ReiThera and Exothera Collaborate to Develop Large-scale, Low Cost per Dose Manufacturing Process to Deliver Novel Vaccines to Low- and Middle-Income Countries

-  Collaboration awarded €3 million grant by the Bill & Melinda Gates Foundation

-  Focus on developing a scale-up manufacturing process for the production of ReiThera's vaccine candidates based on its GRAd platform, including its COVID-19 vaccine candidate (GRAd-COV2)

-  Scale-up development will use Univercells Technologies NevoLine™ Upstream platform, which provides automated large-scale virus manufacturing in a compact footprint

ROME, Italy and JUMET, Belgium, April 12, 2022 /PRNewswire/ -- ReiThera Srl, a biotech company dedicated to the technology development, GMP manufacturing and clinical translation of genetic vaccines and medicinal products for advanced therapies, and Exothera, a full-service Contract Development and Manufacturing Organization (CDMO), announced today that they have entered into a collaboration agreement to develop a large-scale, low cost per dose manufacturing process for the production of ReiThera's novel vaccines.

The collaboration will be financed by a €3 million grant awarded by the Bill & Melinda Gates Foundation to develop and deliver new low-cost vaccines based on ReiThera's GRAd technology platform, including against COVID-19 and HIV, mostly for Low- and Middle-Income countries (LMIC) in Africa. Immunization remains one of the most impactful and cost-effective public health interventions in Low and Middle-Income countries who are still struggling to secure access to adequate supplies.

The scale-up manufacturing process will leverage Exothera's unique expertise using the NevoLine™ Upstream platform (integrating the intensified structured fixed-bed scale-X™ nitro bioreactor), developed by Exothera's sister company, Univercells Technologies. This innovative biomanufacturing technology has a highly compact footprint while delivering unmatched cost-effective vaccine production.

Under the terms of the agreement, Exothera will scale up the proprietary cell line into the NevoLine and infect them with GRAd vector to create the bulk vaccine product, which ReiThera will then purify. The viral bulk generated after the infection will be purified by a high performing process developed by ReiThera.

ReiThera will start with its GRAd vector currently used in its COVID-19 vaccine candidate (GRAd-COV2) for the initial process development set-up and transition it into final form for further clinical trial purposes in its state-of-the-art GMP manufacturing facility.

Stefano Colloca, ReiThera's Chief Technology Officer and co-Founder, commented, "This collaboration with Exothera is an important step in providing ReiThera's novel vaccines for further study in a range of serious diseases, and in particular for seeking a solution that makes these vaccines more readily available once approved to people in LMIC regions. This second Bill & Melinda Gates Foundation grant, following an initial grant to ReiThera in November 2021 to support the development of the GRAd platform, provides further validation of ReiThera's innovative technology and underscores our technical expertise in clinical manufacturing and bio-risk management."

"ReiThera's innovative GRAd platform technology paired with Exothera's process development and scaling-up know-how has the potential to make important vaccines available for all," said José Castillo, Exothera's Chairman. "Combining our process know-how with Univercells Technologies' Nevoline will provide Low- and Middle-Income countries with access to much needed solutions for unmet medical needs such as HIV as well as against the current global pandemic."

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 has its headquarters, R&D laboratories and GMP facilities in Rome, Italy. 

For further information see: www.reithera.com

About Exothera SA

Exothera is a viral vector CDMO (contract manufacturing and development organization) using standard and innovative bioproduction platforms to rapidly deliver affordable viral vector-based vaccines and cell and gene therapies. As a Univercells company, Exothera capitalizes on novel manufacturing technologies and best-in-class bioprocessing expertise to provide custom-made process optimization and GMP clinical and commercial production of viral vectors. Based on its extensive technology expertise, Exothera selects technologies to optimally answer customer needs for cost-effective and agile viral vector manufacturing and provides QC services and analytical development.

LinkedIn: https://www.linkedin.com/company/exothera / Website: www.exothera.world

About the GRAd Platform

Simian adenoviral (SAd) vectors have been extensively used as delivery agents for genetic vaccine candidates against multiple infectious diseases, including Ebola and RSV (Respiratory Syncytial Virus), in different populations, including the elderly and infants enrolled in early and late-stage clinical trials to date. 

ReiThera's novel GRAd vector belongs to species C adenoviruses that are considered the most potent vaccine carriers and has low seroprevalence in humans. This means that GRAd vaccine immunogenicity is not hampered by pre-existing anti-human adenovirus antibodies.

About Univercell's NevoLine™ Upstream platform

The NevoLine™ Upstream platform is an innovative biomanufacturing technology that delivers cost-effective viral production. The high-performance, intensified platform features a flexible design to accommodate viral vaccine, gene therapy, and oncolytic virus production. The platform integrates all upstream and midstream unit operations such as cell culture, virus production, clarification, concentration, dilution, and conditioning to deliver a concentrated, clarified bulk product. With the NevoLine™ Upstream platform automated GMP clinical and commercial-scale upstream production is achieved within a 3 m² footprint, a 3-fold reduction in equipment footprint compared to conventional technologies.

SOURCE EXOTHERA