353rd Edition – May 14, 2019

Sirnaomics Inc. has taken in yet another $11 million in investments, closing a Series C funding round that totaled $47 million.

The Gaithersburg biopharmaceutical company kicked off the round last year with $25 million in Series C1 financing — one of the biggest venture deals of the year last year in a generous overall haul for Maryland biotech companies. That was followed by an $11 million raise as part of a Series C2 round in January.

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Are you an experienced biohealth industry executive seeking full time or part time employment as a consultant or start-up C suite executive? BioHealth Innovation is establishing a database of experienced industry executives who may be able to share their expertise with early stage/growing companies.  To be considered by companies or technology transfer organizations seeking leaders for their spin-out companies and/or advisors to support their business growth, please complete the following form.

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What do the technologies that led to the success of Kite Pharma, the creation of the pioneering immune-oncology cancer treatment avelumab (BAVENCIOⓇ) and the founding of miRecule, Inc. all have in common?

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Viela Bio spun out of AstraZeneca last year with six autoimmune and inflammation-aimed programs and $250 million. Now, the biotech is reporting positive pivotal data for its lead drug in a rare, autoimmune disease, teeing it up for an FDA filing later this year.

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In the past year Sonavex has landed not one, but two FDA 510(k) clearances for their ultrasound-based medical devices. This first of its kind solution is comprised of two components, EchoMark and EchoSure, that use a customized ultrasound technology to perform real-time blood flow monitoring for postoperative patients.

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The Bio Lab Pilot is a reimbursement grant program created by the Montgomery County Economic Development Corporation (MCEDC) with funding support from the Maryland Department of Commerce.

MCEDC recognizes the financial challenges small BioHealth companies face when securing small wet lab space in the region. Because young BioHealth companies are not always well-suited for conventional financing mechanisms for lab and office fit-out, MCEDC’s year-long pilot project will award grants to small-scale biotech companies that are struggling to fund lab fit-out costs.

The Bio Lab Pilot will focus on growth-stage BioHealth companies that want to lease small wet lab space in Montgomery County that is less than 5,000sf. This project will not fund shared lab space or incubators.

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Four biotechnology companies were looking to raise a combined $303.9 million starting on Thursday as they announced Wednesday the pricings of their initial public offerings.

The companies – NextCure, Milestone Pharmaceuticals, Cortexyme and Axcella Health – all said Wednesday that they would begin trading on the Nasdaq Thursday, with their offerings expected to close Monday. BioPharmCatalyst, a biotech and healthcare investor website, had listed the companies as expected to begin trading Wednesday.

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It’s not often a piece of property with existing research facilities in a perfect location comes on the market.

So when a 12-acre portion of the former Walter Reed Army Medical Center campus in Washington, D.C., became available a few years ago, it was too good an opportunity for Children’s National Health System to pass up. The pediatric research hospital is now in the midst of building a new $190 million pediatric research and innovation campus on the site that is expected to open in 2020.

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MJ Biotech, Inc. (f/k/a Michael James Enterprises, Inc.) (OTC: MJTV) announces that the Company has executed a Letter of Intent to explore a strategic relationship with VideoKall, Inc., a new player in telehealth, pioneering the first unmanned micro-clinics for indoor, mobile, and outdoor locations. Once the relationship is formalized, MJ Biotech will raise funds to pursue areas of common interests with market penetration in underserved locations across the US.

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By: Brian Darmody, CEO, Association of University Research Parks (AURP)

Across the country and around the world, cities, research universities, government labs and other actors are reformulating the way anchor institutions can help lead technology-based economic development as the geography of innovation shifts.

Julie Wagner, Bruce Katz, Tom Osha and others have formed the Global Institute on Innovation Districts (GIID) https://www.giid.org/, which is doing research and policy implementation to advance Innovation Districts around the world. These districts, defined by GIID are “geographic areas where leading-edge anchor institutions and companies cluster and connect with start-ups, business incubators, and accelerators. Compact, transit-accessible, and technically-wired, innovation districts foster open collaboration, grow talent, and offer mixed-used housing, office, and retail.”

