402nd Edition – April 21, 2020

In these uncertain times, we are proud to have so many BioHealth Capital Region federal, state, local and private sector organizations focused on combatting COVID19. Please use these links to stay abreast of the last news and resources available for your business.

District of Columbia

Maryland

• Governor’s Update – https://governor.maryland.gov/coronavirus/
• General Update – https://coronavirus.maryland.gov/
• Business Resources – https://govstatus.egov.com/md-coronavirus-business

Montgomery County, MD

Virginia

US Small Business Administration

Volunteers

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Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? There are a couple openings remaining for tomorrow (Wednesday) ‘s EIR session. Schedule your feedback session with BHI EIRs by videoconference here by 2 p.m. today, Tuesday and forward your power point deck to BHI at that time. Next month’s session is scheduled for May 27th.

Click here to schedule a time with us and send your slide deck to: bhi(at)biohealthinnovation.org.

Contact Judy Costello for more information.

E:  jcostello(at)BioHealthInnovation.org

P: 301.637.8854P: 301.637.8854

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Direct Relief today announced a donation from AstraZeneca of 3 million surgical masks for US healthcare workers battling Covid-19.

“For the dedicated and courageous healthcare workers across this country treating Covid-19 and non-Covid19 patients, working without an adequate supply of face masks and other protective equipment is like going into battle without body armor,” said Direct Relief CEO Thomas Tighe. “This generous and timely donation from AstraZeneca will make a substantial difference in keeping these vital workers safe and able to continue providing care for us all.”

Image: Pallets of surgical masks, donated by AstraZeneca, are prepared at Direct Relief’s global distribution facility in California for delivery via FedEx to health workers battling Covid-19 across the United States. (Photo: Direct Relief)

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It was a year ago this month that Johnson & Johnson Innovation first unveiled plans to launch a healthcare innovation facility in Washington, D.C., in collaboration with BARDA—also known as the Biomedical Advanced Research and Development Authority, a component of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

BARDA’s mission: the innovation, advanced research and development, acquisition and manufacturing of medical countermeasures—vaccines, drugs, therapeutics, diagnostic tools and non-pharmaceutical products—needed to protect us from chemical, biological, radiological and nuclear (CBRN) health security threats, as well as pandemic influenza and emerging infectious diseases.

Image: Photo courtesy of Children’s National Hospital

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Bethesda’s Aledade Inc. has done it again.

The fast-growing health tech startup, which helps physician practices cut costs and build accountable care organizations, has raked in a whopping $64 million in Series C financing, after kicking of 2019 with $56 million in then-new investments — and all in a moment of general investor restraint.

The funding will enable Aledade to continue expanding its national network of doctor-led ACOs, the company said Monday. It will also support the addition of more value-based contracts with Medicare, Medicaid and commercial health plans. It comes as Aledade sees annual revenue grow 60% and projects it will surpass $150 million within the next year, it said in an email to the WBJ.

Image: Farzad Mostashari is the CEO and founder of Aledade. JOANNE S. LAWTON

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RESI is planning its first ever, dedicated, digital partnering event on April 29-30th with over 200 investors participating! We’re offering a special opportunity to our tech hubs to help your companies continue their business development in these difficult times. If you are able to promote this event among your constituents, we would like to offer them the possibility to register at a 50% discount, good until April 17th. That means the registration for 2 full days of partnering will cost less than $300!

Special 50% Discount Offer for Tech Hub Constituents (2-Day registration only, ends April 17th) Registration price $595 = $297.50

REGISTER HERE Discount Code: RESITH50

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RIVERDALE, Md., April 17, 2020 /PRNewswire/ — 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.

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.

Image: PRNewsfoto/Medcura, Inc.

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QIAGEN N.V. QGEN announces the receipt of the FDA’s approval for its therascreen BRAF V600E RGQ polymerase chain reaction (“PCR”) Kit (therascreen BRAF V600E) as a companion diagnostic to the BRAF inhibitor, BRAFTOVI (encorafenib). The company also announced the subsequent launch of the kit. The FDA approved the use of the PCR kit as a companion diagnostic in combination with cetuximab to treat adult patients, who have metastatic colorectal cancer (“CRC”), with a BRAF V600E mutation after prior therapy. Notably, CRC patients having the mutation will be identified, using an FDA-approved test.

