BHI Weekly News Archives

Catalyze and BioHealth Innovation announce transatlantic partnership.

Amsterdam and Rockville, Maryland — Catalyze and BioHealth Innovation, Inc. have entered an agreement to actively bridge the Life Sciences communities in the US and the EU. This transatlantic partnership will increase opportunities for translating biohealth discoveries to market through grant writing services, expanded technology commercialization and international soft-landing support. The two parties have a wide range of resources and knowledge which combined will better aid in delivering high-impact, customer-specific solutions.

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Dr. Andrew Lees, founder and Chief Scientific Officer of Fina Biosolutions, holds over 25 patents and is the author or co-author of more than 70 peer-reviewed papers. He holds a B.S. in Chemistry from Harvey Mudd College and a Ph.D. in Biophysics from The Johns Hopkins University. GlaxoSmithKline, the Serum Institute of India, the Chengdu Institute of Biological Products, and others all use conjugation chemistry (CDAP) developed by Dr. Lees in their S. pneumonia and meningococcal conjugate vaccines. He received the Johns Hopkins University Distinguished Alumni Award in 2019 for his efforts in making conjugate vaccines affordable for low-income countries.

Dr. Lees is also an associate professor at the University of Maryland School of Medicine’s Center for Vaccine Development, an affiliate at the University of Maryland Bioprocessing Scale-Up Facility, and an adjunct professor in the Department of Medicine at the Uniformed Services University. He teaches protein chromatography through the post-graduate level and is a frequent speaker on conjugation chemistry and biotech entrepreneurship. 

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A newly formed Baltimore company has raised $110 million to commercialize a cancer-detecting blood test, developed by Johns Hopkins researchers, that doctors would give patients during routine physicals.

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Emergent BioSolutions Inc. (NYSE: EBS) today announced a contract award by the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) valued at approximately $535 million over 10 years for the continued supply of Vaccinia Immune Globulin Intravenous (VIGIV) into the U.S. Strategic National Stockpile (SNS) in support of smallpox preparedness.

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It’s the local company’s first step toward establishing an international presence after it was spun out last year from MedImmune.

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Regenxbio (RGNX) announced that a gene therapy developed based on its technology was approved by the FDA. This gene therapy product is known as Zolgensma, which Novartis (NVS) now owns after acquiring AveXis for $8.7 billion back in 2018. While Novartis does own Zolgensma, it will have to pay royalties to Regenxbio on net sales for it. That means Regenxbio can start earning revenue for one of its very first products. The company is in good shape because it has many other gene therapy programs in its pipeline. The most notable one would be RGX-314, which is being developed to treat patients with wet age-related macular degeneration.

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QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the immediate launch of its therascreen® PIK3CA RGQ PCR Kit (therascreen PIK3CA Kit) after it received U.S. regulatory approval as a companion diagnostic to aid in identifying breast cancer patients eligible for treatment with PIQRAY (alpelisib), a newly approved therapy developed and marketed by Novartis.

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A Baltimore-based regenerative medicine firm called LifeSprout, which makes synthetic products used to restore soft tissue, has secured $6.5 million in financing.

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MCEDC discovers how Jeff is using the availability of raw talent and novel technology unique to Montgomery County, MD to help cure HIV and cancers with gene and cell therapy research.

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Today, the Biotechnology Innovation Organization (BIO) released the 2019 Emerging Therapeutic Company Trend Report, highlighting ten years (2009-2018) of biotechnology funding and deal making across five areas: venture capital, Initial Public Offerings (IPOs), follow-on public offerings, licensing, and acquisitions. The report also contains a 2019 snapshot of the industry’s clinical pipeline to highlight the significant contribution of emerging companies.

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The BIO International Convention is being held in Philadelphia from June 3-6, with more than 16,000 attendees expected from around the world. The convention draws a list of who’s who in drug discovery, biomanufacturing, genomics, biofuels, nanotechnology and cell therapy, with more than 7,000 companies and 47,000 partnering meetings.

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June 12, 2019!

Register now for the 3rd annual Technology Showcase! The 2019 Technology Showcase will again highlight technologies being developed at the NCI and Frederick National Laboratory for Cancer Research (FNLCR) to encourage technology licensing and collaborations, startup company formation and the translation of NCI discoveries into solutions to benefit patients.

