Senior AbbVie liaison quits job to launch neuro startup, with sights set on ALS
About a year ago, Howard Berman was sitting in a waiting room at Houston Methodist Hospital with his father, who was showing cognitive loss. They were there to see Joseph Masdeu, one of the leading neurologists in the area.
“You know what?” Berman recalls Masdeu saying. “Why don’t you meet with Dr. Stan Appel, he’s working on some very innovative work in the field of neurodegenerative disease.”
And so last spring, Berman found himself in a private meeting with Appel, the 86-year-old co-director of Houston Methodist’s Neurology Institute, who was donning his iconic bow tie.
Appel presented on his regulatory T cell (Treg) research — and by the third slide, Berman was hooked. Not long after, he quit his job at AbbVie and launched Coya Therapeutics — named after an island off Costa Rica — to develop Appel’s Treg approach for ALS.
On Wednesday, Coya unveiled a $10 million Series A to advance that program and build out a pipeline.
“We want to do for ALS what people did for HIV and AIDS,” Berman said: extend patients’ lives. ALS patients typically live an average of three years after diagnosis, he added.
Appel and his team observed that many ALS patients have low levels of Treg cells, or ones that don’t function properly. Improving the number and function of the Treg cells, they hypothesized, just might slow the progression of disease.
Many companies have eyed Treg cell therapies in the last decade, but the rarity and plasticity of endogenous Treg cells pose a significant challenge.
Coya’s process begins with leukapheresis, or drawing a patient’s blood and isolating the Treg cells. Then scientists add certain types of agents — like rapamycin or IL-2 — designed to stabilize the Tregs and help them grow and function properly. Coya then expands the cells, converting them from millions to billions of Tregs, which are frozen for future use.
“What we found out is you can infuse the cells, (and) it stops progression for about a month… during the course of infusion. But when you stop the infusions, what happens is the patients start to decline again,” Berman said. “It’s not a one-shot deal. You need to be able to give it monthly,” he added later.
Their longest cryopreserved cells have been frozen for a year and a half. And so far, they’re still viable, according to Berman.
Coya has already conducted a Phase I trial, which “successfully demonstrated… the safety and tolerability of autologous infusions of expanded Tregs in ALS patients, with the potential of slowing or halting disease progression,” Appel said in a statement.
An ongoing Phase II trial with eight patients should produce data this June or July, Berman added.
“We will be working with the FDA to design another trial that will really provide, hopefully, compelling data to bring us into an approval process,” he said.
The company is also going after Parkinson’s, Alzheimer’s, frontotemporal dementia and other autoimmune diseases, as well as non-cell based exosomes and small molecules.
“We’re not just a cell therapy company per sé,” Berman said.