Encephalomyelitis, Venezuelan Equine

BOSTON and PANAMA CITY, Panama, Aug. 3, 2023 /PRNewswire/ -- Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming and biosecurity, and the Government of the Republic of Panama's Gorgas Memorial Institute for Health Studies, today announced that they have entered into a Memorandum of Understanding ("MOU") with the intent to develop and implement new biosecurity capabilities in Latin America. Ginkgo, through its biosecurity and public health unit, Concentric by Ginkgo, aims to support the Gorgas Institute as it builds Panama's foundational bioeconomy that will serve not only the country, but also the surrounding region. These efforts will bolster Panama's biosecurity infrastructure, giving the country key tools to detect, identify, and monitor current and future pathogens. It will also be Concentric's first Latin American program, as the company continues to expand operations internationally. As part of the program, Concentric will collaborate with the Gorgas Institute to strengthen their current surveillance infrastructure for COVID-19, as well as other respiratory and enteric pathogens, leveraging Concentric's expertise in wastewater monitoring, lab enablement, and bioinformatics analysis and decision support. The program is expected to operate in strategic locations that can help bolster both national and regional public health and security throughout Panama. These include, but are not limited to, wastewater surveillance in major urban centers like Panama City, as well as at ports-of-entry, including the border crossing in the Darien National Park and Tocumen International Airport (PTY). By establishing these monitoring programs, Panama will become a critical node in Concentric's global network that collects data to help public health and national security officials detect and respond to emerging biological threats. The information captured from these programs is expected to play a key role in strengthening not only Panama's COVID-19 and novel pathogen detection infrastructure, but also provide key data for regional pandemic preparedness. "We're honored to collaborate with the Republic of Panama to strengthen the region's health security capabilities through pathogen threat detection in Panama City and the Darien region," said Matt McKnight, General Manager, Biosecurity at Ginkgo Bioworks. "Robust bio-surveillance in Panama is critical not only for the health of the country, but also for the security of the Western Hemisphere, and I am confident this partnership will strengthen health security in the region and the world." "These detection and monitoring programs are an important aspect of Panama's public health initiatives. We are excited to collaborate with Concentric on these important biosecurity programs," said Dr. Juan Miguel Pascale, General Director of Gorgas Memorial Institute for Health Studies. About Ginkgo Bioworks Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats. For more information, visit ginkgobioworks.com and concentricbyginkgo.com, read our blog, or follow us on social media channels such as Twitter (@Ginkgo and @ConcentricByGBW), Instagram (@GinkgoBioworks and @ConcentricByGinkgo), or LinkedIn. About the Gorgas Memorial Institute for Health Studies Gorgas Memorial Institute is the national reference laboratory and research institute of Panama, and the support arm of the Ministry of Health. Founded in 1928 in memory of Dr. William C. Gorgas who implemented public health measures that allowed the control of malaria and yellow fever enabling the construction of the Panama Canal, its research has been centered in the study of tropical diseases: leishmaniasis, malaria, yellow fever, Dengue, Zika and Chikungunya among other arbovirosis as well as the surveillance of Influenza and respiratory viruses and endemic agents such as Hantavirus, Venezuelan and Eastern Equine Encephalitis. During the last decade it has also been involved in HIV surveillance and in research of non-communicable diseases in the country. For more information, visit Forward-Looking Statements of Ginkgo Bioworks This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the capabilities and potential success of the partnership and Ginkgo's biosecurity platform. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) volatility in the price of Ginkgo's securities due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, and changes in laws and regulations affecting Ginkgo's business, (ii) the ability to implement business plans, forecasts, and other expectations, and to identify and realize additional business opportunities, (iii) the risk of downturns in demand for products using synthetic biology, (iv) the unpredictability of the duration of the COVID-19 pandemic and the demand for COVID-19 testing and the commercial viability of our COVID-19 testing business, (v) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, (vi) our ability to realize the expected benefits of merger and acquisition transactions, (vii) the outcome of any legal proceedings against Ginkgo, including as a result of recent acquisitions, (viii) our ability to realize the expected benefits from and the success of our Foundry platform programs, (ix) our ability to successfully develop engineered cells, bioprocesses, data packages or other deliverables, and (x) the product development or commercialization success of our customers. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the "SEC") on May 10, 2023 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations. GINKGO MEDIA CONTACT: [email protected] GINKGO INVESTOR CONTACT: [email protected] REPUBLIC OF PANAMA MEDIA CONTACT: [email protected] [email protected] SOURCE Ginkgo Bioworks

