Dec 30, 2019

Commencement of phase 1 trial for AZD0466 utilising DEP®

Commencement of phase 1 trial for AZD0466 utilising DEP®
  • AstraZeneca has commenced its first-in-human/phase 1 clinical trial for AZD0466 in the US in a range of cancers
  • AZD0466 utilises Starpharma’s proprietary DEP® delivery technology and is a highly optimised nanomedicine formulation of a novel dual Bcl2/xL inhibitor
  • US$3 million milestone payment to Starpharma has been triggered by the first dose of AZD0466 administered in the trial under its multi-product DEP® licence with AstraZeneca

Melbourne, Australia; 30 December 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that AstraZeneca (LSE/STO/NYSE: AZN) has commenced a phase 1 clinical trial of AZD0466 (DEP® Bcl2/xL conjugate) and the first patient has been successfully dosed. The trial will recruit patients with a range of cancers and will be conducted at 4-5 US sites.

The development of AZD0466, is being progressed under a multi-product license whereby Starpharma is eligible to receive development, launch and sales milestones of up to US$124 million, plus tiered royalties on net sales. The first dose of AZD0466 administered in the phase 1 trial has triggered a milestone payment to Starpharma of US$3 million. AstraZeneca also funds the development costs of DEP® AstraZeneca products under the license.

AstraZeneca describes AZD0466 as having the potential to be a ‘best-in-class’ agent in this field with a broad opportunity in solid and haematological tumours (blood cancers) due to its ability to target both Bcl2 and Bcl/xL[1].

Bcl2 is a clinically validated oncology target with the Bcl2 inhibitor, venetoclax (VenclextaTM - AbbVie/Genentech), being approved by the US FDA in 2016 with estimated peak global sales projected to be between US$2-3 billion[2].

Dr Jackie Fairley, Starpharma CEO, commented: “It is really exciting to achieve this important milestone both for our collaboration with AstraZeneca and for Starpharma’s DEP® platform. This is our first partnered DEP® product to enter the clinic, alongside our three internal DEP® products, DEP® docetaxel, DEP® cabazitaxel and DEP® irinotecan. AZD0466 is a great illustration of the benefits that can be created for novel agents using Starpharma’s DEP® platform and we look forward to further updates as the trial progresses”.

Download ASX Announcement: Commencement of phase 1 trial for AZD0466 utilising DEP®

 

[1] 3rd AstraZeneca-MedImmune-CRUK Cambridge Centre Symposium 2017 presentation

[2] https://www.fiercepharma.com/pharma/abbvie-roche-drive-venclexta-toward-3b-rituxan-combo-nod-cll

 This contains certain forward-looking statements.