Marburg Virus Disease

[Caption] Sabin Vaccine Institute delivered 700 doses of its Marburg vaccine to Rwanda on Oct. 5, 2024. WASHINGTON, Oct. 05, 2024 (GLOBE NEWSWIRE) -- The Sabin Vaccine Institute has provided its investigational Marburg vaccine to Rwanda to support the ongoing outbreak response. The initial shipment of approximately 700 vaccine doses will be used in a trial targeting frontline workers, including healthcare professionals who have been hardest hit by the deadly virus. Sabin has entered into a clinical trial agreement with the Rwanda Biomedical Centre, the trial sponsor, to provide investigational doses for the Phase 2 rapid response open-label study. Per the approved protocol, approximately 700 high-risk adults, starting with health care providers, will be dosed at 6 clinical trial sites in Rwanda. Pending a request from Rwandan officials and authorization from BARDA, Sabin plans to supply additional vaccines. Currently, there are no licensed vaccines or treatments for Marburg, which has a mortality rate of up to 88%. Sabin’s single-dose vaccine, based on the cAd3 platform, is in Phase 2 trials in Uganda and Kenya with no safety concerns reported to date. Results from Phase 1 clinical trials and nonclinical studies indicate that the vaccine is safe and elicits rapid, robust immune responses. Rwanda declared the Marburg outbreak on September 27, and as of October 5, it had infected 46 people and claimed 12 lives. While most cases are among health workers in two facilities in Kigali, the capital, a smaller number are spread across a few other districts. Sabin has been working directly with Rwandan officials and partners since the outbreak began to mount a response. "We were able to ship Marburg vaccine doses within 7 days of being contacted by the Rwanda government for assistance. Working alongside our partners, we moved with lightning speed to prepare shipments, finalize protocols, and secure the necessary regulatory and legal approvals,” says Sabin Chief Executive Officer Amy Finan. “This swift emergency response demonstrates that a dedicated, collaborative group of individuals and organizations can achieve remarkable results when united by a common cause: to contain a lethal disease outbreak and prevent further loss of life.” Rwanda’s Minister of Health Dr. Sabin Nsanzimana points out that “in emergency situations, the success of clinical trials relies on quick, strategic, global partnerships that bring together expertise, resources, and innovation. Today, a week after this Marburg outbreak was first confirmed, we are receiving doses of the Sabin Vaccine Institute’s Marburg vaccine candidate to protect our health workers and other high-risk groups, and also advance scientific tools which will ensure this virus can be effectively controlled now and in the future.” Sabin’s manufacturing partner, Italy-based ReiThera, has produced the drug substance and filled and finished doses for shipment to Rwanda. “At ReiThera, we believe in the transformative power of global collaboration to advance science and create lasting impact,” says ReiThera CEO Stefano Colloca. “Our partnership with Sabin highlights our shared commitment to developing a life-saving vaccine against Marburg disease with a mutual goal: to save lives and ensure that even the most vulnerable communities around the world have access to vital and equitable protection.” Once rare, Marburg virus disease outbreaks have surged in Africa in recent years, with incidents reported in 2023 in Tanzania (Rwanda's neighbor) and Equatorial Guinea. Marburg belongs to the same virus family as Ebola and is transmitted from fruit bats to humans, spreading from person to person through contact with infected bodily fluids. Sabin’s Phase 2 clinical trials for Marburg, which began last year, are currently monitoring participants in Uganda and Kenya, including younger (18-50 years) and older age groups (51-70 years). Interim results are expected next year, and Sabin also plans to launch a similar Phase 2 trial in the U.S. next year. Sabin’s development program, which includes clinical trials and manufacturing of clinical trial material that have been leveraged in this donation, is supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, under multi-year contracts. BARDA has to date obligated $235 million to Sabin for advancing vaccine research and development against Sudan ebolavirus and Marburg virus diseases. In addition to ReiThera and Rwanda’s government, Sabin is grateful for all these organizations including CEPI, GSK, IQVIA, kENUP Africa, National Institutes of Health's Vaccine Research Center, WHO, and World Courier who have contributed to our past and current efforts. About the 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. Media Contact: Monika Guttman Media Relations Specialist Sabin Vaccine Institute +1 (202) 662-1841 press@sabin.org A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2e9400c0-1467-4956-b52d-64891ed3fc1d

ROME, Italy I October 1st, 2024 I The collaboration between ReiThera and the Sabin Vaccine Institute (SVI) 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 SVI, ReiThera has manufactured, released, and shipped the vaccine to Uganda. Since 2019, ReiThera has been supporting the SVI 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, more than 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 Central Africa. In the fall of 2022, ReiThera and the SVI, 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, which ultimately resulted in 55 deaths. 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. Sabin’s single-dose investigational Sudan ebolavirus vaccine is based on the ChAd3 simian adenoviral platform. It has it has been found to be promising in preclinical challenge studies as well as in Phase 1 clinical studies, demonstrating safety and eliciting a rapid and robust immune response in humans comparable to the protective immune response observed in monkeys. The Phase 2 clinical trial will evaluate the vaccine’s safety and immunogenicity in a larger group of individuals. “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 SOURCE: ReiThera