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Funding and Research Opportunities

The following funding opportunity announcements from the NHLBI or other components of the National Institutes of Health, might be of interest:

Notices

Notice of Intent to Publish a Funding Opportunity Announcement for Maximizing the Scientific Value of Existing Biospecimen Collections: Scientific Opportunities for Exploratory Research (R21 Clinical Trial Not Allowed)

(NOT-OD-19-100)National Heart, Lung, and Blood Institute

Notice of Intent to Publish a Funding Opportunity Announcement for Secondary Analyses of Existing Datasets of Tobacco Use and Health (R21 Clinical Trial Not Allowed)

(NOT-OD-19-104)National Heart, Lung, and Blood Institute

Notice of Correction to Award Budget for RFA-HL-19-024 “Short-Term Research Education Program to Increase Diversity in Health-Related Research (R25 Clinical Trial Not Allowed)”

(NOT-HL-19-698) National Heart, Lung, and Blood Institute

Notice of Change to Key Dates in RFA-RM-19-005 ” NIH Directors Pioneer Award Program (DP1 Clinical Trial Optional)”

(NOT-RM-19-007) Office of Strategic Coordination (Common Fund)

Program Announcements

Lasker Clinical Research Scholars Program (Si2/R00 Clinical Trial Optional)

(PAR-19-262) National Heart, Lung, and Blood Institute

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Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical stage biopharmaceutical company developing innovative therapies to improve patient outcomes in cancers that are difficult to treat, today announced that it will voluntarily transfer its stock exchange listing to the Nasdaq Capital Market from its current listing on NYSE American.

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For aspiring entrepreneurs, the thought of building a company from scratch can be daunting. What if no one wants to buy what you’re selling? Where will the money come from to grow the business? And what will happen if you fail?

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A newborn. A fatal diagnosis. And soon, a one-time gene replacement cure in the first weeks of life.

The cost? You don’t want to know.

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The great American political divide shows no sign of ending as the United States lurches toward the 2020 presidential election. However, one of the few areas where the parties have joined together in recent years has been where NIH funding is concerned.

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Crystal R Icenhour, PhD, is one of the rising stars of American biotechnology. After more than 25 years in medical research and biotech, she was named founding CEO of Aperiomics, a company that harnesses the power of next-generation sequencing to identify any known pathogen (bacteria, virus, fungi or parasite) in a single test. Aperiomics is the only company of its kind and scope in the world. Throughout Dr.Icenhour’s career, she has demonstrated strong leadership in business and science and has dedicated herself to “bridging the translational gap between these two worlds.”

Dr. Icenhour is an expert in infectious disease diagnostics and her mission is to change the entire thinking about pathogen diagnosis. Up to 75% of infections are never accurately diagnosed, leaving millions of people suffering from chronic infection. Aperiomics, under her leadership, has developed a technology that identifies all known pathogens – every bacteria, parasite, virus, and fungus – from clinical samples in one test.

Dr. Icenhour holds two patents, has authored and co-authored numerous research articles and theses, and has been a prolific speaker and presenter at scientific conferences.  She has served on review panels for National Science Foundation and Environmental Protection Agency and National Institutes of Health Small Business Innovation Research (SBIR) grants.  She is also an adjunct assistant professor at Duke University Medical Center’s Division of Infectious Diseases in their Department of Medicine.

Before Aperiomics, Dr. Icenhour was president and chief science officer for Phthisis Diagnostics in Charlottesville, VA, a research and development company focused on development of easy-to-use molecular diagnostics for intestinal parasites. While a postdoctoral fellow at the Mayo Clinic College of Medicine, she was the first to identify and characterize Pneumocystis melanins.

Dr. Icenhour serves as Chairman of VirginiaBIO and was chosen to participate in the SpringBoard Enterprises 2016 class of women-led companies.  She is a member of, Sigma Xi, Medical Mycology Society of the Americas, Association for Molecular Pathology, and the American Society for Microbiology. The Kauffman Foundation and Center recognized her as 2012 Entrepreneur of the Year.

Dr. Icenhour received her PhD in Pathobiology and Molecular Medicine from the University of Cincinnati Medical School of Graduate Studies in 2002.  She conducted postdoctoral research in the Thoracic Diseases Research Unit at the Mayo Clinic College of Medicine from 2002-2005 and in the Department of Infectious Diseases at Duke University Medical Center from 2005-2006.  She has been involved in local and national postdoctoral associations including the Mayo Research Fellows Association Executive Committee (president), the Duke University Postdoctoral Association (chair of membership committee), and the National Postdoctoral Association (2008 chair).

