Melbourne - Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that its second radiopharmaceutical candidate, DEP HER2-lutetium, achieved potent and durable anticancer activity, with complete tumour regression, outperforming Herceptin labelled with lutetium, in a human breast cancer model (BT474).
Radiotheranostics is a rapidly developing area of cancer treatment and diagnosis, which has recently generated several high-value deals and sales in this category are estimated to grow to $12-15 billion by 2030.[2] Recent deals include the acquisition of Endocyte by Novartis for US$2.1 billion and the acquisition of Sirtex by CDH Genetech for A$1.9 billion.
Worldwide, breast cancer is the most common cancer in women and the second most common cancer in the US. HER2 (human epidermal growth factor receptor 2) is a growth-promoting protein on the outside of all breast cells. Breast cancer cells with higher-than-normal levels of HER2 are called HER2-positive. These cancers tend to grow and spread faster than other breast cancers but are much more likely to respond to treatments with drugs that target the HER2 protein (such as Herceptin).[3] The HER2 receptor also exists in some other cancers such as gastric, colon, bladder and biliary cancers.
HER2 cancer treatments include Roche's Herceptin and Perjeta with sales of approximately US$7 billion and US$4 billion respectively.[4]
DEP HER2-lutetium is a proprietary dendrimer developed by Starpharma which incorporates the radioisotope lutetium-177 (177Lu) and a novel HER2 targeting moiety (nanobody).
This study evaluated the anticancer activity of different doses of DEP HER2-lutetium and DEP lutetium compared to Herceptin labelled with lutetium in the BT474 human breast cancer model. The study was conducted at University of Queensland's Centre for Advanced Imaging.
Dr Jackie Fairley, CEO of Starpharma commented: 'We and our specialist radiotheranostics clinical advisers are very excited by these latest data. Starpharma now has multiple potential DEP products in the radiopharmaceuticals and radiodiagnostic area. We are delighted to continue working with Professor Kristofer Thurecht at the University of Queensland's Centre for Advanced Imaging, as well as building strong relationships with radionuclide specialists and clinicians.'
About DEP radiotheranostics
DEP radiotheranostics (i.e., radio diagnostics and therapeutics) incorporate radioisotopes on to the DEP scaffold. DEP radiopharmaceutical conjugates selectively penetrate and accumulate within tumours and more effectively delivers radiation to kill tumour cells, that may be unreachable by conventional therapies. The addition of targeting groups, such as HER2, onto the DEP radiopharmaceutical can further enhance efficacy. Patent applications for DEP lutetium, DEP zirconium and DEP HER2- lutetium have been filed.
Starpharma's DEP platform
Starpharma's proprietary drug delivery platform technology, DEP, is being used to improve pharmaceuticals, to reduce key toxicities and enhance their performance. The DEP platform is highly versatile and can be used with a wide range of targeting moieties (e.g., small molecules, peptides, antibodies, antibody fragments) and radioisotopes.
The Company has three clinical stage DEP products, as well as numerous partnered programs. DEP partnerships include oncology programs with AstraZeneca, with Merck in the area of Antibody Drug Conjugates (ADCs), with Chase Sun in the area of anti-infectives and other world leading pharmaceutical companies. Starpharma's partnered DEP programs have the potential to generate significant future milestones and royalties.
About Starpharma
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) is a global biopharmaceutical company and a world leader in the development of new pharmaceutical and medical products based on proprietary polymers called dendrimers, with programs for COVID-19, DEP drug delivery and VivaGel. Starpharma has developed VIRALEZE, an antiviral nasal spray for COVID-19, which is complementary to vaccines and other preventative measures such as distancing and PPE. VIRALEZE is registered for sale in the UK/Europe, with launch of product expected in Q1 CY2021. SPL7013 is utilised in approved products - the VivaGel condom and VivaGel BV. VivaGel BV has been licensed in >160 countries, is approved in >40 countries and available for sale in the UK, Europe, Japan, South East Asia, Australia and New Zealand.
As a leading company in dendrimer-based drug delivery, Starpharma's proprietary drug delivery platform technology, DEP, is being used to improve pharmaceuticals, to reduce toxicities and enhance their performance. There are numerous internal and partnered programs underway to develop DEP versions of existing drugs, particularly in the area of anti-cancer therapies. DEP partnerships include oncology programs with AstraZeneca, with Merck in the area of Antibody Drug Conjugates (ADCs), with Chase Sun in the area of anti-infectives and other world leading pharmaceutical companies. Starpharma's partnered DEP programs have the potential to generate significant future milestones and royalties
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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 health authorities' requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any health 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 clinical trial results, including additional analysis of existing clinical data, and new clinical 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.
STARPHARMA HOLDINGS LIMITED 