We were incorporated in the State of Nevada on November 16, 2009 under the
name “Online Disruptive Technologies, Inc.” with authorized capital
of 500,000,000 shares of common stock with a par value of $0.001 per share and
20,000,000 shares of preferred stock with a par value of $0.001 per share. On
March 24, 2010, we entered into a share purchase agreement with Benjamin Cherniak,
whereby we acquired all of the issued and outstanding shares of RelationshipScoreboard.com
Entertainment, Inc. (“RSE”) in consideration for the issuance of
16,000,000 of our common shares. RSE was incorporated in the State of Nevada
on November 16, 2009. There were no related party interests in the acquisition
of RSE.
The Savicell™ platform is a blood test designed for the early detection
of disease. It is a broad platform with applications for cancer, autoimmune
diseases, and infectious diseases. While our focus initially is on early diagnosis
of disease, we believe our technology may have additional applications in drug
response monitoring for therapies that impact immune response. Immunotherapy,
both for treating cancer and autoimmune diseases, is an example where metabolic
shift profiles could indicate response to drug treatment.
Initially, Savicell is focused on the multibillion-dollar cancer diagnosis
market. Savicell deploys Well-Shield™ technology, a Liquid ImmunoBiopsy™
diagnostic platform. In contrast to existing technologies that evaluate secretions
of cancer cells, Well-Shield’s ImmunoBiopsy platform receives data directly
from the immune system. Importantly, Well-Shield is different in that it is
a functional test measuring the metabolic activation profile of the immune system
as an indicator of disease status. As an immune system test, it is inherently
suited for early detection.
The technology has now received intellectual property protection with a patent
approved in the United States, China, Japan and Europe. Furthermore, the patent
process is ongoing in several other countries.
Disease intrusion and cell malformation, including cancer, are first detected
by the immune system, which energizes to rid the body of the malignancy. The
initial immune response to disease is intricate, deploying different metabolic
pathways and subtypes of cells. The Well-ShieldTM technology is designed to
detect and interpret these differential metabolic responses.
The Savicell vision is to develop and commercialize a line of patient-friendly
blood tests that enable early diagnosis, staging, and monitoring, thereby saving
lives and ensuring appropriate treatment. Cancer is our initial focus.
The need for early diagnosis
Cancer cases are increasing, with more than 20 million new cases predicted
in 2025, compared to 12 million in 2008. Early detection is very important because
it can improve outcomes. Typically, more treatment options are available when
cancer is diagnosed early, and survival improves. In the United States, the
five-year survival rate improves by at least four times with early diagnosis
and before cancer has spread. Unfortunately, to date, the majority of cancer
patients are diagnosed at later stages.
While surgical biopsies are the norm, they are invasive and expensive. The
need for simpler and more efficient processes for cancer detection has incentivized
some 38 companies in the United States to work on creating liquid biopsies.
In a 2015 report, investment bank Piper Jaffray valued the potential market
for liquid biopsies at $29 billion in the United States alone.
Using technologies based on circulating tumor cells, exosomes, and circulating
tumor nucleic acids, liquid biopsy companies are making progress in developing
products that have advantages versus current technologies. However, it appears
more likely that these types of liquid biopsy technologies best support late
stage cancers, with technical challenges remaining for early-stage cancers and
early cancer screening.
In contrast, the Well-Shield patented ImmunoBiopsy platform is unique in the
Liquid Biopsy market. And we believe that as an immune system functional test
it is inherently better suited for early detection.
Product focus
Savicell conducted clinical work for tests specific to breast and lung cancers
in multiple medical centers. We had encouraging early reviews of our breast
cancer and lung cancer analyses albeit on relatively small sample sizes. Specifically,
we distinguished between breast cancer patients and healthy donors, and lung
cancer patients and healthy donors, with high sensitivity and specificity of
greater than 95% in both cancers. In addition, we were able to show that there
is a metabolic profile difference between other breast disease donors and breast
cancer donors and between COPD (chronic obstructive pulmonary disease) donors
and lung cancer donors.
Based on this early potential, Savicell has decided to focus our resources
on lung cancer as our lead product. We are working to increase the population
size of the lung cancer clinical test and continue to fine-tune a predictive
algorithm to identify lung cancer. Early results of this effort generated promising
cross-validation of 72 donors from our clinical study. This cohort includes
36 diseased donors, together with a control group of 36 age- and sex-matched
healthy donors. In practice this means that every lung cancer (patient) donor
in the cohort was matched with a healthy donor of the same gender and similar
age. This practice helps us control for sampling biases.
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