COLUMBIA, Md., May 4, 2020 (Newswire.com) – Intralytix, Inc. announced today that it has received a multimillion-dollar grant (AI 148054) from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), for the clinical development of its bacteriophage therapy preparation for managing infections caused by the bacterial pathogen Shigella. Dr. Alexander Sulakvelidze, Executive Vice President of Intralytix and the Program Director of the multi-PI grant, commented, “We are very pleased to have this collaborative opportunity with NIAID. The project will address a significant public health issue, as it is expected to help reduce the burden of disease caused by Shigella. It will also help enhance our program on developing bacteriophage-based therapeutic preparations as complementing modalities to other anti-infectives, such as vaccines and antibiotics, for managing bacterial diseases, including those caused by multi-drug resistant bacterial pathogens.” Dr. Sulakvelidze concluded, “This award paves the way for an important clinical study, and also shows that Intralytix continues to demonstrate innovative leadership in successfully developing bacteriophage products for various applications.”

ROCKVILLE, Md.--(BUSINESS WIRE)--20/20 GeneSystems, Inc. announced today that it will offer in its CLIA laboratory a COVID-19 antibody test that received an Emergency Use Authorization (EUA) from the FDA on May 3. According to test manufacturer Roche Diagnostics, the blood test has a specificity greater than 99.8% and sensitivity of 100% (14‑days post-PCR confirmation) and is used to determine if a person has developed antibodies to SARS-CoV-2, the virus that causes COVID-19.

Of all the venture funding flowing into the medtech industry, a lower proportion than ever is being invested in companies at the start-up stage, a new analysis by Evaluate Vantage shows. Less than 5% of venture cash has been put into seed funding and series A rounds so far this year.

This shifting of cash from early into later rounds is a continuation of a trend that has been clear for some time. What is somewhat unexpected, however, is the relative prominence of series D financings in 2020 so far. Granted, this year is hardly typical; perhaps the pressures of the pandemic have pushed investors to mid- as well as late-stage rounds.

WASHINGTON, D.C., May 22, 2020 – Connected DMV’s COVID-19 Strategic Renewal Task Force held its kickoff meeting on Thursday and affirmed their support for regional collaboration to tackle the pandemic with the following statement:

“The COVID-19 health pandemic has reinforced the importance of regional collaboration and cooperation between the District, Maryland and Virginia. It is also a necessity, if we are to secure the long-term stability and vitality of the DMV, solidify our position as a hub of innovation and leadership, and instill confidence in all our residents – on the safest path forward. Together and inclusive of our diverse communities, we need to define how our region can best recover, emerge, and thrive after the most acute conditions of the pandemic have subsided. The Connected DMV Strategic Renewal Task Force is committed to that shared future. Every step we make together as a region will ensure a stronger future for the DMV.”

The phase I trial in healthy adult volunteers began in April. More than 1,000 immunisations have been completed and follow-up is currently ongoing.

The next study will enrol up to 10,260 adults and children and will involve a number of partner institutions across the country.

The phase II part of the study involves expanding the age range of people the vaccine is assessed in, to include a small number of older adults and children:

• Aged 56-69 • Aged over 70 • Aged between 5-12 years

REUTERS: Oxford University and AstraZeneca are recruiting around 10,000 adults and children in Britain for trials of an experimental coronavirus vaccine, a day after receiving US backing worth up to US$1.2 billion.

Institutions across Britain had begun enrolling up to 10,260 adults and children to see how well the human immune system responds to the vaccine and how safe it is, the university said.

GAITHERSBURG, Md., May 25, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX‑CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. NVX‑CoV2373 includes Novavax’ proprietary Matrix‑M™ adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020.

WASHINGTON - (May 21,2020) -- Children's National Hospital is establishing a regional pediatric telehealth consortium in response to coronavirus with $928,000 in funding awarded by the Federal Communications Commission's Wireline Competition Bureau. The funding, which is part of the FCC's COVID-19 Telehealth Program, enables the nationally-ranked pediatric hospital to expand its telehealth platform to support 15 healthcare sites in the D.C.-Maryland-Virginia region serving children and young adults, providing care to children with COVID-19 as well as those who are medically vulnerable and helping to protect healthcare workers as the pandemic threat continues.

