MELBOURNE, Australia, Sept. 15, 2021 /PRNewswire/ — DEP® cabazitaxel is a proprietary nanoparticle 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® cabazitaxel is 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 in prostate 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® cabazitaxel have 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, and several DEP® commercial partnerships with companies, including AstraZeneca, Chase Sun and Merck & Co., Inc., to develop DEP® versions of their products or ADCs.
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