430th Edition, November 3, 2020

Over the past nine months, more than $7 billion in federal money has poured into the BioHealth Capital Region in support of therapies, diagnostics, and vaccines against COVID-19. In that short time, the region has shown its importance in halting the spread of the ongoing pandemic.

At the 6th Annual BioHealth Capital Region Forum, COVID-19 was a central focus of attendees and panelists. One panel, Strength of Our Region: Combating Infectious Diseases, included representatives from four companies in the region that provided an overview of the region’s role in combating the novel coronavirus as well as other infectious threats. Company representatives from Novavax, Emergent BioSolutions, BioFactura, and Aperiomics pointed to the work conducted by their organizations in COVID, as well as other infectious diseases, including Ebola, influenza, RSV, and SARS. The panel was moderated by Karen Smith, chief medical officer of Emergent BioSolutions, who said she was struck early on in the pandemic that companies in the BioHealth Capital region battling the pandemic are “all in the same storm, just in slightly different boats.” She said they are all trying to figure out a solution to this pandemic but in different manners due to their areas of expertise.

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The Glocal Innovation Life Sciences Meet-Up is run by the UK/Europe based #coffeebuddies online Thought-Leadership community. This is headed by Prof Tony Sedgwick and Graham Combe, and has an Agile Leaders Advisory Board of 18 life science innovation leaders and investors.

This Meet-Up has been inspired by huge advances in technology that allow us to connect, engage, inspire and entertain life science professionals from around the world. There are no boundaries for our abilities to connect and network with other global Thought-Leaders. We started with connecting our #coffeebuddies community with networks in Australia and NZ which is a phenomenal success. This event is the first in the series where we connect with the East Coast of the Americas.

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MADISON, Wis. and CAMBRIDGE, Mass., Oct. 27, 2020 /PRNewswire/ — Exact Sciences Corp. (Nasdaq: EXAS) and Thrive Earlier Detection Corp. (“Thrive”), a healthcare company dedicated to incorporating earlier cancer detection into routine medical care, today announced they have entered into a definitive agreement under which Exact Sciences will acquire Thrive for cash and stock consideration of up to $2.15 billion. The transaction was unanimously approved by both companies’ Boards of Directors and is anticipated to close during the first quarter of 2021, subject to regulatory approval and the satisfaction of other conditions.

Combining Thrive’s pioneering early-stage screening test, CancerSEEK, with Exact Sciences’ best-in-class scientific platform, clinical organization, and commercial infrastructure will establish Exact Sciences as a leading competitor in blood-based, multi-cancer screening. Thrive, with an early version of CancerSEEK, has conducted a first-of-its-kind 10,000-patient, prospective, interventional study in a real-world clinical setting. In this landmark study, using its mutation and protein biomarker approach, CancerSEEK achieved promising results detecting 10 different types of cancer, including seven with no recommended screening guidelines, with very few false positives. Bringing together highly complementary scientific approaches and the strengths of both organizations, Exact Sciences expects to develop a more accurate test and accelerate the widespread adoption of this potentially life-saving advancement.https://d-1827656436805240469.ampproject.net/2010132225002/frame.htmlAd

Image: https://biobuzz.io

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GAITHERSBURG, Md., Nov. 02, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the expansion of its Maryland campus to accommodate the company’s rapid growth as it works to develop its candidate vaccine against COVID-19 and advance its influenza vaccine for global markets. Novavax has secured two additional properties in Gaithersburg, Maryland to support the Company’s immediate need for additional laboratory and office space for manufacturing, R&D and business operations.

The Company currently has a large pivotal Phase 3 trial underway in the UK with another slated to begin in the United States and Mexico in November, as well as several Phase 2 trials ongoing and in the planning phases around the globe. Novavax has also created a global production network to enable manufacturing and rapid distribution across the U.S., Asia and Europe if and when its COVID-19 vaccine is approved for use. The Company also reported positive Phase 3 data for its influenza vaccine candidate, NanoFlu, earlier this year. Novavax has received $2 billion in funding for its COVID-19 vaccine efforts, including up to $1.6 billion from the U.S. government to help address the global pandemic and up to $388 million from the Coalition for Epidemic Preparedness Innovations (CEPI).

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ROCKVILLE, Md., Oct. 27, 2020 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will receive a milestone payment of $80.0 million from Novartis AG based upon the achievement of $1.0 billion in cumulative net sales of Zolgensma. REGENXBIO expects to recognize this revenue in the third quarter of 2020.

