i. short amount of time by using a

i.              
Introduction of venture, technology and project

 

Correlia Biosystems is focused on the
detection of proteins and through their ANDI (Accelerated, Non-Diffuse
Interaction) gel, they aim to make protein data more accessible in order to aid
the drug development process, life science as well as personalized medicine.
They develop streamlined assay platforms that quantify proteins for proteomic
and pharmaceutical applications. Their first product, the SimpleScan platform,
uses the ANDI technology in order to capture target molecules through a 3D
mesh.

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The technology they have worked on results in
a dramatic cut in time and sample volume required for detecting the proteins.
At the same time, SimpleScan collects more data points per hour from
miniaturized samples compared to other immunoassay systems out there. The
advantages of having a technology that provides results in a very short amount
of time by using a far smaller sample allows laboratories to speed up their
research and development process and hence have more opportunities to keep up
with the emerging markets. Correlia’s first entry market is focused on
pre-clinical drug development and animal testing specifically. The product’s
features enable labs to acquire more and improved sampling data and reduce animal
usage. (Hendrickson, K., 2017)

 

Given the scalability of the technology and
the ability to produce data to assess protein biomarkers in any biological
system, the team decided to explore the cancer diagnostics market. Therefore,
they would like to know who is exploring the market at the moment, if any of
their competitors has considered entering that market, how significant are the
competitors, if there are any gaps within the segment, and finishing off with a
bottom up market analysis.

Image 1: Correlia’s current point of care
testing for medical diagnostics

 

With regards to the cancer diagnostics
market, Correlia is interested in the immuno-oncology treatments. Our immune
system has the capacity of detecting and destroying cancer cells, however there
are cancer cells that grow faster than the immune system is able to kill them
and at the same time, there are other cancer cells that evade detection and
therefore become less visible for the immune system to get rid of them.
Therefore, immuno-oncology aims to reinforce the patient’s immune system so
their bodies are able to better attack the cancer cells. Immuno-oncology is an
emerging market where there are patients participating in clinical trials in
order to defeat their cancer with immunotherapies. However, there are other
scenarios where treatment is paired up with chemotherapy as the reinforcement
of the immune system means that the patients will be less susceptible to infections
as well as other side-effects of chemotherapy. (Biological Therapies for Cancer, 2018)

 

Correlia’s technology comes into play in
immuno-oncology as it is able to detect protein biomarkers. White blood cells
produce cytokines which are signaling proteins, which can enhance a patient’s
immune response and act as a natural killer, inhibit the growth of the cancer
cells and reinforce the immune system. In some cases, such as gene therapy and
adoptive cell transfer, researchers collect the cytotoxic T cells from the
patient’s tumor, then they exponentially grow the cells that have the greatest
antitumor activity and these laboratory T cells are then infused into the
patients which them kill the tumor cells. Correlia’s SimpleScan would be able
to detect the cytokines by using a smaller sample of the patient’s tumor and
then would be able to provide results within 10 minutes rather than the 3 hours
it takes for the competitors to approach the same results.

 

 

ii.             
Companies working on immunotherapy

 

In 2016 the
immunotherapy market was USD $61.9 billion and because of the increasing rate
of incidence in cancer the market is said to be growing. It is important for Correlia
to be aware of the companies that are currently working under the immunotherapy
segment as there may exist a possibility of funding or collaboration in between
them in order to maximize the usability of their technology. The companies that
are leading in the development of cancer treatments within immunotherapy are as
follows:

 

Taplmmune, Inc.

 

Currently
working on the immunotherapy segment and focusing on technology that addresses
several types of cancer in order to target tumors and metastatic diseases. The
technology is catered specifically to address the side-effects and deficiencies
that emerge from cancer vaccines. Yet, the technology also has potential of
being a standalone treatment as well. At the moment, the company is going
through two clinical stage T-cell vaccines in Phase II and Phase Ib/IIa
clinical trials focusing on ovarian as well as breast cancer. Earlier
in 2017, the company announced that, “its lead cancer vaccine candidate,
TPIV 200, received a positive recommendation from an independent Data Safety
Monitoring Board (DSMB) to continue dosing triple-negative breast cancer (TNBC)
patients in an ongoing Phase 2 clinical trial.” It is mentioned that Mayo
Clinic is sponsoring a clinical trial involving around 300 patients with triple
negative breast cancer. The study will be testing the effectiveness of two
immunotherapies, TPIV 200 and AstraZeneca. (F,
PRnewswire, 2017)

 

AstraZeneca 

 

Is a
multinational pharmaceutical company with a variety of products for diseases
such as cancer, cardiovascular, gastrointestinal, neuroscience, among others. In
June 2017, it announced the results from their Phase III OlympiAD trial
comparing LYNPARZA™ to standard of care chemotherapy for patients with breast
cancer, to be positive. The trial results specifically showed that the patients
treated with LYNPARZA™ had reduced their chances, by 42%, of the disease
worsening or death.