ST. LOUIS, July 31, 2023 (GLOBE NEWSWIRE) -- Defender Pharmaceuticals, Inc. (the “Company” or “Defender”), a privately held life sciences company based in St. Louis, today announced that it had entered into an exclusive license agreement with the U.S. Army Medical Materiel Development Activity (USAMMDA), a subordinate laboratory of the U.S. Army. Medical Research and Development Command (USAMRDC), to develop and commercialize a total of eight products for use against the following tropical diseases: tularemia (rabbit virus); Venezuelan Equine Encephalitis (two formulations); Eastern Equine Encephalitis; Western Equine Encephalitis; Rift Valley Fever; chikungunya and Q Fever. The agreement was entered into on July 25th, 2023 and covers eight investigational vaccines that have been part of the Army’s Special Immunization Program. Under the agreement, USAMMDA will transfer the Investigational New Drug applications for each of the eight products, related data, and biological materials to Defender. Development work on these products will commence once this transfer is complete. Defender plans to work collaboratively with USAMMDA during the term of the agreement, with ongoing support from USAMRDC’s Office of Regulated Activities to advance product development, licensure, and commercialization of the licensed technology. “Entering into this license agreement with the U.S. Army is a significant step forward for Defender as a company and reinforces the strong and highly collaborative relationship we have established with the U.S. military and other government agencies,” said Barry I. Feinberg, M.D. and President & CEO of Defender Pharmaceuticals. “We are excited to begin work on these important and potentially life-saving products to protect not only our nation’s warfighters but everyone throughout the world exposed to these disease threats.” About the Tropical Diseases Information about Q Fever can be found at: Q Fever: Epidemiology and Statistics,” U.S. Centers for Disease Control and Prevention, available: https://www.cdc.gov/qfever/stats/index.html Information about Chikungunya Virus can be found at: Chikungunya Virus,” U.S. Centers for Disease Control and Prevention, June 2, 2022, available: https://www.cdc.gov/chikungunya/index.html Information about Rift Valley Fever can be found at: Rift Valley Fever, U.S. Centers for Disease Control and Prevention, Feb. 25, 2020, available: https://www.cdc.gov/vhf/rvf/index.html#:~:text=Rift%20Valley%20fever%20(RVF)%20is,through%20bites%20from%20infected%20mosquitoes Information about Lassa Fever can be found at: Lassa Fever: Signs and Symptoms,” U.S. Center for Disease Control and Prevention, March 25, 2014, available: https://www.cdc.gov/vhf/lassa/symptoms/index.html Information about Western Equine Encephalitis Virus can be found at: Western Equine Encephalitis,” Army Public Health Center, Entomological Sciences Division, FACT SHEET 18-045-0317, available:https://phc.amedd.army.mil/PHC%20Resource%20Library/WesternEquineEncephalitis_FS_18-045-0317.pdf Information about Eastern Equine Encephalitis Virus can be found at: Eastern Equine Encephalitis Virus: Statistics and Maps”, Oct. 31, 2022, Centers for Disease Control and Prevention, available: https://www.cdc.gov/easternequineencephalitis/statistics-maps/index.html Information about Venezuelan Equine Encephalitis can be found at: Venezuelan Equine Encephalomyelitis Standard Operating Procedures: 1. Overview of Etiology and Ecology,” U.S. Department of Agriculture, August 2013, available: https://www.aphis.usda.gov/animal_health/emergency_management/downloads/sop/sop_vee_e-e.pdf Information about Tularemia can be found at: Frequently Asked Questions (FAQ) About Tularemia,” U.S. Centers for Disease Control and Prevention, available: https://emergency.cdc.gov/agent/tularemia/faq.asp#:~:text=Tularemia%2C%20also%20known%20as%20%E2%80%9Crabbit,all%20U.S.%20states%20except%20Hawaii About Defender Pharmaceuticals, Inc. Defender Pharmaceuticals, Inc., located in St. Louis, MO, is a privately held life sciences company focused on discovering, developing and commercializing medicines to help safeguard health across civilian and military populations. Our work with the Department of Defense, NASA, the Department of Veterans Affairs, and other institutions advance our mission to improve the health of patients and help make the world a more secure place. Cautionary Note on Forward-Looking Statements Various statements in this press release, including but not limited to statements regarding Defender’s plans to co-develop products to treat various tropical diseases and pursue FDA approval, are forward-looking statements under securities law. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Examples of forward-looking statements include, among others, statements we make regarding our product candidates and the development thereof, such as the Company’s tropical disease co-development program; the therapeutic potential of our tropical disease product candidates; the Company’s regulatory plans and timelines for the tropical disease product candidates, including our planned submission of a New Drug Application for each of these product candidates. The process by which investigational therapies, such as these tropical disease product candidates, could potentially lead to an approved product is long and subject to highly significant risks. Other risk factors relevant to Defender include our reliance on third-party contract research organizations; the reliance of Defender on contract manufacturers to supply its products for research, development and commercialization and the risk of supply interruption from such contract manufacturers; the timing, plans and reviews by regulatory authorities of marketing applications such as NDAs for the tropical disease product candidates; alignment with the FDA on the regulatory pathway to approval for the tropical disease product candidates; market acceptance for approved product; competition; the possible impairment of, inability to obtain, and costs to obtain intellectual property rights; possible safety or efficacy concerns that could emerge as new data are generated during development and following commercialization; and general business, financial, and accounting risks and litigation. The forward-looking statements contained in this press release reflect Defender’s current views with respect to future events as of the date of this press release, and Defender does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. For media inquiries, please contact info@defenderpharma.com. For more information about Defender Pharmaceuticals, please visit www.defenderpharma.com. Source: Defender Pharmaceuticals, Inc.

