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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.

Avacta Group plc (LON:AVCT) Chief Executive Officer Alastair Smith caught up with DirectorsTalk for an exclusive interview to discuss interim results, major milestones in the next 3-6 months, COVID testing developments and appointing Stifel as joint broker.

Q1: Now, you have reported
on progress for the six month period up to the 30th June, how would you summarise
the progress made during this period?

A1: Well, given the
extraordinary circumstances that everyone’s been through, to have achieved the
financial and the operational performance that we have makes me very, very
pleased indeed. I’ve said it before but I have to say that’s a reflection of
the attitude and commitment of my colleagues in Avacta Group who have dealt
with the challenges and the risks that the pandemic has presented and just
simply got on with it.

So, it’s been a period of
continued solid progress in the therapeutics division, moving AVA6000 towards
the clinic with the CTA filing expected before the end of the year and we’ve
maintained really good progress in our partner programs with LG, Daewoong and ADC
Therapeutics.

It’s also been, and continues to
be, a period of extraordinary growth really in the diagnostics division so there
are multiple opportunities as everyone knows in the area of COVID testing
created by the generation of Affimer binders to the virus.

In addition to that, the team in Wetherby
has positioned the company for ISO 13485 accreditation later in the year and
expanded the production and assay development facilities.

So, all in all, in spite of the pandemic, it’s been a really excellent period of growth from the Group.

Q2: Just looking forward, what are
the next major milestones that you expect to be hitting in the coming months,
say 3-6 months?

A2: So, I would put that
into three groups, first of all the movement of AVA6000 pro-doxorubicin to the phase
I clinical trial for that that asset. As I said, we’re aiming for a UK
regulation filing, a CTA, before the end of the year and then expecting to dose
first patients in the first quarter of next year as well as the back backend of
the first quarter of next year. So, both of those very much newsworthy
milestones. Then we would expect to see that first meaningful data from that
phase I study around the middle of the year,  Q3 next year, and again, that’s an important
newsworthy milestone.

The second group of milestones I would
place around the coronavirus antigens testing so in terms of the rapid antigen
tests, the lateral flow test, aiming for clinical validation for professional by
the end of the year. So, as I say, initial self-certification for professional
use and then as much in parallel as we possibly can doing the work for CEO marking
for consumer self-testing. Also, in this bucket is the additional commercial
opportunities, not least with Adeptrix around the BAMS essay which we regard as
a very interesting opportunity but potentially other partnerships, licensing of
the Affimer spike proteins for third parties.

The third group, core business as it were so core diagnostics and therapeutic commercial progress, we’ve continued despite things being slowed down, of course, by the pandemic, we continue to make progress in terms of business development and technology evaluation. So, I would expect to be talking about new commercial partnerships in both of those divisions in the next three to six months.

Q3: In relation to the COVID
testing developments, are you receiving any support from the government at all?

A3: I’ve been asked that a lot and I can’t talk about the interactions we’re having with the government in any detail of course but what I will say is I’m very pleased there’s now a detailed dialogue which is very helpful in guiding our developments so that we can directly address the national requirements, but I can’t really say more.

Q4: I think you answered this
earlier, but the COVID-19 rapid antigen test, when will that be available?

A4: So, I think as
everyone knows we’re in the process of technology transfer and manufacturing
scale up which is being carried out by BBI Solutions, one of our manufacturing
partners and Cytiva. That is very much a development process, developing large
scale robust manufacturing processes and, as I’ve said a number of times, the
key milestone that we need to get to is the pilot batch of test devices. At that
time, when we have that pilot batch and we’ve gone through that development
process, we’ll be able to get a much clearer timeline to product launch.

It’s essential that that
manufacturing process development is done properly because it’s a  significant de-risking step, rushing it and
ended up with a process that isn’t robust is a mistake and it simply pushes the
risks down the line to the clinical validation, which I’m not prepared to
allow.

So, we expect to carry out the clinical validation in Q4, as I said, and as soon as we have that pilot batch, I will be able to give a much clearer timeline through that clinical validation, CE marking and product launch.

