EpiAxis is pursuing three parallel arms to its development plan, namely a clinical, a pre-clinical and a discovery inhibitor arm.
In the clinical arm, the aim is to firstly validate the target LSD1 & PKC theta Â in a cohort of patients with metastatic breast cancer by monitoring their CSC burden and immune response in situ. Later, patients will be enrolled in a Phase 1 study of AbraxaneÂ® in combination with Phenelzine Sulfate to assess whether their CSC burden can be abated through LSD1 inhibition.Â In addition, patient derived CSCs from the Phase 1 study will be treated ex-vivo with the Companyâ€™s proprietary inhibitors, arising from the discovery arm.
The pre-clinical arm aims to undertake dose finding and pharmacodynamic studies involving AbraxaneÂ® and Phenelzine Sulfate using MDA-MD 231 cells in a breast xenograft model with nude mice. Those studies will also have a focus of confirming the Mechanism of Action (MoA) associated with LSD1 & PKC theta modulation. Imaging will be performed on the CSC burden, LSD1, PKC theta and PD-L1 status. The immune status arising from LSD1 & PKC theta modulation will be further examined using the 4T1 model in which the mice have a normal immune system, unlike the nude mice.
The discovery arm aims to identify at least two druggable candidates for further pre-clinical development, based on the proprietary nuclear profile of LSD1 & PKC theta and their candidates. These are being screened using human cancer cell lines, with lead candidates entering into the pre-clinical arm, where they will be further evaluated using breast xenograft models, in combination with SoC chemotherapies and checkpoint inhibitors.