Combatting Infectious Diseases Welcome

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.

 

rich bendis headshot

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.

 

Cancer is Curable Know Earlier Take Action Together Thrive Detect

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

Novavax Logo

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."

 

Neuraly Logo

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.”

 

Rexan Pharmaceuticals

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.

 

Emmes Logo

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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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.

Spc. Selena M. Castillo

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)

Andrew Lees, Ph.D.

Scientific Director at Fina BioSolutions LLC and Owner, Fina BioSolutions LLC

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®.

 

Desktop with laptop and graphic charts.

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.

 

JAAN BIOTHERAPEUTICS LLC My WordPress Blog

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.

 

Hands With Vote Pins Free Stock Photo

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.

 

AstraZeneca Logo

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.

 

Emmes Logo

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. 

 

New Johns Hopkins Center Will Research COVID 19 Immunity CBS Baltimore

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

Angel Funders Report Cover Images

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.

crabtrap with the brainscope logo

– Winning company has FDA cleared device to rapidly and objectively assess brain injury at point of care.

ROCKVILLE, MARYLAND, October 26, 2020 – BrainScope, a medical neurotechnology company that is a pioneer in the use of A.I. and machine learning in the creation of biomarkers of brain injuries and disease was selected from five finalists as the company with the most commercial potential at the 5th Annual BioHealth Capital Region Crab Trap Competition. The Bethesda, Maryland based company is helping hospital Emergency Departments (EDs) objectively triage the almost five million patients that present each year with suspected mild traumatic brain injuries. BrainScope’s FDA-cleared decision support tool provides a rapid and accurate assessment of the likelihood of a brain bleed and a concussion, at the point of care.

BrainScope’s outstanding 99% sensitivity to a head CT scan is performed without the use of radiation, in a fraction of the time, and can improve ED efficiency and increase patient satisfaction. Clinical studies have demonstrated that when BrainScope is used in triage, hospitals can reduce the number of patients being sent for head CT by about a third. According to BrainScope CEO Susan Hertzberg, “We are honored to have been chosen from this exceptional group of companies and are very excited by the early reception we are receiving from the emergency medical community.  Now more than ever in this COVID-19 world, emergency departments need to have fast, accurate, objective tools to rapidly assess patient status and needed care.”

sirnaomics logo

After posting positive results from a midstage test for its RNAi candidate back in the spring, Sirnaomics has grabbed a $105 million series D round.

The cash boost, co-led by existing investor Rotating Boulder Fund, new investor Walvax Biotechnology Co. Ltd. and Sunshine Riverhead Capital, will go toward the biotech seeking to push deeper into the clinic and one day follow rival and RNA pioneer Alnylam to regulatory approval.

The $105 million will be put toward that R&D process for its RNAi therapeutics, which are on tap to treat a diverse range of diseases including cancers, fibrosis diseases, metabolic diseases and viral infections.

 

TrueGenomix - Charles Cathlin

What happens when you fund Black Founders? With $100K funding & support from Google for Startups Black Founders Fund, TruGenomix plans to further advance its efforts to bring earlier diagnosis & treatment for behavioral health disorders like PTSD to military, veterans, first responders, healthcare workers & trauma-exposed communities at large. This is why the initiative matters: https://goo.gle/2SqjS10

 

Autonomous Therapeutics Inc

Rockville, Md.—Autonomous Therapeutics, Inc. (ATI), a rapidly growing antivirals company, has chosen Montgomery County’s Rockville, Maryland, for its new headquarters. ATI chose to relocate from New York City to take advantage of Rockville’s proximity to leading U.S. researchers, regulators, and funders. Their new 17,700 SF home at 1530 E. Jefferson Street is also in an Opportunity Zone, which offers an advantage for the company in attracting future investment.  

ATI is developing a suite of first-in-class “Therapeutic Interfering Particles” (TIPs) to prevent respiratory pandemics, including influenza and COVID-19. The company’s lead candidates include therapeutics that are designed to prevent infections by any coronavirus strain—from COVID-19 to the next pandemic. ATI has raised millions of dollars in capital from public and private partners to transition its antiviral candidates into first-in-human clinical trials.

