Sabin and ReiThera Enter Clinical Manufacturing Pact

The Sabin Vaccine Institute and its partner ReiThera Srl said that the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, has exercised the first two options, valued at $20 million, under the 2019 contract to advance the development of vaccines against Ebola Sudan and Marburg viruses through Phase 2 clinical trials. In September 2019, BARDA awarded Sabin a development contract, valued at $128 million, and provided the initial funding award of $20.5 million.

 
This second $20 million award will enable the manufacture and release of clinical vaccine material developed by ReiThera, a specialist in the development and cGMP manufacture of adenoviral vector vaccines. The funding will also support non-clinical studies to evaluate efficacy and immune response.
 
Ebola Sudan and Marburg are among the world’s deadliest viruses, causing hemorrhagic fever with subsequent death in an average of 50 percent of cases. A closely related strain, Ebola Zaire, has caused more than 2,200 deaths since 2018 in the Democratic Republic of Congo (DRC), leading the World Health Organization (WHO) to declare it a Public Health Emergency of International Concern.
 
“As the world has begun to appreciate, the next deadly outbreak is not a question of if, but when. At a time when global health and security are under siege by the novel coronavirus, we are grateful for BARDA’s foresight in funding programs like ours that will help guard against future pandemics,” said Amy Finan, chief executive officer, Sabin. “We also greatly value ReiThera’s partnership, given their extensive experience developing and manufacturing these vaccines.”
 
Stefano Colloca, chief technology officer, ReiThera, said, “Our team at ReiThera has more than 20 years’ experience in developing novel adenoviral vaccine platform technologies targeting a range of serious diseases. We believe our approach makes them particularly suitable to safely and rapidly induce protective immunity ahead of and during outbreaks. We are proud therefore to be a part of this important work with Sabin to prevent and control outbreaks of deadly hemorrhagic fevers by developing vaccines for the millions of people at risk.”
 
Under a 2019 agreement between GSK and Sabin, Sabin exclusively licensed the technology for the candidate vaccines, based on GSK’s proprietary ChAd3 platform, and acquired certain patent rights specific to these vaccines. The three candidate vaccines were initially developed collaboratively by the U.S. National Institutes of Health and Okairos, which was acquired by GSK in 2013.
 
This new funding from BARDA will enable Sabin and ReiThera to advance the investigational Ebola Sudan and Marburg vaccines through Good Manufacturing Practice (GMP) manufacturing and release of ChAd3-MARV and ChAd3-SUDV Phase 2 clinical material under Option 1 and conduct pilot efficacy and immunogenicity studies under Option 2. Additional non-clinical studies, as well as Phase 2 clinical trials in the U.S. and Africa, may be supported by an additional $87.5 million in funding under this contract.