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The US FDA approves an extended indication of GSK’s lupus treatment, Benlysta IV, for children five years and older, giving pediatric patients a new therapeutic option. Benlysta (belimumab) from Glaxo-Smith Kline was previously approved in 2011 by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the intravenous administration in adults with systemic lupus erythematosus (SLE) – the recent approval from the FDA extends the indication to children five years and above.

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For Paragon Bioservices, news came quickly earlier this month. On a Thursday in mid-April, Gov. Larry Hogan and other state and county officials joined biotech community supporters at an Anne Arundel County site near BWI Airport that’s increasing capacity for the company’s work with large firms to manufacture new treatments. Specifically, speakers talked about the company’s expertise in gene therapy, which is an area of medicine that involves introducing DNA to fight a genetic disease.

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United Therapeutics and Deka Research and Development have received FDA 510(k) clearance for the co-developed RemUnity system.

The RemUnity system is a subcutaneous delivery system for Remodulin injections. The two companies have co-developed the device that is indicated to treat pulmonary arterial hypertension.

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Two years after Johns Hopkins Technology Ventures opened new office and lab space for its FastForward 1812 incubator on the Johns Hopkins Hospital campus, two companies have moved on to bigger space. LifeSprout, which had been in the incubator for about a year, moved last month to City Garage, where it will have manufacturing capabilities.

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BrainScope announced today the publication of a study conducted by physicians at Washington University Barnes Jewish Medical Center in St. Louis in the peer-reviewed journal The American Journal of Emergency Medicine entitled “Reduction in unnecessary CT scans head-injury in the emergency department using an FDA cleared device.” The study demonstrated that the FDA-cleared BrainScope One medical device reduced the use of unnecessary head CT scans by nearly one-third in a hospital emergency room setting when compared to the use of standard clinical practice.

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Project Onramp today announced they have placed more than 50 students in well-paid internships with top companies for summer 2019 through its first-in-the-nation Project Onramp program. The program will give the students – many of them the first in their families to attend college – hands-on experience and a valuable start towards a career in biotechnology.

“Project Onramp has created a new model for extending opportunities in the thriving biotech industry for high-achieving students who don’t have the personal or family connections that often play a big part in awarding internships,” said David Lucchino, chairman of MassBio and CEO and co-founder of Frequency Therapeutics. “The enthusiastic response from leading life sciences companies in Massachusetts has been overwhelming.”

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Virginia Bio, the premier statewide non-profit trade association representing the life sciences industry in the Commonwealth of Virginia, announced on May 2, 2019, during its innovative, bioscience conference, THRiVE 2019, that three new award winners are getting inducted into the prestigious Outstanding Contribution to Bioscience in Virginia Award Ceremony.

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On April 2, 2019, the U.S. Small Business Administration (SBA) issued a new Policy Directive for the Small Business Innovation Research (SBIR) and the Small Business Technology Transfer (STTR) programs. All provisions in the new Policy Directive apply to both the SBIR and STTR programs unless specifically noted otherwise. The Policy Directive is available here.

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The Biotechnology Innovation Organization (BIO) and the National Institutes of Health (NIH) today announced an agreement to feature Small Business Innovation Research (SBIR)-funded early-stage biomedical companies in an Innovation Zone at the 2019 BIO International Convention. The Innovation Zone companies, focused on drug discovery, diagnostics and other therapeutic platform technologies, will have dedicated exhibit space and participate in BIO’s One-on-One Partnering™ system. Select companies will make 15-minute company presentations in the BIO Business Forum.

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Dr. Horea Rus is an expert in diagnosing and treating patients with multiple sclerosis, and his research laboratory at the University of Maryland is producing new tools for treating the disease that attacks the central nervous system.

On Tuesday, Rus and former postdoc research fellow Cosmin Tegla were issued U.S. Patent 10,280,465 for developing a biomarker, using Sirtuin 1, RGC-32, FasL, and IL-21 proteins, that indicates if a patient with relapsing-remitting MS is in relapse.

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Bahija Jallal, David Berman, Koustubh Ranadel, and now Mohammed Dar lines up as the latest AstraZeneca/MedImmune executive to jump ship into U.K. biotech Immunocore.

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