Asalyxa Bio, a startup with neutrophil targeting drug-delivery
technology invented at University of Michigan that aims to treat a wide range of inflammatory diseases, has secured seed funding to advance toward the first in-human trials next year.
Asalyxa Bio was co-founded by U-M scientists and Orange Grove Bio, a New York-based venture operating company. The company's chief scientific officer is Lola Eniola-Adefeso, who was among the few Michigan researchers working during the depths of the lockdown because her group was making progress on a treatment for Acute Respiratory Distress Syndrome (ARDS), including the variety found in COVID-19 patients.
The company's lead program is ASX-100, a technology that delivers an anti-inflammatory agent directly to overreactive neutrophils. The arrival of ASX-100 reduces the activity of these immune cells and minimizes harm to the body from the immune overreaction that triggers what's known as a "cytokine storm."
Eniola-Adefeso, a chemical engineering professor, and her colleagues found they could improve survival in ARDS mouse models with ASX-100-and then began working on combining the original technology with medicine to treat inflammation more effectively. She said Orange Grove has moved quickly to launch the company and boost development.
"Within weeks, we had a full preclinical and early development plan and started manufacturing clinical drug material," she said. "The broader platform opportunity promises a unique opportunity to treat millions of patients with longstanding, critical needs for novel therapeutic approaches."
Eniola-Adefeso said it's important to increase understanding of neutrophils and their role in innate immunity. She describes neutrophils as the most common yet least glamorous white blood cells, which only recently have begun to receive significant attention from the academic research and biotech communities. She said their lack of specialization makes them good "first responders" in the body when something is wrong, but trouble comes when they don't get the signal to stop responding so other cells can step in and repair the damage.
The company's first set of indications are in acute inflammatory disorders, including
ARDS and COVID-induced ARDS. Even before COVID-19, ARDS was affecting about 500,000 Americans a year, with roughly half dying as a result. There are no approved drugs for ARDS, the leading cause of death from the flu, leaving respiratory support as the current standard of care.
Asalyxa Bio's path to commercialization was aided by U-M's Office of Technology Transfer. Eniola-Adefeso and her team worked closely with Bruce Auerbach, an experienced pharma and biotech entrepreneur who serves as a Tech Transfer mentor-in-residence. Auerbach, together with Tech Transfer associate director of licensing Stefan Koehler, helped establish a pathway for the development of the intellectual property, worked to secure translational funds, and pursued a partnership which would accelerate the path to patients.
Eniola-Adefeso collaborated with Theodore Standiford, chief of the Pulmonary and Critical Care Medicine Division, to conduct preclinical experiments and validate the approach.
"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 Kelly Sexton, U-M associate vice president of research-technology transfer and innovation partnerships. "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."
Company officials are eager to explore what else is possible with the underlying drug-delivery platform in ASX-100.
"We are so pleased to have partnered with the University of Michigan and Dr. Eniola-Adefeso on this breakthrough opportunity," said Marc Appel, CEO of both Asalyxa Bio and Orange Grove Bio. "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."
