• 93% efficacy against predominantly circulating Variants of Concern and Variants of Interest 
• 91% efficacy in high-risk populations 
• 100% efficacy against variants "not considered Variants of Concern/Interest” 
• All COVID-19 hospitalizations/death occurred in the placebo group 
• Company to host investor conference call today at 8:30 am ET

GAITHERSBURG, Md., June 14, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), today announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. The study enrolled 29,960 participants across 119 sites in the U.S. and Mexico to evaluate efficacy, safety and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by the disease.

A few weeks ago, we wrote about how the BioHealth Capital Region’s (BHCR) biotech sector is booming. Advanced biomanufacturing, cell and gene therapy, vaccine development, and the medtech industries have all seen record growth over the past few years.

Biotech innovation is accelerating. There are over a thousand cell and gene therapies in the clinical pipeline. Big Data, automation, and gene editing technologies like CRISPR — in addition to the creation of a COVID-19 vaccine in less than a year—are revolutionizing drug development and forcing the industry to reimagine what’s possible. 

The Gaithersburg biotech expects more data on its latest vaccine trial within days.

Image: Novavax's future headquarters is located at 700 Quince Orchard Road in Gaithersburg. SARA GILGORE / WBJ

Maryland universities, Montgomery County government and the private sector are teaming up to capitalize on local momentum in life sciences created over the past year as the pandemic catapulted companies in the region to the global stage — and as the need for research and innovation continues.

Montgomery County, the University System of Maryland and Montgomery College signed a memorandum of understanding Friday at the Universities at Shady Grove’s Biomedical Sciences and Engineering Building in Rockville. The collaboration between academia and industry, called the Montgomery/Maryland Life Sciences Education and Innovation Partnership, will aim to create job opportunities for local students and, in doing so, build a talent pipeline for the county’s companies.

Image: Montgomery County Executive Marc Elrich speaks at a press conference as the county, the University System of Maryland and Montgomery College signed a memorandum of understanding Friday at the Universities at Shady Grove’s Biomedical Sciences and Engineering Building in Rockville. HANNAH DENHAM

Novavax, a small American company buoyed by lavish support from the U.S. government, announced on Monday the results of a clinical trial of its Covid-19 vaccine in the United States and Mexico, finding that its two-shot inoculation provides potent protection against the coronavirus.

In the 29,960-person trial, the vaccine demonstrated an overall efficacy of 90.4 percent, on par with the vaccines made by Pfizer-BioNTech and Moderna, and higher than the one-shot vaccine from Johnson & Johnson. The Novavax vaccine showed an efficacy of 100 percent at preventing moderate or severe disease.

The Biden administration today began to flesh out a proposal for a new agency—modeled on the military’s Defense Advanced Research Projects Agency (DARPA)—that would seek to speed the development of medical treatments by funding risky, innovative projects. The agency, dubbed ARPA-Health (ARPA-H), would be housed at the National Institutes of Health and have a 2022 budget of $6.5 billion, according to a White House spending request released today.

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

BioHealth Innovation, Inc. (BHI), is a Montgomery County innovation intermediary that translates market-relevant research into commercial success by bringing together management, funding, and markets. BHI is seeking two experienced life science professionals with product development and investment experience to join the BHI team to serve as a part-time Entrepreneurs-in-Residence (EIR) at the National Institutes of Health (NIH).

These positions will report to and work closely with our lead at the NIH Small business Education and Entrepreneurial Development (SEED) Office to support academic and small business innovators in their efforts to validate the potential health impacts of promising scientific discoveries and advance them into healthcare products that improve patient care and enhance health.

Click here to download the full job description.

I am delighted to announce that FREE Registration is open for the annual Conference, Targeting Metabesity2021, organized by our colleagues Kinexum and the Kitalys Institute. This four-day event will be virtual from 9:00 am-5:00 pm eastern time each day, October 11-14. Many of you attended last year, and once again we are notifying you of the event and the benefits of early FREE registration.

This year, Targeting Metabesity tackles the barriers to translating scientific breakthroughs into a national policy for increased healthy longevity, with outstanding speakers that challenge convention thinking about our aging.

