Emergent BioSolutions Signs Development and Manufacturing Agreement with Vaxart for their Experimental Oral Vaccine Candidate for Coronavirus Disease

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GAITHERSBURG, Md., March 18, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into an agreement with Vaxart, Inc. (Nasdaq: VXRT), a clinical-stage biotechnology company, whereby Emergent has agreed to utilize its molecule-to-market contract development and manufacturing (CDMO) services to develop and manufacture Vaxart’s experimental oral vaccine candidate for coronavirus disease (COVID-19). Development services will begin immediately, and upon Vaxart’s election, Emergent agrees to produce clinical material expected to enable Vaxart to initiate a Phase 1 clinical study anticipated early in the second half of 2020. Vaxart’s oral recombinant vaccine candidate is based on its proprietary VAAST™ platform.

“Emergent is pleased to deploy our nimble CDMO expertise to support fellow innovators, like Vaxart, and advance an experimental COVID-19 vaccine candidate,” said Syed T. Husain, senior vice president and CDMO business unit head at Emergent BioSolutions. “We look forward to applying our broad molecule-to-market services, including our ability to work with a multitude of delivery systems, execute under expedited timelines, and meet Vaxart’s potential need for future scalability and large-scale capacity for commercial quantities.”

Under the terms of the agreement, Emergent will provide development services out of its Gaithersburg, Md. location and manufacture drug substance at its Bayview facility in Baltimore, Md., designated a Center for Innovation in Advanced Development and Manufacturing (CIADM) by the U.S. Department of Health and Human Services. Emergent’s Bayview CIADM is the same facility used to manufacture drug substance for the company’s recently announced Novavax collaboration. The facility has the capacity to produce tens to hundreds of millions of doses of vaccine on an annual basis, based upon the platform technology being leveraged. Additionally, it has the unique capability of producing at clinical scale, to get vaccine candidates quickly into the clinic, and in parallel, scaling up to produce commercial volumes to meet customer demand.

“I’m pleased that we are joining forces with an experienced manufacturer such as Emergent to help advance our oral COVID-19 vaccine to the clinic,” said Wouter Latour, MD, chief executive officer of Vaxart. “We believe an oral vaccine administered using a room temperature-stable tablet may offer enormous logistical advantages in the roll-out of a large vaccination campaign, and Emergent is a great partner to help in this endeavor.”

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.

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 advance potential solutions to combat coronavirus disease as well as the anticipated production level and use of the COVID-19 experimental vaccine candidate in a Phase 1 clinical study in the expected timeframe, 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 program; the timing of and ability to obtain and maintain regulatory approvals for the product candidate; 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

BioHealth Capital Region Forum Postponed Due to COVID-19 Outbreak

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The BioHealth Capital Region Forum Planning Committee has made the difficult decision to postpone our 6th annual BioHealth Capital Region Forum that was scheduled for April 14th and 15th at AstraZeneca. We believe the health and safety of all participants is of paramount importance. Following the most recent reports from the CDC, the WHO, and the state of Maryland’s ban on gatherings of 250 people or more, we have made this decision.

 

We are proud of the leadership taken by many of our region’s companies along with federal and state officials in combating the spread of COVID-19.  We want to address both the growing threat of the coronavirus and the state of our region during a Virtual Update on April 14th.

 

Please stay connected with the BioHealth Capital Region via Twitter, LinkedIn, and Facebook.

 

We are exploring combining the BioHealth Capital Regional Forum with the BioHealth Capital Regional Investment Conference in October and will advise you of our future direction on these events as soon as we develop our path forward. Thank you for your patience and understanding with this difficult decision. We look forward to e-convening on April 14th.

 

Cordially,

 

The BioHealth Capital Region Forum Planning Committee

 

 

Stewart L. Edelstein, Ph.D., Executive Director of the Universities at Shady Grove, Joins Rich Bendis on BioTalk

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Executive Director of the Universities at Shady Grove, Stewart L. Edelstein, Ph.D., joins BioTalk to discuss his career, USG, and its role in the BioHealth Capital Region

Dr. Stewart Edelstein joined the Universities at Shady Grove (USG) as Executive Director in 2002 and in 2007 was named to the dual title of Associate Vice Chancellor for Academic Affairs for the University System of Maryland (USM).

USG is a regional campus of USM that offers both undergraduate and graduate degree programs from nine partner universities. During Dr. Edelstein’s tenure, USG expanded its number of participating universities, as well as the breadth and depth of its academic programs, and enrollment has grown significantly, to more than 3,000 students. The campus’s capacity for future enrollment growth has doubled with the recent opening of a new Biomedical Sciences and Engineering Education Facility, which is expanding degree and certification offerings in healthcare, engineering, biosciences, computer science and other areas.

