Emergex Signs Agreement with George Mason University for Highly Pathogenic RNA Virus Studies

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Abingdon, UK, 22 April 2020 – Emergex Vaccines Holding Limited (‘Emergex’), a biotechnology company developing CD8+ priming set-point vaccines to prevent serious infectious diseases, today announced that it has entered into an agreement with the George Mason University, based in Virginia, in the United States.

The agreement specifies that George Mason University’s National Center for Biodefense and Infectious Diseases will provide their unique expertise and resources as a partner in the development of Emergex’s vaccines against highly pathogenic RNA viruses. In particular, George Mason University’s Biosafety 3 capabilities, coupled with their experience in dealing with RNA viruses, means that they are a well-suited collaborator on the vaccine validation studies, as well as the optimization of vaccine design.

Professor Thomas Rademacher, CEO and co-founder of Emergex, commented, “Everyone in the world today has or will be affected by highly pathogenic RNA viruses such as bird flu, Ebola, COVID-19, etc. These viruses have caused significant morbidity and mortality, especially in high-risk groups such as the immunocompromised or elderly. We are therefore very excited to announce today this agreement with George Mason University, which adds an important capability to Emergex’s vaccine program.”

Dr Aarthi Narayanan, Associate Professor of Systems Biology in George Mason University’s College of Science, added, “My colleagues and I are looking forward to partnering with Emergex and we are especially pleased to be lending our expertise to efforts to create a vaccine during these challenging times. As members of the faculty of a premier research university, we work with other thought leaders to address global threats. This is how we make progress, and collaboration is the top priority for the College of Science, the Institute for Biohealth Innovation, and the University as a whole.

Emergex’s set-point vaccines have been designed to offer advantages compared to traditional vaccines. These vaccines modify the initial immune status of the recipients in a way that ‘primes’ their immune systems to recognise subsequent infectious agents much like a natural infection would do, and thus preventing an acute or severe manifestation of the disease. They do this by providing a cell-mediated immune response (a T-cell response) rather than a humoral immune response (an antibody based immune response) which should stimulate longer lasting immunity. They are self-adjuvanted and limit or eliminate the allergic, autoimmune or antibody mediated side effects associated with the traditional vaccines. They are also 100% synthetic and do not contain any RNA or DNA – do not use inactivated or live-attenuated pathogens – and therefore should be inherently safer to develop and use.

About Emergex
Emergex, a UK-based biotechnology company headquartered in Abingdon, UK, is pioneering the development of set-point vaccines to address some of the world’s most immediate health threats such as Dengue Fever, Zika, Ebola, pandemic flu and serious intra-cellular bacterial infections.

These set-point vaccines are population based and modify the initial immune status of recipients in a way that ‘primes’ their immune systems to recognise subsequent infectious agents much like a natural infection would do, preventing an acute or severe manifestation of the disease.

Emergex combines validated technologies together with the very latest scientific insights to develop its vaccines, including using synthetic peptide codes determined on actual infected cells and using a proprietary gold nanoparticle carrier system for programming.

The Company has a growing pipeline of vaccine candidates. The most advanced development programme is a vaccine for Dengue Fever, which may also be disease modifying for other Flaviviruses such as the Zika and Yellow Fever viruses. Emergex also has programmes in development for a universal Influenza vaccine and a universal Filovirus vaccine (including viruses such as Ebola and Marburg) and discovery programmes for a Yellow Fever Booster vaccine and a Chikungunya vaccine.

Find out more online at www.emergexvaccines.com.

About George Mason University
George Mason University is Virginia’s largest public research university. Located near Washington, D.C., Mason enrolls more than 37,000 students from 130 countries and all 50 states. Mason has grown rapidly over the last half-century and is recognized for its innovation and entrepreneurship, remarkable diversity, and commitment to accessibility.

The Institute for Biohealth Innovation (IBI) promotes and supports biohealth-related research activities of faculty, staff, and students at George Mason University. The IBI connects Mason researchers in biohealth with potential collaborators, both within the university and externally, to advance human health research. Learn more and hear more from our researchers at ibi.gmu.edu.

