ERRATUM: ReiThera's manufactured Sudan Ebolavirus Vaccine reaches a key milestone with launching of Sabin Vaccine Institute-sponsored Phase 2 Trial in Uganda

• Sabin Vaccine Institute has initiated a Phase 2 clinical trial in Uganda for a Sudan ebolavirus vaccine, with ReiThera responsible for the manufacturing and shipping of the doses
• Since 2019, ReiThera has supported Sabin in the quest for a Sudan ebolavirus vaccine by developing a highly-performing production process leading to the stockpiling of the equivalent of 200,000 doses of the Sudan ebolavirus vaccine
• In 2022, ReiThera and Sabin shipped 1,100 vaccine doses to Uganda contributing to the containment of a local outbreak resulted in 55 deaths

ROME, Italy, October 1^st, 2024- The collaboration between ReiThera and the Sabin Vaccine Institute has reached an important milestone in the fight against life-threatening infectious diseases, with the initiation of a Phase 2 clinical trial in Uganda for the development of a vaccine against Sudan ebolavirus. In support of this challenging effort led by Sabin, ReiThera has manufactured, released, and shipped the vaccine to Uganda.

Since 2019, ReiThera has been supporting the Sabin team by developing an innovative, intensified production process based on cell perfusion in stirred-tank bioreactors for the manufacturing of Sudan ebolavirus vaccine clinical lots. The introduction of this process step resulted in a more than fourfold increase in volumetric productivity compared to the standard process. This approach, combined with an updated downstream process, has led to the release of a high-quality product at the desired vaccine dose and since the beginning of the program, the equivalent of 200,000 doses of the Sudan ebolavirus vaccine have been manufactured and released by ReiThera.

This effort has generated an impressive vaccine stockpile, ready to be deployed in the event of an unanticipated outbreak in Africa. In December 2022, Reithera and Sabin, under the WHO umbrella, were the first to ship 1,100 doses of the Sudan ebolavirus vaccine to Uganda to help with a local outbreak.

Sudan ebolavirus is a filovirus, in the same family as Marburg virus disease and Zaire ebolavirus, which killed 11,325 people in the outbreak in West Africa from 2014 to 2016. Ebolavirus disease spreads between people via direct contact with the blood or other bodily fluids of infected individuals and is highly virulent, causing hemorrhagic fever and multiple organ failure.

Sabin’s single-dose investigational Sudan ebolavirus vaccine is based on the ChAd3 simian adenoviral platform. It was found to protect monkeys from death following viral inoculation and was safe and immunogenic in humans in two Phase 1 trials, generating antibody responses comparable to those observed in the protected monkeys. The Phase 2 clinical trial will evaluate the vaccine’s safety and immunogenicity in a larger group of individuals in sub-Saharan Africa where the disease is endemic.

“Our ability to rapidly produce and deliver high-quality vaccine doses underscores ReiThera’s dedication to supporting Sabin and the global health community in preparing for and responding to unexpected outbreaks,” says Stefano Colloca, Chief Executive Officer of ReiThera. “Our work with Sabin exemplifies how our innovative production processes can make a significant impact in readiness and response to unexpected health emergencies.” 

About ReiThera Srl

ReiThera Srl is a CDMO company dedicated to technology and process development and GMP manufacturing, providing support for the clinical translation of genetic vaccines and medicinal products for advanced therapies.

The company has extensive expertise in developing scalable processes for viral-vector manufacturing and a consolidated experience in GMP production of Adeno-Associated Vector (AAV), Lentivirus, Adeno Viral vector (AdV), Modified Vaccinia Ankara and Herpes Simplex Vector.

ReiThera's core manufacturing capacity is based in a state-of-the-art facility, which includes stirred-tank bioreactors at scales of 50L, 200L, 1000L, and 2000L, as well as fixed-bed bioreactors for cell growth in adherence. The GMP facility also comprises a filling suite and quality control laboratories.

ReiThera's headquarters, R&D laboratories, and GMP facilities are located in Rome, Italy. For more information, visit www.reithera.com   

About Sabin Vaccine Institute

The Sabin Vaccine Institute is a leading advocate for expanding vaccine access and uptake globally, advancing vaccine research and development, and amplifying vaccine knowledge and innovation. Unlocking the potential of vaccines through partnership, Sabin has built a robust ecosystem of funders, innovators, implementers, practitioners, policy makers and public stakeholders to advance its vision of a future free from preventable diseases. As a non-profit with three decades of experience, Sabin is committed to finding solutions that last and extending the full benefits of vaccines to all people, regardless of who they are or where they live. At Sabin, we believe in the power of vaccines to change the world. For more information, visit www.sabin.org and follow us on X, @SabinVaccine.