Feb 09, 2021

AZD0466 clinical DEP® program global expansion

AZD0466 clinical DEP® program global expansion
  • AZD0466 clinical development program expanded to incorporate global clinical trial
  • Clinical expansion facilitates patient recruitment into a global Phase 1 study in haematological tumours
  • AZD0466 is a highly optimised nanomedicine formulation of AstraZeneca’s novel dual Bcl2/xL inhibitor which utilises Starpharma’s DEP® technology

Melbourne, Australia; 9 February 2021: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that it had been advised by AstraZeneca of its intention to expand the clinical program for AZD0466 to include a multi-centre global Phase 1 study. The study will recruit patients with acute leukaemias.

AZD0466 is a highly optimised nanomedicine formulation of AstraZeneca’s novel dual Bcl2/xL inhibitor which utilises Starpharma’s DEP® technology. Preclinical data presented at the 2020 AACR[1] Annual Meeting has shown significant improvement in therapeutic index delivered by the DEP® technology, which enabled the progression of AZD0466 into the clinic. Three scientific posters highlighted the potent and broad ranging anti-cancer activity of AZD0466 which results from the dual Bcl2 and Bcl/xL activity and provided positive preclinical data for AZD0466 in haematological cancers, including those resistant to venetoclax (VenclextaTM - AbbVie/Genentech). AZD0466 demonstrated superior anti-cancer activity in preclinical models of haematological cancers, including Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) and Non-Hodgkin’s Lymphoma.

Dr Jackie Fairley, CEO of Starpharma commented: “We are excited to see the global expansion of the clinical program for AZD0466 and AstraZeneca’s commitment to bringing this important medicine to patients in need, as quickly as possible. There has been great enthusiasm for the global study from investigators and we understand that the intention is to expedite development of AZD0466 with the objective of obtaining regulatory approval for specific indications of high unmet clinical need. We look forward to further progress and clinical data for this exciting oncology medicine”.

BcL inhibitors have attracted a lot of interest due to their role in cancer cell death (apoptosis), and the unique dual BcL2/xl inhibition by AZD0466 holds significant promise for both haematological and solid cancers. Bcl2 is a clinically validated oncology target with the Bcl2 inhibitor, venetoclax, being approved by the US FDA in 2016.

About AZD0466

AZD0466 is a dendrimer-based formulation of a novel dual Bcl2/xL inhibitor developed under Starpharma’s multi-product DEP® licence with AstraZeneca. AZD0466 utilises DEP® to improve the formulation characteristics and therapeutic index of the anti-cancer agent and is currently in a phase 1 trial in the US. AZD0466 is described as having the potential to be a ‘best-in-class’ agent with a broad opportunity in solid and haematological tumours (blood cancers) due to its ability to target both Bcl2 and Bcl/xL. AZD0466 has demonstrated excellent anti-cancer activity in a wide range of preclinical tumour models including Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Non-Hodgkin’s Lymphoma and Small Cell Lung Cancer (SCLC).

The development of AZD0466 is being progressed under a multi-product licence whereby Starpharma is eligible to receive development, launch and sales milestones.

Download ASX Announcement: AZD0466 clinical DEP® program global expansion (PDF 59kb)

[1] American Association for Cancer Research (AACR)

 This contains certain forward-looking statements.