CARLSBAD – Alberta Canada-based Entos Pharmaceuticals is stretching out its San Diego footprint with a new manufacturing facility in Carlsbad.
The 32,000-square-foot building at 2070 Las Palmas Dr. has 20,000 square feet of manufacturing space, including a lipid formulation production suite with additional suites dedicated to mRNA and plasmid DNA manufacturing.
Entos’ key development is its Fusogenix proteolipid vehicle (PLV) drug delivery system that is formulated using a FAST (Fusion-Associated Small Transmembrane) protein technology that enables fusion of the proteo-lipid vehicle with the plasma membrane of target cells. Nucleic acid payloads are delivered intact into the cytoplasm for immediate use as a therapeutic agent.
In Janualry 2022, Entos signed an agreement worth up to $450 million to give exclusive rights to Eli Lilly for Fusogenix nucleic acid delivery technology in the research, development and commercialization of nucleic acid products targeting the central and peripheral nervous system.
“That necessitated an expansion in the U.S.,” said Entos Pharmaceuticals CEO John Lewis, Ph.D.
In addition to the partnership with Eli Lilly, Entos and its subsidiary company Aegis Life last year entered into a grant agreement with the Bill & Melina Gates Foundation. As part of the agreement, the Foundation will provide funding support to develop the Fusogenix PLV platform for the delivery of DNA-encoded monoclonal antibodies for the treatment of infectious diseases such as HIV, influenzas, and malaria. Aegis is licensed to use Entos’ technology to develop therapeutics and vaccines for infectious diseases.
Developing Own Pipeline
Along with the Carlsbad manufacturing facility, Entos has two R&D sites in Torrey Pines where the company is developing its own genetic medicine programs, including Covigenix, a COVID-19 booster vaccine, as well as future candidates in rare disease, eye and ophthalmic conditions, oncology, and other infectious diseases.
The expansion into Carlsbad was to create a facility to support Phase I, II and II clinical manufacturing, but also pilot up to eventual commercial manufacturing of Entos’ pipeline products Lewis said, adding that the company wanted to have its manufacturing staff and R&D staff close by as the teams worked together to optimize its scale-up manufacturing.
“Our Carlsbad site represents a strategic opportunity for us to expedite the development of GMP-grade Fusogenix PLV required for clinical trials,” Lewis said. “GMP production is a crucial milestone in our mission to develop and manufacture safe and effective genetic medicines to address global health challenges.”
Lewis said the location was also “serendipitous” because the space already had a typical GMP infrastructure there.
“We invested about $2 million to bring it up to clinical therapeutic GMP standards,” he added.
When the new facility is fully operational, it will employ 25 to 30 technical employees and up to 20 support employees.
Those employees will be led by Swapnil Ballal who was announced as Entos’ vice president of manufacturing concurrently with the announcement of the new facility.
“This marks an exciting era for Entos,” Ballal said. “The successful commissioning of the site, followed by GMP batch manufacturing, exemplifies the potential of our facility. With mRNA and pDNA capabilities, Entos is poised to internally manufacture a substantial portion of our drug product, aligning with the rapid pace of development of our exciting product pipeline.”
Entos’ development strategy also includes establishing a future manufacturing site in Edmonton, to enable more commercial manufacturing. The company also maintains a location in London, England.
CEO: John Lewis, Ph.D.,
HEADQUARTERS: Edmonton, Alberta, Canada
BUSINESS: Genomic medicines and drug delivery systems
EMPLOYEES: 70 (about half in San Diego)
NOTABLE: Entos CEO John Lewis trained at The Scripps Research Institute and received a Ph.D. in biochemistry from the University of Victoria.