Axelia Oncology has entered into a clinical supply agreement with Regeneron to study the use of the PBS-listed PD-1 inhibitor LIBTAYO (cemiplimab) with the Australian company's investigative candidate, AXA-042.
AXA-042 is an innate immune modulator targeting toll-like-receptors (TLR) 2/6.
Axelia said the agreement covers its Phase 1 clinical trial evaluating the safety and tolerability of AXA-042 as a monotherapy and in combination with LIBTAYO across a range of solid tumours.
The development of AXA-042 is based on vaccine adjuvant research from the laboratory of Professor David Jackson at the Peter Doherty Institute for Infection and Immunity at the University of Melbourne.
“AXA-042 is a fully synthetic, systemically administered agonist targeting the TLR2/6 heterodimer which elicits a differentiated chemokine/cytokine profile with respect to other TLR agonists in the clinic," said Phil Kearney, the CEO of Axelia Oncology.
"In preclinical studies, AXA-042 efficacy was macrophage-dependent and demonstrated enhanced activity in combination with checkpoint inhibitors. These data provide a strong rationale for use of AXA-042 in cancer types unresponsive to anti-PD-1 due to myeloid cell mediated immune suppression.
"The monotherapy arm of the PhI trial has shown strong target engagement and impact on disease course in some patients, suggesting additional benefit may accrue with Libtayo.
"We are therefore excited to have the opportunity to assess AXA-042 in combination with Regeneron’s LIBTAYO. Their continued investment in immuno-oncology innovation is clearly aligned with our approach to cancer immunotherapy and we are delighted to be working with them as we progress through the clinic.”
Under the terms of the agreement, Axelia Oncology will sponsor and be responsible for the conduct of the clinical study, which will be initiated at six clinical trial sites in Australia.