Starpharma: Commencement of Phase 1 Trial for AZD0466 Utilising DEP® Delivery Technology

• 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--(BUSINESS WIRE)--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/xL¹.

Bcl2 is a clinically validated oncology target with the Bcl2 inhibitor, venetoclax (Venclexta™ - AbbVie/Genentech), being approved by the US FDA in 2016 with estimated peak global sales projected to be between US$2-3 billion².

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.”

About Starpharma
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY), located in Melbourne Australia, is an ASX 300 company and is a world leader in the development of dendrimer products for pharmaceutical, life science and other applications.

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