Apogenix Releases Promising Data on Immuno-Oncology Drug

October 11, 2018

Apogenix, a biopharmaceutical company developing next generation immuno-oncology therapeutics, announced today that new data published in Journal of Immunotherapy[1]demonstrate the potent anti-tumor efficacy of Apogenix' HERA-CD40L. HERA-CD40L acts directly on cells of the innate immune system as well as on antigen-presenting cells, thereby promoting specific T cell-mediated anti-tumor immunity. In contrast to antibodies, HERA-CD40L does not depend on Fcγ receptor-mediated crosslinking for activity. As the first pure CD40 receptor agonist with a well-defined mechanism of action, HERA-CD40L is not restrained by dose-limiting toxicities observed with anti-CD40 antibodies.

The strong anti-tumor efficacy of HERA-CD40L was demonstrated in multiple in vitro and in vivo tumor models. A comprehensive in vitro analysis of the mechanism of action revealed that HERA-CD40L induced the development of pro-inflammatory antigen-presenting cells, including B cells, macrophages, and dendritic cells. Specifically, HERA-CD40L promoted a shift in the balance from tumor-promoting (M2-type) macrophages to anti-tumor (M1-type) macrophages. The potent antigen-specific activation of T cells by HERA-CD40L-treated macrophages led to an immune response specifically directed against the tumor. This is an important advantage over numerous other immunotherapeutic approaches that often cause serious side effects due to non-specific activation of the immune system.

"HERA-CD40L is a novel TNF superfamily receptor agonist based on our proprietary HERA-ligand technology platform that has demonstrated a strong anti-tumor efficacy in preclinical tumor models," said Harald Fricke, M.D., Chief Medical Officer of Apogenix. "CD40 is a key target because it has a unique role in initiating an antigen-specific immune response against tumors. We will continue to apply our HERA-ligand technology to address other TNF superfamily receptors that play a critical role in the anti-tumor immune response and evaluate the synergistic potential of these development candidates in combination with traditional cancer therapies as well as other immuno-oncology therapeutics."

The company claims that HERA-CD40L is perfectly suitable for standard large-scale production processes. The mechanism of action of HERA-CD40L as a central mediator of T cell activation and co-stimulation predestines this molecule for combination with other therapeutic methods, such as radiotherapy or checkpoint inhibition.

Apogenix is currently developing six additional candidates based on its HERA-ligand technology. Earlier in October of 2018, the company published positive data related to its candidate, HERA-CD27L



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