DEP® cabazitaxel (Phase 2)
DEP® cabazitaxel is an enhanced version of leading prostate cancer drug cabazitaxel (Jevtana®).
Cabazitaxel (Jevtana®) had global sales of US$536M in 2020 despite having multiple US FDA “Black Box” warnings.
The advantages* of DEP® cabazitaxel include:
DEP® cabazitaxel has patent filings to 2039 (plus up to an additional ~5 years).
*Multiple preclinical studies have established improved efficacy, survival, and safety with DEP® with many different drugs.
Download DEP® Drug Delivery Summary (pdf file, 1007kb).
DEP® cabazitaxel clinical status
DEP® cabazitaxel phase 2 program is currently underway. The program is an open-label trial, with the objective of establishing anti-tumour activity (efficacy) & safety.
Encouraging efficacy signals have been observed in trial patients, including radiographic responses, prolonged stable disease, and substantial tumour marker reductions (e.g. Prostate Specific Antigen - PSA), in cancers including prostate, ovarian, lung, gastroesophageal and others.
- DEP® cabazitaxel progresses to phase 2 on positive results
- Promising efficacy signals observed in ongoing DEP® trials, including DEP® cabazitaxel escalation phase
DEP® cabazitaxel case studies
Last Update: 24 June 2021
DEP® cabazitaxel phase 1 results
- 14 patients enrolled and received DEP® cabazitaxel at doses between 2 mg/m2 to 25 mg/m2
- Up to 15 cycles of DEP® cabazitaxel; no steroid, antihistamine or anti-emetic pre-treatment
- Encouraging signs of efficacy were observed in 67% of patients evaluable for treatment response, including:
- Prolonged stable disease in multiple patients and in a variety of cancer types, including prostate, gastro-oesophageal, breast, ovarian, cholangiocarcinoma and pancreatic (& at doses several-fold lower than usually used for cabazitaxel).
- One prostate cancer patient experienced >47 weeks stable disease & a reduction in Prostate Specific Antigen (PSA) of 79%
- One stage IV ovarian cancer patient achieved a reduction in tumour biomarker
(CA-125) of 56%
- One stage III cholangiocarcinoma cancer patient achieved a 82% decrease in a tumour biomarker after two cycles
- Significantly lower levels of side effects usually associated with Jevtana such as bone marrow toxicity (neutropenia, anaemia, thrombocytopenia), anorexia and vomiting. No cases of hypersensitivity; no cases of hair-loss; no need for anti-nausea medications
(Evaluable patients are those patients who have received ≥1 dose DEP® cabazitaxel and have had a tumour assessment conducted post treatment)
Full Results Announcement
DEP® cabazitaxel preclinical results
Preclinical studies demonstrated that DEP® cabazitaxel achieved significantly superior anti-cancer effects across a range of important cancer types when compared to Jevtana® (standard cabazitaxel).
Figure 1: Antitumour activity of DEP® cabazitaxel as compared to Cabazitacel (Jevtana®) in a human breast cancer xenograft model
Starpharma’s DEP® cabazitaxel was compared with Jevtana® in a human breast cancer preclinical model (xenograft). DEP® cabazitaxel significantly outperformed Jevtana® with respect to both level and duration of tumour regression (anticancer activity). Within four weeks of dosing, 100% of mice treated with Starpharma’s DEP® cabazitaxel were tumour free and remained so for the duration of the extended study (150 days). In contrast, the Jevtana® treated group exhibited significant tumour regrowth from day 60 onwards (Figure 1). Tumour growth in both drug treated groups was significantly inhibited compared with the vehicle group (P<0.0001).1
1Statistical analysis of tumour growth inhibition was performed using ANOVA and Dunnett’s post hoc test.
- DEP® docetaxel and DEP® cabazitaxel outperform in human pancreatic cancer model
- DEP® cabazitaxel shows complete and sustained tumour regression in breast cancer model
- Starpharma's DEP® eliminates cabazitaxel neutropenia
DEP® posters showcased at AACR 2020 Annual Meeting
DEP® cabazitaxel was one of Starpharma's three clinical DEP® products featured in poster presentations at the 2020 Annual American Association for Cancer Research Annual Meeting. These posters showcase preclinical data from Starpharma’s products DEP® docetaxel, DEP® cabazitaxel and DEP® irinotecan, which are all in phase 2 clinical trials. The preclinical data presented at AACR comprises a series of xenograft studies showing enhanced efficacy of DEP® products used as a monotherapy or in combination with standard of care therapies.
- 1715 / 1 - Anti-cancer activity of a SN-38 nanoparticle, DEP® irinotecan, in human colon and pancreatic cancer xenograft models
- 1716 / 2 - Anticancer activity of the taxane nanoparticles, DEP® docetaxel and DEP® cabazitaxel