The College of Science at Mason is a leader in scientific discovery creating innovative solutions for the rapidly-changing needs of today’s world. Mason’s College of Science blends traditional science education with sought-after programs in disciplines as diverse as personalized medicine, infectious diseases, geoinformatics, climate dynamics, materials science, astronomy, forensic science, and applied mathematics. The College encourages meaningful education and research at all levels offering innovative undergraduate programs, minors, certificates, and graduate degree opportunities, as well as global, transfer-focused, and online, or hybrid, programs that allow professionals the opportunity to reskill or change careers. Learn more at science.gmu.edu.

George Mason University Biomedical Research Laboratory is one of thirteen Regional Biocontainment Laboratories constructed with funding support from the National Institute of Allergy and Infectious Diseases/National Institutes of Health (NIAID/NIH). The BRL is a state-of-the-art laboratory with biosafety level 3 and aerosolization capabilities where scientists perform pioneering research of infectious diseases, both emerging and potential bio threat agents. Learn more at ncbid.gmu.edu.

BioBuzz: Industry Leaders Outline Best Strategies for Attracting Talent in the BioHealth Capital Region

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Recruiting and attracting talent is one of the top priorities and challenges for biotech and life science companies, even amid the current coronavirus pandemic. To help address those challenges, WorkForce Genetics organized a virtual panel of HR and talent acquisition leaders and local CEO’s to share their insights and best practices.

On April 15th over 125 attendees joined the online panel event which was co-hosted by the Society of Physician Entrepreneurs (SOPE), entitled “Attracting Talent in the BioHealth Capital Region.” Panelists included Marty Rosendale, CEO of the Maryland Tech Council (MTC); Kate Surdez, VP, Human Resources at Viela Bio; and Matthew Levy, Associate Director, Talent Acquisition at Kite Pharma, a Gilead Company. Dr. Jeffrey Hausfield, Chairman of the Board and Chief Medical Officer at BioFactura and the Co-founder and President of SoPE, acted as the panel’s moderator.

Topics covered during the discussion included regional branding, employer branding, small versus large company recruiting strategies, competition for talent and workforce development.  However, an important topic that was addressed early on was how the panelists and their respective organizations have pivoted to adapt to the coronavirus pandemic.

Click here to read more via BioBuzz

Medcura, Inc., a Commercial-Stage Medical Device Company, Announced Today That It Has Moved Into a New Purpose-Built Facility in Riverdale, Maryland That Will Support the Manufacture and Commercialization of Its Growing Product Line

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Medcura chose the Discovery District, a growing center for technology and innovation, where high-tech companies can build businesses that develop, manufacture and commercialize disruptive new products. The Company worked with Terrapin Development and St. John Properties to design and deliver a facility that can house product development, manufacturing and leadership functions that will support commercialization of consumer, clinical, surgical and military applications of its proprietary platform. The Company intends to manufacture core cGMP compliant hemostatic and wound treatment materials at a scale necessary for commercial launch and in support of the clinical development of implantable devices.

“Expanding into this new plant is just the next stage in our growth arc,” said Larry Tiffany, Chief Executive Officer. “These new headquarters give the Company state-of-the art manufacturing and R&D labs, while providing a new corporate home where our growing team can build a successful business. By co-locating our product development and manufacturing, we can now more effectively integrate innovations in our chemistry, product design, and means of delivery across our commercial product lines.”

“We’re thrilled that Medcura has joined a growing group of innovative and entrepreneurial companies that are creating jobs in multiple high-tech industries and are the foundation of our thriving Discovery District,” said Ken Ullman, Chief Strategy Officer for Economic Development at the University of Maryland. “Our goal is to foster the rapid growth of companies like Medcura that are started at the University of Maryland and mature to commercialize disruptive new technologies while helping to transform our community.”