“Zolgensma is a transformative, one-time gene therapy for the treatment of pediatric patients with SMA, a debilitating and potentially deadly disease, and the first approved gene therapy based on REGENXBIO’s NAV Technology. We believe that this achievement provides further validation of the broad potential of NAV Technology to improve the lives of patients in need,” said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. “We are pleased to have contributed to a therapy that has impacted the lives of over 700 patients with SMA and their families around the world.”

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GAITHERSBURG, Md.–(BUSINESS WIRE)–Neuraly, Inc., a clinical stage biotechnology company pioneering disease-modifying agents for neurodegenerative disorders, today announced it has received clearance of an investigational new drug application (IND) to initiate a Phase 2B trial of NLY01 in patients with Alzheimer’s disease. NLY01 is also being evaluated in patients with Parkinson’s disease in a Phase 2 trial initiated in February 2020.

“Initiation of this Phase 2 study in Alzheimer’s disease represents an important milestone in the ongoing advancement of NLY01,” said Seulki Lee, Ph.D., President and Chief Executive Officer of Neuraly. “Alzheimer’s has proven to be a particularly challenging disease to address therapeutically. We believe that targeting neuroinflammation via this novel mechanism of action represents a compelling pathway with the potential to be a disease-modifying agent for both Alzheimer’s and Parkinson’s disease.”

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ROCKVILLE, Md., Nov. 02, 2020 (GLOBE NEWSWIRE) — Rexahn Pharmaceuticals, Inc. (NASDAQ:REXN) (“Rexahn”) announced today that at its special meeting of stockholders held on November 2, 2020, Rexahn’s stockholders approved all of the proposals presented, including: (i) the issuance of shares of Rexahn common stock pursuant to the Agreement and Plan of Merger and Reorganization, dated June 17, 2020, as amended, by and among Rexahn, Razor Merger Sub, Inc. and Ocuphire Pharma, Inc. (“Ocuphire”) and the change of control of Rexahn resulting from the merger; (ii) a reverse stock split of Rexahn common stock, at a ratio of one new share for every 3 to 5 shares outstanding, with such final ratio to be approved by Rexahn’s board of directors; (iii) changing the name of Rexahn from “Rexahn Pharmaceuticals, Inc.” to “Ocuphire Pharma, Inc.”; (iv) the adoption of the Ocuphire Pharma, Inc. 2020 Equity Incentive Plan; and (v) the issuance of shares of Rexahn common stock upon the exercise of warrants to be issued in the pre-merger financing and the issuance of additional shares of Rexahn common stock that may be issued following the closing of the pre-merger financing.

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ROCKVILLE, Md., Oct. 29, 2020 /PRNewswire/ — Emmes today announced that the Montgomery County Chamber of Commerce has selected Emmes as the recipient of its 2020 Corporate Achievement Award. Dr. Anne Lindblad, who recently retired as the company’s president and chief executive officer, accepted the award at a virtual event hosted by the chamber on October 29.

According to Lowell Yoder, chairman of the Montgomery County Chamber of Commerce and M&T Bank’s group vice president for the Greater Washington Market, “Over the years, Emmes has set high standards for financial performance, sound management, and sustained growth – while contributing significantly to our community along the way.”

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Through a partnership with NIH, D.C. virtual reality startup Floreo is expanding from autism spectrum disorder to attention deficit hyperactivity disorder.

Image: Floreo’s platform allows kids to practice skills such as pointing or eye contact, with a linked tablet for parents to follow along. COURTESY FLOREO

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Greater Baltimore is one of few regions ideally suited to pioneer the future of digital health, an industry that will revolutionize healthcare as we know it. Companies in Greater Baltimore benefit from a rich ecosystem of healthcare assets that collectively provide every component necessary for digital health innovation: transformative research, specialized business incubation, access to funding, a talented workforce, and easily-accessible local and federal clients. The growing list of successes among Greater Baltimore’s digital health companies and groundbreaking partnerships showcase tremendous potential for this industry to play a defining role in the Region and influence healthcare throughout the nation for decades to come. The pandemic has accelerated the development of digital health technologies.

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The U.S. Army will spend a combined $599 million to procure two leading COVID-19 candidates—AstraZeneca’s vaccine AZD1222, co-developed with the University of Oxford and a spinout company; and Eli Lilly’s neutralizing antibody bamlanivimab (LY-CoV555).

The U.S. Department of Defense (DoD) disclosed yesterday that the Army this week awarded firm-fixed-price contracts of $312.5 million with Lilly (W911QY-21-C-0016) on Tuesday, and more than $286.9 million with AstraZeneca (W15QKN-21-C-0003) on Wednesday. The contracts, awarded by U.S. Army Contracting Command, cover an unspecified quantity of bamlanivimab to be made at a Lilly production site in Indianapolis; and 200 million doses of AZD1222 to be produced at AstraZeneca sites in West Chester Township, OH, and Albuquerque, NM.

