• AZD0466 shown to be well tolerated in patients with advanced haematological malignancies, with no dose-limiting toxicities (DLTs) reported to date
• AstraZeneca presents preliminary AZD0466 clinical trial results from an ongoing Phase 1/2 multi-centre trial at the 64^th American Society of Hematology (ASH) Annual Meeting 2022
• AZD0466 is a highly optimised dendrimer nanoparticle formulation of an AstraZeneca drug which utilises Starpharma’s DEP^® technology and is being developed by AstraZeneca under its multi-product license with Starpharma. Under this agreement, Starpharma stands to receive milestones of up to US$124M, plus royalties
• Patient recruitment is ongoing for the Phase 1/2 multi-centre trial in patients with advanced relapsed/refractory leukemia at escalating doses of AZD0466 as a precursor to the Phase 2 component of the trial

Melbourne, Australia; 13 December 2022: Starpharma (ASX: SPL, OTCQX: SPHRY) today announces preliminary AZD0466 clinical trial results from the ongoing Phase 1/2 trial in patients with advanced relapsed/refractory leukemia (NCT04865419), presented by Starpharma’s partner AstraZeneca at the 2022 American Society of Hematology (ASH) Annual Meeting today.

The clinical data reported show that AZD0466 has been well tolerated, with no DLTs reported to date and no discontinuations due to treatment-related adverse events. Five dose escalations have already been successfully completed, with further dose escalations underway. This Phase 1/2 trial in relapsed/refractory leukemia patients continues to enroll at 17 sites across the United States, Europe, Asia and Australia, with more than 30 additional sites planned.

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 reduce certain toxicities. Starpharma has developed three clinical stage products using the DEP^® technology, which is also the subject of multiple partnerships with leading pharmaceutical companies, including AstraZeneca, Merck & Co., Inc., Genentech, and Chase Sun.

These AZD0466 clinical results were presented in a poster presentation by AstraZeneca at the ASH Annual Meeting today. The poster is available to view here. AZD0466 was also highlighted in a session titled ‘Emerging AstraZeneca Hematology Pipeline’. Starpharma is also participating in the ASH conference and meeting with partners while in the US.

Dr Jackie Fairley, Starpharma CEO, commented: “We are delighted to see these AZD0466 clinical trial results presented for the first time at the ASH meeting in New Orleans. AZD0466 is the result of a highly successful collaboration between AstraZeneca and Starpharma and the presentation of this trial data marks an important milestone in the development of AZD0466. This positive clinical data further validates the potential of Starpharma’s DEP^® technology in a fourth clinical-stage oncology product.”

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^®[1]).

In addition to this clinical trial in patients with advanced relapsed/refractory leukemias, AZD0466 is also being trialed in patients with non-Hodgkin lymphoma, with other indications under consideration. AZD0466 has shown efficacy in both solid and haematological tumours in preclinical models, including resistant/refractory leukemia models.

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/Download ASX Announcement: Positive AZD0466 clinical data presented by AstraZeneca

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^[1] In 2021, Venclexta^®, marketed by AbbVie and Roche, had sales of ~US$1.82 billion, growing at 36% per annum (Abbvie, Press Releases, AbbVie Reports Full-Year and Fourth Quarter 2021 Financial Results, published on 2 February 2022)