Birmingham’s Incysus receives FDA clearance, is expanding team


It has been a busy month for Birmingham-based Incysus, which announced recently it received approval from the U.S. Food and Drug Administration to test its brain cancer therapy in humans.

This announcement came after the company’s presentation at the American Association for Cancer Research Annual Meeting, where the company’s cofounder and chief scientific officer Dr. Lawrence Lamb presented new data on the company’s drug-resistant immunotherapy research that showed its brain cancer therapy works in animals.

The FDA-approved testing will take place at the University of Alabama at Birmingham (UAB)’s O’Neal Comprehensive Cancer Center, where Incsysus, located in Innovation Depot, and UAB will initiate a Phase 1 clinical trial this year to evaluate the safety of the company’s Drug Resistant Immunotherapy platform.



“This represents a significant milestone for Incysus as we continue to work toward improving patient outcomes,” said William Ho, president and CEO of the company. “We are pleased to have received FDA approval to conduct this clinical trial and look forward to the initiation of this Phase 1 study.”

The company, which spun out of UAB in 2016, also announced it hired Vice President of Clinical Operations Melissa Beelen, who will manage the human testing of Incysus’ brain cancer therapy in Birmingham.

In parallel with its brain cancer therapy development, Incysus is also developing a therapy to cure leukemia and lymphoma, which has already received approval from the FDA to test in humans. That testing will begin this year and will also fall under Beelen’s management.

Earlier this year, the company raised $10 million in a Series A round to be used to support advancement of its drug-resistant immunotherapy technology.

The Birmingham Business Alliance (BBA) has worked closely with Incysus, which contributes significantly to Birmingham’s reputation in science, research and product development.

“The BBA is proud to be working with Incysus as they continue to achieve important clinical and corporate milestones in the development of their cutting-edge scientific platform,” said Jon Nugent, vice president of innovation and technology at the BBA. “We are particularly pleased that they have located their scientific headquarters here in Birmingham. Their presence adds significantly to our community’s reputation as a center for world-class science, research and product development.”