Unmet Need / Invention Novelty: Men with prostate cancer develop resistance to androgen deprivation therapy (castration resistant prostate cancer) and must rely on less defined subsequent lines of therapy. Increasing resistance develops with each subsequent line of hormonal therapy. There exists an unmet clinical need to overcome resistance to hormone deprivation therapy and establish a more efficacious standard treatment for patients progressing on second-line hormonal therapy.
Technical Details: Researchers at Johns Hopkins have developed a sequential drug regimen to overcome resistance in men with castration resistant prostate cancer. The team previously reported on high dose testosterone as an effective second-line hormonal therapy for men with castrate resistant prostate cancer. Here, the researchers build on the successes of their findings to develop a treatment for patients progressing on standard second-line hormonal therapy that consists of sequential high dose testosterone and anti-androgen therapy followed by immune therapy. Sequential high dose testosterone and anti-androgen appears enhances and prolongs and survival and appears superior to second-line antiandrogen alone. This sequential method has the potential to become preferred standard therapy. The method also enhances the response to immune therapy.
Value Proposition:
· Sequential drug regimen proven safe in men with CRPC
· Enhances hormonal response and sensitivity to immune therapy
· Overcomes resistance to increase survival in men with CRPC
Looking for Partners to: Develop and commercialize as a second line therapy for men with
castration resistant prostate cancer.
Stage of Development: Phase 2 clinical trial
Data Availability: in vitro and in vivo and human safety
Inventors: Samuel Denmeade, John Isaacs, Emmanuel Antonarakis, Sushant Kachhap & Mark Markowski
Patent Status: Provisional patent application filed.
Publication(s)/Clinical Trials:
· Denmeade et al. 2021. TRANSFORMER: A Randomized Phase II Study Comparing Bipolar Androgen Therapy Versus Enzalutamide in Asymptomatic Men With Castration-Resistant Metastatic Prostate Cancer. J Clin Oncol., 39(12):1371-1382.
· Sena et al. 2021. Bipolar androgen therapy sensitizes castration-resistant prostate cancer to subsequent androgen receptor ablative therapy. Eur J Cancer, 144:302-309;
· NCT02090114