Q5: Finally, you announced the
other day that you’ve appointed Stifel as joint broker, can you comment further
on that?

A5: Well, Stifel provide
us with additional life sciences specialist sales capability and a strong US
capital markets reach so that will help us to continue the work that I’ve been
doing over the last 18 months or so in the US getting Avacta Group’s technology
platforms known and attracting US investment.

So, it’s a medium term project but
one that we’re delighted to have Stifel on board to help us with.

Avacta Group plc (LON:AVCT) Chief Executive Officer Alistair Smith caught up with DirectorsTalk for an exclusive interview to discuss BBI Solutions as a manufacturing partner, the performance of the prototype with Cytiva, expanding their contract with Daewoong Pharmaceutical and the progress of the COVID-19 test with Adeptrix.

Q1: Avacta Group announced this morning that you’ve appointed BBI Solutions as manufacturing partner for the COVID-19 test that you’re developing. Could you just take us through the details of that please?

A1: As you’ve said, we’ve appointed BBI Solutions as manufacturing partner for the lateral flow COVID-19 saliva test that we’re developing with Cytiva & we’ve been working with BBI & Cytiva over the past couple of weeks on what you call ‘technology transfer’ That means transferring the design & the manufacturing processes so that BBI can start the process of designing & implementing a robust & large scale manufacturing process capable of producing millions of tests per month.

So, we’ve spent a lot of time with BBI to define the quickest plan possible to develop & validate that robust manufacturing process, obviously so we can bring the tests to market in the quickest possible time.

Q2: Now, since you’re already in the process of transferring to BBI, I assume that means that the prototype device developed with Cytiva is actually working well?

A2: Yes, I’m very pleased indeed with the progress made with Cytiva & the performance of the prototype.

Cytiva has been optimising the prototype for a few weeks & the performance of the test in the lab which is called analytical performance is very good. I’m not going to go into the detailed analytical performance figures right now because, to be frank, they’re commercially sensitive as you can imagine but there will be an appropriate time to discuss those along with the clinical performance.

So, as you said in your question, the fact that we’re now getting on with that tech transfer to BBI means that we’re ready to do that.

Q3: What are the next steps in the development of the test to bring it to market?

A3: As I’ve said, we’ve worked with BBI over the past couple of weeks to compress the manufacturing process development quite drastically from what’s normally a much longer timeline.

We need to complete the tech transfer process & that gives BBI the information that they need & they can be done quite quickly. BBI will then develop a manufacturing process capable of scale up to millions of tests per month & then produce a pilot batch &, again, that can be done quite quickly.

Our intention, which is not the norm, is to use the pilot batch for clinical validation so that will shorten the overall timeline & that allows us to start the clinical validation much sooner than would normally be the case. Several validation batches are then produced & that shows that the manufacturing process is robust & repeatable & so on.

We would then have the clinical data in hand, technical file complete & at that point we’re in a position to CE mark the product & launch the product so there’s some very clear stages to go through now & we’ll keep the market updated as we hit each of those key milestones.

I think it’s important to say that we expect the demand for our coronavirus test to be very high indeed so we continue to actively pursue other manufacturing partners to ensure that we’ve got the capacity to meet that demand.

Q4: Last week you announced that the existing agreement with Daewoong Pharmaceutical had been expanded to include SARS-CoV-2 neutralising Affimer reagents. Can you just explain that for us please?

A4: We’re working with Daewoong through our joint venture in Korea called AffyXell to develop stem cell therapies that incorporate Affimer therapeutics. So, the background is what we’ve shown is stem cells can make & secrete the Affimer therapies so the stems cells actually make the Affimer drugs.

Our original agreement was centred around doing that with Affimers that help control local inflammation & immune response at the site of action where the stems cells are repairing tissue. So, in simple terms, these are next generation stem cell therapies capable of not only repairing tissues but also making their own supply of anti-inflammatory Affimer drugs locally in the patients.

What we’ve agreed now with Daewoong, last week, was to expand our agreement to include Affimer molecules that neutralise viruses & the obvious target is SARS-Cov-2 which is COVID19. The agreement actually includes any virus infection & therefore covers future pandemics which I think is very interesting as well.

