On December 5, 2022 Ellipses Pharma Limited ("Ellipses"), a global drug development company focused on accelerating the development of new oncology treatments, reported that it will present a "Trial in Progress" poster detailing the design of a Phase 1/2 trial of vosilasarm (EP0062) in advanced breast cancer at the San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas on Tuesday, 6 December from 5:00pm to 6:15pm CST (Press release, Ellipses Pharma, DEC 5, 2022, View Source [SID1234624817]).
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Vosilasarm is a selective androgen receptor modulator (SARM) under development for the potential treatment of advanced breast cancer. This study is designed to further extend the evaluation of vosilasarm as a potential therapy for AR+/HER2–/ER+ advanced breast cancer, with the primary aim of identifying a recommended phase 2 dose (RP2D). Recruitment has commenced and the study will recruit up to 130 patients globally.
Presentation details
Title
A phase 1/2 study to evaluate the safety and efficacy of EP0062, an oral Selective Androgen Receptor Modulator (SARM), for the treatment of AR+/HER2-/ER+ advanced breast cancer
Presenter
Professor Elgene Lim, Institute of Medical Research, University of New South Wales, Sydney, Australia;
Abstract number
OT1-02-02
Date and time
Tuesday December 6, 2022; 5:00 PM – 6:15 PM
Session name
Trial in Progress Session
Location
Henry B. González Convention, San Antonio, Texas
Professor Hendrik-Tobias Arkenau, Global Head of Drug Development and Chief Medical Officer at Ellipses, said:
"Developing promising assets at speed is fundamental to the work of Ellipses, and we are excited to be presenting this ongoing study at such an important scientific conference. We look forward to presenting further details on this trial, including results, in the future."
Dr Rajan Jethwa, CEO of Ellipses, said:
"The initiation of this trial for vosilasarm is another key milestone towards our goal of accelerating the development of promising cancer drugs. I am excited by the potential across our pipeline to make available much-needed drugs for patients with cancer."
About vosilasarm / EP0062
Vosilasarm is an oral, non-steroidal, SARM currently being developed for the treatment of AR+/HER2-/ER+ advanced breast cancer. The efficacy and safety of vosilasarm has previously been investigated in a small Phase 1 clinical trial of AR+/HER2–/ER+ advanced breast cancer, and was demonstrated to have acceptable tolerability with preliminary evidence of clinical efficacy (LoRusso et al. Clinical Breast Cancer 2022 22;1 67-77).
About AR+/HER2–/ER+ advanced breast cancer
Despite recent progress, advanced ER+/HER2- breast cancer remains an area of high unmet medical need. It is estimated that 75-90% of advanced ER+ breast cancers are androgen receptor (AR) positive. It has been established that the AR acts as a tumour suppressor in multiple contexts of ER+ breast cancer, including where resistance to current endocrine-based regimens develops (Hickey et al. Nature Medicine 2021 27; 310-320). This provides the rationale for evaluating vosilasarm, an AR agonist, as a potential treatment strategy.