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

Rhea-AI Summary

MELBOURNE, Australia, Sept. 15, 2021 /PRNewswire/ -- Starpharma's DEP^® cabazitaxel, a nanoparticle version of cabazitaxel, shows enhanced safety with improved side effect profiles compared to Jevtana^®. It is in late phase 2 clinical trials for solid tumors, including prostate cancer, with encouraging efficacy signals observed in multiple cancer types despite patients' extensive prior treatments. The US patent granted for DEP^® cabazitaxel extends protection until 2039, supporting its unique drug delivery technology. The company plans to advance its clinical program and explore commercial licensing opportunities.

Positive

• DEP cabazitaxel shows improved side effect profile with significantly reduced bone marrow toxicity.
• Encouraging efficacy signals in multiple tumors including prostate, ovarian, and gastro-oesophageal cancers.
• New US patent extends intellectual property protection to 2039, highlighting unique drug delivery technology.
• Active recruitment for late phase 2 clinical trials demonstrates progress in development.

Negative

• None.

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.

investor.relations@starpharma.com 

View original content:https://www.prnewswire.com/news-releases/us-patent-and-trademark-office-grants-new-patent-for-dep-cabazitaxel-one-of-starpharmas-phase-2-clinical-stage-cancer-treatments-301377264.html

SOURCE Starpharma

FAQ

What is DEP cabazitaxel and how does it compare to Jevtana?

DEP cabazitaxel is a nanoparticle formulation of cabazitaxel that shows fewer side effects, particularly lower rates of severe bone marrow toxicity compared to Jevtana.

What are the results of the phase 2 clinical trials for DEP cabazitaxel?

The trials have shown promising efficacy signals in various tumor types, including significant reductions in prostate-specific antigen levels.

What is the significance of the new US patent for DEP cabazitaxel?

The new US patent reinforces Starpharma's intellectual property for DEP cabazitaxel, extending its protection until 2039 and ensuring competitive advantage.

What types of cancers are being targeted in the DEP cabazitaxel clinical trials?

The clinical trials for DEP cabazitaxel are focusing on solid tumors, particularly prostate, ovarian, and gastro-oesophageal cancers.

What are the next steps for Starpharma regarding DEP cabazitaxel?

Starpharma aims to complete the phase 2 clinical program and engage in commercial licensing discussions for DEP cabazitaxel.