Total considerations of up to USD 83 million with the majority secured for Phase 2 development of the multivalent MVA-BN® WEV vaccine candidate, in addition to options for Phase 3 preparatory work COPENHAGEN, Denmark, December 23, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today a new agreement with the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), for the advanced development of MVA-BN® WEV, a prophylactic vaccine candidate against Western, Eastern and Venezuelan equine encephalitis virus, which can cause a rare, but potentially deadly mosquito-borne illness in humans1. Currently, no approved vaccines for human use are available. The new agreement has a total value up to USD 83 million, of which the secured base agreement of USD 55 million covers the costs for a clinical Phase 2 dose finding study of MVA-BN WEV, further non-clinical studies, process development and manufacturing of clinical trial material. Furthermore, the agreement includes options valued at USD 28 million to support Phase 3 preparations. The base agreement will run from 2023 through 2026 with the majority of revenue from the agreement being recognized in that timeframe. Based on current projections, the Phase 2 clinical study could start in 2024. Based on the ability of the MVA-BN® vaccine platform to protect against multiple threats, this effort has the capability to pivot and expand to other threat agents of interest. MVA-BN WEV was initially developed under an agreement with DoD in 2018, that included the demonstration of protective efficacy in animals and a Phase 1 first-in-human trial of MVA-BN WEV. Data of the trial were reported in June 2020, showing that the vaccine was well tolerated and immunogenic across all dose groups. Venezuelan equine encephalitis virus neutralizing antibody responses were observed in all dose groups, with peak levels reached after the second vaccination. Recent data confirm neutralizing antibody responses also against western and eastern equine encephalitis viruses that were durable throughout the 6-months follow up period. “We are proud to continue our partnership with the U.S. government on the development of a much-needed vaccine to combat equine encephalitis, which is another emerging disease, often leading to serious complications and even death. Using the same platform technology, upon which our mpox vaccine was also built, we are truly leveraging our core experience in R&D innovation and vaccine manufacturing to help build a stronger preparedness for the U.S. and its citizens, and we look forward to continuing our work with DoD on this important program, “said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. The contents of this announcement do not change the Company’s financial guidance for 2022. About MVA-BN® WEV MVA-BN WEV is a multi-valent vaccine candidate since it incorporates antigens from all three equine encephalitis viruses: western, eastern and Venezuelan. It is based on Bavarian Nordic’s proprietary MVA-BN platform technology, which is also used in the Company’s marketed vaccines against smallpox, mpox and Ebola. The platform is also employed the RSV vaccine candidate, currently in Phase 3 development in older adults. About Equine Encephalitis Viruses Eastern, Venezuelan and western equine encephalitis viruses belong to the family alphavirus, and are transmitted through mosquitos, as well as birds and some mammals. While the viruses vary in infection rates and severity of disease, all three pathogens are associated with risks of flu-like symptoms, potential central nervous disorders, and death. All three viruses are considered as potential biological threats, having been investigated as potential biological weapons at various times in the past century. The viruses belong to the U.S. list of prioritized pathogens amongst other agents, like smallpox, anthrax and other lethal diseases, which are covered by the current vaccination policy for U.S. military personnel being deployed around the globe. However, there are currently no approved vaccines for human use against any of the equine encephalitis viruses. In recent years, the U.S. has seen a rise in human cases of eastern equine encephalitis, particularly in the southern and northeastern parts of the country, correlating with increased observations of mosquitos carrying the virus in these regions. According to the U.S Centers for Disease Control and Prevention (CDC), 38 cases were reported in 2019, compared to an annual average of 7 cases over the past decade. On average, more than 4 of 10 infected individuals die after contracting the virus. Federal funding acknowledgment The initial development of MVA-BN WEV has been funded in whole or in part with federal funds under an Other Transaction Authority agreement with U.S. Army Contracting Command-New Jersey through the Medical CBRN Defense Consortium, MCDC-17-04-001/2018-315. The advanced development of MVA-BN WEV is funded in whole or in part with federal funds under agreement W911SR-23-9-0008. About Bavarian Nordic Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacturing 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, also for the protection against mpox. The vaccine is also approved in Canada and Europe. Our commercial product portfolio furthermore contains market-leading vaccines against rabies and 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, 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. 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. 45 / 2022 1 Ronca SE, Dineley KT, Paessler S. Neurological Sequelae Resulting from Encephalitic Alphavirus Infection. Front Microbiol. 2016 Jun 20;7:959. Attachment 2022-45-en