This new plant provides an ideal footprint for the Company’s expanding business. The manufacturing lab (see pictures enclosed), is over four times larger than the Company’s prior accommodations and provides strict isolation for the manufacture of commercial materials while the Company continues to innovate across the hall in an advanced R&D lab.

Moving into this new facility is quite timely, as the Company evaluates co-development opportunities with some of the world’s largest healthcare companies. These relationships are based on coating Medcura’s high-performance materials onto, or infusing them into, market-leading products. By improving the performance of a partner’s product line, particularly in bleeding environments where the patient’s own clotting ability is compromised, these relationships can deliver increased clinical productivity and patient outcomes through decisive and cost-effective bleeding management in an antibacterial environment.

GSK, AstraZeneca in talks for joint U.K. COVID-19 diagnostics project: Bloomberg

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GlaxoSmithKline and AstraZeneca are considering forming a joint laboratory to help the U.K. government stretch and expand its supplies for COVID-19 diagnostic tests, according to a report from Bloomberg.

Even though diagnostics are not their core efforts, the plan is for the two Big Pharmas to test a range of different reagents, chemical mixtures and other materials for new ways to help detect the spreading novel coronavirus. Successes would be provided to other manufacturers or the U.K.’s National Health Service.

An AstraZeneca spokesperson told Bloomberg the company has contacted the government about using “in-house scientific capabilities to increase the effectiveness of the national testing effort” but did not provide specifics. Meanwhile, GSK said it has provided lab equipment and scientific advice, according to the report.

Click here to read more via FierceBiotech

Emergent BioSolutions Executive Vice President, Manufacturing and Technical Operations, Sean Kirk Guests on BioTalk

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Sean M. Kirk, Executive Vice President, Manufacturing and Technical Operations at Emergent BioSolutions joins Rich Bendis to discuss the COVID-19 Health Crisis, Emergent’s Capabilities in Manufacturing in the BioHealth Capital Region and Beyond

 

Listen now via Apple Podcasts (https://apple.co/3aDYSLz), Google Podcasts (https://bit.ly/2Uzh5o6), Spotify (https://spoti.fi/3bIzTqt), and TuneIn (https://bit.ly/3bOKSyV)

 

Mr. Kirk joined Emergent BioSolutions in 2003 and has served as executive vice president, manufacturing and technical operations since April 2019. Prior to this position, Mr. Kirk has held various senior leadership roles including senior vice president, manufacturing operations and contract development and manufacturing operations (CDMO) business unit lead from April 2017 to March 2019, senior vice president, biodefense operations from November 2015 to March 2017, senior vice president, biosciences operations from February 2014 to November 2015 and senior vice president, biodefense vaccines and therapeutics development from March 2012 to February 2014. Mr. Kirk also served in multiple roles of increasing responsibility at Emergent’s manufacturing operations site in Lansing, Michigan.

 

Before joining Emergent, Mr. Kirk worked at Merial, a multinational animal health company, serving in various positions from 1996 to 2001. Mr. Kirk received both an M.B.A. and B.S. in Microbiology from the University of Georgia.

Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding

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The NIH is deeply concerned for the health and safety of people involved in NIH research, and about the effects on the biomedical enterprise in the areas affected by the HHS declared public health emergency for COVID-19. Due to the potential exceptional impact, we want to assure our recipient community that NIH will be doing our part to help you continue your research.

This is a rapidly evolving situation and we will provide updated guidance and information as it becomes available.

See page update history.

Guidance

Proposal Submission & Award Management

Human Subjects & Clinical Trials

Animal Welfare

Peer Review

  • Based on NIH Guidance on Travel and Meetings Link to Non-U.S. Government Site - Click for Disclaimer, in-person NIH peer review meetings are being held in alternate formats. Scientific review officers will be in contact with peer reviewers about these changes.

FAQs – FAQs last updated on March 30, 2020 (history).

