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For more than two decades, MaxCyte, Inc. has been shaping the field of cell therapy with its cell engineering platform that has become a staple of the industry, used by multiple companies in more than a dozen clinical trials.
The Rockville-based company could see the FDA approve the first therapy developed with MaxCyte’s platform within the next 12 months. Earlier this year, CRISPR Therapeutics and Vertex Pharmaceuticals submitted a Biologics License Application to the FDA for exa-cel, a gene therapy designed to treat two hematologic disorders, sickle cell disease and transfusion-dependent beta thalassemia.
“This is a really exciting time for the company,” MaxCyte Chief Executive Officer Doug Doerfler said. “If approved by the FDA, exa-cel will be the first non-viral cell engineered product ever. MaxCyte is really making a difference enabling a whole new class of therapies.”
Doerfler said MaxCyte has worked alongside CRISPR Therapeutics since the company first began to use the MaxCyte-developed platform. MaxCyte has been with CRISPR from the point of concept through the clinic and hopefully through commercialization, Doerfler said. That’s a service that other partner companies enjoy as well, he noted.
Doerfler has envisioned this non-viral cell approach to treating disease since his days at Bethesda Research Labs. The technology platform was designed to engineer blood cells as a therapeutic approach to treating diseases.
“Our focus is on solving problems that once solved can be used to treat patients who cannot currently be treated,” he said.
If the FDA approves exa-cel, it will be the first approval feather in the company’s cap but it’s unlikely to be its last. Other companies using the MaxCyte platform are also advancing their developmental programs through the clinic toward eventual commercialization.
Beyond a looming first approval for MaxCyte, the company has seen significant growth. In 2022, MaxCyte moved into a new 67,000 square-foot facility in Rockville. The new space, which is located in the heart of Maryland’s thriving I-270 Biotech Corridor, will enable the company to support the expanding needs of its partners as they move their MaxCyte-backed assets through clinical development toward potential commercialization, Doerfler said. The advanced capabilities of MaxCyte’s new facility will allow the company to expand and advance its own platform approaches.
In fact, in addition to the company’s leading cell therapy platform, MaxCyte is planning to develop a new approach into monoclonal antibodies. Doerfler said this move is being made at the request of the company’s partners who are looking for a new approach with this modality.
The new Rockville facility will provide MaxCyte with the space it needs for all of its internal manufacturing requirements. Additionally, Doerfler said the new site has enabled MaxCyte to expand its process development.
When MaxCyte began looking for a new site, Doerfler said he knew the company would remain in Maryland. Since the company’s launch in 1999, Doerfler said MaxCyte has enjoyed significant support from state and local governments, as well as organizations like TEDCO and the Maryland Tech Council. MaxCyte also benefitted from its proximity to both academic research institutions, as well as federal facilities, such as the National Institutes of Health and FDA.
“Maryland is a great environment for the scientific community,” Doerfler said. “In gene therapy development, over and over again, you’re seeing the leadership coming from Maryland, the NIH, the FDA… there’s great institutions here supporting science. There are also multiple international companies based in Maryland. The world comes to Maryland. There’s a great international community here. The scientific world is global, human healthcare is global, it’s important to be in a place where you can talk to others and begin to address the needs of patients.”
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