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:

  • Improved side effect profile
  • Detergent-free formulation
  • No steroid pre-treatment
  • Tumour-targeting
  • Improved efficacy

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.

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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.

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DEP® cabazitaxel case studies

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Last Update: 24 June 2021

DEP® cabazitaxel phase 1 results

(Dose escalation)

  • 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)

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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).

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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.

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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. 

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Download DEP® Drug Delivery Summary (pdf file, 1007kb) or Contact Us for further information.