US Patent and Trademark Office grants new patent for DEP® cabazitaxel, one of Starpharma's phase 2 clinical-stage cancer treatments

MELBOURNE,Australia,Sept. 15,2021 -- DEP® cabazitaxelis a proprietarynanoparticle version of leading prostate cancer drug cabazitaxel (Jevtana®),which had global sales of US$536 million in 2020. Starpharma's DEP® cabazitaxel is a water soluble,polysorbate-80 free formulation,without requirement for pre-treatment with steroids nor G-CSF to reduce the risk of severe bone marrow toxicity.

In preclinical and clinical studies,DEP® cabazitaxel has shown an improved side effect profile,notably markedly reduced bone marrow toxicity demonstrated by lower rates of severe neutropenia,thrombocytopenia,and severe anaemia,which are experienced by a significant proportion of Jevtana® treated patients.

The composition of matter patent builds on Starpharma's suite of existing international patents for DEP® cabazitaxel. It specifically covers a DEP® dendrimer conjugated to multiple cabazitaxel drug molecules via a particular releasable linker,with a patent term to 2039 and potential for a 5-year extension.

Starpharma CEO,Dr Jackie Fairley,commented: "The grant of this new US patent illustrates the unique and compelling benefits of Starpharma's DEP® drug delivery technology and DEP®cabazitaxel.We look forward to completing the phase 2 clinical program for DEP® cabazitaxel,in parallel with commercial licensing discussions."

DEP®cabazitaxelis in late phase 2 clinical development,recruiting patients with solid tissue tumours,including prostate,ovarian and gastro-oesophageal cancers.

Encouraging efficacy signals have been observed in multiple tumour types,including inprostate cancer where radiological responses,significant reductions in prostate-specific antigen (PSA) and no new bone metastases were observed. These efficacy signals were observed despite patients having been heavily pre-treated with an average of 30 prior cycles of treatment,and in some cases with more than 100 cycles and up to 10 different treatment regimens. Patients treated with DEP®cabazitaxelhave also exhibited encouraging efficacy signals in gastro-oesophageal,ovarian,cholangiocarcinoma,lung and head and neck cancers.

DEP®cabazitaxel was developed using Starpharma's proprietary DEP® drug delivery platform,used by the company and partners to create novel nanoparticle formulations of existing and new drugs to enhance their therapeutic and commercial value. DEP® drug delivery is applicable to a wide range of drugs in oncology and other therapeutic areas. Starpharma has three phase 2 clinical-stage DEP® assets,multiple preclinical DEP® programs,andseveral DEP® commercial partnerships with companies,including AstraZeneca,Chase Sun and Merck & Co.,Inc.,to develop DEP® versions of their products or ADCs.

investor.relations@starpharma.com

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