Image: Spc. Selena M. Castillo prepares to administer a flu vaccination on Fort Sill, Okla., Nov. 15, 2019. Spc. Castillo is a medic for 3rd Battalion, 2nd Air Defense Artillery Regiment, 31st Air Defense Artillery Brigade. The U.S. Army will spend a combined $599 million to procure two leading COVID-19 candidates—AstraZenca’s vaccine AZD1222, co-developed with the University of Oxford and a spinout company; and Eli Lilly’s neutralizing antibody bamlanivimab (LY-CoV555). (Photo By: Army Sgt. Amanda Hunt, U.S. Department of Defense)

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Fina Biosolutions has been issued European patent No. 3099800, Expression and Purification of CRM Proteins and Related Proteins, and Protein Domains. The patent covers expression of the conjugate vaccine carrier protein CRM197 in our E. coli strain engineered to have an oxidative cytoplasm. FinaBio markets the E. coli expressed CRM197 under the name EcoCRM®.

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WAKEFIELD, Mass. and FAIRFAX, Va., Oct. 30, 2020 (GLOBE NEWSWIRE) — Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, and George Mason University’s (Mason’s) National Center for Biodefense and Infectious Diseases (NCBID), today jointly announce completion of extensive laboratory testing supporting anti-SARS-CoV-2 activity of Brilacidin, a defensin-mimetic drug candidate, which is being developed as a potential COVID-19 treatment.

Research findings are being submitted for peer-review publication. A preprint, available for download at the link below, is in the process of being posted to bioRxiv.org.

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Sep 05, 2020 (IssueWire via COMTEX) — San Diego, Sep 5, 2020 (Issuewire.com) – Jaan Biotherapeutics (“JBT”), announced that it has been awarded a Small Business Innovation Research (SBIR) grant from the National Heart, Lung, and Blood Institute, part of the National Institutes of Health under Award Number R43HL154884. Under the Phase I grant, JBT intends to advance its lead cardiac muscle regeneration viral delivered drug, JBT-miR2 through preclinical testing in large animals. The first indication of JBT-miR2 is for the treatment of Ischemic Heart Disease (IHD), the single largest cause of death of both men and women in the Western World.

JBT-miR2 is a first in class viral delivered microRNA inhibitor that reprograms cardiac muscle cells to divide within the damaged heart, and repair the heart muscle after permanent heart muscle injury, for example following a heart attack.

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When all the votes are cast and counted in this year’s momentous November 3 election, the results will have deep and potentially long-lasting impacts on numerous areas of society, including science. President Donald Trump and his challenger, former vice president Joe Biden, have presented vastly different visions for handling crucial issues—ranging from the deadly coronavirus pandemic to the damaging impacts of climate change and immigration policies.

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Have you heard of a little thing called Covid-19? So has Big Pharma, and the race to develop a vaccine is on. It’s high-stakes geopolitical chess and every country and company involved badly wants to win, including Anglo-Swedish drugmaker AstraZeneca.

When Oxford’s Jenner Institute partnered with AstraZeneca on its vaccine candidate, ChAdOx1 nCoV-19, analysts scratched their heads. AstraZeneca is not a leader in vaccines, unlike its major UK competitor GlaxoSmithKline. It’s relatively small and has a tumultuous history. But if you look, the signs are there that AstraZeneca is building a blueprint to thrive as a 21st century pharma company.

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Three Emmes employees were among the co-authors of the recent report, “Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults.” The employees are Jim Albert, lead project manager; Dr. Mat Makowski, senior biostatistician; and Kaitlyn Cross, senior biostatistician.

In its role as the statistical and data collection and coordination center, Emmes managed development of the statistical analysis plan and performed all data analysis.

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ANNAPOLIS (WJZ) — A NIH initiative will fund a new Johns Hopkins center to research COVID-19 immunity as the pandemic continues to affect people of all ages.

The five-year grant will fund more than $2 million a year to the new Johns Hopkins Excellence in Pathogen to support the studies, to start immediately, the immune elements that determine whether people get mild or severe coronavirus after being exposed.

Image: https://baltimore.cbslocal.com – From Video

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Leverage the only verified source of angel investment data to anticipate future trends with the Angel Funders Report 2020!

The Angel Funders Report 2020 is the only source of verified data provided directly by active angel investing groups. The report is based on information collected from a variety of ACA member groups, including some of the most active investing communities. It analyzes angel capital investments made during 2019, and features profiles and insights from leading angel investors and startup company executives. The Angel Funders Report 2020 also includes initial perspectives regarding the impact of the COVID-19 pandemic on the investing ecosystem.

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