IIQ: Breakthrough Result - Mass Market Cancer Test Next?

Disclosure: S3 Consortium Pty Ltd (the Company) and Associated Entities own 1,150,000 IIQ Shares and 575,000 IIQ Options at the time of publishing this article. The Company has been engaged by IIQ to share our commentary on the progress of our Investment in IIQ over time.

The new data is here.

Inoviq (ASX:IIQ) has just delivered results for a breakthrough ovarian cancer test.

This morning IIQ announced results of a landmark study showing its ovarian cancer test detected all stage 1 and 2 ovarian cancers - with no missed diagnosis.

IIQ’s ovarian cancer screening test achieved 77% sensitivity at 99.6% specificity in a case-control study.

(Source: IIQ announcement)

IIQ exceeded globally accepted clinical performance criteria for ovarian cancer screening in asymptomatic women (women that show no symptoms).

IIQ now has the opportunity to develop the first-ever population screening tool for ovarian cancer.

Currently, no ovarian cancer screening tests are approved by regulators - due to their poor early-stage detection of cancer.

Catching ovarian cancer early is very important as the cancer does not present any symptoms until it is very advanced...

... meaning higher risk of death and more difficult treatment to get rid of it.

The market needs an early stage ovarian cancer test that can be used by all women (not just high risk ones), and IIQ may have just demonstrated they can develop it...

The big bet now for IIQ is for its screening test to be used by all healthy women periodically for a routine ovarian cancer check.

The data was presented a few hours ago at the world’s biggest cancer conference.

With this data in hand, IIQ can now move straight into clinical development and rapid commercialisation.

Ovarian cancer is the world’s deadliest gynaecological cancer.

It’s the eighth most common cancer in women worldwide.

Ovarian cancer is often called the ‘silent killer’ - as it is usually asymptomatic in the early stages of disease.

(Asymptomatic means someone has a disease but is not showing any symptoms... so they don’t know they have it yet)

Catching cancer early allows for the best chance of beating it.

There are currently no screening tests for ovarian cancer that can be used for all women.

There are screening methods for high-risk individuals - but not for the population at large.

This means IIQ’s product has the potential to be a mass market product for all women given its accuracy and simplicity.

Current tests can be uncomfortable and intrusive - and only done if the woman is already showing symptoms.

Not the kind of thing you would do if you don’t have any symptoms... but this means it’s impossible to catch ovarian cancer early...

But with the data published this morning on the ASX, IIQ could change all of that.

In December, IIQ announced the first data from its ovarian cancer screening test.

This morning IIQ has announced they were able to optimise the results of its ovarian cancer test to reduce the level of false positives.

A big step forward in the development of a mass market product.

The results now show the test to be incredibly specific at 99.6% as well as relatively sensitive at 77%.

These numbers exceed the "internationally recognized criteria for population screening".

Population screening in this context would be IIQ’s test being used by all women to try and detect ovarian cancer EARLY.

IIQ’s test could be used by any woman to see if they have ovarian cancer, without the risks of unnecessary (and frankly quite stressful and traumatic) follow-ups from a false positive test.

(Imagine being told you had cancer, then going to follow up doctor visits and more tests, and then eventually being told “oops, you don’t actually have cancer”... not a pleasant experience at all. This is why screening tests seek to minimise ‘false positives’ as much as possible.

IIQ says that the results exceed globally accepted clinical performance criteria for ovarian cancer screening in asymptomatic women.

Next, IIQ will undertake a “clinical validation study” to ensure that the results can be repeated in a larger sample size and in a clinical laboratory.

IIQ has the opportunity to develop the first-ever population screening tool for ovarian cancer

Ovarian cancer is one of the deadliest cancer types for females, killing ~4.8% of all female cancer patients.

AND early detection is incredibly important for ovarian cancer.

If a woman is diagnosed at Stage 1 - the survival rates can be over 90%.

If a woman is diagnosed at later stages, then the survival rates drop significantly - only 29% of women survive if the cancer is detected at stages 3/4.

The big problem is that ovarian cancer can be asymptomatic in the early stages - meaning most females will never know they had it until it's too late.

For example, ~70% of all ovarian cancer in Australia is diagnosed as stage 3 or 4 cancer...

At the moment there is no way of testing for and detecting ovarian cancer EARLY in women.

We think IIQ’s test could change that after the data published today.

The big bet for IIQ with this test is seeing it become a test that gets sent out to all women periodically for a routine check.

Similar to the way men are tested for prostate cancer...