 

Juno Therapeutics Inc.

 

Is
investing into creating a biopharmaceutical company with the focus on the
development of innovative cellular immunotherapies in order to treat cancer.
Juno Therapeutics Inc. is under the development of cell-based cancer
immunotherapies from chimeric antigen receptors and T-cell receptor
technologies. With the aim of genetically engineering the T cells in order to
recognize and kill the cancer cells. The technology the company is investing in
serves for the treatment of a variety of B-cell malignancies and at the same
time solid tumors. (F, PRnewswire, 2017)

 

Bristol-Myers
Squibb

 

Bristol-Myers
Squibb is a large American pharmaceutical company that manufactures products
for areas such as cancer, HIV/AIDS, cardiovascular disease, diabetes, among
others. It recently announced the licensing of Phase I for an immuno-oncology
drug from the Japanese company Ono Pharmaceutical with a US40-million-dollar
deal.

The drug
development is focused on a drug intended to target the immuno-suppressive features
in the tumor microenvironment. The collaboration with Ono opens the doors to a
wider oncology portfolio that broadens the range of tumors that could be
tackled. (Adams, B. 2017)

 

At the same time, early in
2018, the company announced a co-led US 75-million-dollar investment with New
Enterprise Associates (NEA), in Personal Genome Diagnostics (PGDx). The
portfolio compromised by the PGDx includes tests designed to identify genetic
mutations relevant to the treatment of multiple cancer types in tissue, blood
or plasma samples. (Taylor, N.P., 2018)

 

Syndax Pharmaceuticals Inc.

 

Syndax is a pharmaceutical
company in clinical stage focused on developing therapies to target multiple
cancer indicators. The company’s leading product is the entinostat which is said to have positive effects on cancer cells
as well as immune regulatory cells, enhancing the body’s immune response to
tumors that have been receptive to immunotherapies. At the moment, entinostat is being evaluated in a
combination therapy in Phase Ib/II with Merck ., Inc. (Report, T.L., 2017)

 

Roche

 

Roche is a European
multinational healthcare company that has several other companies around North
America and Asia with different focuses, and it is the third largest
pharmaceutical company worldwide. One of their companies, Greentech, developed tecentriq, a humanized engineered
monoclonal antibody against the protein programmed cell death-ligand 1 (PD-L1).
Having been in several clinical trials since 2015, in 2016 it was FDA approved
from bladder cancer treatments and in May 2017 it failed Phase III trial for
second line bladder cancer. However, in November 2017, it was the first in the
PD-L1 to be FDA approved for bladder cancer. Even though they were the first
ones to be approved, in the meantime other big pharmaceuticals such as Bristol-Myers
Squibb, Pfizer and Merch were able to dig deep into the development of their
cancer treatments. The company mentioned that a study of tecentriq, avastin and chemotherapy showed a clinically meaningful
reduction in the risk of the disease worsening or it is resulting in death,
compares to only avastin and
chemotherapy by itself. (Carroll, J.)

 

Based on a report published by Statista, the
statistics displaying the top ten pharmaceutical companies based on oncology
revenue in 2016, mention that Roche is leading since it generated 26.5 billion
US dollars in oncology revenue and it is expected to raise 27.8 billion US
dollars in 2022. Likewise, the company that follows is Celgene generating 10
billion US dollar in 2016 and expected to almost double that amount by 2022.
Other companies among the top 10 expected to increase their revenue
significantly in the next 8 years are Novartis, Bristol-Myers Squibb, Pfizer
and Johnson & Johnson.

 

Chart 1: Statista chart
showing Top 10 pharmaceutical companies based on global oncology market share
in 2016 and 2022.

