403rdEdition – April 28, 2020

FDA Cleared Medical Device Improves Feeding Outcomes of Infants Born Prematurely

Olathe, KS and Rockville, MD, April 28, 2020—Innara Health, developer of the only FDA cleared medical device designed to improve the feeding outcomes of infants born prematurely, is partnering with BioHealth Innovation (BHI) to support the company’s plans for growth through greater market access and the development of NextGen technology.  Innara Health is dedicated to improving feeding outcomes for newborn and infants born prematurely.  “As we continue to expand our domestic footprint, we are very fortunate to call BHI our partner as their infrastructure and access will certainly support Innara in our journey to redesign the NTrainer, enter into adjacent markets, and expand globally” states Innara CEO Chris Mathia.  “We are excited to support Chris and his team as they expand, grow and develop new technology ultimately enabling many more NICU patients to return home to their families sooner and healthier” said BHI CEO Rich Bendis.

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Immunomic Therapeutics, Inc., (“ITI”) a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today the close of a $61.3M financing led by HLB Co., LTD, a global pharmaceutical company focused on developing novel cancer drugs. This represents the second closing in the investment process for the HLB Consortium, ($10M was placed in February 2020), and substantially increases their holding in Immunomic Therapeutics to 47.6% of the common stock. HLB also secured an option to make further investment into the company in the months ahead.

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Gentian AS, a Norwegian company, with its US office at BioHealth Innovation in Rockville, Maryland is seeking collaborators to investigate if two of the biomarkers in their portfolio, cystatin C (FDA510(k) cleared) and plasma calprotectin (US research only), could potentially be useful for detection of the severely affected COVID-19 patients.

High mortality and long hospitalization are consequences of the severe cases with COVID-19 pneumonia. Gentian therefore believes that it is important to identify biomarkers that can aid in early, rapid and effective identification of the severely affected patients.

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BALTIMORE, Md., April 27, 2020 /PRNewswire/ — LifeSprout, a privately-held regenerative medicine company founded with technology licensed from Johns Hopkins University, has closed a $28.5 million Series A financing. The company is using proceeds to support clinical development of novel therapeutic products from its Regenerative Matrix platform.

The financing was led by Redmile Group, LLC, with new institutional investors Nexus Management, LP, Emerald Development Managers, LP, and the Abell Foundation joining the syndicate.

“We are delighted to complement the lead investment from Redmile with a strong cadre of Maryland-based and international investors,” stated Sashank Reddy, MD, PhD, co-founder of LifeSprout. “The early, visionary investments made by the Maryland Stem Cell Research Fund and others made this new financing possible.”

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A Baltimore company will be at the forefront of producing a potential coronavirus vaccine.

Once a COVID-19 vaccine is ready for mass production, the company is going to be making hundreds of millions of them.

“We’ll be providing the drug substance manufacturing which is essentially the vaccine itself,” says Syed Husain, senior vice president of Emergent BioSolutions.

All of that work will happen at Emergent BioSolutions, which is located in front of Johns Hopkins Bayview.

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BALTIMORE–(BUSINESS WIRE)–Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, announced today that the company has received market clearance from the U.S. Food and Drug Administration (FDA) for PGDx elio™ tissue complete, a comprehensive diagnostic kit that can be used by molecular laboratories to perform genomic profiling of cancer in a more efficient, reliable, and accurate manner. By automating the data analysis process, which is incorporated in the cleared product, PGDx is enabling the scalability of precision medicine in healthcare systems across the country.

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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 provided additional long-term data from the ongoing Phase I/IIa trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD).

“I am impressed by the overall outcomes in patients after a one-time administration of RGX-314. I believe that RGX-314 is the leading gene therapy program for a major retinal disease such as wet AMD and could be an important potential one-time treatment option for AMD patients who require frequent and burdensome anti-VEGF injections. Real-world evidence demonstrates that patients lose vision over time with our current standard of care and incur significant treatment burden with frequent clinic visits and injections,” said Allen C. Ho, M.D., Director of Retina Research at Wills Eye Hospital and Mid Atlantic Retina and investigator surgeon in the RGX-314 trial.

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Alexandria LaunchLabs™ in Maryland, will provide fully equipped, affordable laboratory/office space with flexible lease terms, supporting infrastructure, access to amenities, and supporting services and programming through the project’s consortium of world-class partners, including Alexandria Venture Investments, BioHealth Innovation, Montgomery County, and the City of Gaithersburg. This unique, startup environment will accelerate the growth of local early-stage life science companies.

