418th Edition – August 11, 2020

Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your complimentary virtual feedback session with BHI Entrepreneurs-in-Residence and Analysts on one of the following dates: 8/26. (45 minute blocks of time beginning at 9:00 in the morning. Pre-registration is required; sign up www.tinyurl.com/EIRFeedback. For questions/more information, contact BHI

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BioHealth Innovation (BHI) was created in 2012 by Rich Bendis and key industry leaders to accelerate the commercialization of high potential scientist entrepreneurs and companies within the BioHealth Capital Region (BHCR), which consists of Maryland, Virginia and Washington, D.C.

Prior to BHI’s launch, the region’s development efforts were heavily focused on academic and government research assets. BHI’s mission is to give the life science industry a greater voice within the region and to be more market and entrepreneur-driven. During the last 8.5 years, BHI has grown substantially and spearheaded the effort to create a strong regional brand that is now known as the BHCR.

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Reporting to Vice President and Chief Innovation Officer, the senior licensing associate independently manages a docket of technologies and has advanced level skills in technology marketing and licensing. The individual assumes primary responsibility for directly facilitating the technology transfer, development and commercialization of assigned technologies and faculty/departmental clients, assisting faculty and staff with the establishment of new commercialization agreements and business development relationships, supporting the establishment of R&D collaborations with industry partners to advance early stage discoveries, and managing relationships with key stakeholders internal and external the organization to proactively enable technology transfer. The Senior Licensing Associate will provide high quality services including invention receipt and capture, patentability assessment, market outreach (in-depth marketing support strategic and tactical), business development (structuring, drafting and negotiating commercialization agreements) and shall deliver the highest quality of customer service. This position will also manage other functions for the office as assigned in addition to technology licensing.

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The BioHealth Capital Region and BioForward Wisconsin come together as Lisa Johnson joins Rich Bendis on BioTalk to discuss her career, the industry, and growing biohealth in the Midwest. 

Listen now via Google https://bit.ly/2DtF6Y1, Apple, https://apple.co/3fJU0q3, Spotify https://spoti.fi/3fFpb5H, TuneIn https://bit.ly/3iqNAh9, and YouTube Audio https://bit.ly/2PERPcH

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GAITHERSBURG, Md. and OSAKA, Japan, Aug. 07, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK), today announced a partnership for the development, manufacturing and commercialization of NVX‑CoV2373, Novavax’ COVID‑19 vaccine candidate, in Japan. NVX‑CoV2373 is a stable, prefusion protein made using Novavax’ recombinant protein nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant. Takeda will receive funding from the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) to support the technology transfer, establishment of infrastructure and scale-up of manufacturing. Takeda anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year1.

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GAITHERSBURG, Md.–(BUSINESS WIRE)–Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria, today announced Mayo Clinic has committed $1.75M as a lead investor in a $7 million convertible note financing round.

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Download an A to Z business guide that offers federal, state and local resources to help your Montgomery County business succeed. The newly expanded, 14-page MCEDC Business Resource Guide. Find funding, training, talent, support for women and diverse businesses and more—a handy guide to use and share.

Click here to download.

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GAITHERSBURG, Md., Aug. 04, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) (the “Company”) announced today that it intends to offer $400 million aggregate principal amount of senior unsecured notes with an expected maturity date of August 2028 (the “Notes”). The Notes will be fully and unconditionally guaranteed on a senior unsecured basis by all of the Company’s direct and indirect subsidiaries that guarantee debt under its credit facilities. The Company intends to use the net proceeds of the offering to repay the $353 million outstanding under its $600 million revolving credit facility with the remainder to be used for general corporate purposes.

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The study found the candidate elicits “robust antibody responses” and is well-tolerated, the company said Tuesday.

Image: Novavax is advancing a Covid-19 vaccine candidate through clinical trials. COURTESY NOVAVAX

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ROCKVILLE, Md., Aug. 6, 2020 /PRNewswire/ — Emmes today announced that three corporate vice presidents have been promoted. Dr. Traci Clemons has been named chief research officer, Marian Ewell is now chief scientific innovation officer, and Jennifer Hester is the company’s chief human resources officer. These are all newly created positions for the company.