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GERMANTOWN, Md., April 20, 2020 /PRNewswire/ — Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to initiate a Phase I/II trial for Precigen’s PRGN-2009, a first-in-class, off-the-shelf (OTS) investigational immunotherapy utilizing the AdenoVerse™ platform designed to activate the immune system to recognize and target HPV+ solid tumors. HPV+ cancers represent a significant health burden in indications such as head and neck, cervical, vaginal and anal cancer.

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TENANT AMENITIES

• Proximate to Rockville Metro Station and Rockville Town Square, which offers major amenities, including restaurants, retail, lodging, and banking
• Access to Route 28, Route 355, I-270, and Route 200/ICC
• Ample parking
• Direct loading
• Separate metering for utilities
• Emergency generator
• Zoned for Mixed-Use Business (MXB)

Click here for more information.

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GlaxoSmithKline CEO Emma Walmsley on Tuesday told CNBC’s Jim Cramer that her company’s newly announced partnership with industry peer Sanofi is an “unprecedented collaboration” between competitors.

The European pharmaceutical giants are combining their resources to develop a Covid-19 vaccine and aim to produce a batch within the next 20 months.

Image: https://www.cnbc.com

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The world is anxiously awaiting effective treatments for Covid-19, which is ravaging most countries. Fortunately, some of the best minds in our public and private sectors are putting everything they have into developing effective vaccines, drugs, and tests that are so desperately needed. Because of the Bayh-Dole Act, which allows academic institutions and federal laboratories to effectively license their discoveries so they can make the leap from being laboratory concepts into useful products, these partnerships are proceeding at full speed. Unfortunately, some want to undo this model at the very time we need it the most.

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British drug giant AstraZeneca is rushing forward a big clinical trial for its blood cancer drug Calquence because it has shown early promising results in later-stage COVID-19 patients—those in intensive care units and on ventilators. Calquence and top-selling leukemia drug Imbruvica are the latest hopes in getting coronavirus patients off ventilators, where there is a 50% mortality rate.

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The COVID-19 crisis brought a shortage of ventilators that can help people battling the lung condition caused by the disease and led to a dire puzzle that leaders in the government and healthcare system are working to solve: how to acquire enough ventilators so that doctors don’t have to face the choice of refusing the machine to someone who needs it.

Image: The ventilator splitter prototype. (Photo courtesy of Johns Hopkins/Will Kirk)

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SEATTLE, April 14, 2020 /PRNewswire/ — After elevated venture capital (VC) investment in the past few years, deal activity maintained momentum in the first quarter of 2020 amid the impending economic downturn due to the COVID-19 pandemic, which will slow activity through the rest of the year, according to the PitchBook-NVCA Venture Monitor, the authoritative quarterly report on venture capital activity in the entrepreneurial ecosystem jointly produced by PitchBook and the National Venture Capital Association (NVCA), with support from Silicon Valley Bank and Carta.

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Virginia Governor Ralph Northam on Monday issued an order to residents stay at home until June 10, part of expanded efforts to curtail the coronavirus pandemic that continues to spread across the country.

“I want to be clear: Do not go out unless you need to go out. This is very different than wanting to go out,” the Democratic governor said in announcing the order.

Northam noted that “some of our beaches and other recreational areas were literally packed” over the weekend, and warned that, “everyone who is gathering in a crowd is putting themselves and others at risk.”

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ABBOTT PARK, Ill., April 15, 2020 /PRNewswire/ — Abbott (NYSE: ABT) announced today the launch of its third COVID-19 test, a lab-based serology blood test for the detection of the antibody, IgG, that identifies if a person has had the novel coronavirus (COVID-19). Antibody testing is an important next step to tell if someone has been previously infected. It will provide more understanding of the virus, including how long antibodies stay in the body and if they provide immunity. This type of knowledge could help support the development of treatments and vaccines.