A couple of hours ago, IIQ presented the following data at the American Society of Clinical Oncology (ASCO) conference in Chicago, USA:

(Source)

The ASCO Annual Meeting is the largest oncology conference in the world with tens of thousands of oncologists, researchers, and biotech professionals attending.

Presenting new data at cancer conferences like this builds industry credibility and visibility for IIQ.

Conferences also present an opportunity for IIQ to lay the groundwork for potential licensing/partnership deals.

There is currently US$323M spent each year on screening for ovarian cancer in high risk patients...

To be able to detect ovarian cancer early, women need to be tested, not just high risk women, which could make the screening market for ovarian cancer a lot bigger than it is today.

The current recommended approach for high-risk women (those with a family history of ovarian cancer, BRCA1/2 mutations, or other risk factors) is surveillance using blood tests and transvaginal ultrasounds.

Transvaginal ultrasounds are uncomfortable, intrusive, and time consuming - not a reasonable option for a screening tool for the population at large.

Next, IIQ will start a clinical validation study, with an Investigational Device Exemption Application (IDE) application scheduled for next year.

The IDE will allow IIQ to enter into larger clinical studies in anticipation for marketing approval in 2028:

(Source)

IIQ aims to obtain Breakthrough Device Designation (BDD) and pursue FDA approval via the Premarket Approval (PMA) pathway.

(BDD would mean IIQ’s test could get FDA approvals a lot quicker)

A pivotal clinical study will be conducted to assess the test’s effectiveness for screening ovarian cancer in asymptomatic, average-risk women.

How does IIQ’s technology work?

IIQ has a proprietary exosome platform with multiple research, diagnostic, and therapeutic applications.

Exosomes are tiny “packages” released by all human cells to help them communicate with each other.

Exosomes are 200 times smaller than a cell.

They work by carrying molecular cargo (like DNA and proteins) that act as cell messages.

These messages can also be used as biomarkers for disease and help humans understand and diagnose whether someone has a particular disease.

Think of exosomes as the “couriers” or “postmen” for messages being delivered around the human body.

They pick up and drop off messages (biological information) to different parts of the body which trigger tailored responses from different cells.

These messages have information, and if IIQ is able to identify what that information is, it is able to detect issues in the body like cancer.

What data did IIQ present at the ASCO conference?

IIQ evaluated over 100,000 exosome biomarkers from plasma, and used machine learning to identify the most informative biomarkers that could screen for cancer.

These were then used to develop a screening test, and the results were collected in December last year.

Since then, IIQ has refined its analysis of that data to create a test that has specificity of 99.6% and sensitivity of 77%.

In diagnostics, there is often an inverse relationship between sensitivity and specificity.

• Sensitivity: The ability of a test to correctly identify those WITH the disease (true positive rate).
• Specificity: The ability of a test to correctly identify those WITHOUT the disease (true negative rate).

When IIQ first collected the data in December, the company said that the “study demonstrated... early stages of ovarian cancer, achieving a sensitivity of more than 90% and specificity of 96% for Stage 1”.

However, in the announcement today, IIQ was able to optimise these results to be incredibly specific 99.6% - without compromising too much on sensitivity, which came in at 77%.

(Source)

In the announcement, IIQ highlighted that the results exceed globally accepted clinical performance criteria for ovarian cancer screening in asymptomatic women.

As we’ve said above a few times, there are currently no screening tests approved for ovarian cancer due to poor early-stage detection.

But if ovarian cancer is caught early, the survival rate is 90%.

IIQ’s test is designed for mass market, early stage adoption in regular risk-women.

Having a low number of false positives is very important for this kind of test.

To illustrate why, let's use an example:

If you screen 1 million healthy women, a 96% specificity would mean 40,000 false positives.

These 40,000 women would then undergo unnecessary, expensive, and potentially invasive follow-up tests (imaging, biopsies, surgeries, etc...), causing significant anxiety, financial burden, and potential complications.

This is unsustainable and unethical for a population screening program for a disease like ovarian cancer.

IIQ’s new results: Lower Sensitivity (77%) with very high Specificity (99.6%)

If you screen 1 million healthy women a 99.6% specificity would mean only 4,000 false positives (0.4% of 1 million).

This dramatically reduces the number of women subjected to unnecessary follow-ups, making the screening program much more feasible and beneficial.

So securing a high level of specificity is crucial to any population screening tool.

Presenting this kind of data at the ASCO conference could set IIQ up for a potential licensing deal later down the line.

Often, big pharma companies will use conferences like ASCO to scout out innovative and groundbreaking technology to potentially invest in.

