ArcticZymes has entered into an agreement with ReiThera to supply its SAN product for ReiThera’s COVID-19 vaccine candidate
Tromsø, 02 July, 2020: ArcticZymes AS (OSE:AZT), a subsidiary of ArcticZymes Technologies ASA, announces that it has entered into a supply agreement with vaccine specialist ReiThera Srl (Rome, Italy) for the supply of Salt Active Nuclease (SAN-HQ) to be used in the development and manufacturing of ReiThera’s novel vaccine candidate against COVID-19. The vaccine candidate, which is based on ReiThera’s viral vector technology, is scheduled to enter clinical trials soon.
SAN-HQ has established itself within the viral vector-based biopharmaceutical segment, where viruses are used to deliver genetic material into cells to treat or prevent disease. Due to safety concerns, regulators require manufacturers to minimize and control the amount of exogenous nucleic acids impurities (DNA or RNA not encapsulated by the vector) in the final dosage. Therefore, one or more nuclease treatments are often implemented in the downstream processing of the virus, in which the nuclease digests exogenous DNA. Exogenous DNA can also cause the viral particles to aggregate, which reduces both yield and potency of the vector. One of the key strategies to reduce aggregation involves keeping the virus at elevated salt concentrations. Unlike other commercially available nucleases, SAN-HQ digests nucleic acids with high efficiency at high salt concentrations. Furthermore SAN-HQ is utilized at much lower quantities which means less enzyme needs to be removed from the virus following its use which is another key advantage.
To put it into context, the manufacturing process of viral vaccines is a complicated and lengthy multi-stage process with many steps. SAN-HQ is utilised for one part of this process and does not end up as part of the final therapeutic vaccine. Hence, the supply deal relates to the provision of this essential component to streamline part of the process.
ReiThera, together with Leukocare AG (Germany) and Univercells S.A. (Belgium), has formed a pan-European consortium to fast-track the development of its vaccine against the novel coronavirus SARS-CoV-2, which causes COVID-19.
ArcticZymes AS, CEO, Jethro Holter said:
“We are delighted to expand our relationship in supporting ReiThera and its consortium partners with fast tracking its activities to develop a vaccine against the novel coronavirus SARS-CoV-2. ReiThera is a leading European company in genetic vaccine development focused on bringing innovative therapeutics to market via leveraging the best technologies such as ArcticZymes’ SAN-HQ. We look forward to supporting ReiThera in the development and future commercialisation of their vaccine.”
“This agreement seamlessly fits with our efforts to scale up SAN-HQ which is supported by the Innovation Norway funding recently granted to ArcticZymes in May 2020. The timely scaling of SAN-HQ production will satisfy future commercial demand from our partners such as ReiThera.”
ReiThera’s Project Manager, Marco Soriani, said:
“ReiThera’s effort to develop a vaccine against the coronavirus that causes COVID-19 relies on its solid partnerships with key pharmaceutical stakeholders, such as ArcticZymes, which provide crucial technologies to ensure a consistently high-quality product. We look forward to working with ArcticZymes on this important product development program, which aims to tackle the global COVID-19 pandemic.”
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About ReiThera Srl
ReiThera Srl is a biotech company dedicated to the technology development, GMP manufacturing and clinical translation of genetic vaccines and medicinal products for advanced therapies. The company’s management and scientific teams have developed a highly innovative technological platform based on simian adeno-vectored vaccines against several infectious diseases, such as RSV and Ebola. ReiThera is led by an experienced management team that has worked together for many years in previous successful enterprises, including Okairos (acquired by GSK), and has a long-standing expertise in scalable processes for viral vector manufacturing, supported by a cGMP facility inclusive of filling suite and quality control laboratories. ReiThera is also part of a pan-European consortium focused on the development and large-scale manufacture of an adeno-viral vector vaccine against COVID-19.
ReiThera has its headquarters, R&D laboratories and GMP facilities in Rome, Italy.