Avacta

AACR data continue to support confidence in AVA6000

Lighthouse | 10 April 2024

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  • Interim data from the Phase I trial of AVA6000, a peptide drug conjugate, have been presented in a poster at the 2024 American Association for Cancer Research (AACR) Annual Meeting in San Diego. These are the latest findings in 42 patients (as of 11 March data cutoff), including some from the seventh and final cohort in the three-weekly dosing arm. Importantly, the data reaffirm prior observations that AVA6000 is selectively activated at the target tumour site, resulting in lower toxicities than standard doxorubicin, and leading to anti-tumour effects in cancers with over-expression of FAP and which are sensitive to doxorubicin monotherapy.
  • Updated safety data for AVA6000 continue to show a lower incidence of severe (Grade 3 and 4) treatment-related adverse events (AEs) compared to doxorubicin. This observation is consistent when analysing all AEs, including mild to moderate. Two dose-limiting toxicities (DLTs) were observed in earlier cohorts; of note the patient with Grade 2 cardiac failure at 120mg/m2 had a significant risk of cardiovascular disease and an expert cardiovascular review concluded it was not anthracycline related. In each DLT case, the cohort was expanded and the dose escalated to the next cohort. More recently, there were no DLTs at the seventh dose level of 385 mg/m2 (equivalent to c 3.5x the normal doxorubicin dose) and a Safety Data Monitoring Committee (SDMC) concluded that this dose was safe. Overall, most compelling was the fact that no maximum tolerated dose was achieved.
  • The poster also includes an overview of the best overall response, stratified by FAP status. In the 15 patients with cancer types categorised as high FAP (based on a literature review), there were: 2 partial responses (≥30% decrease in the sum of diameters of the target lesion) of which 1 is confirmed and 1 is unconfirmed and both are ongoing; and 3 minor responses (a 10-29% decrease), with two ongoing. Ongoing patients could potentially see improved responses in the future. Seven patients had stable disease for ≥16 weeks. Recall that patients in this trial had been heavily pretreated (median of three prior regimens) and most patients would typically not be offered an anthracycline like doxorubicin. Hence responses were not expected.
  • Given the favourable safety in the three-weekly dosing arm, coupled with PK/PD modelling, patients are currently being enrolled in a two-weekly safety study, with three patients already dosed in the first cohort (160mg/m2) in the US. Approvals have also been granted to start the trial in the UK. First cohort safety data should be reviewed by the SDMC by the end of April.

Trinity Delta view: The proprietary pre|CISION platform is key to Avacta’s investment case, hence updated data that continue to support key hypotheses for AVA6000 are reassuring. Future efficacy data from studies planned to start in H224 will be key, and could also help to more broadly validate pre|CISION. The recent £31.1m fundraise (March 2024 Lighthouse), which provides a cash runway of c 24 months ie into early 2026, will be used to advance the therapeutics pipeline, in particular AVA6000, and should cover a number of value inflection points in AVA6000’s development. Our valuation and forecasts are currently suspended; our last published valuation was £672m (equivalent to 237p/share).

Lighthouse

10 April 2024

Price53.75p
Market Cap£195.13m
Primary exchangeAIM
SectorHealthcare
Company CodeAVCT
Corporate clientYes

Company description

Avacta owns two novel technology platforms: Affimer and pre|CISION. Affimer proteins are antibody mimetics being developed as diagnostic reagents and oncology therapeutics. pre|CISION improves potency and reduces toxicity of cancer drugs by only activating them inside the tumour. Successful clinical trials would be transformative for Avacta.

Analysts

Lala Gregorek
lgregorek@trinitydelta.org
+44 (0) 20 3637 5043

Philippa Gardner
pgardner@trinitydelta.org
+44 (0) 20 3637 5042

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