• Avalo’s SAB is comprised of key opinion leaders in immunology and the LIGHT-signaling network

WAYNE, Pa. and ROCKVILLE, Md., May 22, 2023 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX) announced the appointment of Dr. Michael Croft and Dr. Jeff Edelson to the company’s Scientific Advisory Board (SAB). The SAB, which is led by Dr. Carl Ware, provides strategic and scientific guidance to Avalo as it progresses its pipeline of therapies that target the LIGHT-signaling network, notably AVTX-002 (anti-LIGHT mAb) and AVTX-008 (BTLA agonist fusion protein).

Avalo’s SAB comprises (biographies below):

• Carl Ware, Ph.D., Chair of Avalo’s SAB
• Michael Croft, Ph.D.
• Jeff Edelson, M.D.
  

“The addition of Drs. Croft and Edelson to our SAB greatly strengthens our scientific core and further enhances Avalo’s standing as a leader in the LIGHT-signaling pathway immunoregulation,” said Dr. Garry Neil, Chief Executive Officer and Chairman of the Board. “The members of our SAB, which is led by Dr. Carl Ware, are world renowned experts and leaders in the industry who have made pioneering contributions to the immunology field. Their combined knowledge and expertise of the LIGHT-signaling network, tumor necrosis factor superfamily, and inflammatory and autoimmune disease, including asthma, is invaluable to our research and development efforts. Their insights will be crucial to Avalo as we approach a transformational topline data readout this quarter of our Phase 2 PEAK trial of AVTX-002 in patients with non-eosinophilic asthma.”

Biographies

Carl Ware, Ph.D. (Director and Professor, Infectious and Inflammatory Diseases Center at Sanford Burnham Prebys Medical Institute) is recognized for his extensive research on the tumor necrosis factor (TNF) superfamily and its role in immune responses. Throughout his career, he has focused on unraveling the molecular mechanisms underlying TNF signaling and its impact on inflammation, cell survival, and immune regulation. Dr. Ware's studies have contributed to a better understanding of TNF receptor signaling pathways and their implications in various diseases, including cancer and autoimmune disorders. He is the discoverer of the LIGHT-signaling network and Avalo’s two lead compounds, AVTX-002 (anti-LIGHT mAb) and AVTX-008 (BTLA agonist fusion protein).

At the Sanford Burnham Prebys Medical Discovery Institute, Dr. Ware has held several prominent positions, including his current position of Director of the Infectious and Inflammatory Diseases Center. His work has resulted in numerous publications in prestigious scientific journals, earning him international recognition and numerous accolades for his scientific achievements. Dr. Ware's research has not only provided insights into fundamental immunological processes but also paved the way for the development of therapeutic interventions targeting TNF-related pathways.

Michael Croft, Ph.D. (Director, Academic Affairs and Professor, Center for Autoimmunity and Inflammation at La Jolla Institute for Immunology) has made many significant contributions to the field of immunology, particularly in the area of T-cell biology. He has conducted pioneering research on the tumor necrosis factor (TNF) superfamily, focusing on understanding the functions and signaling pathways of these proteins in immune regulation, inflammation, and the immune response to cancer, including studies of LIGHT and its receptors and their potential contribution to several inflammatory diseases including asthma.

As a scientist at the La Jolla Institute for Immunology, Dr. Croft has made groundbreaking discoveries in the field of immune costimulatory/checkpoint molecules, including OX40, 4-1BB, LIGHT and others and their potential as therapeutic targets. His work has shed light on the mechanisms by which these molecules modulate T-cell responses and has paved the way for the development of novel immunotherapies for autoimmune and inflammatory disease and for cancer treatment.  

Dr. Croft's research findings have been widely published in top-tier scientific journals, and he has received numerous honors and awards for his contributions to immunology. His work continues to influence the field and holds promise for the development of new strategies to suppress chronic inflammatory diseases and enhance immune responses against cancer and infectious diseases.

Jeff Edelson, M.D. greatly strengthens our clinical and scientific team. He has conducted extensive research in the areas of lung biology, immunotherapy, and targeted therapies including asthma and other respiratory diseases. His work has focused on understanding the molecular mechanisms underlying lung inflammation, asthma, COPD as well as identifying new therapeutic targets for lung disease and oncology. Through his research, he has made notable discoveries that have improved our understanding of lung biology and contributed to the development of innovative treatment strategies. After a distinguished academic career, he has held a number of leadership positions in both large and small pharma including GSK, Aventis Pharma and J&J. In these roles, he has played a pivotal role in the development and clinical testing of several therapeutics. Dr. Edelson has extensive experience in the design and execution of clinical trials, evaluating the safety and efficacy of new drugs and treatment approaches.

Throughout his career, Dr. Edelson has been widely published in esteemed scientific journals, sharing his research findings and insights with the scientific community. He has also been actively involved in professional organizations and has served on advisory boards and committees related to basic research and drug development.

About AVTX-002
AVTX-002, Avalo’s lead development asset, is a fully human monoclonal antibody (mAb), 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). There is increasing evidence that the dysregulation of the LIGHT-signaling network which includes LIGHT, its receptors HVEM and LTβR and the downstream costimulatory/checkpoint BTLA, is 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, including NEA. AVTX-002 previously demonstrated proof of concept in COVID-19 induced acute respiratory distress syndrome including reduction in mortality and respiratory failure.

About AVTX-002 PEAK Trial
The Phase 2 PEAK Trial is a randomized, double-blind, placebo-controlled, parallel group trial designed to evaluate the safety and efficacy of AVTX-002 for the treatment of poorly controlled NEA (NCT05288504). Following 12 weeks of treatment, the efficacy and safety of AVTX-002 will be evaluated compared with placebo. The primary endpoint is the proportion of patients who experience any of the following asthma-related events: (i) ≥6 additional reliever puffs of a short-acting beta-agonist (compared to baseline) in a 24-hour period on 2 consecutive days, or (ii) increase in inhaled corticosteroid dose ≥4 times than the dose at baseline, or (iii) a decrease in peak flow of 30% or more (compared to baseline) on 2 consecutive days of treatment, or (iv) an asthma exacerbation requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days, or (v) a hospitalization or emergency room visit because of an asthma exacerbation.

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 Avalo Therapeutics
Avalo Therapeutics is a clinical stage biotechnology company focused on the treatment of immune dysregulation by developing therapies that target the LIGHT-signaling 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 β receptor (TNFRSF3), form an immune regulatory network with two co-receptors of herpesvirus entry mediator, costimulatory/checkpoint inhibitor B and T Lymphocyte Attenuator (BTLA), and CD160 (the LIGHT-signaling network). Accumulating evidence points to the dysregulation of the LIGHT-signaling 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: the development of product candidates or products; timing and success of trial results and regulatory review; potential attributes and benefits of product candidates; 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: drug development costs, timing and other risks, including reliance on investigators and enrollment of patients in clinical trials, which might be slowed by COVID-19 or other widespread health events; Avalo's debt and cash position and the need for it to raise additional capital in the near future; reliance on key personnel; regulatory risks; general economic and market risks and uncertainties, including those caused by COVID-19 or other widespread health events; 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.

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