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Entos Pharmaceuticals (Entos), a Canada-based biotechnology company, opened a good manufacturing practice (GMP) clinical manufacturing facility in Carlsbad, San Diego, California, US, to produce drug substances needed for investigational new drug (IND)-enabling studies and clinical trials to advance its proprietary and partnered programmes.

The facility is pivotal for the production of genetic medicines including recombinant protein, mRNA, and plasmid DNA, leveraging Entos’ Fusogenix proteolipid vehicle (PLV) drug delivery system.

The facility was commissioned in January 2024 and completed its inaugural GMP manufacturing run.

The company invested approximately $2m to upgrade the facility to meet the standards required for clinical therapeutic GMP. Upon reaching full operational capacity, the facility is expected to employ 25 to 30 technical staff members and an additional 20 support personnel.

Entos GMP clinical manufacturing facility details

The manufacturing facility spanning 32,000ft² (2,973m²), encompasses 20,000ft² of manufacturing space. It houses a lipid formulation production suite and other dedicated suites for the manufacturing of recombinant protein, mRNA, and plasmid DNA.

The facility supports the clinical development of genetic medicine programmes, including Covigenix, a Covid-19 booster vaccine, and future candidates for rare diseases, eye and ophthalmic conditions, oncology, and other infectious diseases. It also supports Entos’ clinical trials, which are crucial for its in-house and collaborative programmes focussing on central nervous system disorders.

The company’s expansion into Carlsbad not only accommodates Phase I, II, and III clinical manufacturing but also scales up to eventually support the commercial manufacturing of Entos’ pipeline products.

The facility provides an opportunity to accelerate the production of GMP-grade Fusogenix PLV, which is essential for clinical trials.

Fusogenix PLV drug delivery system details and developments

The Fusogenix PLV drug delivery systems are formulated with Fusion-Associated Small Transmembrane (FAST) proteins to allow the delivery of various nucleic acid therapies such as gene therapy, clustered regularly interspaced short palindromic repeats (CRISPR), mRNA or DNA directly into target cells through direct fusion.

Nucleic acid payloads are directly delivered into the cytoplasm intact, ready for immediate therapeutic use. The Fusogenix PLV platform is not only utilised for the development of Covid-19 DNA vaccines but is also instrumental in delivering nanomedicine throughout the body. It offers advantages over conventional lipid-based delivery systems such as high tolerability at systemic doses, sustained activity with repeated dosing, and extensive biodistribution across all organs and tissues.

Entos entered an agreement with Eli Lilly in January 2022, valued at up to $450m to grant exclusive rights to the Fusogenix nucleic acid delivery technology for the research, development, and commercialisation of nucleic acid products targeting the central and peripheral nervous system. The partnership made it necessary for the company to expand in the US.

Additionally, Entos and its subsidiary Aegis Life have secured a grant agreement with the Bill & Melinda Gates Foundation to fund the development of the Fusogenix PLV platform for delivering DNA-encoded monoclonal antibodies to combat infectious diseases such as HIV, malaria and influenza. Aegis is licensed to use Entos’ technology for developing therapeutics and vaccines for these diseases.

Marketing commentary on Entos Pharmaceuticals

Entos Pharmaceuticals is committed to the development of safe, effective, and re-dosable nucleic acid delivery technologies to shape the future of genetic medicine. It has a workforce of approximately 70 people.

Besides the Carlsbad manufacturing facility, the company operates two research and development (R&D) sites in Torrey Pines, San Diego. The company is actively developing its genetic medicine programmes and is planning to establish a future manufacturing site in Edmonton, Canada, for increased commercial manufacturing capacity.

Entos Pharmaceuticals is dedicated to creating precision nucleic acid therapies to meet clinical needs that are currently unaddressed. Its pipeline includes therapeutic candidates for oncology, vaccines, Covid-19 DNA vaccines, age-related diseases, genetic diseases, and neurological disorders being developed in collaboration with partners such as OncoSenX, Aegis Life, OISIN Biotechnologies, and Eli Lilly.