To learn more about the Conference and review the roster of eminent speakers and provocative topics; please visit www.Metabesity2021.org

To go directly to the registration page, visit https://www.xcdsystem.com/metabesity/attendee/index.cfm?ID=3wsGCbK .

The Office of the County Executive at Montgomery County, Maryland recently announced the appointment of Judy Costello as Special Projects Manager. As Special Projects Manager, Judy supports a wide range of business and economic development-related projects (i.e., business/large employer recruitment and retention, education and workforce, small business and innovation, climate change, and transportation). Her focus covers multiple industries within the County.

Friday, June 11, at 10:30 a.m.

Universities at Shady Grove,
Biomedical Sciences and Engineering Building
9631 Gudelsky Drive, Rockville
(Parking in Lot 2, directly in front of BSE building)

Montgomery County, the University System of Maryland and Montgomery College will be signing a Memorandum of Understanding (MOU) to create the Montgomery/Maryland Life Sciences Education and Innovation Partnership to facilitate collaboration among industry and the academic partners on cutting-edge research, and allow students from across Maryland opportunities to gain work experience and conduct translational research with Montgomery County’s industry leaders. It is envisioned that the Montgomery/Maryland Life Sciences Education and Innovation Partnership will guide the future of post-pandemic education leveraging existing assets to create an economic development powerhouse for Maryland in life and regulatory sciences.

The year 2020 tested the biotech industry and the entire nation. Maryland’s life sciences community can be proud that it passed those tests with distinction. As COVID-19 spread across the globe, Maryland companies stepped up to help save millions of lives. Maryland-based leaders such as AstraZeneca; Becton, Dickinson and Company; GlaxoSmithKline; Emergent BioSolutions; Novavax; Pfizer; and Qiagen Sciences were among the Maryland companies involved in these efforts.

Image: https://www.fiercebiotech.com

Leiden & Tokyo, June 7, 2021 - MIMETAS has been awarded the ‘Deshima Business Award” in the category ‘newly established’ by the NCCJ, and the Embassy of the Kingdom of the Netherlands. The award highlights companies with Dutch roots that lead the way in Japan – those companies that have demonstrated successful business development in Japan and have added value to society.

https://www.youtube.com/watch?app=desktop&v=llOFRNF_VeQ&feature=youtu.be

The quantum-computing power of IonQ Inc. could eventually be put to work in some of SoftBank Group Corp.’s portfolio companies as part of a recently-announced strategic partnership with the tech investor.

SoftBank Investment Advisers, which runs its SoftBank Vision Funds 1 and 2, has taken a “large” equity stake in the College Park, Md.-based startup, though not a majority stake, said Peter Chapman, chief executive of IonQ, without giving specifics.

IonQ is SoftBank’s first investment in quantum computing, said Kirthiga Reddy, partner at SoftBank Investment Advisers.

Image: IonQ's trapped-ion chip, pictured above, will eventually be placed in a quantum-computing device about the size of an Xbox video-game console, expected to be completed by 2023. PHOTO: IONQ

Gaithersburg, MD (June 8, 2021) – miRecule, Inc. (“miRecule”), an emerging biotech company focused on the development of cutting-edge RNA therapeutics, announced the hiring of Fu-An Kang, Ph.D. to serve as its Vice President of Research. Dr. Kang joins miRecule after serving for 6 years as the Senior Director of Chemistry at Abzena, a leading chemistry, biologics and antibody-drug conjugate (ADC) research organization.

Image: https://mirecule.com

Maryland is offering a new program to match international prospects with local incubators throughout the state. The Maryland Soft Landing Program, announced by Maryland Commerce Secretary Kelly M. Schulz at the 2021 SelectUSA Investment Summit, will promote existing “soft landing” programs in the state’s various business incubators, while growing Maryland’s hub of international companies.

NEWARK, Del., June 8, 2021 /PRNewswire/ -- The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is pleased to announce funding for 10 new projects in technology, workforce development, and their Global Health Fund initiative, resulting from the Institute's Project Call 4.1, and with a total value of approximately $4.6M.