Under Dr. Edelstein’s leadership, USG has collaborated with Montgomery College and Montgomery County Public Schools (MCPS) to better articulate curriculum planning and degree completion initiatives within the county. An important partnership is a series of 2+2+2 programs – together with MCPS and MC – to create education and career pathways in professional fields. These initiatives place special emphasis on strengthening the pipeline for underrepresented and first-generation college student populations.

Dr. Edelstein serves on the Montgomery County Chamber of Commerce’s board of directors and as co-chair of its Economic Development Committee. He is on the board of Identity, WorkSource Montgomery, and Montgomery Moving Forward, and on the Maryland Cybersecurity Council. He served as a member of the Montgomery County Bioscience Task Force, the Montgomery County Smart Growth Initiative, and the Montgomery County Life Sciences Advisory Committee. He has been honored for his many contributions to the community by the Montgomery County Chamber, the Montgomery County Board of Education, and by the County Executive’s Hispanic Gala.

Prior to arriving at USG, Dr. Edelstein enjoyed a 25-year career at the University of Maryland, College Park, where he ultimately served as Senior Associate Dean of the College of Behavioral and Social Sciences. Dr. Edelstein received his bachelor’s degree from the State University of New York at Buffalo and his master’s degree and Ph.D. from the University of California at Berkeley.

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BioBuzz: Altimmune Becomes The Second Maryland-Based Biotech Advance Potential Coronavirus/COVID-19 Vaccine

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As the coronavirus COVID-19 continues to spread across the U.S.  — there are currently 150 confirmed cases with 11 total deaths as of this writing — several BioHealth Capital Region (BHCR) life science companies are urgently pushing to develop and deploy a COVID-19 vaccine.

In another encouraging sign, Altimmune, which is located in Gaithersburg, Maryland announced that it had made progress on a potential vaccine. The company has advanced a potential single-dose, recombinant intranasal vaccine using its proprietary technology. Altimmune’s research scientists have completed the design and synthesis of the vaccine and it is now moving into animal testing. Altimmune projects that clinical testing of the coronavirus vaccine could begin as early as August 2020.

The potential new COVID-19 vaccine has been developed using the same technology that was deployed to create NasoVAX™, Altimmune’s recombinant intranasal vaccine for influenza, which is currently Phase 2A trials. NasoVAX, according to Altimmune’s recent press release, has shown “…the ability of intranasal vaccine delivery to stimulate a durable and broad immune response against the influenza virus.” The company believes that a COVID-19 vaccine delivered intranasally provides a more direct immune response to the likely point of the initial viral attack.

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Chris Frew, Founder of BioBuzz and Workforce Genetics, Joins Rich Bendis on BioTalk

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BioBuzz and Workforce Genetics Founder, Chris Frew, Joins BioTalk to discuss building two organizations, talent acquisition, and his role in the BioHealth Capital Region

Chris is the Founder and CEO of Workforce Genetics, LLC (WGx), and BioBuzz Media to foster highly engaging experiences that connect people and companies across biohealth ecosystems. His insights into talent attraction, employer branding, and marketing have helped top companies to tackle their most pressing challenges in the new talent economy. Previously as Vice President at Breezio, a leading innovator in cloud-based online communities, he lead the development of the new Internship Network of Maryland (inMD) platform that was approved by Gov. Hogan in 2017. As Vice President of Tech USA’s Scientific Division Chris founded and ran a national staffing division operating at $23M annually when he left in 2015. Chris is passionate about impacting others, especially his family and his team, and helping to foster a strong community within the BioHealth Capital Region. He is a Maryland native and a graduate of Towson University. Learn more at https://www.workforcegenetics.com/ and http://biobuzz.io/

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Novavax Advances Development of Novel COVID-19 Vaccine

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  • Vaccine candidate derived from coronavirus spike (S) protein
  • Matrix-M™ adjuvant expected to boost immune responses
  • Phase 1 clinical trial planned for late spring

GAITHERSBURG, Md., Feb. 26, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced progress in its efforts to develop a novel vaccine to protect against coronavirus disease COVID-19. Novavax has produced and is currently assessing multiple nanoparticle vaccine candidates in animal models prior to identifying an optimal candidate for human testing, which is expected to begin by the end of spring 2020.

Novavax created the COVID-19 vaccine candidates using its proprietary recombinant protein nanoparticle technology platform to generate antigens derived from the coronavirus spike (S) protein. Novavax expects to utilize its proprietary Matrix-M™ adjuvant with its COVID-19 vaccine candidate to enhance  immune responses.

“Our previous experience working with other corona  viruses, including both MERS and SARS, allowed us to mobilize quickly against COVID-19 and successfully complete the critical preliminary steps to engineer viable vaccine candidates,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “Now that the protein has been expressed stably in our baculovirus system, we aim to identify the optimal candidate and scale up production of sufficient vaccine for preliminary clinical trials. We are now well-positioned to advance the COVID-19 vaccine candidate to Phase I clinical testing in May or June.”