AND an ovarian cancer screening test could be valuable to companies doing:

1. Diagnostics - the big players in diagnostics would want to get exposure to a test that could screen and detect early stage ovarian cancer...
2. Therapeutics - the big players treating ovarian cancer will want to help develop a test that detects more ovarian cancer... Some of the biggest pharmaceutical companies in the world have approved therapeutics for ovarian cancer including $344BN AstraZeneca.

OR a company that might look to do both... $47BN Roche is working on an ovarian cancer diagnostic test to sit alongside its therapeutics.

IIQ is an exosome technology platform company

IIQ is a platform company, applying its exosome technologies to three different markets:

1. Research Tools (US$661M market size) - IIQ has an exosome-based tool used by researchers to enable biomarker discovery (identifying diseases) and validation (supporting the research of new treatments). This tool is already generating revenues for the company.
2. Diagnostic Products (US$6.1BN market size) - IIQ is developing tests for screening and monitoring for various conditions, including breast cancer, ovarian cancer and neurodegenerative diseases like Alzheimer’s. Today’s ovarian cancer screening results relate to this market.
3. Therapeutics (US$55.3BN market size) - A “weaponised” exosome engineered to target and treat solid tumours.

Here is a breakdown of IIQ’s product portfolio below:

(Source)

More on IIQ’s use of exosomes as a cancer “therapeutic”

IIQ is in the early stages of developing its own cancer therapeutic product, using exosomes to target and kill breast cancer.

In December last year IIQ published data in a proof of concept study that showed it could engineer cells to continuously produce exosomes that specifically target and kill breast cancer cells.

We covered this news here: IIQ successfully weaponises exosomes - cancer cells located and killed in proof of concept study.

In the Proof of Concept study, IIQ was able to kill 30% of triple negative breast cancer cells in a test tube.

IIQ did this by attaching something called a chimeric antigen receptor (CAR) to natural killer (NK) cells which are part of the body's immune system.

Think of a CAR as a targeting device that helps the body's immune system find and kill cancer cells.

This data was so promising that it led to a deal with the prestigious Peter MacCallum Cancer Centre (Peter Mac) in Melbourne.

We cover this news in more detail here: IIQ pairs up with prestigious Peter Mac on potential breakthrough breast cancer research (with a string of catalysts to follow)

With over 47,000 patients, Peter Mac brings more than research prestige, it provides IIQ with access to advanced infrastructure, well practiced preclinical models, and decades of experience in translational cancer research.

The institution is among only a handful globally that combines a dedicated cancer hospital with a fully integrated cancer research program.

That means there is a ready and willing cohort of patients to which cutting edge treatments can be quickly deployed in a clinical setting.

IIQ says to expect more data in the form of mice models in Q3 2025.

A prelude to eventual human trials at some point in the future.

The dream scenario for IIQ is to both diagnose and treat cancer with its exosome technology.

What is next for IIQ?

There’s a lot going on for IIQ.

Here is a quick summary of the key catalysts we will be watching out for over the coming months (the catalyst related to today’s announcement is bolded):

• 🔄Further updates on solid tumour therapy in vivo studies (targeting Q3 in vitro results and Q4 in vivo results with Peter Mac this year)
• 🔄A lab partner for SubB2M tests (for breast cancer monitoring - expected this quarter)
• 🔄Clinical validation studies for the ovarian cancer screening test (expected this quarter) - that’s what today’s news was all about
• 🔄 Development of exosome diagnostic for neurodegenerative conditions like Alzheimer’s and Parkinson's. (Diagnostic development to start in Q3 of this year)

What could go wrong?

Although the data published by IIQ is extremely promising, there is still a risk that the technology fails in a clinical validation study.

The technology is still at an early stage, and while IIQ has limited revenue streams, there are always risks with emerging technologies.

Technology risk

Exosomes are still an emerging field of scientific research, and there may be undiscovered drawbacks to exosomal products, in particular as they apply to therapeutics.

For example, IIQ’s preclinical research on exosome therapies may not yield the desired results or may not be deemed acceptable in the eyes of a regulatory body.

Source: “What could go wrong - IIQ Investment Memo 2024”

To see more risks, check out our IIQ Investment Memo here.

Our IIQ Investment Memo

Our Investment Memo provides a short, high-level summary of our reasons for Investing. We use this memo to track the progress of all our Investments over time.

In our IIQ Investment Memo, you can find the following:

• What does IIQ do?
• The macro theme for IIQ
• Our IIQ Big Bet
• What we want to see IIQ achieve
• Why we are Invested in IIQ
• The key risks to our Investment Thesis
• Our Investment Plan