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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).  

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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.

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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

USM to resume some in person learning on campuses this fall chancellor says Washington Business Journal

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

Maryland s Immunomic Therapeutics Exceeds Fundraising Goal Envisions Future IPO BioBuzz

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.

 

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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/

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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. 

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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

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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).

 

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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. 

 

EntrepreneursReport Q1 2020 pdf

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.

This illustration, created at the Centers for Disease Control and Prevention (CDC), reveals ultrastructural morphology exhibited by coronaviruses. A novel coronavirus, named Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China in 2019. The illness caused by this virus has been named coronavirus disease 2019 (COVID-19). (CDC/Alissa Eckert, MS)

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.

 

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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

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Are you working with a technology that may be valuable to the fight against COVID-19? BHI has expanded its federal funding assistance program to provide resources to assist early stage companies seeking funding through the NIH, NSF, DOD, MTEC, and BARDA.  BHI also continues to support SBIR and STTR applications (with a win rate that is twice the national average).

To learn how the BioHealth Innovation team can help you advance your technologies, please contact BHI to schedule a conversation.

 
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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.

 

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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

 

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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.

 

Fina Bio Andrew Lees

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.

 
Breethe

Last week, Abiomed acquired Baltimore-based startup Breethe for its innovative respiratory device. Breethe is a startup out of the University of Maryland, Baltimore (UMB) that was founded by Bartley P. Griffith, MD, the Thomas E. and Alice Marie Hales Distinguished Professor in Transplant Surgery and director of the cardiac and lung transplant programs at the University of Maryland School of Medicine (UMSOM).

Image: https://www.umaryland.edu

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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. 

 
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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?  Sign up by noon 5/22 to schedule your feedback session with BHI Entrepreneurs-in-Residence and analysts on May 27th.  Pre-registration is required; sign up here.  For questions/more information, contact This email address is being protected from spambots. You need JavaScript enabled to view it. .

 
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Intralytix Receives Multimillion-Dollar Clinical Trial Award From NIAID to Manage Shigella Infections in Humans

COLUMBIA, Md., May 4, 2020 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.

Image: https://biobuzz.inloop.com

Venable LLP

Since the enactment of the CARES Act, the Small Business Administration and U.S. Department of the Treasury have continually updated the rules governing the Paycheck Protection Program (PPP) through formal rulemaking and less formal guidance. Join a team of Venable Financial Services and Corporate partners for a discussion around guidance for preparing for an audit (and potential investigation). Our discussion will include best practices for documenting decision making, what we can expect from the SBA going forward, and how best to manage an audit and address any potential investigation.

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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.

 

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I know what you’re thinking…it’s hard enough to raise venture capital for life science/healthcare startups in normal times, but throw a global pandemic and economic meltdown into the mix and even the best-laid plans will certainly go astray! So here are the questions that entrepreneurs would like answers to: Is there an inevitable slowdown in venture financing? How can VC firms conduct due diligence efficiently and thoroughly during a lockdown? Is a videoconference enough to establish a trusting relationship with a CEO and a Board? Does every startup have to take a hit on valuation if they want to get funding? Has the Coronavirus fundamentally changed expectations, time horizons, governance, and risk tolerance? What’s it gonna take to get someone to write a check?

 

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The Association of University Research Parks (AURP), a global nonprofit membership organization serving the university and institutional research parks community, today announced its BIO Health Caucus will take place June 3-4, 2020 in a digital environment. AURP’s BIO Health Caucus represents anchor life science institutions building communities of health innovations in the U.S and around the world.

AURP’s 2020 BIO Health Caucus explores trends in life science research, opportunity zone funding, the marriage of life science and philanthropy, and finding funding for projects and facilities during a global pandemic. At this digital event, attendees will discover the role that biomedical clusters play in innovation ecosystems and translating discoveries from lab to market.

Image: Joel Marcus

UM Ventures Backed Startup Breethe Acquired by Abiomed to Bring Better Solutions to Patients Suffering from Lung Failure UM Ventures

BALTIMORE, May 7, 2020 /PRNewswire/ -- Pumas-AI, a University of Maryland, Baltimore (UMB) startup company, has been granted worldwide, exclusive rights to Lyv, a cutting-edge clinical decision support system designed to help health care professionals personalize treatment trajectories for patients in real-time.