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ANNAPOLIS, MD—After weeks of consulting with leading scientists, business leaders, and public health experts, Governor Larry Hogan today introduced the ‘Maryland Strong: Roadmap to Recovery,’ which provides a safe, effective, and gradual approach to reopening the state as it continues to combat the COVID-19 pandemic.

“As we begin to reopen, it will continue to be important for Marylanders, particularly older and more vulnerable Marylanders, to continue to stay home as much as they can,” said Governor Hogan. “All Marylanders should continue to avoid crowds and gatherings, and they should continue to practice physical distancing and to take precautions to protect themselves, their families, and their fellow Marylanders. Together, we are going to defeat this virus, and together, the State of Maryland will return stronger and better than ever.”

Image: https://governor.maryland.gov

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Maryland Gov. Larry Hogan on Friday announced his three-phase plan to eventually reopen the state amid the coronavirus pandemic.

Hogan called the plan a “well-thought-out, gradual, safe and effective path forward,” supported by four pillars he has spoken about often in recent weeks: increases in testing, personal protective equipment, contact tracing and hospital surge capacity.

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Emergex Vaccines Holding Limited (‘Emergex’), a biotechnology company developing CD8+ priming set-point vaccines to prevent serious infectious diseases, today announced that it has entered into an agreement with the George Mason University, based in Virginia, in the United States.

The agreement specifies that George Mason University’s National Center for Biodefense and Infectious Diseases will provide their unique expertise and resources as a partner in the development of Emergex’s vaccines against highly pathogenic RNA viruses. In particular, George Mason University’s Biosafety 3 capabilities, coupled with their experience in dealing with RNA viruses, means that they are a well-suited collaborator on the vaccine validation studies, as well as the optimization of vaccine design.

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The rapid growth of biopharma is causing a shift to a new paradigm for the drug development and delivery model. In the same manner that the personal computing industry grew and developed business models that fit the way products were sourced, constructed and delivered, a business model for biopharma is taking shape.

Image: https://www.biospace.com

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Johnson & Johnson (NYSE:JNJ) says it will work with Emergent BioSolutions (NYSE:EBS) to produce more than a billion doses of a COVID-19 vaccine candidate, as it seeks to scale up global manufacturing of its potential treatment.

J&J says it is already preparing for clinical vaccine production at its Leiden facility in the Netherlands, with the aim of starting its Phase 1 clinical trial of its vaccine candidate on humans in September and potentially having it ready under an emergency use authorization next year.

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In the coronavirus era, a host of epidemiological terms have entered common public use. There’s the now-ubiquitous “social distancing,” and the newly politicized “flatten the curve.” And as states and local governments seek a way out of lockdowns that have brought their economies to a near-standstill, “contact tracing” has made its way into everyday conversation as well.

Image: Public health nurse Lee Cherie Booth conducts a test for COVID-19 outside of the Salt Lake City Public Health Center on April 10, 2020, accompanied by Salt Lake County infectious disease nurse Travis Langston. When a swab test comes back positive, contact tracing starts. Scott G Winterton—The Deseret News via AP

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When a child gets seriously sick, it’s up to us to fight for the world that they believe in. Johnson & Johnson Innovation is at the forefront of that fight. Helping to build a better future for the next child battling cancer, fighting the flu or facing the need for surgery.

The JLABS @ Washington, DC Children’s QuickFire Challenge invites innovators to submit game changing ideas, technologies, and solutions that have the potential to impact pediatric oncology, pediatric surgery and influenza. The innovator(s) with the best idea(s) will be awarded up to $150,000 in total grant funding; one year of residency at JLABS @ Washington, DC with the use of a bench, workstation, and access to the JLABS @ Washington, DC community; and mentorship from experts at the Johnson & Johnson Family of Companies

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Maryland tech companies started the year bringing in a surge of venture capital funding, and three of the state’s top 10 deals were in Baltimore, according to data from the latest PwC/CB Insights MoneyTree report. But a downturn in the last two weeks as the COVID-19 pandemic-caused slowdown took hold is leaving reason to keep celebrations on lockdown for now.