 

With regards
to the immunotherapy market and the trends present, RNCOS published a report
called “Immuno-oncology Report – Global Forecast to 2022”, which provides a
detailed study of the segment as well as insight about the major drivers and
factors impacting the development and growth of the industry. It is mentioned
that the immuno-oncology market has the potential of growing to US $100 billion
by 2022. It is fair to note that the market is divided by products focused on
monoclonal antibodies, therapeutic vaccines and immune checkpoint inhibitors.

 

Potential
opportunities for companies focused on immunotherapy exist, one of them being
the newly released study that mentioned how “decreased plasma DEK oncogene
levels correlate with negative disease and advanced tumor stage”. It is
mentioned that head and neck cancer (HNC) is one of the most common diseases in
the world, hence the importance in studying potential treatments. The study
mentioned investigated if DEK could be detected in human plasma and if the
levels of DEK correlated with clinical and pathological variables of head and
neck squamous cell carcinoma. The results showed lower plasma concentrations of
DEK protein in p16 negative tumors in comparison to normal controls and
patients with p16 positive tumors. Given that HNC is the sixth most common
malignancy in the world, it would be interesting to see how companies react to the
news about the DEK protein.

 

 

 

iii.           
Correlia competitors working under
cancer diagnostics

 

Correlia’s competitors are those companies or
products that integrate complex assays or other immunoassays and provide
results for pharma and diagnostics use. The top competitors identified are
SimplePlex, MesoScale, Quanterix, and Luminex. Correlia’s value proposition
mentions how their technology differs from their competitors, however for this
report it is important to explore how far these other companies have gone into
the development of their technologies in order to adapt to the cancer
diagnostics segment.

 

For instance, MesoScale
offers singleplex and multiplex assays that measure biomarkers such as
phosphoproteins, intracellular signaling proteins and biomarkers related to
angiogenesis and apoptosis. At the moment, the company is under development for
a blood-based proteomic test that will study the risk of colon cancer in patients,
using dried blood spots as a sample source. It is mentioned that running the
test would cost less than $150 and potentially in the future this could
decrease to $50 or less.

 

SimplexPlex
PD-L1 ELISA is a potential predictive cancer biomarker that can suppress the
immune response against a tumor. PD-1 and PD-L1 are both immune checkpoint
proteins that can prevent the T cell response. The SimplePlex technology is an
automatic format for detection of PD-L1 from human serum and plasma. It is fair
to mention that ELISA is one of the most used and popular immunoassay
technologies in the market at the moment.

 

 

 

Quanterix
is a company that automatized biomarker analysis, and have
recently announced their SR-X Ultra-Sensitive Biomarker Detection System. The
instrument allows researchers to detect ultra-sensitive proteins and nucleic
acid in an affordable manner. The system also provides flexibility to alter and
design assays to identify proteins directly from blood. (Kaufman, L. 2018)

 

The company filed for an IPO in December 2017
offering 3.3 million shares at a price range of $14 to $16 and raised US 64
million dollars. Nasdaq published an article mentioning that depending on the
success of Quanterix’s “Simoa” technology, if it was able to surpass its
competitors such as Luminex, then the company would potentially have access to
and estimated US 30-million-dollar market. (US
IPO., 2017)

 

Even though it looks like all of Correlia’s
major competitors have already explored and adapted their technologies in order
to compete in the cancer diagnostics sector, Correlia has the advantage of
having a very quick result response compared to the other competitors. Looking
at the table below, it seems like none of their competitors which are in the
cancer diagnostics sector are even close to delivering results in such a short
amount of time. Which means, that if Correlia’s is able to maintain their
competitive advantage over the other companies when entering the new market,
there would be a clear differentiation and opportunity for them.   

 

 

Product

Result speed

Sample size

Data quality &
Sensitivity

SimplePlex

3 hours

MesoScale

4.5 hours

Quanterix

2.5 hours

Luminex

2.5 hours

Correlia’s SimpleScan

10 minutes

25x improvement

100x improvement

 

 

 

 

 

 

 

 

 

 

However, Correlia should also look into which
of their features is more important to clinics when diagnosing cancer and then
advertise their product accordingly. Derived from general knowledge, it seems
like the speedy results would be an important factor that clinics would be
interested in, as this would allow them to make decisions faster and at the same
time move into talking about treatment methods sooner than if the utilized another
instrument. Correlia should talk to clinics and specifically check to see if
this is a feature that is critical for the process of the cancer diagnostics.