Image: Dr. Traci Clemons

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GAITHERSBURG, Md., July 23, 2020 /PRNewswire/ — Shreis Scalene Therapeutics LLC (SSTx), a MD-USA-based medical device company will fast-track the manufacture and distribution of the CE-marked (EU-Class 1) Scalene Hypercharge Corona Canon (SHYCOCAN) under US FDA ‘Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”

Image: SHYCOCAN Devices

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This invitation-only event is free for executive level biotech leaders and is presented by BioHealth Innovation, Virginia Bio, Children’s National Health System, Johns Hopkins University, JPMorgan, Maryland Department of Commerce, George Mason University, University System of Maryland, Wilson Sonsini Goodrich & Rosati and AstraZeneca.

The BioHealth Capital Region—Maryland, Virginia, and Washington, DC—sets the bar high for biotech innovation. So please join us for our 6th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

For more information about our speakers and event schedule, please visit www.biohealthcapital.com/forum-2020

#BHCRForum20

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With so much attention on COVID-19 treatment and vaccine developments, life science laboratories are getting more notice.

Alexandria Real Estate Equities (NYSE:ARE) is a real estate investment trust (REIT) based in Pasadena, California. It’s the largest landlord in the US for laboratories and related offices.

Its top companies by rent revenues include Amgen (NASDAQ:AMGN), Bristol-Myers Squibb (NYSE:BMY), Celgene, Eli Lilly (NYSE:LLY), Merck (NYSE:MRK)—which we own in Profitable Investing—Moderna (NASDAQ:MRNA), Novartis (NYSE:NVS), Pfizer (NYSE:PFE) and Sanofi (NASDAQ:SNY).

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The University of Maryland School of Medicine and about 30 other U.S. centers have begun recruiting thousands of volunteers living in COVID-19 hot spots to join the nation’s most advanced trial for a vaccine against the disease.

The vaccine was developed by the Massachusetts biotech company Moderna along with the National Institutes of Health. It is among several vaccines to reach a Phase 3 trial globally but was the first one announced under Operation Warp Speed, the federal program to quickly identify, produce and distribute 300 million doses of a COVID-19 vaccine.

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PHILADELPHIA, Aug. 5, 2020 /PRNewswire/ — GSK today launched a national campaign to help increase low rates of vaccination among older adults. The campaign, Brought to You By Vaccines, will educate adults ages 50 and older about the value of vaccines and the urgent need to talk to their healthcare provider or pharmacist about the recommended vaccines they need or may have recently missed.

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The U.S. Department of Defense (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) awarded Johns Hopkins researchers $35 million for clinical trials to test a convalescent blood plasma outpatient treatment to fight COVID-19.

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ROCKVILLE, Md.–(BUSINESS WIRE)– 20/20 GeneSystems, Inc. is proud to announce that in partnership with Linkou Chang Gung Memorial Hospital, the largest hospital in Taiwan, it has won the 2020 Taipei Biotech “Technology Transfer Cooperation Award” Gold Medal Award, the Oscar in the biotechnology industry, for its OneTest an artificial intelligence (AI) powered blood test that can assist in the early detection of many common cancers.

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The two co-founders behind TruGenomix have a vision for helping veterans and others who might be prone to post-traumatic stress disorder (PTSD). A new partnership with Sanford Health will help them work toward this vision.

Charles Cathlin serves as chief executive officer, and Tshaka Cunningham, Ph.D., is chief scientific officer of their small, veteran-owned precision behavioral health company based in Maryland.

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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 reported positive one year data from patients in Cohorts 4 and 5 of the Phase I/IIa trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD). The Company plans to initiate a pivotal program for subretinal delivery of RGX-314 in patients with wet AMD by the end of 2020. In addition, REGENXBIO today announced that a Phase II trial of RGX-314 for the treatment of wet AMD delivered to the suprachoroidal space (AAVIATE) is active and expected to enroll patients in the third quarter of 2020.

