Partnered Program Update
2023-07-31 · Starpharma Pty Ltd · original starpharma.com ↗
Partnered program update Melbourne, Australia; 31 July 2023: Following communication from AstraZeneca on Friday 28 July 2023 and the subsequent release of AstraZeneca’s H1 and Q2 2023 results announcement that day, Starpharma (ASX: SPL, OTCQX: SPHRY) reports that AstraZeneca has made the decision to discontinue the development of AZD0466, after an internal review, prompted by a small number of asymptomatic adverse events (AEs) that were unrelated to Starpharma’s dendrimer drug delivery technology. These AEs have been observed in the two clinical trials evaluating AZD0466 in haematological indications (NCT04865419 and NCT05205161). AstraZenec a's decision follows the implementation of a voluntary partial clinical hold on study NCT04865419 by AstraZeneca, announced by Starpharma on 27 June 2023. The AEs leading to this decision were asymptomatic and detected through routine laboratory testing. The AEs do not adversely impact the therapeutic and commercial potential of DEP®. Starpharma CEO, Jackie Fairley said: “Whilst this decision is clearly not what Starpharma would have hoped for, we note that it relates to haematological malignancies and at the highest three dose groups of AZD0466 and was not due to our dendrimer technology. “DEP® has demonstrated multiple benefits in Starpharma’s clinical studies in patients with solid tissue tumours, including significant preferential accumulation in these tumours compared to blood levels.” This development with AZD0466 does not impact Starpharma’s DEP ® platform, the Company’s internal clinical and preclinical DEP® programs, or DEP® partnerships. Starpharma’s multi-product DEP® License agreement with AstraZeneca remains in effect. About Starpharma Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY) is a biopharmaceutical company focussed on the development of pharmaceutical and medical products for unmet patient needs, including in the areas of oncology and infectious diseases. Starpharma’s innovative technology is based on proprietary polymers called dendrimers, which are precise, synthetically manufactured, nanoscale molecules. The unique properties of dendrimers – including their size, structure, high degree of branching, polyvalency, and water solubility – are advantageous in medical and pharmaceutical applications. Starpharma uses its dendrimer technology to develop novel therapeutics and to improve the performance of existing pharmaceuticals. Starpharma’s portfolio includes multiple clinical stage oncology products, which utilise its Dendrimer Enhanced Product (‘DEP®’) drug delivery technology; and marketed products, including VIRALEZE™ and VivaGel ® BV, which utilise SPL7013, a proprietary dendrimer with antimicrobial properties. Starpharma’s DEP® drug delivery platform is being used to enhance the effectiveness of existing and novel therapies and to reduce drug-related toxicities through controlled and specified drug delivery. In addition to Starpharma’s internal DEP ® programs, Starpharma has multiple DEP ® partnerships with international biopharmaceutical companies including AstraZeneca (oncology); MSD (antibody drug conjugates); Chase Sun (anti-infectives); and other world leading pharmaceutical companies. Due to the broad applicability and optionality of Starpharma’s DEP® platform, partnered DEP® programs have the potential to generate significant future milestones and royalties. Starpharma’s topical antiviral nasal spray, VIRALEZE™, is now registered in more than 35 countries*, including in Europe, in the UK, and in Asia. Starpharma’s novel non-antibiotic vaginal gel, VivaGel ® BV, for treatment of bacterial vaginosis (BV) and prevention of recurrent BV, is registered in more than 50 countries, including in the UK, in Europe, in Southeast Asia, South Africa, Australia and New Zealand. Starpharma.com | Twitter | LinkedIn 2 Media: Sumit Media Grant Titmus Mob: +61 419 388 161 [email protected] Starpharma Holdings Limited Dr Jackie Fairley, Chief Executive Officer Justin Cahill, 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 Chair, Mr Rob Thomas. Forward Looking Statements This document contains certain forward-looking statements, relating to Starpharma’s business, which can be identified by the us e 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 futu re sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may c ause actual results to be materially different from any future results, performance or achievements expressed or implied by such sta tements. 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 th e approval and commercialization of the product candidates could be affected by, among other things, unexpected trial results, including a dditional 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 gen eral public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidat es, financial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumption s prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Star pharma is providing this information as of the date of this document and does not assume any obligation to update any forward-looking sta tements contained in this document as a result of new information, future events or developments or otherwise. Clinical case studies an d other clinical information given in this document are given for illustrative purposes only and are not necessarily a guide to product performance and no representation or warranty is made by any person as to the likelihood of achievement or reasonableness of future results. Nothing contained in this document nor any information made available to you is, or shall be relied upon as, a promise, representation, warranty or guarantee as to the past, present or the future performance of any Starpharma product.
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