Cellergy Pharma is working to cure severe allergic diseases, including two large, underserved severe allergic disease markets (uncontrollable severe allergic asthma and severe food allergy), by using novel cancer-fighting CAR T cells that target and eliminate the source of allergic disease, called immunoglobulin-E (IgE)-producing cells.
The Wilmington-based company is re-engineering CAR T cells, first approved by the FDA in 2017, to destroy not cancer cells but immune cells that cause disease. “We are the first company in the world to target the antibody IgE, which causes all allergic diseases, but leave all other cells untouched,” says Ronald P. Dudek, president. Severe asthma alone costs the U.S. $60 billion and 3,500-4,000 deaths a year, he says.
The technology was developed by Cellergy co-founder and Chief Science Officer Mark Ma, MBBS, PhD, an immunologist. “Lucky for Delaware, he moved from the University of Pennsylvania to the Nemours Children’s Hospital here,” Dudek says. Nemours, a co-recipient of the grant, is a partner in the company as well.
Cellergy got a big boost in January 2024 when it received a Phase I Small Business Technology Transfer (STTR) grant of $300,000, from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. It used the money to hire a full-time bench scientist, Pooja Singhmar, PhD, who will develop the company’s lead CAR T cell product in conjunction with Dr. Ma. The money also pays for Cellergy’s new lab, which has been set up at The Innovation Space in Wilmington. “That was a real step forward for us to transition from virtual to real, to enable us to move forward to the development of our first product,” Dudek says. “Innovation Space is a remarkable business that seeds biotech companies. It is a lab space with shared instrumentation, which is huge. Otherwise, the expense would be almost defeating for a startup.”
The company also saved about $200,000, which it had budgeted to hire a consultant to help steer it through the complex regulatory process. “We had the good fortune of meeting the president of a regulatory consult company at a meeting, and he was so taken with our technology, he agreed to consult with us for equity only,” Dudek says. “That has accelerated our timeline and helped us move ahead. He thought our approach was really amazing.”
The timeline may have accelerated, but that first product is still several years off; Cellergy hopes to begin Phase I clinical study in 2026, with Phase II and III in 2028, leading to a product launch in 2031, says Dudek. “It takes a long time to develop a therapeutic product.”
He should know. Cellergy is his fourth CAR T startup company. He began his career in 1980 as a “lab rat” doing research on T cell receptors at Scripps Research Institute in San Diego, then earned his MBA from UC Berkeley in 1989. “I have an eye for smart technology,” he says, “and when I saw Mark’s, it clicked with me.”
