Bernhard-Nocht-Institut für Tropenmedizin

NIH-funded trial will evaluate the effects of a synthetic version of vitamin B1 on cognitive function that was developed by Burke Institute for people with early Alzheimer's disease For more information about the trial and to find a study site, visit benfoteam.org WHITE PLAINS, N.Y., Sept. 23, 2024 /PRNewswire/ -- A completely different approach to stopping the progression of Alzheimer's disease pioneered by a research institute based in Westchester County, NY is now being tested nationwide. The Burke Neurological Institute (BNI), an affiliation of Weill Cornell Medicine, in partnership with the Alzheimer's Disease Cooperative Study (ADCS) at University of California San Diego and Columbia University Irving Medical Center, have launched a national clinical trial to investigate the therapeutic potential of a BNI and Weill Cornell Medicine-developed form of benfotiamine, a synthetic version of vitamin B1 (thiamine), as a treatment for mild cognitive impairment (MCI) and early Alzheimer's disease (AD). The BenfoTeam trial (The Phase 2A-2B study) taking place at 50 sites across the U.S. will evaluate the effects of benfotiamine on cognitive function and whether high doses benefit people 50-89 with mild AD and MCI. The trial is funded by the National Institute on Aging (NIA), a part of the National Institutes of Health (NIH). Benfotiamine is a synthetic drug which can increase blood thiamine up to 100 times the normal level. These levels of blood thiamine cannot be achieved by taking thiamine alone. The brain tissue in people with AD shows a thiamine deficiency, even with a sufficient supply of thiamine in a person's blood. The trial is investigating whether the delivery of thiamine via drug will increase the amount of thiamine getting to the brain and slow cognitive decline in people with early AD. Currently, 5.8 million Americans are living with AD with this number projected to rise to nearly 14 million people by 2050. "The approach of using benfotiamine in patients with mild Alzheimer's is very promising," said Rajiv Ratan, M.D., Ph.D., Executive Director at Burke Neurological Institute. "This clinical trial builds on years of hard work to address a disease that affects millions of patients " Howard Feldman, Director of the ADCS at UC San Diego said, "The launch of the BenfoTeam clinical trial represents a fresh approach with a potential treatment that is readily accessible, scientifically compelling, and cost-effective – that's a trifecta for a potential AD therapy in a Phase 2 trial – and benfotiamine has a strong safety profile." Gary E. Gibson, Ph.D., Professor of Neurosciences at BNI, has spent decades conducting studies to better understand Alzheimer's disease and how to develop new therapies to treat the disease. The BenfoTeam study builds on Gibson's scientific research conducted at Burke Neurological Institute – the only research institute in the U.S. dedicated to finding treatments to repair the brain and spinal cord. Gibson said many existing treatments or drugs in development only treat the symptoms of Alzheimer's disease such as amyloid plaques, but do not address the root cause of the disease. Benfotiamine has been shown to improve memory and diminish plaques, tangles, inflammation, and oxidative stress in animal models. In addition, unlike many of the other recently approved treatments for Alzheimer's disease, benfotiamine can be taken by mouth and does not require infusions. "In people with Alzheimer's disease, reductions in brain glucose utilization track closely with cognitive decline and we already know that thiamine deficiencies can cause dementia," said Gibson, who is also a Professor of Neuroscience in the Feil Family Brain and Mind Research Institute at Weill Cornell Medicine. "We think people with mild cognitive impairment and Alzheimer's disease may not be getting enough thiamine delivered to the brain." Jose Luchsinger, M.D., MPH, Vice-Chair for Clinical and Epidemiologic Research at Columbia University and a BenfoTeam trial co-Principal Investigator said, "While Alzheimer's disease impacts all aging populations, it is not clear that recently approved Alzheimer's therapies benefit underrepresented racial and ethnic groups. The BenfoTeam trial is designed for all patient populations.'' Participation in the trial for each patient will last 18 months (plus screening) and enrollment is planned for 406 participants. For more information about the trial and to find a study site, visit benfoteam.org or call 877-807-1290 (toll free). This research will be supported by the NIH's National Institute on Aging (R01AG076634). This content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH's National Institute on Aging. The ClinicalTrials.gov ID number for this study is: NCT06223360. About the BenfoTeam Partnership The BenfoTeam clinical research trial is funded by a grant from the National Institute on Aging (NIA) (R01AG076634). The clinical research trial is coordinated by