WASHINGTON, DC, USA I July 15, 2024 I Sabin Vaccine Institute launched a Phase 2 clinical trial for its vaccine against Sudan ebolavirus, with healthy volunteers receiving the single-dose vaccine at Makerere University Walter Reed Project (MUWRP) in Uganda. There are currently no approved vaccines for this strain of ebolavirus, which saw an outbreak end just last year. Ebolavirus disease kills on average half the people infected, according to the World Health Organization. Sudan ebolavirus is a filovirus, in the same family as Marburg virus disease and Zaire ebolavirus, which killed 11,325 in one outbreak in West Africa from 2014-16. Ebolavirus disease spreads between people via direct contact with the blood or other bodily fluids of infected people and is highly virulent, causing hemorrhagic fever. Based on the same cAd3 platform as its Marburg vaccine candidate, Sabin’s single-dose investigational Sudan ebolavirus vaccine was found to be promising in Phase 1 clinical and non-clinical studies, with results showing it to be safe, while eliciting rapid and robust immune responses that lasted up to 12 months. This is Sabin’s second Phase 2 clinical trial partnership with MUWRP, based in Uganda’s capital, Kampala. A Phase 2 trial for a Marburg vaccine is already underway, having recently completed enrollment . Initial results from the Marburg trial are expected later this year. Dr. Betty Mwesigwa, deputy executive director of MUWRP, is once again the principal investigator (PI) for the Sabin-sponsored trial for the Sudan ebolavirus vaccine. In the coming weeks, participants will also be enrolled at the Kenya Medical Research Institute in Siaya, Kenya, with Dr. Videlis Nduba serving as PI for that site. In all, 125 volunteers will participate in the trial across the two countries. “We are delighted to advance a vaccine candidate that can thwart a deadly and devastating disease, especially one that caused a fairly recent outbreak and for which no approved treatments exist,” says Amy Finan, Sabin’s Chief Executive Officer. “Sabin’s vaccine candidate is backed by strong safety and immunogenicity data, and we hope this trial will yield further evidence to move the vaccine closer to licensure.” The most recent outbreak of Sudan ebolavirus occurred in the fall of 2022 in Uganda, after six suspicious deaths in the Mubende district. That outbreak ultimately resulted in 55 deaths. Sabin’s vaccine was the first to arrive in Uganda during that outbreak after the World Health Organization included it as one of three vaccines for possible use in an outbreak trial. The outbreak ended on January 11 , prior to vaccine being deployed for use. “Makerere University Walter Reed Project is pleased to partner with the Sabin Vaccine Institute once again,” says Dr. Mwesigwa. “Uganda has the most experience with Sudan ebolavirus outbreaks so we understand the importance of testing and researching an effective Sudan ebolavirus vaccine that could be used in the event of an outbreak.” The Phase 2 clinical trial will evaluate safety and immunogenicity for the vaccine among a larger group of individuals than in previous trials. This is a randomized, placebo-controlled, double-blind study, meaning that neither the participants nor the researchers will know whether trial participants receive a vaccine dose or a placebo dose until after the trial is over, an approach used to help reduce experimental bias. Participants in the clinical trial will be monitored for a full year and will include both younger (18-50 years) and older age groups (51-70 years). Interim results are expected next year. In addition to the current trial in Uganda and Kenya, Sabin plans to conduct a similar Phase 2 clinical trial for Sudan ebolavirus vaccine in the U.S. The Sudan ebolavirus vaccine trials are supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, under multi-year contracts between the organizations. To date, Sabin has received around $216 million in contract awards from BARDA for furthering vaccine research and development against Sudan ebolavirus and Marburg virus diseases. BARDA and Sabin began working together in September 2019 to develop the two monovalent vaccine candidates. This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract numbers 75A50119C00055 and 75A50123C00010. About the 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. About Sabin’s Vaccine R&D Using the cAd3 Platform In August 2019, Sabin announced exclusive agreements with GSK for Sabin to advance the development of the prophylactic candidate vaccines against the deadly Zaire ebolavirus, Sudan ebolavirus and Marburg virus. 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. The candidate vaccines, based on GSK’s proprietary cAd3 platform, were further developed by GSK, including the Phase 2 development for the Zaire ebolavirus vaccine. Under the agreements between GSK and Sabin, Sabin exclusively licensed the technology for all three candidate vaccines and acquired certain patent rights specific to these vaccines. About the Makerere University Walter Reed Project MUWRP is a non-profit biomedical research organization with a mission to mitigate disease threats through quality research, health care and disease surveillance. The project’s scope includes, among others; clinical research in infectious and non-infectious diseases such as HIV, Ebola, Marburg, COVID-19, Influenza and Influenza-like illnesses, and neglected tropical diseases such as Schistosomiasis, among others. A major part of the clinical research are clinical trials, where the MUWRP has conducted more than 12 phase 1 and 2 vaccine clinical trials including the first Ebola vaccine trial in Africa. SOURCE: Sabin Vaccine Institute