Small molecules for neuro / psychiatric disorders

Avalo Therapeutics is a clinical-stage biotechnology company that focuses on developing innovative treatments for immune dysregulation. Their lead product candidate, AVTX-009, is a humanized monoclonal antibody (IgG4) designed to target interleukin-1β (IL-1β), a key mediator in the inflammatory process. By binding to IL-1β with high affinity, AVTX-009 neutralizes its activity, which is particularly relevant in various autoimmune and inflammatory diseases. The company is currently conducting Phase 2 clinical trials for AVTX-009, specifically targeting hidradenitis suppurativa (HS), a chronic inflammatory skin condition. The therapeutic potential of AVTX-009 is underscored by its favorable safety profile and its ability to provide effective anti-inflammatory properties, which may lead to improved patient outcomes.

In addition to AVTX-009, Avalo Therapeutics is advancing two other product candidates: quisovalimab, an anti-LIGHT monoclonal antibody, and AVTX-008, a BTLA agonist fusion protein. These candidates are part of Avalo's broader pipeline aimed at addressing various immune-mediated diseases. The company’s strategic focus on targeting specific inflammatory pathways highlights its commitment to developing therapies that can significantly improve the quality of life for patients suffering from conditions driven by immune dysregulation. Through its innovative approach, Avalo Therapeutics aims to provide new treatment options in areas where current therapies are limited.

United States

Avalo Therapeutics Inc. (Name changed from Cerecor Inc.) is a biopharmaceutical company focused on the discovery, development and commercialization of prescription pharmaceuticals whose primary activity is in the human brain. We are a Delaware corporation, organized in April 2011 in partnership with various laboratories and research institutes at Johns Hopkins Medical Institute ("JHMI"​). Cerecor is focused on translational medicine – the accelerated transfer of technology from the academic laboratory to early human trials, with the goal of rapid commercialization. We acquire rights to early stage therapeutic technologies ("assets"​) from universities, finance and manage the development of these assets into drug candidates (to first major milestone or value inflection point) and then either commercialize or outlicense the asset. 

Digestive System Diseases

Immune System Diseases

Infectious Diseases

Lung Diseases

Avalo Therapeutics 

Leukocyte Adhesion Deficiency Type II

CERC-801, CERC-802 and CERC-803 are monosaccharide therapies with known &nbsp;therapeutic utility for the treatment of select congenital disorders of &nbsp;glycosylation (CDGs). Oral administration at therapeutic doses of &nbsp;CERC-801, CERC-802, and CERC-803 replenishes critical metabolic &nbsp;intermediates that are reduced or absent due to genetic mutation, &nbsp;overcoming single enzyme defects in respective CDGs to support &nbsp;glycoprotein synthesis, maintenance and function.

AVTX-803 (CERC-803) 

COVID-19

CERC-002 is an anti-LIGHT (part of the Tumor Necrosis Super Family 14) fully human monoclonal antibody licensed from Kyowa Kirin Co., Ltd. in the clinic. It offers the potential to treat cytokine storm-induced COVID-19 ARDS in the near-term and broader ARDS indication beyond. It is currently being developed as a therapy for Pediatric Crohn’s Disease and now cytokine storm induced COVID-19 ARDS. Cerecor has also developed a validated serum/plasma free LIGHT assay in collaboration with Myriad RBM. This assay has shown to have high sensitivity and specificity for free LIGHT which has been shown to be elevated in patients with active Crohn’s disease and with COVID-19 related ARDS.

Quisovalimab/ AVTX-002 (CERC-002) 

Asthma

CERC-002 is an anti-LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with HSV Glycoprotein D for HVEM, a receptor expressed by T lymphocytes (part of the Tumor Necrosis Super Family 14)), fully human, monoclonal antibody being developed as a treatment for Pediatric Crohn’s Disease.

Quisovalimab/AVTX-002 (CERC-002) 

Autoimmune disease

Hidradenitis suppurativa

AVTX-009 is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity and neutralizes its activity. IL-1β is a central driver in the inflammatory process. Overproduction or dysregulation of IL-1β is implicated in&nbsp;many&nbsp;autoimmune and inflammatory diseases. IL-1β is a major, validated target for therapeutic intervention. There is evidence that inhibition of IL-1β could be effective in HS and a variety of inflammatory&nbsp;diseases in dermatology, gastroenterology, and rheumatology.

AVTX-009

Crohns disease

Quisovalimab/ AVTX-002 (CERC-002)

Adult Onset Still's Disease

Multiple myeloma

CERC-007 is a high affinity, fully human monoclonal &nbsp;antibody targeting the proinflammatory cytokine IL-18. It is in &nbsp;development for multiple auto-immune diseases, including Still’s disease &nbsp;(adult onset Still’s disease (AOSD) and systemic juvenile idiopathic &nbsp;arthritis (sJIA)), and multiple myeloma (MM).
<a href="https://ir.cerecor.com/press-releases/detail/125/cerecor-doses-first-patient-in-a-phase-1b-proof-of-concept">Source</a>

AVTX-007 (CERC-007)

Metabolic disorder

Rare genetic disease

CERC-801 is an ultra-pure, oral, crystalline formulation of D-galactose, a naturally occurring monosaccharide found in dairy products and fruit. D-Galactose is consumed by the body to provide substrates for protein glycosylation, the process by which carbohydrates are utilized to modify certain proteins as it relates to protein structure and function. CERC-801 has been granted Orphan Drug Designation and awarded Rare Pediatric Disease Designation by the FDA, granting eligibility for receipt of a Priority Review Voucher upon approval of an NDA.

AVTX-801 (CERC-801)

CERC-802 is an ultra-pure formulation of D-mannose, a naturally occurring monosaccharide commonly found in animals, microorganisms, and plants, including edible fruits and herbs. D-mannose is consumed by the body to provide substrates for protein glycosylation, the process by which carbohydrates are utilized to modify certain proteins as it relates to protein structure and function. CERC-802 has been granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation by the FDA, making the Company eligible to receive a Priority Review Voucher (PRV) upon approval of an NDA.

AVTX-802 (CERC-802)

Lymphatic malformations

CERC-006 is an orally available blocker of mTOR complex 1 and 2 that &nbsp;is being developed for the treatment of serious lymphatic malformations &nbsp;(LM) not treatable with surgery or sclerotherapy. Because a large &nbsp;majority of LM patients have activating mutations in the PK/AKT/mTOR &nbsp;pathway, we believe CERC-006 has the potential to specifically reduce &nbsp;proliferation of the abnormal cells that cause LM, reduce the size of &nbsp;neoplastic lesions and restore lymphatic function; ultimately improving &nbsp;and prolonging the lives of many affected children. A Phase 1b/2a &nbsp;proof-of-concept trial to test the safety and efficacy of CERC-006 in LM &nbsp;is planned to begin in 2021.
<a href="https://ir.cerecor.com/press-releases/detail/101/cerecor-receives-rare-pediatric-disease-designation-for">Source</a>

Avalo Therapeutics

Company Details