the Alzheimer's Disease Cooperative Study (ADCS) at University of California San Diego School of Medicine and is led by principal investigators from the Burke Neurological Institute and Weill Cornell Medicine, Columbia University Irving Medical Center, and UC San Diego. SOURCE Burke Neurological Institute WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Vaccine was well tolerated across all dose groups with no observed difference in adverse event pro first and second vaccination Strong booster effect demonstrated after second vaccination with antibody titers above levels detected in humans after COVID-19 disease and neutralization titers significantly above those reported for currently approved SARS-CoV-2 vaccines Strong cross neutralization of SARS-CoV2 variants, including the Delta variant COPENHAGEN, Denmark, August 9, 2021 – Bavarian Nordic A/S (OMX: BAVA) today reported initial results from the first-in-human trial of ABNCoV2, led by the PREVENT-nCoV consortium. The Phase 1/2 dose-escalation trial enrolled 45 healthy SARS-CoV-2-naïve adult volunteers at the Radboud University Medical Centre in the Netherlands, who received two doses (dose ranges from 6-70 μg) of ABNCoV2, formulated with and without adjuvant. The results demonstrate that the vaccine was well tolerated across all dose groups with no observed difference in the adverse event pro first and second vaccination. No serious adverse events were reported and the safety pro comparable to other vaccines based on recombinant protein-technology. In all dose groups, antibody titers were significantly higher after the boost vaccination and were up to 12-fold higher than those measured in convalescent human samples and significantly higher than those reported for current approved COVID-19 vaccines. Importantly, high neutralization titers were demonstrated against all SARS-CoV-2 variants of concern, including the dominant Delta variant. Final results from the study are expected later in the second half of 2021. Paul Chaplin, President and CEO of Bavarian Nordic, commented: “We are very pleased to report positive results from this first-in-human trial of our COVID-19 vaccine, confirming its ability to induce strong and broad antibody levels, superior to those of the current approved vaccines, while also providing a favorable safety profile. These data are highly encouraging for our planned Phase 2 trial later this month, which is designed to evaluate the vaccine’s potential as a universal booster vaccine.” Bavarian Nordic will further advance the development of the vaccine candidate and has planned a Phase 2 trial in up to 210 subjects. The aim of the trial, in addition to confirming the Phase 1 findings, is to evaluate ABNCoV2 as a booster vaccine for individuals with previous COVID-19 disease or vaccination. The trial will be conducted at two centers in Germany and is expected to be initiated later in August, pending final approval from the Ethics Committee. In parallel, Bavarian Nordic is preparing for a Phase 3 trial of ABNCoV2 in 2022, pending external funding. About ABNCoV2 ABNCoV2 is a next-generation COVID-19 vaccine candidate, initially developed by AdaptVac using their proprietary capsid virus like particle (cVLP) technology. AdaptVac is member of the PREVENT-nCoV consortium which has received a Horizon 2020 EU grant to fund the first-in-human trial of the vaccine. Other members of the consortium are ExpreS2ion, Leiden University Medical Center (LUMC), Institute for Tropical Medicine (ITM) at University of Tübingen, The Department of Immunology and Microbiology (ISIM) at University of Copenhagen, and the Laboratory of Virology at Wageningen University. Bavarian Nordic has licensed the global commercialization rights to the vaccine and has assumed the responsibility for further clinical development towards licensure. About Bavarian Nordic Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacture and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. Government of a non-replicating smallpox vaccine, which has been approved by the FDA under the trade name JYNNEOS®, also for the protection against monkeypox. The vaccine is approved as a smallpox vaccine in Europe under the trade name IMVANEX® and in Canada under the trade name IMVAMUNE®. Our commercial product portfolio furthermore contains the market-leading vaccine Rabipur®/RabAvert® against rabies and Encepur® against tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an Ebola vaccine, MVABEA®, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next generation COVID-19 vaccine based on an in-licensed capsid virus-like particle technology. The vaccine candidate, ABNCoV2, is currently being investigated in clinical trials. For more information visit . Forward-looking statements This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. Contacts Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43 US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600 Company Announcement no. 25 / 2021 Attachment 2021-25-en