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Avacta progressing AV6000 safety and dosage trials


Avacata [LON:AVCT], the AIM-listed biotech company has continued its positive progress this year so far.

The Yorkshire-based life sciences company’s shares opened at 146p this morning, and has offered a 20.9% year-to-date return and a 9.6% one-year return, with its shares ranging between 90.97p and 187.98p over a 52-week period.

The company has a market capitalisation of GBP378.7m. Avacta listed in January 2016.

When we last looked at the pharmaceutical company in January we noted that excitement has been building as the company has been progressing with its Phase 1 study for its pro-doxorubicin (AVA6000) treatment for cancerous tumours.

Investors and backers cite AVA6000 as a breakthrough technology in that it delivers Doxorubicin, an effective chemotherapy medication in a targeted ‘wrap-around’ manner, bypassing the side effects of the chemotherapy treatment. The AVA6000 clinical phase one safety study trial is for Avacta’s pre|CISION platform technology, that can be used to target the release of active chemotherapy to cancerous tumour tissues. Although Doxorubicin is an effective anti-cancer drug it is systemic in nature, dissolves in the bloodstream and travels around the whole body, and unfortunately not only attacks cancerous cells, but healthy ones that are vulnerable to the drug too, such as the heart, or liver, or lungs. This means that many patients can’t take it, as they are too ill or weak and won’t survive the treatment.

The novel design of AVA6000 however, means that the Doxorubicin is only released when it encounters the Fibroblast activation protein alpha, or the ‘FAP-alpha’ protein, which although naturally-occurring in the body, is given off in high concentrations in the Tumour Micro Environment – namely by cancerous cells.

Torpedo approach

What this means, is that the chemotherapy treatment is targeted like a torpedo at the cancerous growth, as opposed to the current approach of ‘carpet-bombing’ the whole body in order to kill off the cancer. Fundamentally, as CEO, Alastair Smith has said in the past, it allows chemotherapy without the side effects. Moreover, as previously reported, AVA6000 is allowing clinicians to increase the dosage of Doxorubicin, as with the therapy, the medication is targeted specifically at the cancers.

At the beginning of the year, Avacta reported that through AVA6000, researchers were able to deliver twice the current maximum permitted dosage of Doxorubicin (as to deliver a general dose of this large would be dangerous to the patient) and have been increasing the dosage to deliver a maximum tolerated dose before any side effects emerge. The trials have reached 250mg/m2 and in the next two rounds Avacta has the capacity to expand to 400mg/m2 with the option of pushing on from this high watermark. The current AVA6000 trial is a pre-cursor to Phase 1B and Phase 2 trials in the process of affirming the platform for clinical use.

Therapetically-significant delivery

Smith said in a recent video presentation: “The analysis of tumour biopsies from six patients [part of the P1 study] shown that the precision technology [of AVA6000] can deliver a therapeutically-significant level of Doxorubicin to the tumour tissue compared to the systemic levels at the same timepoint.”

The other exciting development coming from Avacta’s headquarters in Wetherby is an update on AVA3996, a precision tumour-targeted proteasome inhibitor. The proteasome, as Smith explained, is the cell’s garbage disposal unit, that breaks down protein waste. It’s a really important part of healthy cell function, as without it a cell can’t survive. This is true for healthy cells as well as cancerous cells.

Smith said: “if you inhibit the garbage disposal system [in other words, turn off the cell’s proteasome] this leads to cell death.” AVA3996 is the delivery mechanism which delivers AVSA2727D, the inhibitor. Smith believes the inhibitor market will be worth USD2.3bn by 2026. However, inhibitors have severe dose-limiting toxicities, that has limited the approval of inhibitors to solid tumours to date, having been limited to blood cancer treatment.

Avacta is hoping that AVA3996 might become a solution for inhibitor delivery to solid tumours. Again, the Avacta inhibitor is looking at the specificity of Fap-A proteins. Currently AVA3996 is in animal testing. Following initial trials, Smith said that: “…AVA3996 has the potential to target the delivery of an effective proteasome inhibitor – AVA2727D – to FAP-A rich tumour tissue.”

Always bigger fish

The company is making significant progress on two fronts, but what does this mean for its share price? Well, just considering AVA6000, if the testing confirms that it can post Doxorubicin through the letterbox of a tumour, without damaging its neighbours, the platform could be a significant step forwards in chemotherapy treatments and dealing with one of the biggest causes of mortality in the western hemisphere. And if the platform can be adapted to deliver other chemotherapy drugs it could totally change cancer treatment globally.

Obviously, ‘finding a cure for cancer’ is one of the biggest pharmaceutical quests in the modern age, and if the results are as exciting as Avacta believes, big pharma will surely sit up and take notice.

AVA3996 is another novel, exciting therapy in the cancer treatment sphere, and although a fair way behind AVA6000, it also could be a game-changing platform and having two winners come out a small pharmaceutical research house definitely makes Avacta a hot piece of property and ‘one to watch’.

The company is due to publish its year-end results a week tomorrow (25th April).

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This article does not constitute investment advice. Do your own research or consult a professional advisor.

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