3PBIOVIAN announced in September 2024 that it has been selected by Rokote Laboratories Finland Ltd. as CDMO partner for GMP manufacturing of adenovirus type 5 (Ad5) vector-based candidate expressing a modified SARS-CoV-2 spike protein. The partnership aims to bring Rokote Laboratories’ intranasal FINCoVac 2.1 vaccine to Phase I clinical studies with 3PBIOVIAN providing Drug Substance and Drug Product. FINCoVac 2.1 is intended to elicit a strong mucosal immune response in the nasopharyngeal cells, potentially preventing infection and transmission.
Ad5 vector
The agreement covers GMP manufacturing of the Ad5 vector using 3PBIOVIAN’s standard process at facilities in Turku, Finland. With “extensive experience” in adenovirus GMP manufacturing solutions, 3PBIOVIAN pursues “successful scalability and GMP compliance”. To meet Rokote Laboratories’ “urgent” needs, the programme has advanced “exceptionally fast”.
FINCoVac 2.1
Rokote Laboratories seeks to “consolidate” the use of new vaccine technology in Finland, focusing on a second-generation coronavirus vaccine, FINCoVac 2.1. It is designed to “meet the challenge of the rapidly mutating variants” with applications as an “easy-to-dose booster”. The vaccine consists of an adenoviral vector, to which the SARS-CoV-2 viral spike protein gene has been transferred. FINCoVac is administered intranasally, so it is expected to offer a “wider immune response” than vaccines that are administered intramuscularly.
Dr Erkko Ylösmäki, CEO of Rokote Laboratories, is pleased with the partnership with 3PBIOVIAN to manufacture the vaccine.
“The ability to use 3PBIOVIAN’s standard process for rapid GMP batch production, along with their extensive experience with adenovirus-based processes, made 3PBIOVIAN the ideal CDMO partner.”
Dr Ylösmäki is excited to start the collaboration and hopes that “together we can further advance Finnish vaccine development”. Deputy CEO at 3PBIOVIAN, Antti Nieminen, commented that the company has “about two-decade-long history” in viral vector development processes and GMP-manufacturing of adenoviruses.
“We are happy to have a role in the journey of this novel second-generation coronavirus vaccine to clinical trials.”
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