drugset / Press release

AZD0466 trial opens MD Anderson Cancer Center as a site

2020-07-26 · Starpharma Pty Ltd · original starpharma.com ↗

AZD0466 trial opens MD Anderson Cancer Center as a site Melbourne, Australia; 27 July 2020: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced the opening of the MD Anderson Cancer Center as a further trial site for the phase 1 trial of AZD0466, AstraZeneca’s first DEP® product. The University of Texas MD Anderson Cancer Center (MDACC) is one of the world’s most respected cancer hospitals and is based in Houston, Texas. It is the largest cancer center in the US and is devoted exclusively to cancer patient care, research, education and prevention. The Center conducts hundreds of clinical trials to test new oncology treatments. AZD0466 is a highly optimised nanomedicine formulation of AstraZeneca’s novel dual Bcl2/xL inhibitor which utilises Starpharma’s DEP® technology. The development of AZD0466 is being progressed under a multi-product licence whereby Starpharma is eligible to receive development, launch and sales milestones. Dr Jackie Fairley, Starpharma CEO, commented: “We’re pleased to see the ongoing progress of the AZD0466 trial. It is exciting to have this highly novel DEP®-based product being made available to patients at this leading international cancer center.” 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). 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. Starpharma’s underlying technology is built around dendrimers – a type of synthetic nanoscale polymer that is highly regular in size and structure and well suited to pharmaceutical and medical uses. Starpharma has two core development programs: VivaGel® portfolio and DEP® drug delivery with the Company developing several products internally and others via commercial partnerships. VivaGel®: Starpharma’s women’s health product - VivaGel® BV is based on SPL7013, astodrimer sodium, a proprietary dendrimer. VivaGel® BV for bacterial vaginosis (BV), is available for sale under the brand names Betafem® BV Gel (UK), Betadine BV™ (Europe), Betadine™ BV Gel (Asia) and Fleurstat BVgel (Australia and New Zealand) and a new drug application has been submitted to the US FDA. Starpharma has licensed the sales and marketing of VivaGel® BV to ITF Pharma for the US; Mundipharma for Europe, Russia, CIS, Asia, the Middle East, Africa, and Latin America; and to Aspen Pharmacare for Australia and New Zealand. Starpharma also has licence agreements to market the VivaGel® condom (an antiviral condom which includes VivaGel® in the lubricant) in several regions, including Australia, Europe, Canada, China, and Japan (Okamoto). The VivaGel® condom has been launched in Japan under Okamoto’s 003 brand, and in Australia and Canada under the LifeStyles Dual Protect® brand. The VivaGel® condom is approved in Europe. DEP® - Dendrimer Enhanced Product®: Starpharma’s DEP® drug delivery platform has demonstrated reproducible preclinical benefits across multiple internal and partnered DEP® programs, including improved efficacy, safety, and survival. Starpharma has three internal DEP® products – DEP® docetaxel, DEP® cabazitaxel and DEP® irinotecan - in clinical development in patients with solid tumours. Starpharma’s partnered DEP® programs include a multiproduct DEP® licence with AstraZeneca, which involves the development and commercialisation of two novel oncology compounds, with potential to add more. In June 2019 Starpharma signed a Development and Option agreement with AstraZeneca for a DEP® version of one of AstraZeneca’s major marketed oncology medicines. Starpharma.com | Twitter | LinkedIn 2 Media: WE Communications Rebecca Wilson Mob: +61 417 382 391 [email protected] Arthur Chan +61 2 9237 2805 [email protected] Starpharma Holdings Limited Dr Jackie Fairley, Chief Executive Officer Nigel Baade, CFO and Company Secretary +61 3 8532 2704 [email protected] 4-6 Southampton Crescent Abbotsford Vic 3067 Disclosure This ASX Announcement was authorised for release by the Chairman, Mr Rob Thomas. Forward Looking Statements This document contains certain forward-looking statements, relating to Starpharma’s business, which can be identified by the use of forward-looking terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “targeting”, “aiming”, “set to”, “potential”, “seeking to”, “goal”, “could provide”, “intends”, “is being developed”, “could be”, “on track”, or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s and other authorities’ requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations regarding the approval and commercialization of the product candidates could be affected by, among other things, unexpected trial results, including additional analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated, or expected. Starpharma is providing this information as of the date of this document and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events, or developments or otherwise.

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