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BHI Managing Director, Economic Development, Judy Costello joins BioTalk to discuss her Career, BioHealth Innovation, and the BioHealth Capital Region

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Judy Costello is the Managing Director of Economic Development for BioHealth Innovation, Inc. (BHI). A longtime supporter of the region’s entrepreneur and start-up communities, Judy Costello joined BioHealth Innovation in August 2017. Prior to that she served as Director of the Maryland Department of Commerce’s Office of BioHealth and Life Sciences and Deputy Director of the department’s BioMaryland Center. She previously worked for fifteen years for the Business Alliance organizing venture pitch forums, entrepreneur bootcamps, tech transfer showcases, educational seminars, and other programs connecting entrepreneurs, faculty innovators, students, and industry leaders in Maryland, DC and Virginia with each other and with those providing funding and other resources to young companies.

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BioBuzz: Hiring During a Biotech Boom: The Talent Challenges Facing Companies Across All Markets – Part 1

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Part 1: This article is the first in a new series where we will explore the impact that the booming biotech market is having on hiring and talent strategies for companies and for biotech clusters.

Life science industry growth projections for the next decade mean the battle to acquire and retain the best talent will continue in 2020 and beyond, both here in the U.S. and globally.  The many top biotech clusters across the U.S., including the BioHealth Capital Region (BHCR), will experience a new set of challenges as competition for talent becomes more fierce.

According to a recent CBRE report entitled “Markets Positioned for ‘Century of Biology’,” 2019 was a year of explosive growth for the biotech industry, fueled in part by the rapid emergence and proliferation of personalized medicine, including the burgeoning cell and gene therapy industries. The CBRE report calculates the life sciences sector is growing at its fastest pace since 2000, expanding 3.2% year-over-year

Rent for lab space in the Boston-Cambridge cluster, according to this same report, increased by double digits in 2019 and 1.9M square feet of lab space is currently under construction there. Another recent report by MassBio showed “…that the Massachusetts biopharma industry experienced the highest year-over-year employment growth in over a decade, adding over 4,300 new jobs from 2017 to 2018 for 6.4% growth.” More specifically,  the report cites that biotech research & development (R&D) employment growth was nearly 50% over the past 10 years. Additionally, New York currently has 1.5M square feet of lab space under construction; Seattle, Houston, Austin and Denver were tagged by CBRE as emerging clusters. The next decade is ripe for disruption and more explosive change and growth.

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BioBuzz: Vigene Biosciences Opens New Rockville Headquarters

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Vigene Biosciences officially opened its new, state-of-the-art 51,000 square foot cell and gene therapy manufacturing facility in Rockville, Maryland at a ribbon-cutting ceremony on January 29th.

The grand opening marked a major milestone for the company, which has grown from three employees to approximately 100 team members since launching in 2012. The $20M project has increased Vigene’s footprint to 71,000 total square feet, amplifying its capacity to serve its clients and achieve the company’s ultimate mission: Making gene therapy treatments more affordable for people and families battling cancer and genetic disorders.

The ribbon-cutting ceremony was a vibrant, joyful celebration of Vigene’s remarkable achievements. It was also a moment of real hope for families seeking better, more affordable gene and cell therapies for loved ones stricken with cancer and rare diseases.

Gina Hann, the founder of the non-profit organization Batten Hope, was Vigene Biosciences’ grand opening special guest. Her seven-year-old son, Joseph, known as JoJo, was diagnosed with a rare form of Batten disease at age five. Batten disease is a terminal, genetic, neural-degenerative disease. Hann spoke to the rapt crowd about her family’s experiences and her son’s courageous battle with Batten disease.

“I want everyone in this building to understand why the work that you are doing is so, so important. This is a great day for the rare disease community, and in case you’re wondering who this community is I want to give you a sense of it: one in ten. Look around this room and how many people are here. One in ten are impacted directly by rare disease,” stated Hann.

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So, You Want to Join a Life Science Startup?

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Why You Should Consider Workplace Culture Before Taking the Leap

The startup mythology has its origins in the tales of geniuses like Walt Disney, Bill Gates and Jeff Bezos’ going from small California garages to world domination. And the startup mystique became part of popular culture with Silicon Valley companies like Google and others creating workplace cultures where employees skateboarded down hallways, enjoyed yoga and meditation sessions onsite, and blew off steam with breaks at the company-provided vintage arcade and craft coffee bar.

These startup stereotypes bely a stark reality, however: Most startups are risky and operate on tighter budgets until they survive long enough to mature and raise ample funding.

If you get in at the right inflection point, the spoils of joining a startup can be life-changing. Regardless, leaving an established life science company for a bioscience startup is a tough decision defined by the high-risk, high-reward nature of these fledgling companies fighting to win funding and bring its product to the market.

For those in the early stages of their life science career, joining a bioscience startup could be a no brainer—there’s likely a lot less risk and so much more to gain. For the less experienced, stock options are not the only potential windfall; startup culture will likely furnish development opportunities to less-experienced workers not readily available to them in larger, established biotech or big pharma organizations.

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