Melbourne, Australia; 14 June 2023: Starpharma (ASX: SPL, OTCQX: SPHRY) today announces the presentation of AZD0466 clinical data by AstraZeneca at the European Hematology Association 2023 Hybrid Congress (EHA Congress), which was held from 8 - 11 June 2023. The scientific poster and corresponding abstract are appended.

AZD0466 is a highly optimised dendrimer nanoparticle formulation of AstraZeneca’s dual Bcl-2/xL inhibitor, AZD4320, which utilises Starpharma’s DEP® technology and is being developed by AstraZeneca under their multi-product DEP® license with Starpharma for patients with advanced blood cancers. AZD0466 is the first candidate under Starpharma’s multi-product license with AstraZeneca whereby Starpharma is eligible to receive development, launch and sales milestones, in addition to royalties. The EHA Congress is an international haematology conference that brings together clinicians, researchers, and other industry stakeholders to showcase the latest advances in haematology clinical research. The AZD0466 clinical data presented by AstraZeneca at the EHA Congress are from the ongoing global Phase 1/2 dose escalation and expansion study in patients with advanced haematological malignancies – relapsed/refractory acute myeloid leukaemia (AML) or acute lymphocytic leukaemia (ALL) (NCT04865419).

As of the poster data cutoff date¹, 26 patients had received ≥1 dose of AZD0466 up to 3600mg. AZD0466 continues to be well tolerated in patients with relapsed/refractory acute leukaemia, with adverse events matching expected toxicity based on data from preclinical studies, and evidence of Bcl/xL on-target anti-leukaemia clinical activity in line with preclinical models. This study continues to enrol patients at 20 international trial sites. In parallel with the ongoing study in patients with acute leukaemias, AZD0466 is also being evaluated in patients with advanced non-Hodgkin lymphoma (NCT05205161), with recruitment ongoing at over 20 sites globally.

Starpharma’s dendrimer drug delivery technology, known as DEP®, is used to enhance the therapeutic properties of drugs to improve solubility, efficacy, pharmacokinetics, targeting, and to reduce certain toxicities. Starpharma has established partnerships with three of the world’s largest pharmaceutical companies – AstraZeneca, MSD, and Genentech – and has also developed three clinical-stage anticancer products based on its DEP® technology, with others in preclinical development.

Starpharma CEO, Dr Jackie Fairley, commented: “We are delighted to see AstraZeneca publicising AZD0466 at international conferences. This poster presentation at the European Hematology Association Hybrid Congress is just one of a number of poster presentations and journal articles published by AstraZeneca over the last year for AZD0466, which is being progressed through two global clinical trials in patients with advanced blood cancers. We look forward to seeing additional clinical data from these clinical trials.”

About AZD0466 and Starpharma’s multi-product DEP® license with AstraZeneca
AZD0466 is a highly optimised dendrimer nanoparticle formulation of AstraZeneca’s dual Bcl-2/xL inhibitor, AZD4320, which utilises Starpharma’s DEP® technology and is being developed by AstraZeneca under their multi-product DEP® license with Starpharma. AZD0466 is in a novel class of oncology drugs called dual Bcl-2/xL inhibitors which seek to overcome drug resistance which occurs in treatment with BcL-2-specific inhibitors including venetoclax. AZD0466 allows for efficient delivery of AstraZeneca’s dual Bcl-2/xL inhibitor, with an optimised release profile also designed to reduce the potential for toxicities associated with dual Bcl-2/xL inhibition. Dual Bcl-2/xL inhibition with AZD0466 also has the potential for broader activity than the marketed Bcl-2-specific inhibitor, venetoclax (Venclexta®). AZD0466 is the first candidate under Starpharma’s multi-product license with AstraZeneca. Starpharma is eligible to receive development, launch and sales milestones, in addition to royalties. To date, Starpharma has received US$7M in milestones for AZD0466, with the potential to receive milestones of up to US$124M, plus royalties.

View or download the ASX Announcement (PDF) here. 

¹ 9 March 2023