The National Institute for Innovation in Manufacturing Biopharmaceuticals (PRNewsfoto/National Institute for Innovati) "Since our inception five years ago, we have been able to fund many great projects that have resulted in significant advancements in the biopharma industry, and this year is no different. The eagerness and ambition this industry has to continuously improve is always encouraging, and I am looking forward to seeing how our newest projects will contribute to accelerating the industry's manufacturing process," states Kelvin H. Lee, Institute Director.

The efforts to develop a Covid-19 vaccine accelerated the already strong demand for life sciences real estate in Maryland, and tenants now want lab space faster than developers can build it. 

The market's vacancy rate has fallen so low that life sciences companies often can't find space that meets their time-sensitive needs, experts say, leading them to look to other markets. 

Image: Courtesy of Matan Cos. A rendering of one of Matan Cos.' Progress Labs buildings on the I-270 corridor.

In 1976, an Atari engineer named Ron Wayne took a 10% ownership stake in a new technology startup created by a pair of fellow co-workers, meant to serve as the tiebreaker in the ambitious triumvirate.

The enterprise showed early potential, but Wayne became concerned that should the young venture flounder, he would be personally liable for the company’s debts as well. So, he cashed out his 10% stake for $2,300. 

This episode is the first of a new podcast series, where we will visit with different leaders striving to grow economic development in their areas or regions of interest. We will be discussing new initiatives, new models, the interest and investment in Technology Parks, Incubators and Accelerators as well as other creative economic development platforms being implemented throughout the country within public and private initiatives.

As states ease COVID restrictions, more and more people post their vaccine selfies and the Centers for Disease Control and Prevention updates its mask guidance. It’s beginning to feel like the country is getting back to normal and, in many ways, we are. But the truth is that what we do now in this moment will determine whether we’ve learned the right lessons from the last year of a pandemic that’s cost the world more than 3 million lives.

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

June 3, 2021 (Washington, D.C.)— The once-in-a-generation pandemic highlighted both the region’s continued lag in economic competitiveness and the absence of a cohesive and coordinated economic development strategy. The Regional Economic Development Strategy (REDS) initiative, launched by Connected DMV, has released the first regional cross-sector blueprint to advance economic opportunity and social equity in Greater Washington, the culmination of a year of work by the REDS Steering Committee.

Image: https://www.connecteddmv.org

Startups can’t stay in the early stage forever. While a young company can benefit from the early momentum of pitch wins and resources found in a community, it eventually must figure out its business model, and ultimately scale.

Hearing leading local investors describe Baltimore’s startup community at a Baltimore Innovation Week 2021 panel discussion dubbed “Strengthening Baltimore as a Hub for Innovation,” this reporter was left with the impression that the ecosystem as a whole feels a bit like a startup.

Image: Photo by Flicker user Phil! Gold

In diverse cities like the District of Columbia, health inequities are driven by systemic racial and socioeconomic disparities.[1] Underserved communities, including neighborhoods where most residents are people of color or where income disparities exist, are unjustly burdened with disproportionate comorbidities, negative health outcomes and obstacles to accessing care. [2]

According to a recent Health Equity Report by the District of Columbia Department of Health, the District’s mortality rate caused by leading diseases such as chronic heart disease, cancer, and diabetes outranked the United States’ rate in 2015.[3] These rates were even higher in the District’s Black and Hispanic residents compared to its White residents.[2]

In 2007, there were five times as many men as women in officer roles at Genentech, and female directors (the level preceding officers) were leaving at twice the rate as their male counterparts. To achieve equitable representation among men and women in leadership positions and stem the flow of departing talent, we rethought and revised our recruiting, professional development, and succession planning processes. Today, because of those efforts and a top-down commitment to change, men and women are nearly equally represented among our overall employee population and in officer and director roles.

A Maryland mega-development, initially pitched as a home for Under Armour, may now become a biotech cluster, according to developers.