Click here to read more via grants.nih.gov

Emergent BioSolutions Signs Agreement With Novavax to Manufacture NanoFlu™

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  • CDMO agreement for NanoFlu to support pathway to licensure
  • Expanded collaboration now includes NanoFlu and COVID-19 vaccine candidate

GAITHERSBURG, Md., March 31, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced an agreement with Novavax, Inc. (NASDAQ:NVAX) whereby Emergent will provide molecule-to-market contract development and manufacturing (CDMO) services to produce Novavax’s NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M™ adjuvant. Novavax recently announced that NanoFlu met all primary objectives in its Phase 3 clinical trial evaluating immunogenicity and safety in adults aged 65 and older.

“Emergent is pleased to expand our collaboration with Novavax to include large-scale production of NanoFlu, their novel influenza vaccine,” said Syed T. Husain, SVP and CDMO business unit head at Emergent BioSolutions. “Our flexible and integrated CDMO offerings allow us to work with expedited timelines, execute on simultaneous engagements, and serve varying needs and approaches of customers like Novavax. As a trusted partner, we are committed to supporting Novavax’s goals to advance their influenza program while maintaining the option to allocate capacity for a potential scaled-up COVID-19 program.”

Under the terms of the agreement, Emergent will provide drug substance manufacturing services, including technology transfer and process validation and performance qualification to pave the way for commercial manufacturing. This work will be conducted at Emergent’s Baltimore Bayview location, which is designated by the U.S. Department of Health and Human Services (HHS) as a Center for Innovation in Advanced Development and Manufacturing (CIADM), and where the COVID-19 experimental vaccine candidate of Novavax is also being produced. The collaboration allows for flexibility to deploy capacity towards an expanded COVID-19 program.

“Our confidence in partnering with Emergent comes from their reputation for high quality production and ability to scale-up manufacturing,” said Stanley C. Erck, president and chief executive officer of Novavax. “We believe Emergent’s manufacturing capabilities will allow us to capitalize on NanoFlu as an innovative, improved alternative to traditional egg-based flu vaccines.”

Emergent’s Bayview facility has unique capabilities across four independent suites to produce at clinical scale to get candidates rapidly into the clinic, while at the same time scaling up to enable large-scale manufacturing to up to 4000L to prepare for production of commercial volumes to meet customer demand. Additionally, as a CIADM, it has the capacity to produce tens to hundreds of millions of doses of vaccine on an annual basis, based upon the platform technology being used.

About Emergent BioSolutions
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

About NanoFlu™ and Matrix-M™
NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. The qNIV vaccine antigens were derived from A/Brisbane 02/2018 H1N1, A/Kansas 14/2017 H3N2, B/Maryland 15/2016 and B/Phuket 3073/2013. NanoFlu contains Novavax’s patented saponin-based Matrix-M adjuvant, which has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes.

About Novavax
Novavax, Inc. (Nasdaq: NVAX), is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial. ResVax™, its RSV vaccine for infants via maternal immunization, is the only vaccine to demonstrate efficacy in a Phase 3 clinical trial. Novavax recently initiated development of a vaccine program against COVID-19. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic nanoparticles addressing urgent global health needs.

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our ability to produce the influenza vaccine candidate at the prescribed scale and timeline and pave its potential pathway to licensure, as well as deploy capacity toward an expanded COVID-19 program, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including the success of the planned development programs; the timing of and ability to obtain and maintain regulatory approvals for the product candidates; and our commercialization, marketing and manufacturing capabilities. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.

Investor Contact:
Robert G. Burrows
Vice President, Investor Relations
240-631-3280
BurrowsR@ebsi.com

Media Contact:
Lynn Kieffer
Vice President, Corporate Communications
240-631-3391
KiefferL@ebsi.com

BioBuzz: Good News Stories Emerging from the Capital Region Show Solidarity Amid Coronavirus

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Endless social media scrolls, 24/7 news channels, newspapers, and radio waves are inundating the public with scary COVID-19 statistics, harrowing tales of medical workers on the front lines of the coronavirus battle, a roller coaster ride stock market and images of empty grocery store shelves and panicked shoppers.

