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Asalyxa Bio Launches with Novel Neutrophil-Targeting Drug Delivery Platform Technology

Asalyxa Bio Launches with Novel Neutrophil-Targeting Drug Delivery Platform Technology and Lead Candidate, ASX-100, for Acute Respiratory Distress Syndrome (ARDS) and COVID-19 Patients

University of Michigan spinout readies for clinical trials with lead candidate ASX-100, a novel spherical particle that releases a safe and effective anti-inflammatory agent, salicylic acid, directly to over-reactive immune cells

ANN ARBOR, MI – August 25, 2020 – Asalyxa Bio, a new spinout from the University of Michigan focused on severe neutrophil-mediated diseases, today announced its formation and seed funding to accelerate ASX-100 into first-in-human trials in 2021. The company was co-founded by Orange Grove Bio (OGB), a New York-based venture operating company and leading scientists at the university. Marc Appel, the CEO of OGB, will serve as the CEO of Asalyxa Bio, with Dr. Lola Eniola-Adefeso, a Michigan professor, serving as Chief Scientific Officer. They are complemented by a development team with decades of biotech and pharmaceutical drug discovery and development experience.

“This new collaboration with Orange Grove Bio will enable the rapid development and commercialization of this important and innovative technology from Dr. Eniola-Adefeso’s laboratory, “ said Dr. Kelly Sexton, Associate Vice President of Research-Technology Transfer and Innovation Partnerships at the University of Michigan. “We have high hopes both for Asalyxa’s success and for future opportunities to work with Orange Grove to bring U-M technologies to the clinic to address unmet medical needs.”

ASX-100 is a novel, spherical polymer particle that degrades into salicylic acid – an active metabolite of aspirin – and a food additive that is listed as GRAS (generally regards as safe) by the FDA. The particles, with a size similar to many bacteria, are recognized as foreign by neutrophils in the blood. Neutrophils are immune cells that are involved in the systemic response to infection and injury. These neutrophils “eat” (phagocytose) the ASX-100 particles, and degrade them to release the anti-inflammatory agent. This delivers a very high dose of drug directly into the neutrophils, while the systemic dose remains low.

Asalyxa is initially pursing ASX-100 for use in Acute Respiratory Distress Syndrome (ARDS) and other acute tissue injuries. Recently, COVID-19 has drawn attention to ARDS, but ARDS was already a critical, unmet health problem, affecting approximately 500,000 Americans each year. 40% to 60% of those patients will die, similar to what is seen with hospitalized COVID-19 patients on respirators. ARDS is also the leading cause of death each year from the flu. There are no approved drugs for ARDS; respiratory support is the current standard of care.

Neutrophils are a key contributor to the development of ARDS. In general, neutrophils migrate towards a site of infection and recruit other immune cells to join them, in an effort to resolve the problem. However, in acute or severe infections, the neutrophils can over-react and recruit significantly more immune cells to the injury than are helpful. This can lead to tissue damage and trigger the cytokine storm seen in many patients. The targeted delivery of ASX-100 into neutrophils provides a very high localized dose of drug to these cells, reducing the activity of the neutrophils and minimizing harm to the body from the immune response.

In addition to pursuing ARDS, Asalyxa is developing the underlying, targeted-delivery platform in ASX-100 to transport a broader set of drugs directly into neutrophils.

“We are so pleased to have partnered with the University of Michigan and Dr. Eniola-Adefeso on this breakthrough opportunity,” said Appel. “The platform has incredible breadth to address a wide-range of inflammatory disorders with great unmet medical need, and ASX-100 provides an immediate opportunity to address the severe needs in ARDS and COVID-19-related ARDS.”

Eniola-Adefeso added, “The Orange Grove team has been exceptional in moving quickly to launch Asalyxa and advance ASX-100 into late preclinical development. Within weeks, we had a full preclinical and early development plan and started manufacturing of clinical drug material. The broader platform opportunity promises a unique opportunity to treat millions of patients with long-standing, critical needs for novel therapeutic approaches.”

About Asalyxa Bio

Asalyxa Bio is drug development and platform technology company focused on novel therapeutics to treat major unmet medical needs caused by the dysregulation of immune signaling. With applications across a wide array of disease areas and conditions, Asalyxa’s platform technology enables delivery of existing and novel drugs directly into over-reactive immune cells.

About Orange Grove Bio

Orange Grove Bio (OGB) is an emerging, preclinical, capital allocation and asset development biotech company. OGB partners with universities and entrepreneurs to develop innovative treatments for important diseases, particularly cancer and immune disorders.

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Contacts:

Asalyxa Bio f

Marc Appel, Chief Executive Officer

mappel@orangegrovebio.com

+1 (845) 558-5286

John Prista Freshley, Head of Corporate Development

jfreshley@orangegrovebio.com

+1 (734) 926-5530

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