The Lyv platform leverages clinical research and Electronic Health Record (EHR) data from millions of patients to derive algorithms that can personalize health care delivery. Lyv will have modules for anti-infectives, anti-epileptics, anti-coagulants, and anti-cancer that can be used in a hospital setting, and can also incorporate algorithms during new drug development. By personalizing treatment, Lyv can help improve therapeutic success rates and minimize dosing errors.

 

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ROCKVILLE, Md.--(BUSINESS WIRE)--May 5, 2020--

Immunomic Therapeutics, Inc., (“ITI”) a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today the appointment of five new members to its Board of Directors from HLB, Co. Ltd (“HLB”) and its HLB Bio subsidiaries.

“I am delighted to welcome the new members from HLB to our board as they bring exceptional scientific, operational and commercial expertise to the group,” said Dr. William Hearl, CEO of Immunomic Therapeutics. “As we advance our UNITE platform and our efforts in immune-oncology, their expertise and successful track record in bringing novel oncology drugs to market will be invaluable to our team.”

 

Emergent Kramer

Emergent Biosolutions CEO Robert Kramer told CNBC Monday it is uncertain that a coronavirus vaccine can be available by the end of the year to fulfill President Donald Trump’s wishes.

The specialty biopharmaceutical company is collaborating with drug giant Johnson & Johnson on a Covid-19 vaccine candidate, which Johnson & Johnson hopes will receive emergency use authorization in 2021.

 

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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.

 

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When VAST Data hit the hallmark of this era’s Silicon Valley start-up boom last month, a $1 billion so-called unicorn valuation, it didn’t come through a perfect pitch delivered in a venture capital firm’s conference room. Face-to-face interactions typically considered crucial to VC transactions have moved online as Covid-19 spreads, but for VAST the virtual meetings weren’t deal breakers.

Image: A man cleans up on the trading floor, following traders testing positive for Coronavirus disease (COVID-19), at the New York Stock Exchange (NYSE) in New York, U.S., March 19, 2020. Lucas Jackson | Reuters

Social Media

Social media is no longer just a numbers game for pharma companies. Counting followers, tallying likes or tracking shares was a good start, but numbers alone can’t tell if business goals are met.

That’s especially true in the current era of paid promotions, where numbers can be artificially inflated. Pharma companies today need to figure out how social media helps them reach the right influencers and key opinion leaders, drive traffic to websites or change perceptions of the products or company.

 

Rich Bendis

Today we hear phrases such as “In these difficult times” to highlight the challenges of the world with COVID-19 which is on all of our minds. Many industries have been adjusting via telecommuting employees if possible, while others cut back hours, furlough staff, or letting employees go. In the biotech industry and, more specifically, the BioHealth Capital Region (BHCR), we have seen a call to action and new collaborations by local key players in our shared mission to find a test, vaccine, and treatment for COVID-19. Before the current healthcare crisis, the BHCR had become the 4th largest biopharma hub in the United States as ranked by Genetic Engineering News in their annual study. We have over 1,000 biohealth companies in the such as AstraZeneca, Emergent, GSK, Qiagen, Novavax, and others, many of which are making valuable contributions during this COVID-19 pandemic as well as what they do in their everyday operations. The region is also the home of National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) and their Director, Dr. Anthony S. Fauci, who has become a Trusted National Treasure. NIH also has 6,000 scientist and 16,000 overall workers in Bethesda, Md. Which makes it the largest basic research institution in the world. We are also home to the U.S. Food and Drug Administration (FDA) which has accelerated approvals in this time of crisis. We also have leading educational and healthcare institutions like the University System of Maryland, John’s Hopkins, George Mason, and Children’s National Health System and many more.

The May 4th edition of the Washington Post features an article titled “Maryland plays an outsized role in worldwide hunt for a coronavirus vaccine” by senior regional correspondent covering government and politics, Robert McCartney. This article highlights the efforts over half-a-dozen companies in the region focused on different aspects of the COVID-19 crisis and how some have begun working together to find solutions faster.

The BioHealth Innovation Team, along with the BioHealth Capital Region Community, are proud of the hard work and research taking place and find that in the face of adversity, the BHCR is coming together and is forgetting about how artificial boundaries like State and County lines, Bridges and Rivers have prevented collaboration in the past.

 We will all get through this together. 

  • Rich Bendis, President and CEO