Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that that the U.S. Food and Drug Administration (FDA) has authorised the use of AstraZeneca’s DEP^® Bcl2/xL conjugate AZD0466 in clinical trials under an investigational new drug (IND) application. This is the first DEP^® candidate to reach this milestone from Starpharma’s multiproduct license with AstraZeneca.

Authorisation by the FDA precedes the commencement of US clinical trials, with the AZD0466 clinical program expected to commence later this year following site set-up and ethics committee/IRB approvals.

AZD0466 is a highly optimised nanomedicine formulation of a novel dual Bcl2/xL inhibitor which utilises Starpharma’s DEP^® delivery technology to improve the therapeutic margin[1].

AstraZeneca describes AZD0466 as having the potential to be a best-in-class agent in this field with a broad combination opportunity in solid and haematological tumours (blood cancers)[2] due to its ability to target both Bcl2 and BclxL.

The Bcl family of proteins are important in the regulation of cell death, known as apoptosis. Bcl2 is a clinically validated oncology target with venetoclax (Venclexta^TM - AbbVie/Genentech) being approved by the US FDA in 2016 with estimated peak global sales projected to be between US$2-3 billion[3].

Starpharma CEO, Dr Jackie Fairley commented: “This first partnered DEP^® product to receive IND clearance is a really exciting and significant milestone, not only for our collaboration with AstraZeneca, but also for Starpharma’s DEP^® platform more broadly. This milestone, together with the recent announcement of the granting of a US patent for DEP^® Bcl2/xL inhibitor conjugates, demonstrates both the therapeutic and commercial benefits of the DEP^® platform and provides further validation for DEP^®. We look forward to AstraZeneca commencing clinical trials for AZD0466 in the near future and are excited to be involved with such a ground-breaking therapy”.

AZD0466 is the first DEP^® product under Starpharma’s previously announced multiproduct DEP^® license with AstraZeneca, with Starpharma eligible to receive development, launch and sales milestones of up to US$124 million, plus tiered royalties on net sales.  Starpharma has previously received US$4 million in milestones under this license. AstraZeneca funds the development costs of DEP^® AstraZeneca products under the license, including AZD0466.

Starpharma also has three other clinical-stage products (DEP^® docetaxel, DEP^® cabazitaxel and DEP^® irinotecan) which utilise its novel, patented DEP^® technology, therefore AZD0466 will be the fourth DEP^® product to enter the clinic.

Download ASX Announcement: FDA Authorisation of First-in-Human Clinical Trial with AstraZeneca’s DEP® product AZD0466 (pdf file, 65kb)

[1] https://www.astrazeneca.com/content/dam/az/events_files/asco-2019/20190601%20Prsn%20bos3.pdf

[2] 3rd AstraZeneca-MedImmune-CRUK Cambridge Centre Symposium 2017 presentation

[3] https://www.fiercepharma.com/pharma/abbvie-roche-snag-another-cll-nod-time-for-venclexta-gazyva; https://www.fiercepharma.com/pharma/abbvie-roche-drive-venclexta-toward-3b-rituxan-combo-nod-cll