Aminex Therapeutics, Inc., is a drug development company totally focused on development of a unique cancer drug therapy in the general category of cancer immunotherapies, referred to as checkpoint inhibitors. Aminex’s novel cancer immunotherapy drug, AMXT 1501/DFMO, enables, in multiple animal trials, the immune system to attack and clear cancer and its ability to spread. AMXT 1501/DFMO negates two major immune system suppressors--polyamines and myeloid-derived suppressor cells (MDSCs). Further, it reduces the effect of the MYC oncogene, thought to be involved with more than forty percent of cancers. DFMO itself is a special drug separately of interest today in neuroblastoma, colorectal cancer prevention, glioblastoma and Alzheimer’s. AMXT 1501 has been specifically developed to enhance and extend, in conjunction with DFMO, the ability of the immune system to recognize and attack multiple cancers.
Aminex has operated with private funding since its founding in 2009. We have raised about $9.0 million to date in specific tranches to complete all remaining FDA preclinical requirements for AMXT 1501/DFMO human clinical trials. The final preclinical task, submittal of an Independent New Drug (IND) application to the FDA, is now scheduled for September 2017. This summer Aminex will complete a $3.9 million Convertible Note offering initiated in 2016. This precedes a planned Series B round of $8-9 million to fund the remainder of the Phase 1/2A human clinical trials which will start later in 2017.
An extensive array of animal data supports the likelihood that AMXT 1501/DFMO should be effective in human cancer clinical trials. Initial signals of efficacy in cancer patients with solid tumors could be observed as early as second half 2018. Our vision is for AMXT 1501/DFMO to be a foundational and transformational drug therapy, for use alone or in combination with other immunotherapy treatments. AMXT 1501/DFMO’s small molecule design and low chemical production costs will allow substantial pricing flexibility compared to the pricing of current biologics and cell therapy treatments. Aminex believes AMXT 1501/DFMO has low adverse effects risk and high likelihood for major benefit for mankind.