Listen now on Google Play bit.ly/2CzdnA9, iTunes, apple.co/2Arsfze, TuneIn bit.ly/2M60Wmx.

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Meet Up with AURP at BIO in Philadelphia forAURP’s BIO Health Caucus#AURPBHC2019
June 2 – 3, 2019

At AURP’s BIO Health Caucus, we will explore trends in life science research, opportunity zone funding resources, the marriage of life science and philanthropy in global partnership opportunities. Discover the unique roles that biomedical innovation cluster and research parks play in innovation ecosystems around the globe. Translating discoveries from the lab to the market has never been more important. Connect with AURP at booth #3955 or One-on-One Partnering! 

Register Now!

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Maryland Commerce is leading a delegation of 20 biohealth and life sciences companies, educational institutions, federal agencies, and city and county economic development offices to the 2019 BIO International Convention in Philadelphia next month. 

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There are few, if any, more innovative, more daring, and more iconic health care executives. We’ll hear about the process that drives groundbreaking invention, and her dream of permanently alleviating the shortage of transplantable organs.Martine Rothblatt, founder and CEO of United Therapeutics presents her organization’s latest innovation, followed by a conversation with “Fast Money” Host and “Power Lunch” co-anchor, Melissa Lee.

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NAVAN, Inc. (NAVAN), a privately-held biotechnology company enabling the development of next generation cell and gene therapies through its novel, non-viral NanoStraw platform, announced today the appointment Heidi Hagen, Co-founder and Chief Strategy Officer for Vineti, Inc., and Howard Grimes, Ph.D., Associate Vice President and Associate Vice Provost for Institutional Initiatives at The University of Texas at San Antonio, to its Strategic Advisory Board.

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If you need great photographer for your event, contact UZI Photography who covered the 5th Annual BioHeallth Capital Region Forum

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The BioHealth Capital Region (BHCR) continues to grow rapidly with new startups and a greater number of clinical and commercial stage companies. The region expects to add approximately 2,000 life science-related jobs in the near term with more on the way. Whether it’s Kite Pharma building a new manufacturing site in Frederick County, MD, the growth of cell and gene therapy companies such as Autolus, Inc., REGENEXBIO, and RoosterBIO, Inc. or recent acquisitions of companies like Paragon BioServices, Inc., it’s evident that the BHCR is thriving.

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The Maryland Tech Council (MTC), Maryland’s largest technology trade association, announced the winners of its 31st Annual Industry Awards during a celebration and ceremony at the Bethesda North Marriott Hotel & Conference Center attended by more than 630 business leaders from around the state.

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Scott Gottlieb, who resigned as head of the FDA in March, has rejoined NEA as a special partner focused on healthcare investments. Gottlieb was a venture partner with the firm for 10 years before leading the FDA. Founded in 1977, the Maryland-based firm’s portfolio includes Opendoor and Desktop Metal.

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This is the first raise for the business, which has been profitable and fueled growth organically up to this point.

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Navitas Life Sciences, a TAKE Solutions Enterprise today announced the acquisition of US based niche full service CRO and health research company, KAI Research Inc.

KAI Research brings on board top of class offerings in 3 key areas – Clinical Trial Management, Clinical Research Consultation, and Data Management & Standardization. Through this acquisition, Navitas Life Sciences expands Phase II and Phase III capabilities in North America adding to its current capabilities in Europe and APAC. KAI strengthens Navitas’ therapeutic expertise in mental health, musculoskeletal diseases, neurological disorders, pain, diabetes, infectious diseases and oncology for Pharma and medical devices. The company has differentiated offerings in the areas of patient registries and e-clinical solutions as well as long-standing relationships with clinical sites and trusted network of service providers across the United States and Africa.

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By the end of this year, the biotech expects to have 270 employees in Baltimore’s Camden-Carroll neighborhood.

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A group of high school girls who wanted to create a local community for other young ladies interested in STEM subjects (science, technology, engineering and math) did so by organizing an all-girls math competition. Things turned out better than they expected at the inaugural InteGIRLS math competition on May 18 at Montgomery College in Rockville, Maryland.

