Superlatives and Avacta (AVCT) go hand-in-hand. This morning the company announced outstanding safety and efficacy data for its recently completed sixth patient cohort, which saw a sample population of 35 injected with its potential new blockbuster chemo-targeted AVA6000 cancer drug using a dosage level 2.79x stronger than standard doxorubicin to treat soft tissue sarcomas (see graphic).
The treatment continued to demonstrate an “excellent” safety profile, reporting a “clinically significant reduction in toxicities”, while supporting the aim of administering higher doses, more cycles, and a greater frequency.
The trial also demonstrated “clear signs of efficacy”. Indeed “one patient with soft tissue sarcoma showed a significant reduction in tumour volume, with further signs of activity observed in others, not limited to soft tissue sarcoma”.
In fact, so good were the results, that Avacta has decided to extend its Phase 1a trial to a final seventh cohort using a higher 385 mg/m2 dose, equivalent to 3.5x doxorubicin.
The aim will be to identify a maximum tolerated level (MTD) which can then be used for future studies. Moreover, by having a higher MTD, it might also allow regulators to approve AVA6000 across a wider population with a $1.4bn total addressable market (TAM).
Today’s encouraging news has enabled the board to bring forward the start of its pivotal phase 2 study into 2024, subject to regulatory approvals. The modified approach is to run a separate short study in Q4 2023 - in parallel with cohort 7 - to explore a fortnightly AVA6000 dosing regime, as a 1st line treatment. This would then replace the much longer Phase 1b trial and potentially expand AVA6000’s TAM.
Key clinical and pharmacokinetic data from the amended plan should be available by the end of 2023, after which - assuming the data is positive - Avacta may find itself inundated with offers by large biopharma groups to help commercialise AVA6000 and the broader preCISION platform.
CEO Dr Alastair Smith, commented: “I believe that we are on the verge of a paradigm shift in how chemotherapy is delivered to cancer patients. The safety & initial efficacy signals emerging from the data in the AVA6000 Phase 1 study are very encouraging. The preCISION platform is doing exactly what it was designed to do – target the release of active chemotherapy to the tumour tissue, sparing healthy tissues and improving the safety & tolerability of the drug, whilst delivering potentially superior efficacy.”
"I’m particularly pleased that, even at this early stage, we have a confirmed, significant response in a patient with soft tissue sarcoma, as well as other positive signals across a number of other patients."
"We’re now aiming to accelerate the clinical development of AVA6000 & begin the Phase 2 efficacy study earlier than originally planned."
Broker Singer Capital Markets has a BUY rating on the stock with a 154p a share target price.