ROCKVILLE, Md., May 26, 2020 /PRNewswire/ -- Emmes today announced that its data and statistical analysis work for the Adaptive COVID-19 Treatment Trial (ACTT) played an important role in the accelerated timetable to evaluate remdesivir's effectiveness in treating hospitalized COVID-19 patients. 

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, sponsored the clinical trial, which included 1,063 participants at 60 sites in 10 countries. Emmes has a long history in supporting NIAID's Division of Microbiology and Infectious Diseases and has served as a Statistical and Data Coordinating Center for more than 350 of its clinical trials since 1998.  

AstraZeneca Plc will make as many as 30 million doses of coronavirus vaccine available to the U.K. by September and has committed to delivering 100 million doses this year. The U.K. will be the first country to get access to the vaccine should it be successful.

The vaccine being developed at the University of Oxford will get 65.5 million pounds ($79 million) of funding, U.K. Business Secretary Alok Sharma said today in a statement. The inoculation is already being studied in humans and could reach late-stage trials by the middle of the year. Another 18.5 million pounds will go to Imperial College London as trials accelerate.

ROCKVILLE, MD – May 19, 2020

Creatv MicroTech (Creatv), a cancer screening and diagnostic company with headquarters in Rockville, Maryland, is announcing a collaboration with the University of Miami School of Medicine on a study supported by the National Institutes of Health / National Cancer Institute entitled “MRI Imaging and Biomarkers for Early Detection of Aggressive Prostate Cancer”. Allan Pollack, Sanoj Punnen and Radka Stoyanova are the study’s Principal Investigators.

The study objective is to evaluate and validate the integration of quantitative imaging features with pathologic, molecular and blood markers to better manage prostate cancer diagnosis and treatment selection. Creatv’s biomarker, cancer associated macrophage-like cells (CAMLs) originated within the cancer stroma and can be found along with circulating tumor cells (CTCs).  

Since 2016, CARB-X has been funding and supporting the early development of innovative vaccines, rapid diagnostics, antibiotics and other life-saving therapeutics to address drug-resistant bacteria. Even as we struggle with coronavirus, we must continue the fight against superbugs. www.carb-x.org/60thproject #antibioticresistance #amr #diagnostics #vaccines #antibiotics #microbiome

ROCKVILLE, Md., May 18, 2020 - Emmes today announced that it was ranked as the seventh largest biosciences employer in the greater Washington area. The ranking is compiled annually by the Washington Business Journal.

Emmes reported revenues of $125 million in 2019 and has more than 750 employees globally. More than 675 employees work in Maryland, Virginia and Washington, D.C.

The company is expecting to hire nearly 70 new employees to support new and expanded clinical research projects. This represents an increase of approximately 10 percent of its area-wide workforce. The positions include clinical operations staff, biostatisticians, bioinformatics experts, project control analysts, project managers, data management staff, technical writers, clinical research auditors, and proposal manager. The company has offices in Rockville, MD, Frederick, MD and Tysons Corner, VA. Emmes continues to maintain a robust teleworking environment.

When infectious disease expert Crystal Icenhour began offering COVID-19 testing last month at her Aperiomics commercial laboratory in Sterling, Va., she expected a flood of orders. She could deliver results within 24 hours, compared to backlogged larger labs, and she could process up to 2,500 tests a week.

“We thought we’d be turning work away,” she said. Instead, she runs a few hundred tests a week, “a fraction of our capacity so far.”

Image: Crystal Icenhour, CEO of Aperiomics in Sterling, Va., say they can process about 2500 COVID-19 tests a week. Like many labs in the D.C. region, they are running at a fraction of capacity, despite an urgent need for more widespread testing. Daniella Cheslow / WAMU

University System of Maryland Chancellor Jay Perman said the system's colleges are "planning to resume at least some in-person teaching and learning" in the fall, after the coronavirus forced most campuses nationwide to close down during the spring semester.

Image: Jay Perman is the chancellor of the University System of Maryland. BBJ FILE

Researchers at Cedars-Sinai Medical Center are planning a randomized, controlled trial to evaluate a form of allogeneic cell therapy for COVID-19, after four out of six patients critically ill with the disease recovered well enough following infusions of the cells to be discharged from the hospital. The remaining two patients who received the treatment are also alive, in the hospital.

In 2009, a remarkable partnership started with an unsolicited email and a “cold call.”