 

 

 

iv.           
Market analysis

 

The global cancer biomarkers market is worth
US 11.53 billion dollars in 2017 and is expected to reach US 20.48 million
dollars in 2022, with a compounded annual growth rate of 12.2%.  

 

With cancer becoming more fatal and common
disease, there have been increasing adoption of new tests, and a shift is seen
where clinics are now switching from the blockbuster drugs to more personalized
medicines, which are now, due to technological advancements, become more
accessible to the public. The increase rates of cancer, as well as the
incrementing costs of treatments have spiked up the demand for alternative
treatments. This has driven companies to explore new technologies and invest in
other therapies, drugs and treatments for cancer. Therefore, this increase in
interest for alternative methods, such as research and development sectors of pharmaceutical
and biotechnology companies have served as a catalyst for medical device
companies to be up to date with the science and technology’s potential. The
increase in funding and grants being provided by government agencies have
consequently driven more research facilities to focus on companion diagnostic
tests in oncology.

 

Within the biomarker segment, a report
mentions that the epidermal growth factor receptors segment was the largest
within the global companion diagnostics testes in the oncology market for the
year 2016. Meaning that for the next couple of years, it is expected to
register the highest compounded annual growth rate, due to the increasing
amounts of lung cancer and at the same time the growing investment into
research and developments for biomarkers.

 

The breast cancer segment accounts for the
largest portion of the global companion diagnostics tests in oncology market in
2016, and the lung cancer segment accounts for a large amount as well. Lung
cancer is expected to surpass breast cancer in the compounded annual growth
rate for the next 8 years as the incidence rate is increasing especially in
developing nations. The World Health Organization (WHO) estimated over 1.9
million new cases of lung cancer to be diagnosed in 2013 alone, and the statistics
then showed that the less developed regions, such as China, India, Latin
America, had the highest rates. These developing nations are seeing an increase
in the diagnostics of lung cancer due to the increased smoking habits as well
as the unhealthy air quality citizens are surrounded by.

 

Geographically speaking, due to the focus on technological
developments and the availability of resources and expertise, it is expected
that North America will be leading the global cancer biomarkers market in the
upcoming years, followed by Europe. The Cancer Biomarkers Market – Global Forecast
to 2022 report written by MarketsandMarkets mentions that “The major players in the cancer biomarkers
profiling technology market are Abbott (US), Affymetrix (US), Roche (Switzerland),
Illumina (US), QIAGEN (Netherlands), Agilent (US), Thermo Fisher (US), Merck
(US), Becton Dickinson (US), and Hologic (US)”. (Cancer Biomarkers, 2017)

 

With regards to biomarkers, the protein
biomarkers segments are expected to account for the largest portion of the
total global cancer biomarkers market. It is mentioned that this will be
resulted by potential the protein biomarker tests have in order to detect,
diagnose, and identify therapeutic applications, as well as the low cost of
conduction.

 

 

 

v.            
Conclusion

 

Having gone through the different features
that Correlia has to offer with their SimpleScan technology, it is evident that
they have succeeded in the current drug development sector as they have
differentiated themselves from the other companies in the immunoassay market.
Correlia is known for their technology being able to provide results in a very
quick manner, for the laboratories having to use less of the sample in order to
run the tests, and for their increasing quality and data points when analyzing the
results.

 

Within the pharmaceutical industry, and the immuno-oncology
segment specifically, there are several large leading companies who are working
on innovative drug development and invest into research and development. Even
though they are very large companies that have a lot of capital to effortlessly
invest into the innovative technologies, it is important to be familiar with
them and the methods and treatments that are working on. Knowing about large
pharmaceuticals grants smaller companies opportunities of potentially partnering
up with them or learning from the process and the mistakes or roadblocks they
face.

 

It seems like all of Correlia’s direct
competitors are already in the cancer diagnostics sector, however this should
not discourage them to enter the market sector. Comparing the features offered
by the competitors, Correlia has a clear advantage on the time taken for their
technology to provide results and therefore this would be a very provocative
feature that would make laboratories and clinics choose SimpleScan versus the
other instruments. Likewise, the market analysis section highlights the potential
the cancer biomarker segment has and the trend that shows the growth to come.