 

AstraZeneca Logo

MARSEILLE, France, Oct. 23, 2020 (GLOBE NEWSWIRE) -- Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that AstraZeneca (LSE/STO/Nasdaq: AZN) has dosed the first patient in its Phase 3 clinical trial, INTERLINK-1, evaluating monalizumab in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors (“IO-pretreated”). Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

Dosing of the first patient in this trial has triggered a $50 million milestone payment from AstraZeneca to Innate.

 

BARDA Industry Day 2019

What is BARDA Industry Day?

BARDA Industry Day is the annual meeting held to increase potential partner’s awareness of U.S. Government medical countermeasure priorities, interact with BARDA and ASPR staff, and network with public and private sector colleagues working in the Health Security space. This year,  BARDA Industry Day 2020 will be virtual and will feature one day of exciting speakers, breakout sessions, and valuable networking opportunities!

 

Vaccitech's headquarters in Oxford, England (Jun via Flickr/CC-by-SA 2.0)

The biotech behind AstraZeneca and the University of Oxford’s late-stage pandemic vaccine has hired Margaret (Meg) Marshall, M.D., as its new chief medical officer.

Marshall joined as a consultant to Oxford spinout Vaccitech in the summer, but she now jumps on board full time. This comes two months after it nabbed U.K. government funding for a COVID-19 vaccine it thinks can improve on first-generation prospects, including the AstraZeneca vaccine it helped develop.

Image: Vaccitech's headquarters in Oxford, England (Jun via Flickr/CC-by-SA 2.0)

The Innovation Impact of U S Universities Bush Center

America’s long-term economic growth demands a stepped-up commitment to promoting the innovation impact of the nation’s top-tier universities and other research institutions.

For research institutions themselves, this commitment means prioritizing research, empowering great researchers, building efficient and outcomes-focused technology transfer operations, instilling cultures of innovation and entrepreneurship, and engaging with surrounding business and innovation communities. For America as a whole, it means funding more research resources and paying more attention to the worldwide competition for human talent, including high-skilled immigrants.

 

darmody.brian 2019 headshot

By Brian Darmody 

Seventy-five years ago, Vannevar Bush, an electrical engineer who directed government research during the Second World War, authored Science—The Endless Frontier. His report called for a centralized approach to government research, which led to the creation of the National Science Foundation in 1950 and is credited as a path breaking roadmap for US science policy.  

Over the next 75 years, the federal government invested billions of dollars of research, creating the world’s leading research universities, while places like Stanford University and state of North Carolina launched research parks; tech transfer programs stimulated by the Bayh-Dole Act flourished; and reforms in SEC regulations created the venture capital sector. 

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Global Startup Ecosystem Report GSER 2020 pdf

A few months ago, we all woke up to a new reality as COVID-19 changed everything. Personally, I shut down one of my startups while one of my portfolio’s startups boomed and a close friend — who had closed a large Series B in January — fired a third of her employees.

Then I saw community members rise to the occasion, taking action to help others, and governments acting faster than ever to enact bold and effective policy. Clearly, we are the ones we’ve been waiting for. It’s in our hands as a global community to shape how this will play out.

Cover Page from the Report

In this issue, we discuss how real-world evidence can be an important component of satisfying drug approval and post-approval study requirements and also, can provide other tangible advantages to drug sponsors. We also look at COVID-19’s impact on Medicare telehealth. Other articles include: the next installment in the series of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for entrepreneurs; the Bayh-Dole Act turns 40; and the lack of public guidance available regarding COVID-19 related apps.

 

Alexandria® Building the Future of Life Science™

Real estate investment trusts (REITs) have done an excellent job creating outsized wealth for their investors over the years. From 1972 through the end of last year, REITs generated an average annual total return of 13.3%, which outperformed the S&P 500's 12.1% total return. Those higher long-term returns mean REITs have turned small initial investments into big-time paydays at a faster pace than the S&P 500.