Date: 2015-01-12
Type of information: Development agreement
Compound: companion diagnostic to determine the AR-V7 status of patients with castration-resistant prostate cancer (CRPC) for use with galeterone
Company: Tokai Pharmaceuticals (USA - MA) Johns Hopkins University (USA - MD)
Therapeutic area: Cancer - Oncology - Diagnostic
Type agreement: development licensing
Action mechanism: Galeterone is a highly selective, multi-targeted, oral small molecule drug candidate being developed for the treatment of CRPC that acts by actively disrupting AR signaling, the key driver of prostate cancer growth, via multiple mechanisms of action. Galeterone combines the mechanisms of action of CYP17 inhibition and androgen receptor antagonism with an additional mechanism of androgen receptor degradation. Preclinical evidence suggests galeterone’s mechanism of androgen receptor degradation does not require a functional ligand binding domain to disrupt the activation of the pathway and tumor growth and thus galeterone may have activity even in the presence of C-terminal loss, such as AR-V7. AR-V7 positive prostate tumors express a truncated form of the androgen receptor (AR). These truncated ARs are missing the C-terminal end of the receptor that contains the ligand binding domain, which is known as C-terminal loss. The AR splice variant AR-V7 is the most prevalent of the splice variants that cause C-terminal loss. Clinical data from a prospective trial at the Johns Hopkins University as well as retrospective analyses of studies at MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center have shown that AR-V7 specifically and C-terminal loss generally is associated with poor responsiveness to Zytiga® (abiraterone acetate) and Xtandi® (enzalutamide), two commonly used oral therapies for metastatic CRPC. The Company believes that galeterone has the potential to treat patients with AR-V7 based on data from preclinical studies and retrospective data in patients with C-terminal loss from the Company’s Phase 2 ARMOR2 trial of galeterone.
Disease: castration-resistant prostate cancer
Details: * On January 12, 2015, Tokai Pharmaceuticals announced that it has entered into an agreement with the Johns Hopkins University related to the development of a companion diagnostic to determine the AR-V7 status of patients with castration-resistant prostate cancer (CRPC) for use with the Company’s lead product, galeterone, which is in development for the treatment of AR-V7 positive metastatic CRPC. Under the agreement, the Company has obtained an exclusive, worldwide license from the Johns Hopkins University to patent applications and know-how covering an assay that has been used to determine the AR-V7 status of prostate cancer patients. In addition, the Company announced that it has entered into an agreement with Qiagen under which Qiagen will develop a non-invasive companion diagnostic utilizing an array of novel technologies for use with galeterone. The agreement formalizes an existing collaboration under which work has been ongoing.
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