Ten years later, Rockville, Maryland’s Sanaria and the Bioko Island Malaria Elimination Project (BIMEP) consortium won the P3 Impact Award from a pool of nearly 2,000 applicants, marking a milestone for a unique and remarkable global health consortium that’s turning the tide in the global fight against malaria.

Image: http://www.biohealthcapital.com

The COVID-19 pandemic has caused— and will continue to cause—much uncertainty in the worldwide financial markets. We expect to see substantial declines in the coming months in the number and aggregate dollar value of venture financings, similar to the declines during the dot-com crash in the early 2000s and during the 2008 financial crisis.

We are living and working through a period in human history when scientific leadership and knowledge are crucial for our nation, our organization and ourselves. It is a time for us to bring to the fore the focus on this most critical of human capabilities. 

As you know, against the backdrop of the profound challenges we face as an industry – and now overlaid by the additional impact of COVID-19 – BIO has conducted a search for a new President and CEO. On behalf of the Executive Committee of the BIO Board of Directors, I am delighted to announce that we have appointed Dr. Michelle McMurry-Heath to lead BIO at this pivotal moment in our organization’s history, effective June 1, 2020. 

Immunomic Therapeutics Incorporated (ITI), located in Rockville, Maryland recently announced it had closed on $61.3M in financing, exceeding its initial fundraising projections by over $11M. The Korean investment group HLB Co., LTD led the financing round, which is just the latest accomplishment for the clinical-stage biotechnology company that launched in 2006.

PITTSBURGH, May 14, 2020 /PRNewswire/ -- Net Health, a premier provider of cloud-based Electronic Health Record (EHR) software for specialized care settings, today announced that it has acquired Tissue Analytics, a pioneering developer of automated mobile wound and skin imaging and predictive analytics solutions. The acquisition of Tissue Analytics expands Net Health's leadership position within the wound care market, and for all customers, will accelerate the delivery of next generation wound care technology solutions, including predictive analytics. Net Health is a portfolio company of The Carlyle Group, Level Equity, and Silversmith Capital Partners. Silversmith invested additional equity to support the acquisition of Tissue Analytics.

WASHINGTON — Michelle McMurry-Heath doesn’t talk about biotech the way her peers do.

Where other executives and experts might bring up “access,” and “reimbursement,” McMurry-Heath talks about fairness and ethics.

Image: Michelle McMurry-Heath has been named the new CEO of BIO.

The Trump administration has chosen their drug and vaccine development czar to head up the R&D side of the Covid-19 attack plan, but it’s not Elias Zerhouni.

While Zerhouni — the ex-NIH and ex-Sanofi vet — figured in the headlines as the lead candidate for that spot, Politico and other news outlets are reporting that the administration will tap ex-GSK exec Moncef Slaoui for that role.

Image: https://www.flickr.com/photos/mdgovpics/31274821010/

The Center for Innovative Technology (CIT) office building complex in Herndon has sold for $47.35 million, Gov. Ralph Northam announced Thursday. 

The Virginia Department of General Services (DGS) sold the property Thursday to affiliates of Chicago-based Origami Capital Partners LLC and Timberline Real Estate Partners in a transaction that closed Thursday. Located at 2214 Rock Hill Road, the 149,000-square foot building sits on 26 acres located approximately 3 miles from Washington Dulles International Airport. The complex housed the CIT, the Northern Virginia Technology Council and private technology firms. 

Image: Former Center for Innovative Technology building in Herndon. Photo courtesy Fairfax County Economic Development Authority. 

The lack of treatment options for COVID-19 patients, potential promise in repurposing drugs, and controversy surrounding the anti-malarial drug hydroxychloroquine have created a storm of questions about the drug’s efficacy that the National Institute of Allergy and Infectious Diseases (NIAID) is ready to answer. To do that, the organization is sponsoring a large randomized, controlled clinical trial to determine whether hydroxychloroquine, given in combination with the antibiotic azithromycin, can prevent hospitalization and death due to COVID-19.

Image: Hydroxychloroquine freebase molecule - https://en.wikipedia.org/wiki/Hydroxychloroquine

The NCI Board of Scientific Advisors has approved concepts for an RFA and an RFP to support research in serological testing.

The plan presented to BSA May 12 is intended to distribute $306 million in new money the institute received “to develop, validate, improve, and implement serological testing and associated technologies” under the Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139).