The $5.5B Port Covington development on Baltimore’s waterfront has had several iterations; home to the athletic clothing firm, a cybersecurity center and then a development on pause during the coronavirus pandemic. But in an interview with the Baltimore Sun, Steven Siegel, a partner with Weller Development Co., suggested life sciences may be part of the company’s focus going forward. 

Image: Courtesy of Weller Development Co. - A previous rendering of Port Covington; developers now see a future in constructing a life sciences hub.

The entire D.C. region is poised to work together on economic development efforts to reverse its widening gap between the rich and the poor, according to a group of government, business and academic leaders — but the hard part will be actually making all of the region’s localities play nice together.

Connected DMV, an organization of public and private sector officials assembled as the Covid-19 crisis unfolded, is out with its first stab at crafting a “regional economic development strategy,” released first to the Washington Business Journal on Thursday. As helmed by Fairfax County economic development head Victor Hoskins, the report makes some familiar arguments about the need for regional collaboration and lays out some discrete areas where officials can actually work together.

Image: Fairfax County Economic Development Authority CEO Victor Hoskins is leading Connected DMV's efforts to build regional cooperation. JOANNE S. LAWTON

With dedicated facilities, a collaborative environment, and a talented workforce, Maryland is on the leading edge of a robust and rapidly growing unmanned vehicle community, which also includes robotics. Keep reading to see five ways Maryland excels in unmanned and autonomous systems. 

The U.S. Department of Health and Human Services (HHS) today unveiled a new type of public-private partnership that enables investments using venture capital practices. Through the BARDA Ventures program, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, is launching a partnership with the nonprofit organization Global Health Investment Corporation (GHIC) to accelerate development and commercialization of technologies and medical products needed to respond to or prevent public health emergencies, such as pandemics, and other health security threats.

As the first buildings at Port Covington begin to rise, the project’s developers have a vision for the mini-city sprouting on a South Baltimore peninsula as the nation’s next big biotech hub.

The waterfront neighborhood of apartments, offices, stores and parks now under construction could rival life sciences cores such as Cambridge, Massachusetts, and Mission Bay in San Francisco, members of the development team say.

BioHealth Innovation, Inc. (BHI), is a Montgomery County innovation intermediary that translates market-relevant research into commercial success by bringing together management, funding, and markets. BHI is seeking two experienced life science professionals with product development and investment experience to join the BHI team to serve as a part-time Entrepreneurs-in-Residence (EIR) at the National Institutes of Health (NIH).

These positions will report to and work closely with our lead at the NIH Small business Education and Entrepreneurial Development (SEED) Office to support academic and small business innovators in their efforts to validate the potential health impacts of promising scientific discoveries and advance them into healthcare products that improve patient care and enhance health.

Click here to download the full job description.

“5 Questions With…” is a weekly BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. This week we welcome Sue Carr, RPh, President and Founder, CarrTech, LLC.

Sue Carr RPh is President and Founder of CarrTech LLC, a medical device company. CarrTech has developed, patented, and prototyped an all-in-one package one needle filter device to increase safety and compliance while reducing time and waste. Sue has over 30 years of experience in the pharmaceutical industry in retail management and clinical hospital pharmacy, specializing in ICU, ER, Oncology, and NICU.

GrowthCap is pleased to announce The Top 25 Healthcare Investors of 2021. In our inaugural year for these awards, we wanted to bring forth and recognize not only the most experienced and talented investors in healthcare but also those that help advance innovation across the sector. Over 750 investors were considered.  Whether in healthcare software, healthcare services, medical technologies, biotechnology, the connected patient experience, or other areas, the accomplished individuals who were ultimately selected have demonstrated a deep commitment to healthcare and as a result have succeeded both from a business standpoint as well as in having significant societal impact.

Image: https://growthcapadvisory.com

As biopharma companies continue to cope with the COVID-19 pandemic and position themselves for recovery, digital and analytics can be a powerful tool in manufacturing and operations. It can drive the next wave of business optimization by transforming operational performance, shortening time to market, improving quality and yield, reducing supply chain volatility, and accelerating technology transfers.