Avacta Group plc (LON:AVCT) Chief Executive Officer Alistair Smith caught up with DirectorsTalk for an exclusive interview to discuss the various covid-19 related tests, the key points from the lateral flow rapid antigen test announcement, progress on other tests, taking the preCISION pro drug into the clinic and what other updates we can expect in the coming months.
Q1: Now, Avacta Group is developing several COVID-19 related tests, could you remind us what they are please?
A1: The first of those is the BAMS assay, and that’s a laboratory assay designed to be used in hospital clinical microbiology labs using the installed base of equipment called mass spectrometers, which are currently not used actually for COVID-19 testing. This opportunity to add to the total capacity for hospital testing, alongside PCR, has now been recognised by the UK government, and there’s a pilot study which was announced last week. The test incorporates Affimer reagents that capture the coronavirus spike protein from a clinical sample, such as a swab or saliva sample, and then, the antigen, the virus, is detected using the mass spectrometer. It’s a very sensitive, very specific, high throughput assay capable of running a thousand samples a day on each mass spectrometer.
The second product is an ELISA, which we’re focusing on the research market and ELISA tests are a mainstay of life science’s research. The ELISA that we’ve developed to detect and quantify the SARS-CoV-2 spike protein in a range of different sample types, that was the first step that we took towards developing the other diagnostic products with partners. It’s a really, really good ELISA, and in fact, it’s the best performing ELISA that we’re aware of so we’re launching it commercially to give researchers, globally, another tool to help in the study of the coronavirus.
And of course, we’re developing a rapid antigen lateral flow test. This is a simple test, it looks rather like a pregnancy test, and it can be used to determine whether the individual is infectious or not, with the SARS-CoV-2 virus using saliva or swab samples in just a few minutes.
Q2: Now, this morning you provided the market with an update on the lateral flow rapid antigen test. Could you just take us through the key points of that update please?
A2: We’ve made significant progress with our partners, BBI Solutions, in the development of the scaled up manufacturing process for the lateral flow test. The important news today is that we now have a test that’s performing very well in laboratory tests with a sensitivity in the range that we expect in clinical samples, and it is highly scalable from a manufacturing perspective so that’s a major milestone that we’ve achieved.
We’re now starting a clinical evaluation of the performance of the device and we’re going to do that initially using anterior nasal swab samples, but we continue to develop the saliva test in parallel. There’s been plenty of commentary about how challenging saliva is as a sample, but in fact we’ve made very good progress with saliva, it hasn’t been straightforward, and so we’ve also been using these anterior nasal swabs.
An anterior nasal swab samples the very front part of the nose, in the nostril so it’s simple, painless, very easy to use, very simple to get a sample in that way and can be used by professionals and consumers alike.
BBI Solutions are going to continue to finalise the manufacturing process and validate that, whilst we begin to gather the first clinical data so that we’re in a position to go into the full clinical validation of the final product as soon as possible, at clinical trial sites that we’ve already lined up in the UK and Europe.
Q3: Regarding the other COVID-19 test products that you’ve mentioned, can you just describe the progress that you’re making with those?
A3: The BAMS assay is in the middle of a clinical evaluation right now, that’s at two hospital sites and two universities in the UK that we have established under its own steam. We’re going to use the feedback from these evaluations to make any necessary final tweaks to the protocol before moving into the formal clinical validation of the product, which we will CE mark for professional use in the UK and Europe.
We’re also making very good progress in terms of securing large commercial partners to take both the BAMS and the ELISA products to market with us.
Q4: Despite the intense focus on COVID-19, AVCT is preparing for a major milestone in its therapeutic division, taking the first preCISION pro-drug program into clinic. Are you on target to file the regulatory submission before the end of the year?
A4: Well, it’s a major value inflection point for the company as we transition the therapeutic division into a clinical stage biotech taking AVA6000 Pro-Doxorubicin into the clinic early in 2021. AVA6000, as I’m sure you remember, is a form of the well-known chemotherapy Doxorubicin that’s been modified using our proprietary preCISION chemistry so that it’s inert when it’s given to the patient, becomes activated predominantly in the tumour. This means that the body is spared the systemic exposure to the chemotoxin, which is more targeted to the tumour.
So yes, we’re on target to submit the CTA, the regulatory submission in the UK, by the end of the year, we’re finalizing the regulatory documentation now, and when we receive approval from the MHRA that will allow us to dose first patients, which should be early in Q2 of 2021.
Q5: Finally, when can we expect the next update?
A5: I’m going to continue to update the market as and when we meet major development and commercial milestones, when there’s material new information to provide to the market. And clearly there’s a lot going on right now in Avacta Group so I don’t imagine it’ll be that long before we speak again.
