AxImmune, Inc. is developing clinical stage immuno-oncology (IO) technology in-licensed from Colorado State University (CSU) and Axon Connected, LLC. Animal studies, including at CSU and respected independent testing labs, indicate that Ax-101 is a potent immuno-modulary agent that works synergistically with immune checkpoint inhibitors (ICI’s), such as Keytruda, Yervoy, and Opdivo, improving outcomes and potentially expanding cancers treatable with ICI drugs. Previous Ax-101 single agent human trials show no significant drug related adverse effects and strong anti-tumor activity for patients with functioning immune systems. It is anticipated that co-therapy of Ax-101 and ICI drugs may increase the number of patients who achieve complete recovery and exhibit immunity against recurrence of the same cancer.
Ax–101 is a small molecule immuno-oncology drug with potent anti-tumor activity when used as a single agent, dramatically reducing the size of lymphoma in some patients and stabilizing growth in others with intact immune systems while causing no significant drug related adverse effects. In animals, Ax-101 has been shown to act synergistically with anti-PD-1 drugs. Co-therapy of Ax-101 and an anti-PD-1 drug resulted in improved outcomes for multiple cancers, including increase cure, greater tumor growth inhibition and, with respect to melanoma, immunity to re-challenge with the same cancer.
AxImmune anticipates completion of preclinical testing in Q2 2019.
Following completion of preclinical testing, AxImmune intends to file an IND with the FDA. AxImmune anticipates commencing clinical trials in Q4 2019. Plans are underway to conduct clinical trials at multiple sites.
The strong immuno-modulary action and synergistic effects of Ax-101 with ICI drugs has attracted an impressive group of key opinion leaders to join AxImmune’s Medical and Scientific Advisory Board.