Cizzle Biotechnology Holdings plc (LON:CIZ) Chairman Derek Bickerstaff caught up with DirectorsTalk to discuss the company’s new letter of intent with an NHS-affiliated diagnostics partner to validate and commercialise the CIZ1B early cancer test.
Q1: You have announced the signing of a Letter of Intent with a leading medical diagnostic service provider acting in partnership with the NHS. Can you just explain for us what the Letter of Intent covers and how this fits with your go-to-market strategy for the CIZ1B test? I understand that for commercial reasons, their name is confidential at this time.
A1: We are obviously delighted that we have got to the stage of a Letter of Intent with this group.
I always like to start off these interviews with just a sobering thought about how important it is to diagnose lung cancer early. It helps me remind ourselves why this is such an important task that we are doing and the progress that we are making. I think I always start off by just reminding ourselves that lung cancer is the biggest killer of all the cancers, and today 5,000 people will lose their life to this disease.
For us, it is a passion that we have to try to address that problem. Partly using a licensing strategy, we seek partners around the world that can adopt our proprietary CIZ1B biomarker test for helping detect lung cancer early.
So, this is a stage in the milestones that we have set out for the business to find partners that can do that. We’ve already established a partnership in the United States with a company which we use the same name, Cizzle Bio, they have been making great progress in bringing the test to market there.
But this test was developed here in the UK, it is a UK test developed by Professor Dawn Coverley at the University of York and her team, and they have spent many, many years looking at this particular biomarker and it seemed to us that really, we should be having this test here in the UK. That largely means working with the NHS so finding partnerships that work with the NHS was a critical milestone in our strategy. It is a global licensing strategy. We are a very small virtual business; we keep very low overheads in the business so our strategy is to work with larger partners that have reach and access to clinicians and most importantly can provide the service to patients.
So, we’ve been working very hard since we signed our deal in the United States to do something similar here and that has resulted in a Letter of Intent with a group that, as you say, is confidential at this time. The importance of that is to find access to the NHS, to those clinics around the country that can deliver an early diagnostic test for lung cancer. That’s the reason why this is such an important step for the company today.
Q2: How does the proposed partnership align with the NHS cancer plan to improve early detection rates by 2028? What can Cizzle and its test potentially do for the NHS and for us in the UK?
A2: Well, first off, aren’t we lucky to have the NHS? It is a gold standard of health care in the world, but it suffers because it’s so good. Many of us forget how good it is unless you’ve been in there having their fantastic service they provide. They’re under stress because so many people do want the services of the NHS and the great doctors and nurses and staff that support it. That’s recognised, and we all know that there are long waiting lists. We know there are challenges with providing services and care to patients through the NHS, and, of course, cancer is one of those areas of great importance.
So, the NHS does have a five-year plan to address the problems that it faces, the challenges it has, reducing waiting times. But in the field of cancer, there’s a very specific element of that five-year plan that really, put it simply, is look, we need to diagnose people faster and we need to diagnose diseases early. If we can diagnose cancer early, we will save lives and so that is actually core to one of the pillars of the NHS plan.
We align with that perfectly because at the end of the day, early cancer detection will save lives and, in our case, using the CIZ1B biomarker as a simple blood test, our view is we can help in that process. We can help provide faster, broader access to early cancer testing and more importantly, we can catch those cancers when they’re very early in their stage one and two positions so that the cancer is curable, it’s curative, it’s something that you can address. It’s a sad fact that the reason why those large numbers of people lose their lives each year to cancer is because they’re diagnosed too late.
So, everything we can do to try and diagnose these things much earlier will ultimately save lives. Certainly, in the NHS, and I quoted it in my RNS, that’s going to lead to potentially savings of tens of thousands of lives in the next few years. So, from our viewpoint, we feel very aligned with those goals and we hope that our tests will help in saving lives.
Q3: Just going into a bit more detail, though. What steps will be involved in the validation and commercialisation process of the CIZ1B biomarkers under this agreement?
A3: Well, the good news is we’ve already started. So, we announced our Letter of Intent and we’ve begun the process immediately with a laboratory in the UK. That requires a, if you like, verification and a validation process. We have to replicate in those labs exactly the same type of results as we get in the research labs at the University of York, and for that matter, the same as the commercial laboratories are doing in the United States.
That means the test has to be reliable, has to give the same result each day, it has to be reproducible. We have to determine that in a more commercial laboratory setting, that the test is going to give the right result each time it’s being used. That process has begun; it’s a validation and a verification process that will take some weeks to complete.
From that point onwards, we’ll move into verifying it on known patient samples and that will eventually move us then into a full negotiation period with this group, where we hope we’ll be able to generate similar licensing arrangements as we have in the United States.
Q4: How does this UK partnership complement Cizzle Biotechnology’s existing licensing agreement that you do have in North America and support its broader global expansion strategy?
A: I said very early on in the interview that we are a business that’s developed fantastic technology in terms of the Cizzle biomarker, but it requires partnerships to make that globally available to anybody that wants to benefit from the test. That means, therefore, working with expert clinical groups around the world.
We chose the United States as the first target simply because they have a well-established means within their laboratory set up across the States to provide so-called laboratory developed tests early to patients. That was a licensing arrangement that we set up, it generates for Cizzle, a royalty income, and in the United States, it’s an exclusive deal, which means that we get guaranteed royalties for the first $2.4 million, of which we’ve already received over $500,000 of that. So that’s been very valuable to the business.
We want to roll out similar models elsewhere in the world. As I said early on, it’s very important for us to bring the technology to bear here in its birthplace back in the United Kingdom and ensure that people here in the UK benefit from the support that the research councils and particularly Yorkshire Cancer Research provided in the very early days of getting this test from its origins in the research lab to become a commercial test.
So, it’s a similar arrangement, it will be the similar verification process, it will be the similar deal that we are seeking to partner with somebody that has broad access across the United Kingdom. Hopefully, we’ll be able to roll that out elsewhere in Europe and then onwards throughout the world.
These are very parallel relationships. It’s very much the same type of validation process, it is a very similar way in which we, to our shareholders, bring benefit from the viewpoint of having a royalty based, if you like, revenue sharing process and that’s yet to be negotiated from the Letter of Intent. Obviously, the next steps post that verification process are to achieve that.
Eventually, if we can do that elsewhere in the world, particularly down in Asia, we’ll move it into other key markets such as Latin America, the Middle East, elsewhere.
It’s a global problem. We have a global solution in a very simple, easy to use blood test that can help early cancer diagnosis. If we can roll that out as far as we possibly can, then hopefully we can make a big difference. Instead of losing 5,000 lives a day, we’ll hopefully shrink that number considerably. So, that’s a great goal for us and something fantastic to come out of the UK.