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The Covid-19 Pandemic vividly demonstrates the need for rethinking ways to manufacture biological materials and create sustainable medical product supply lines for the United States. New program funding, new regulatory schemes and new community engagement are all solutions as we witness the renaissance of life science manufacturing in the US from Delaware to Alabama to California. Join a discussion of best bio and pharma manufacturing practices, public policies and programs to help the US respond to the Covid-19 Pandemic and create a more resilient manufacturing infrastructure.

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The Frederick Innovative Technology Center business incubator and accelerator, or FITCI, as it is better known, has been a linchpin for the Frederick, Maryland life science ecosystem for more than 15 years. BioHealth Capital Region signature companies like RoosterBio, Inc., BioFactura, Theradaptive, KempBio (now Kemp Proteins), and Bridgepath Scientific all made their start at FITCI.

Image: https://biobuzz.io

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The year 2020 began with great promise and opportunity for the Aug. 6 guest of the weekly web-based program, Virtual Face to Face with Dr. Bruce Jarrell. After tearful goodbyes here at the University of Maryland, Baltimore (UMB), the University System of Maryland (USM) embraced former president Jay A. Perman, MD, as its new chancellor on Jan. 6.

Image: https://www.umaryland.edu

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The Johns Hopkins University on Thursday reversed plans to bring undergraduate students back for in-person classes, housing, or activities, urging them to stay away from Baltimore for the fall semester. Employees, the campus said, should expect to work from home through the end of the year.

Image: COURTESY OF JOHNS HOPKINS U.

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Today the Cystic Fibrosis Foundation announced a collaboration with Longwood Fund, a biotech-focused venture capital firm, to accelerate innovative therapies for cystic fibrosis. Together, Longwood and the CF Foundation are dedicating resources to advance projects with transformative potential and incentivize early stage companies to prioritize CF drug discovery and development. The Foundation has committed $20 million to the collaboration as part of its Path to a Cure.

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Each year, the FNIH recognizes outstanding achievements by a promising young scientist in biomedical research by bestowing the Lurie Prize in Biomedical Sciences, a $100,000 award. The prize is made possible by a generous gift from philanthropist Ann Lurie.

The awardee is selected by a jury of six distinguished biomedical researchers including:

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Telemedicine is having its moment. Over the last few months, millions of people have relied on video or telephone calls to talk to their doctors. But as the pandemic moves across the United States, and eventually recedes in some places, how long will the moment last?

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Pfizer’s disclosure last week that it may reverse plans to in-shore manufacturing facilities and science jobs to the United States is just the tip of the iceberg of the problems we’ll face if President Trump implements his executive order to implement foreign reference pricing to determine drug prices under Medicare.

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Researchers at the Ragon Institute of MGH, MIT and Harvard, and the University of Washington (UW) School of Medicine, have identified five immune response markers that, collectively, were able to distinguish between those COVID-19 patients who convalesced from the infection, and those who didn’t survive the disease. The researchers used a systems serology technique to generate a detailed profile of SARS-Co-2-specific humoral—antibody generating—responses in hospitalized patients, which they validated in a second patient cohort. The findings indicated that individuals who survived COVID-19 infection and those who died exhibited antibody responses that were primarily directed against different SARS-CoV-2 proteins.

Image: NIH

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Johns Hopkins University became the latest school to announce that it will be conducting classes for the upcoming fall semester virtually, one of the many institutions of higher education to forgo in-person learning as the coronavirus pandemic rages.

This follows the spring 2020 semester that was moved online during the onset of the virus.

Image: https://thehill.com

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GAITHERSBURG, Md., Aug. 04, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced Phase 1 data from its Phase 1/2 randomized, observer-blinded, placebo-controlled trial of its COVID‑19 vaccine with and without Matrix‑M™ adjuvant in healthy adults 18-59 years of age. NVX‑CoV2373, the Company’s recombinant COVID-19 vaccine candidate adjuvanted with Matrix-M, was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. The data have been submitted for peer-review to a scientific journal and to an online preprint server at medRxiv.org.

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