Race appoints clinical and FDA regulatory strategy advisor

Race Oncology is pleased to announce that it has appointed the clinical and regulatory strategy advisor, CCS Associates (CCSA, California, USA) to advise on development options for Bisantrene as an inhibitor of the Fat mass and obesity-associated protein (FTO).

Recent preclinical studies by researchers at the City of Hope Hospital (ASX Announcement: 29 June 2020) has identified Bisantrene to be a highly potent FTO inhibitor at low, non-toxic concentrations1. The FTO protein has been found to be a key driver of cancer progression in a wide range of cancers including breast, lung, kidney, pancreatic, melanoma, glioblastoma, cervical, ovarian, liver, gastric, as well as many leukaemias2. This independent pre-clinical work has repositioned Bisantrene from a traditional chemotherapeutic agent to a targeted agent of wide possible utility across multiple cancer sub-types.

FTO is a key strategic opportunity for Race. The Race team will work closely with CCSA to identify the optimal means of translating this compelling pre-clinical research into clinical practice.

Race’s CSO, Dr Daniel Tillett, commented, “The identification of FTO as a key driver of oncogenic RNA epigenetic change is one of the most interesting cancer discoveries of the last decade. We are excited by the potential of Bisantrene to specifically target FTO and look forward to working closely with CCSA on how to best unlock this opportunity.”

In tandem with this work, CCSA will liaise with Race’s current regulatory advisor to review Race’s Investigational New Drug applications to be submitted to the US Food and Drug Administration (FDA), in line with our existing 5-path strategy. Race is seeking FDA IND approval to investigate Bisantrene for the treatment of Paediatric Acute Myeloid Leukemia (AML) and Adult AML Measurable Residual Disease (MRD). This review is not expected to delay Race’s IND process which continues to be
advanced by our team.

Race’s CEO, Phillip Lynch commented, “CCSA has over 35 years’ experience in providing integrated regulatory advice services and has long term relationships with the National Cancer Institute and FDA regulatory divisions. Their highly capable team and FDA insights around approval processes will help to ensure our clinical plans remain on track and are suitably optimised to drive commercial value for Bisantrene.”

1. Su, R., Dong, L., Li, Y., Gao, M., Han, L., Wunderlich, M., et al. (2020). Targeting FTO Suppresses Cancer Stem Cell Maintenance
and Immune Evasion.
Cancer Cell, 38(1), 79–96.e11.

2. Zhao, W., Qi, X., Liu, L., Ma, S., Liu, J., & Wu, J. (2020). Epigenetic Regulation of m6A Modifications in Human Cancer. Molecular
Therapy – Nucleic Acids, 19, 405–412.