Pipeline

AVS100

(Small Molecule)
AVS100 is a highly selective, orally bioavailable HDAC6 inhibitor intended for the treatment of locally advanced or metastatic solid tumors, including in combination with existing PD-1 inhibitor pembrolizumab. In a majority of advanced solid tumors, response rates remain low such as in metastatic melanoma where only 20-30% of patients are responsive to existing therapies; highlighting substantial unmet need. One of the key correlates with patients who do not respond to existing therapy or progress regardless of standard of care options, are the presence of immunosuppressive cells in the tumor microenvironment (TME) such as tumor associated macrophages. Pro-tumoral macrophages and other myeloid suppressor cells can constitute up to 50% or more of solid tumor cell mass. AVS100 has been proven preclinically to be able to suppress the polarization of tumoral macrophages towards pro-tumoral phenotypes, including in human cells. In preclinical in-vivo studies, AVS100 has substantial efficacy in reducing tumor growth as a monotherapy or in combination with anti-PD1 in multiple models, as well as increasing the overall M1/M2 macrophage ratio in the TME. AVS100 also has an exceptional preclinical safety profile, with no mutagenicity or cardiotoxicity and minimal GLP toxicology drug related findings. AVS100 has been IND cleared by U.S. FDA for conducting a Phase Ia/b trial targeting locally advanced or metastatic solid tumors in combination with pembrolizumab. Avstera intends to initiate this clinical study in the first half of 2024.

AVS200

(Cell Therapy)
AVS200 is Avstera’s first-in-class myeloid cell therapy platform. Avstera intends to advance a lead myeloid cell therapy, designed based on the functions uncovered related to immunosuppressive tumoral pathways and mechanisms to control or suppress those pathways. The company has proof-of-concept in-vivo work of an autologous macrophage cell therapy highlighting PoC of ability to maintain anti-tumoral M1 phenotype effect in multiple models including B16 (see Publications). Avstera is advancing this development in designing novel mRNA-CAR-Macrophage , mRNA-CAR-Monocyte and other undisclosed innovative engineered cell types of which the company hopes to select a lead to advance through IND enabling or via a suitable development partner.