On September 15, 2021 Starpharma reported that it’s DEP cabazitaxel is a proprietary nanoparticle version of leading prostate cancer drug cabazitaxel (Jevtana), which had global sales of US$536 million in 2020 (Press release, Starpharma, SEP 15, 2021, View Source [SID1234587784]). 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 .
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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.