At North Dakota State this semester, I took a course titled “Economics of Entrepreneurship”. It was a deep dive into economic theory with a focus on entrepreneurship. Throughout the course, it surprised me how often I was able to connect anecdotes from sports to the various theories we were learning about. When it came time to write a research paper for the semester, I was able to take an in-depth look at the relation between economic theory and MLB front offices, especially since Billy Beane. Following a few excerpts from what I wrote, I’ll take a look at the Levine-Falvey administration in this context.

ROCKVILLE, Md., May 15, 2020—Supported by a special appropriation by the Council, the Montgomery County Economic Development Corporation (MCEDC) has awarded 25 local businesses with funds totaling $200,000 for the manufacture of Covid-19-related personal protective equipment (PPE).

Councilmember Hans Riemer initiated the appropriation and partnered with MCEDC to create the Local Production Fund. MCEDC administers the fund and matched the Council’s $100,000 appropriation with $100,000 from their budget.

Image: http://councilmemberriemer.com

TOPLINE Public vaccine company Novavax announced today that it will receive up to $388 million from the Coalition for Epidemic Preparedness (CEPI) to continue development and manufacturing of its COVID-19 vaccine candidate.

Silicon Valley Super Angel Angel Investor, Dr. Faz Bashi, M.D., joins BioTalk from the West Coast to discuss the Venture Capital, partnerships and staying connected in the age of COVID-19

Dr. Faz Bashi, M.D., has a background in Immunology and Virology from UCSF. Faz is an active member of the LSA screening committee for Biotechnology and Pharmaceuticals as well as the Medical Device + Digital Health Screening Committee. He is the Emeritus Board member of the Angel Capital Association (ACA), and Chair of the ACA’s Life Sciences Syndication Group, and Affiliate Partner at Boston Millennia Partners and Lead Venture Investor at Portfolia's FemTech Fund

As a result of the ongoing COVID-19 pandemic and the impact on both government and business operations, under the authority of executive order, the Maryland Department of Commerce (Commerce) has delayed the application process for the FY21 BIITC until mid-August 2020. BIITC provides an income tax credit equal to 50% (more in certain locations) of an eligible investment in a QMBC up to $250,000 for each QMBC per fiscal year. Total credits issued during the fiscal year cannot exceed the budget amount and are, therefore, issued on a first come basis. The credit is refundable if the investor has no Maryland income tax liability. Please stay tuned to the Commerce website for updates regarding the new application system and dates. 

Rockville, Maryland’s Fina Biosolutions recently was awarded an SBIR grant to develop a genetically detoxified tetanus toxin as a carrier protein for conjugate vaccines.  The NIAID funded grant is for $289,000 and will use a mutant toxin engineered by Dr. Joseph Barbieri of the Medical College of Wisconsin.  FinaBio’s Scientific Director, Andrew Lees, noted “We are very appreciative of the help from BHI in securing this grant which will help us to commercialize a new genetically detoxified vaccine carrier protein that complements our existing conjugate vaccine portfolio.” FinaBio has created an E. coli strain with an oxidative intracellular environment that grows to very high densities and can express soluble disulfide bonded proteins. The mutant tetanus toxin will be produced in this E. coli strain and compared as vaccine carrier protein with the chemically detoxified protein.  Fina Bio received assistance from This email address is being protected from spambots. You need JavaScript enabled to view it. in preparing the SBIR grant application through its Federal Funding Assistance program.

Early reports of the COVID-19 pandemic, created an initial widespread impression that children were not severely affected by the virus. This understanding was framed by data from China which showed that less than 1 percent of cases occurred in children younger than 10. However, this consensus is now being challenged by new reports, including one in the New England Journal of Medicine from Wuhan Children's Hospital, which found a pediatric infection rate of more than 12 percent.

About 48 hours after a Seattle woman received the first dose of an experimental vaccine against SARS-CoV-2, scientists in China—not to be outdone—announced that they had regulatory approval to launch an ambitious vaccine trial as well. The Seattle volunteer received a messenger RNA vaccine that Moderna Therapeutics developed to prevent infection with the pandemic virus. The Chinese scientists, representing CanSino Biologics, described their plans to evaluate a recombinant vaccine.

Lauren Gardner, an associate engineering professor at Johns Hopkins University, was sitting in a school coffee shop with two graduate students in January, chatting about their work on measles, Dengue fever and the Zika virus, when conversation turned to an emerging coronavirus in China.