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

On December 29, 2019 Starpharma (ASX:SPL, OTCQX:SPHRY) reported 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 (Press release, Starpharma, DEC 29, 2019, View Source [SID1234552623]). The trial will recruit patients with a range of cancers and will be conducted at 4-5 US sites.

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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."