AVA6000 trial20 Jan 2022 15:06
The Avacta AVA6000 pro-drug is based on their pre|Cision technology. The FAP-alpha protein is present at high concentrations in the tumour and on interaction with inert AVA6000, it cleaves it to doxorubicin (i.e., the chemotherapy warhead targeted to the tumour). The pro-drug continues to circulate in the system until most of it is targeted to the tumour site and pre-clinical mouse studies show a high level of targeting: 18x more in the tumour than the heart. There is a ~93% similarity between the human and mouse FAP-alpha.
In human phase-1a trials AVACTA administer an effective dose of 54mg/m2 (0.68 of 80mg/m2) of the prodrug. This is similar in concentration to the current dosage for doxorubicin who will generally undergo 6 rounds of chemo before off target toxicity kicks in. However, AVA6000 has two benefits:
1. higher concentration of doxorubicin will be targeted to the tumour
2. lower concentration of doxorubicin will be circulating off-target
3. because of the above fewer rounds of chemo would be necessary
The clinical trial started ~mid-July 2021 and FDA submission would include pre-clinical data for at least 3 clinical trial patients’: One patient with maximum 6 cycles of pro-drug chemotherapy, one patient with 2 cycles and third patient with 1 cycle. The FDA approved investigational new drug status after 30 days review. Furthermore, the last company presentation by AVACTA indicated that the trial was going well. Finally, this week’s news that AVA3996 also strengthens evidence that AVA6000 has progressed well with top-line PK-PD data to be announced soon.
Once this news is announced, AVA6000 positive date will open up multiple drugs under the preCISION header. Further pipeline to include the pre|Cision forms of Paclitaxel, Oxaliplatin and Gemcitabine. With the reduced timeframe, expense, exceptional pre-clinical data, so far positive news (i.e. no negative news from NCT04969835).
GLA
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