The $227 million that 21 companies raised from investors was a 44% uptick from the $115 million in the fourth quarter of 2019.

Image: The Huntress team. (Courtesy photo)

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Just over three weeks ago the CARES Act, a massive piece of legislation designed to combat the economic havoc being wrought by the coronavirus pandemic, was enacted.

One significant piece of that legislation is the Paycheck Protection Program (PPP), which allows small businesses to borrow funds from the Small Business Administration and affiliated lenders roughly equivalent to 2.5 months of payroll costs. The use of borrowed funds is restricted to “payroll costs” (employee compensation, group health benefits, retirement benefits, state unemployment taxes), rent, mortgage interest, interest on other loans and utilities.

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Across the country, children’s hospitals are grappling with significant financial impacts due to the COVID-19 crisis. We are dealing with substantial decreases in revenue as well as increased expenses directly tied to addressing this global pandemic. Children’s National Hospital is losing $1 million a day. I had a chance to share our challenges with NBC News Reporter Josh Lederman and to spotlight some potential solutions. #covid19 #pediatrics #finances #federalfunding #healthcare #childrenshospital

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Working as an emergency and critical care physician at the University of Maryland School of Medicine, Dr. Steven Tropello is seeing the lack of protective equipment for medical workers up close.

One particular area is during a procedure in which a tube is inserted into a patient’s airway, called intubation. It’s necessary to place someone on a ventilator, but presents danger of spreading the new coronavirus through the air or touch to doctors if they lack protection.

Image: CareCove. (Courtesy photo)

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Most Americans are still stuck at home, but a trio of reports, out from Harvard, Johns Hopkins, and former US Food and Drug Administration Commissioner Scott Gottlieb, are starting to lay a foundation for what reopening the country might look like, if done safely.

Though staying inside is certainly keeping more infections at bay right now, it’s not without its costs.

Aside from the strain stay-at-home orders are putting on families, friends and communities, the newfound national quiet means the US is “hemorrhaging $100 billion to $350 billion a month,” according to the new Harvard analysis, which was released on Monday.

Image: A worker wears a protective face mask in a factory of roll-forming machine maker Gasparini, in Mirano. Reuters

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Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and member of the White House Coronavirus Task Force, says “we are not in a situation where we can say we are exactly where we want to be with regard to testing” capacity for COVID-19 in the U.S.

Fauci, in a discussion for TIME 100 Talks: Finding Hope on Thursday, says that the U.S. needs to not only increase the number of tests, which is happening as commercial testing companies increase production and the Food and Drug Administration continues to clear tests using different types of samples (including ones from the nose and saliva, as well as blood). But, he says, we also needs to make sure tests can actually be run the way they should.

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Even prior to COVID-19, change was afoot in the venture capital industry. Machine learning and algorithms were emerging as new ways to spot winners, and cities like Boston staked out turf as VC hot spots, proving that not all innovation takes place in Silicon Valley.

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We at Gentian AS believe it is the duty of all companies in the health industry to help combat the ongoing pandemic of COVID-19/Corona virus. High mortality and long hospitalisation are the consequences of the severe cases with COVID-19 pneumonia. Hence, it is important to identify biomarkers that early could aid in rapid and effective identification of the severely affected patients. In the Gentian test portfolio, the two biomarkers, cystatin C and plasma calprotectin, could be useful for the early detection of the severely affected COVID-19 patients. To do our part we are reaching out to research/hospital institutions who want to run a trial to assess whether these biomarkers can make a contribution in the detection of severe COVID-19 cases.

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In a different year, incoming freshmen would already have in hand a tightly choreographed schedule for late summer and early fall: the move-in date, the orientation and, finally, the first day of classes.

But on the coronavirus pandemic calendar, there are no dates yet for the next academic year. Just scenarios. And that unprecedented uncertainty is fueling a second wave of crisis for schools already plunged into financial distress.

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Even as the novel coronavirus has derailed daily life and business operations, the life sciences sector continues to see companies make public debuts and ink both financing and partnership deals.

In venture capital, US deal activity in the first quarter tallied 2,300 financings totaling $34.2 billion, according to the latest report by the National Venture Capital Association, which uses data from PitchBook. That’s roughly on track to match the total raised in the past two years, both record-setters in one way or another. But the likelihood of that pace continuing is slim, according to the report.

Image: Sarah de Crescenzo

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