Avalo Therapeutics, Inc. announced that its human B and T Lymphocyte Attenuator (BTLA) agonist fusion protein, AVTX-008, has now entered IND-enabling studies, with a target IND submission date of 2024. The company is currently evaluating a number of immune dysregulation disorders to pursue. BTLA is an immune checkpoint and a key component of the LIGHT-signaling network and complements AVTX-002, the company's fully human anti-LIGHT monoclonal antibody, currently in the Phase 2 PEAK Trial for non-eosinophilic asthma.

In June 2021, Avalo acquired rights to the BTLA fusion protein technology discovered by Dr. Carl Ware and colleagues at the Sanford Burnham Prebys in La Jolla, CA. Under the terms of the agreement, Avalo obtained an exclusive license to a portfolio of issued patents and patent applications covering a lead molecule and derivatives. Avalo has identified a lead, has initiated IND-enabling activities and expects to submit an IND in 2024.

AVTX-008: AVTX-008 is a fully human B and T Lymphocyte Attenuator (BTLA) agonist fusion protein. IND-enabling activities have been initiated with a target IND submission date in 2024. AVTX-002: AVTX-002 is a fully human monoclonal antibody, directed against human LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with Herpes Virus Glycoprotein D for Herpesvirus Entry Mediator (HVEM), a receptor expressed by T lymphocytes).

AVTX-002 is currently in Phase 2 development for non-eosinophilic asthma (PEAK trial) with proof-of-concept data in inflammatory bowel diseases and COVID-19 acute respiratory distress syndrome. AVTX-002 PEAK Trial: The Phase 2 PEAK trial (n=approximately 80) is a 12-week randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of AVTX-002 for the treatment of poorly controlled NEA (NCT05288504). The primary endpoint is the proportion of subjects who experience an asthma-related event.

At baseline, subjects will be randomized to receive either AVTX-002 or placebo once monthly.