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Avalo Advances BTLA Agonist Fusion Protein (AVTX-008) to IND-enabling Stage

Last Updated on September 6, 2022 by GlobeNewsWire

Strategy focused on LIGHT-signaling network targets

WAYNE, Pa. and ROCKVILLE, Md., Sept. 06, 2022 (GLOBE NEWSWIRE) — Avalo Therapeutics, Inc. (NASDAQ: AVTX) announced today 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.

“Avalo is becoming a world-leader through our collaboration with Dr. Ware in this field with two high quality biologic drug candidates that address critical components of the LIGHT-signaling network. Targeting this network has now become our major focus at Avalo,” said Garry Neil, MD, Chief Executive Officer of Avalo. “Targeting BTLA with agonists to limit inflammatory conditions is attracting the attention of the immunology and investment communities.”

Dr. Ware, Director, Infectious and Inflammatory Diseases Center leads the Laboratory of Molecular Immunology at Sanford Burnham Prebys, and Head of Avalo’s Scientific Advisory Board, agreed: “LIGHT and its receptors form a unique immune system network. The network initiates inflammatory responses, and oppositely, the BTLA checkpoint limits hyperactive immune responsiveness. There is increasing evidence that the dysregulation of this LIGHT network is a driver in many autoimmune and inflammatory diseases such as COVID-19 acute respiratory distress syndrome, inflammatory bowel diseases and, potentially, asthma. The ability to modulate different targets within this network should provide the opportunity to develop better therapeutics such as AVTX-002 and AVTX-008.”

About 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.

About 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.

About 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.

About Avalo Therapeutics

Avalo Therapeutics is a clinical stage biotechnology company focused on the treatment of immune dysregulation by developing therapies that target the LIGHT network.

LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with HSV Glycoprotein D for Herpesvirus Entry Mediator (HVEM), a receptor expressed by T lymphocytes; also referred to as TNFSF14) is an immunoregulatory cytokine. LIGHT and its signaling receptors, HVEM (TNFRSF14), and lymphotoxin ? receptor (TNFRSF3), form an immune regulatory network with two co-receptors of herpesvirus entry mediator, checkpoint inhibitor B and T Lymphocyte Attenuator (BTLA), and CD160 (the LIGHT-signaling network). Accumulating evidence points to the dysregulation of the LIGHT network as a disease-driving mechanism in autoimmune and inflammatory reactions in barrier organs. Therefore, we believe reducing LIGHT levels can moderate immune dysregulation in many acute and chronic inflammatory disorders.

For more information about Avalo, please visit www.avalotx.com.

Forward-Looking Statements

This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Avalo’s control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Avalo’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “might,” “will,” “could,” “would,” “should,” “continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” or similar expressions (including their use in the negative), or by discussions of future matters such as: potential attributes and benefits of product candidates; the development of product candidates or products; timing and success of trial results and regulatory review; the future financial and operational outlook; and other statements that are not historical. These statements are based upon the current beliefs and expectations of Avalo’s management but are subject to significant risks and uncertainties, including: Avalo’s cash position and the potential need for it to raise additional capital; drug development costs, timing and other risks, including reliance on investigators and enrollment of patients in clinical trials, which might be slowed by the COVID-19 pandemic; reliance on key personnel, including as a result of recent management and Board of Director changes; regulatory risks; general economic and market risks and uncertainties, including those caused by the COVID-19 pandemic and tensions in Ukraine; and those other risks detailed in Avalo’s filings with the SEC. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Avalo expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Avalo’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For media and investor inquiries

Christopher Sullivan, CFO Avalo Therapeutics, Inc. ir@avalotx.com 410-803-6793

or

Chris BrinzeyICR WestwickeChris.brinzey@westwicke.com 339-970-2843




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