So, in the case of COVID-19, the concept is that the stem cells offer the potential to repair the damage to the lungs that’s caused & if those stem cells can also produce Affimers that neutralise the virus in the lungs then one should have a therapy that not only slows down the progression of the disease through the Affimers but also repairs the damage. That’s the objective.

Q5: Finally, can you provide any update on the high throughput COVID-19 test with Adeptrix?

A5: Avacta Group recently announced that we’re working with the government’s clinical validation programme called CONDOR to evaluate the performance of the Adeptrix COVID-19 test & that’s called BAMS assay. You’ll recall that’s a high throughput so 1,000 samples a day, one technician, it’s a high throughput test for COVID-19 using something called a mass spectrometer which is common in hospitals clinical microbiology labs identifying pathogens that currently unused COVID-19 testing.

So, the test we’re developing combines Affimers to capture the virus from the patient samples with mass spectrometry to provide a very accurate & detailed way of  detecting the virus. Since the mass spectrometry uses really very detailed structural information about the virus, one interesting possibility that’s emerging is that the BMAS assay could quickly identify mutations in the virus as well.

Again, we will update the market as we now go through the process of evaluating & validating the BMAS assay.

Avacta Group plc (LON:AVCT) Chief Executive Officer Alistair Smith caught up with DirectorsTalk for an exclusive interview to discuss progress of the COVID-19 antigen test strips, the next steps in development with Cytiva and how some of the Affimer reagents can prevent the virus from getting into human cells.

Q1: This morning you announced a positive progress update regarding the rapid COVID-19 antigen test development with Cytiva. Could you talk us through that update please?

A1: Just as a reminder, we are using Avacta Group’s Affimer reagents to develop a rapid test strip that intends to use saliva as the sample to detect the virus antigen. So, that’s a test that’s designed to tell you in a few minutes whether you’ve got the disease right now or not and not an antibody test that tells you whether you’ve had it for a while or in the past. So, that’s what we’re developing.

The announcement today was to update the market on positive results from the first set of test strips developed by Cytiva.

So, patients with COVID-19 show a range of concentration of the virus in their saliva and I’m pleased to say that the first attempt, which we announced this morning, the test strips are detecting these spike protein within that clinic development range.

Q2: So, what are the next steps in the development plan with Cytiva?

A2: This is a really good start, now our partners at Cytiva are working to refine and optimise all the different components of the test strips so we can detect the lowest possible concentration of the coronavirus spike protein in the samples. That’s important because it’s going to be a major factor in determining the clinical sensitivity of the test which is key obviously.

Once we’ve optimised the test strip then we’ll have a design that we can transfer to manufacturers who we’re putting in place at the moment. One of our biggest challenges right now is in compressing the normal diagnostic development timeline which could be 18 months or more and compressing that into a matter of weeks.

When we’ve put those manufacturing partners in place and we’ve agreed with them those development plans and timeline then we’ll be able to update the market more accurately.

Q3: Now, you also recently announced that some of the Affimer reagents that you’ve developed which block the interaction between the virus spike protein and a human cell receptor have now been shown to prevent infection of human cells in a model coronavirus system. Could you explain that please?

A3: So, as you said, some of the Affimer reagents that we generate for diagnostic purposes, which is our focus, also block the interaction between the virus spike protein and a receptor on human cells called ACE2. The binding of the coronavirus spike protein to ACE2 is the first step in the virus infecting human cells so in principal, if you can prevent that interaction from occurring you’ve got the potential for a treatment for COVID-19.

Last week, working with Professor David Bhella’s group at Glasgow University Centre for Virus Research, using a model for the coronavirus, Avacta Group showed that if you treat the virus with the Affimer reagents then the virus is prevented from getting into human cells.

So, that’s a really interesting finding and there’s numerous large pharmaceutical companies now investing heavily in developing these types of, what we call, neutralising therapies. We’re working hard to secure a partnership to develop potential Affimer therapies for COVID-19.