Yes, there is a lot of bad news out there. But there’s also a lot of good.

There’s a national commitment to social distancing and sacrifice to protect the most vulnerable members of society. There are tiny acts of everyday kindness in neighborhoods that go unreported. There are virtual happy hours happening on Zoom and Facetime across the globe. There are family get-togethers done via Skype. First, in family history, virtual birthday parties for kids, parents, and grandparents are happening every day.

Most importantly, there are hundreds of thousands of healthcare workers who continue to go to work every day, putting themselves and their families at a higher risk of contagion, to help treat patients, save lives and fight this pandemic. These medical superheroes represent countless acts of good each and every day across the nation, and the world.

The thing about humans is that when times are the toughest, our fundamental humanity becomes the clearest. In many ways, the kindness and generosity and togetherness we’re all experiencing in some way is reminiscent of the terrifying and confusing days and months after 9/11. The U.S. got sucker punched and knocked down, but we collectively dusted ourselves off and immediately started looking for ways to help our neighbors despite the pain and fear we felt.

Unfortunately, good news doesn’t always get ratings or sell newspapers.

So at BioBuzz, we’re going to fill that good news gap by reporting on some of the amazing and selfless work that’s happening in the healthcare and life science community of the BioHealth Capital Region (BHCR).

Here is the BHCR COVID-19 Good News Roundup for March:

Click here to read more via BioBuzz

BioBuzz: 7 BioHealth Capital Region Diagnostics Companies Leading the Fight Against COVID-19

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Prominent research universities and government agencies are keeping the public abreast of the scope of the coronavirus pandemic as well as the reported outcomes of identified cases.

Major media outlets are doing their best to share information in real-time, but often portray spiking case numbers in hotspots like New York City as the accelerating spread of COVID-19. The reality, in many states across the U.S., is that COVID-19 has already infected large swaths of the population, so the coronavirus is not necessarily “spiking” but rather being revealed through better diagnostics and wider access to COVID-19 testing.

Understanding the difference between media reports of sudden spread and spikes versus reporting on stronger testing and therefore the identification of more cases is critical to flattening the curve.

When communities think in terms of spikes and sudden conflagrations of COVID-19 they might think self-distancing isn’t needed if the community where they reside only has a handful of confirmed cases. If communities approach COVID-19 already assuming it is in their community in larger numbers that haven’t yet been identified through diagnostics and testing, they are more likely to stay home, self distance and contribute to flattening the curve.

This is why accurate diagnostics are so critical to stemming COVID-19.

Strong, widely available and easily accessible testing not only gives scientists the data they need to develop vaccines and potential therapies, but it also avoids the perception that COVID-19 isn’t already present in communities in higher numbers than have been confirmed.

If testing is pervasive and strong at the start of an outbreak, our ability to flatten the curve via new scientific discoveries and modified behaviors increases dramatically.

This is why the diagnostics work being done by these 7 BioHealth Capital Region (BHCR) organizations is so important and should be lauded in this time of uncertainty and crisis.

Click here to read more via BioBuzz.

Daily Record – Hopkins to lead coronavirus treatment study backed by Bloomberg and Md.

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Bloomberg Philanthropies and the state of Maryland will spend $4 million to back a Johns Hopkins University study into whether the blood of recovered COVID-19 patients can be used to treat patients suffering from the disease.

The effort will also include researchers from nearly two dozen institutions, including the Mayo Clinic, Stanford University Medical Center and the Albert Einstein College of Medicine. Arturo Casadevall, a professor at the Johns Hopkins University Bloomberg School of Public Health and the Johns Hopkins School of Medicine, will lead the study.

“Johns Hopkins is committed to marshaling our clinical and research expertise to stem the tide of this devastating pandemic worldwide,” Ronald J. Daniels, the university’s president, said in a statement. “Dr. Casadevall, like so many other Hopkins researchers, is joining with partners across the globe in a race against the clock, and his work embodies to the fullest our university’s mission to serve humanity through discovery.”

Click here to read more via The Daily Record

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