This antibody test adds to Abbott’s existing COVID-19 tests that are already being used, including its m2000™ molecular laboratory system and its ID NOW™ molecular point-of-care device.

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The push for convalescent plasma and hyperimmune globulin immunotherapies to use against COVID-19 continues at the federal level, with the U.S. Department of Health and Human Services (HHS) touting collaboration with non-governmental entities to see it done.

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Johns Hopkins University, whose global count of COVID-19 cases and deaths has become one of the most popular sources for information about the disease, has unveiled a new United States map that dives into the pandemic on a county level.

The U.S. map provides information about counties’ health infrastructure, population and policies and cases related to COVID-19, the disease caused by the coronavirus.

Image: Johns Hopkins University’s map tracking the COVID-19 has added county data, including snapshot infographics, like this one of Prince George’s County, for every county in the country. (Johns Hopkins University)

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Current COVID-19 tests detect the presence of the SARS-CoV-2 viral RNA genome in patients’ samples through RT-PCR. They are designed to identify who has the virus in their system, at the time of testing. But, testing in the United States has been inadequate on multiple levels. There are not enough tests, leaving some patients waiting in long lines outside of the hospital and others sleeping overnight in their cars, waiting to be tested. Also, the tests’ levels of sensitivity (identifying those with the disease correctly) and specificity (identifying those without the disease) have been called into question.

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While President Trump continues to promote antimalarial drugs such as hydroxychloroquine sulfate and azithromycin to treat COVID-19—“What do you have to lose?” he exclaimed during the April 4 Coronavirus Task Force Briefing—the global community of drug discovery researchers and biopharmas is developing a much broader menu of therapeutic options.

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“Nobody knew there’d be a pandemic” … “Nobody has ever seen anything like this before” … “Nobody would have ever thought a thing like this could have happened.”

Those were President Trump’s words in March about the COVID-19 pandemic. Trump’s repeated protestations were questioned by, among others, Trump himself, who told the White House press corps on March 17 that, “I felt it was a pandemic long before it was called a pandemic.”

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Summary: Droplets from a cough travel at a speed of 1.2 meters per second at peak velocity. Findings reveal that there is no logical reason to suggest 6 foot of physical distance is substantial at reducing coronavirus transmission.

Source: Western University

A recent Western-led study says two meters might not be far enough away if someone lets an uncovered cough loose in your direction – meaning sneeze and cough etiquette is more than a simple social nicety, but a key to stopping the spread of diseases like COVID-19.

Image: Western Engineering’s cough chamber is a two-metre enclosed cube with an opening and chin rest in the front, which is used as an access point for study participants to cough. Within the cube, a camera and a laser are used to determine the velocity of the expelled droplets from the cough. The image is credited to Frank Neufeld.

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On Thursday morning, the Board of Governors of the Federal Reserve System (Board) released the highly anticipated details of its massive $600 billion Main Street Lending program (Program) to support small and mid-sized businesses with up to 10,000 employees. The Program is particularly welcomed by businesses that are too large to be eligible for loans under for the Paycheck Protection Program (PPP).

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Iceland has 364,000 inhabitants. Currently, roughly 10% of them are aware of whether or not they have COVID-19. This is due to a massive undertaking by Kári Stefánsson, MD, Dr. Med., the co-founder, president, and CEO of deCODE genetics—a population genetics powerhouse that has routinely produced new discoveries in fields such as genomic architecture, cancer genetics, and mental illness. Now, deCODE has combined the most intensive targeted testing and general screening of any population to date for SARS-CoV-2.

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Sanofi and GSK, two of the biggest names in vaccine development, are joining forces on creating a coronavirus vaccine, the companies announced Tuesday.

Sanofi launched the project in February; what’s new is GSK’s contribution of an adjuvant — a substance that is added to a vaccine to enhance people’s immune responses.

Image: JOSEPH N. DISTEFANO

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