 3 study. The
statistical group analyzed the most recently available data from
the U.S. Government National Cancer Registry called SEER. The
Cancer Registry contains data about, among other things, cancer
patients’ disease diagnosis, staging at diagnosis, treatments
administered, and survival of specific cancer populations in the
U.S. The survival data in the U.S. available from the SEER Cancer
Registry for the types of patients treated in our Phase 3 study
during the same time our study was conducted indicated that these
patients had only a 47% survival at three (3) years and a 37%
survival at five (5) years, establishing that the survival in
treating those patients who had been receiving the best SOC
treatments available in the U.S. did not improve during our long
Phase 3 study. That means that the SOC treatment and any follow-up
treatments once the cancer recurred do not look to be responsible
for the patients apparently living longer in our Phase 3
study.
After
treatment with Multikine and the SOC, the patients enrolled in our
study can take any medicine if their tumor recurs. We therefore
considered the possibility that the introduction in late 2016 of
Keytruda and Opdivo, two new cancer immunotherapy drugs for
recurrent head and neck cancer, might be responsible for the lower
than expected death rate in our study. We do not think that this is
the case based on the following: 1) The use of Keytruda and Opdivo
as a treatment should already be accounted for in the SEER database
results which were evaluated since these drugs were used in the
U.S. for patients with recurring disease. 2) Our study was enrolled
in 20+ countries and these drugs were not available in many of
those countries during the time patients were enrolled and treated
in our study. In most of those countries Keytruda and Opdivo are
still not available, even today. 3) Keytruda and Opdivo show a
survival benefit of about 3 months in head and neck cancer once the
initial treatment has failed and the tumor recurs. Any patient who
received a 3-month survival benefit from Keytruda or Opdivo would
already have passed on since the patients in the Phase 3 study
entered/completed treatment between 3.5 and 9 years ago.
Therefore,
the delay in reaching 298 events in the Multikine Phase 3 study
should not be due to Keytruda and Opdivo.
We do
not think the increased survival of the patients in our study is
related to the dropout rate of patients either. While we are
blinded to the study results, we have never heard from the CROs who
run the study that the dropout rate is a problem. In addition, the
actions by the Independent Data Monitoring Committee (IDMC) speak
against that as well. The IDMC, which meets periodically to review
the study and data in an unblinded manner (i.e., they see
everything) is tasked with focusing on the following
areas:
●
Efficacy: to assess
the primary efficacy measure as well as the conditional power and
sample size
●
Safety: to assess
the magnitude of adverse events and monitor for safety
concerns
In
reviewing the conditional power and sample size the IDMC would be
considering the dropout rate. If there was a problem with the
dropout rate, then per the Charter the IDMC is required to tell us
to enroll more patients. They have not done so. As recently as
October 2019, the IDMC recommended “…to continue the trial until the
appropriate number of events has occurred”. In their letter
to us they said that they reviewed “…progression free
and overall survival and limited demographic and safety data
available for the aforementioned protocol.” This language
tells us that they are following the guidelines outlined in their
charter.
We are
treating newly diagnosed cancer patients, hoping to improve the
“intent to cure” treatment, and our Phase 3 trial is a
very large event driven overall survival study, the ‘gold
standard’ of studies for approval of cancer drugs. Patients
have already been in our Phase 3 study between 3.5 and 9 years, and
some people are asking how much longer our study will have to last.
We knew from the start that since the study is event driven it
might take longer to complete than we had estimated, however, it is
taking even longer to complete than we thought. Many of our
shareholders think that simply because it looks as if things are
going well, the study should end before 298 events are reached so
the product can be made available to help patients. This thinking
is incorrect for our situation due to the event-driven study
design.
It is
now established that patients treated with cancer immunotherapy, in
contrast to cancer patients treated with other modalities (surgery,
radiation and chemotherapy) may receive a delayed survival benefit.
Bristol Myers Squib’s (BMS) event driven overall survival
study of their blockbuster immunotherapy drug, Yervoy, which was
developed for the treatment of metastatic melanoma, proved this
concept. At 5 years follow up of patients in a 3 year study of
Yervoy they observed a significant separation in the survival
curves between the immunotherapy treatment regimen and SOC groups
indicating great survival benefit from Yervoy. Had BMS not
continued to follow up with the patients in their study beyond
three years, this valuable information would have been missed.
Since the statistical power to prove the clinical benefit in our
Multikine study is derived from the number of events, regardless of
cause or when they may occur, if our study is ended prematurely we
could miss valuable data and not have sufficient statistical power
to prove Multikine’s benefit. Yervoy went on to become a huge
success helping many melanoma patients. We hope that, as with
Yervoy, the delay we are experiencing in reaching the required 298
events in the 2 comparator groups in our study will be an
indication that patients who were treated with the Multikine
treatment regimen are receiving a delayed survival
benefit.
We are
blinded to the Phase 3 study results. However, it is clear that
there is something occurring in our study that is keeping patients
alive longer than expected. By eliminating the factors other than
Multikine that could contribute to this observed delay in reaching
the required events, and because it is now established that cancer
immunotherapy can produce a delayed survival benefit, we believe
that Multikine is likely producing some kind of a survival benefit,
just as it did in the final Phase 2 study. We are treating advanced
(stages 3 and 4) primary (just diagnosed and not yet treated) head
and neck cancer patients who have cancer in the worst anatomical
regions with regard to survival outcome. They simply do not get
better on their own. In its annual reports published in January
2019 and January 2020 the American Cancer Society indicated that
deaths in oral cancer patients have increased during the past 10
years. This report confirms that the current SOC treatment or
treatments that patients are receiving if their tumor recurs have
not improved in the nine years since we started our Phase 3 study
and validates that an extreme unmet medical need still exists for
these patients.
We
believe that we are nearing the end of this long Phase 3 study, and
we hope the results will prove that stimulating the immune systems
of cancer patients with Multikine to fight cancer BEFORE they are
ravaged by the effects of surgery, radiation, and chemotherapy will
help these patients to survive longer.
And if
we can do so with little to no toxicity as we did in our earlier
Multikine studies, then we will have made a huge contribution to
the cancer armamentarium.
We
thank you for your support. We believe!
Sincerely,
Geert
Kersten
Chief
Executive Officer
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,
areintended 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/A
for the year ended September 30, 2019. 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 otherregulatory 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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