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Data released May 9 by the Alliance for Regenerative Medicine (ARM) illustrates the growth of clinical activity where gene therapy is concerned.

ARM’s Quarterly Regenerative Medicine Global Data Report for the first quarter of 2019 showed 372 gene therapy clinical trials were in progress as of the end of Q1. Interestingly, a majority (217 or 58%) were studies in Phase II, followed by Phase I (123 or 33%), and Phase III (32 or 9%).

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With expansion, Protenus recently moved to new offices in Fells Point.

The healthcare analytics company moved into a 12,000-square-foot office space that’s roughly triple the size of its previous location, according to People Operations Associate Samantha Barber, who gave us a recent tour.

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QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that QuantiFERON ® -TB Access, a new solution under development for diagnosis of latent tuberculosis (TB) infection in low-resource regions with a high disease burden of tuberculosis, will be recognized by the Joint United Nations Programme on HIV/AIDS (UNAIDS) at the organization’s Health Innovation Exchange from May 21-23 in Geneva, Switzerland. The event will be held during the World Health Assembly and brings together ministers of health, nonprofits and industry to spotlight innovations with potential to change the world’s health landscape and benefit sustainable development.

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Wed, Jun 12, 2019 at 11:30 AM

The 3rd Annual NCI and FNLCR Technology Showcase will showcase technologies being developed at the National Cancer Institute (NCI) in Bethesda and Frederick, and Frederick National Laboratory for Cancer Research (FNLCR) to encourage startup formation, technology licensing, and collaborations. It will introduce the local scientific community to the regional technology development stakeholders and highlight available resources.

Prospective investors, established companies, interested stakeholders, entrepreneurs and those looking to commercialize technologies are invited and encouraged to attend. The day will feature short technology summaries by NCI and FNLCR innovators, as well as presentations from regional stakeholders involved with technology development and commercialization. An interactive poster session by innovators and technology ambassadors will concurrently occur.

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Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has successfully obtained marketing authorization for its oral typhoid vaccine Vivotif® (Typhoid Vaccine Live Oral Ty21a) in five additional European Union Member States, including France, Portugal, Poland, Czech Republic and Slovakia as well as approval of harmonized prescribing information in the EU also known as the Summary of Product Characteristics or SmPC.

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Regenxbio will construct a GMP facility in Maryland to produce adeno-associated viral vectors for its gene therapy programs using its NAV technology-based platform.

The good manufacturing practice (GMP) plant will be integrated into Regenxbio’s 132,000 square-foot headquarters in Rockville, Maryland, currently under construction. Financial details have not been disclosed but the manufacturing plant is expected to be operational in 2021.

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The Food and Drug Administration has put out a call for volunteer companies to test out the its digital health pre-certification program for software as a medical device (SaMD) technologies.

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Coming off the record-breaking venture financing numbers of 2018, the first quarter of 2019 displayed some cooling off, in terms of pre-money valuations across all rounds and amounts raised in Series C and later rounds, although the market remained strong by historical standards. Q1 2019 had slightly fewer up rounds for Series B and later financings than did the last two quarters of 2018. Median pre-money valuations declined moderately across all equity rounds in Q1 2019. Median amounts raised remained strong for Seed, Series A, and Series B rounds, with those medians matching or exceeding those of Q4 2018. But the median amount raised in Series C and later rounds declined significantly, falling from the historic high of $31.1 million reached in Q4 2018 to $15.3 million in Q1 2019.

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Alzheimer’s disease (AD) arises from molecular events that scientists are piecing together to discern an overall story, parts of which are well known, others less so. Some of the lesser-known epigenetic events in the Alzheimer’s story have just been filled in by scientists based at the Van Andel Research Institute (VARI). What’s more, these epigenetic events, which occur early in Alzheimer’s, appear to fit well with what we know about the disease’s progression to its most devastating biological features.

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Viral safety is a critical focus during biopharmaceutical manufacturing (1–5). Although well-characterized mammalian cells such as the Chinese hamster ovary (CHO) line have been used for decades, both endogenous expression of retroviral-like particles and exogenous contamination events from viruses warrant continued vigilance (6, 7). International regulatory agencies require biomanufacturers to validate the “viral clearance” efficacy of their downstream manufacturing process steps before resulting products can be awarded clinical trial or commercial approval (8–10).

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There are, undoubtedly, many factors that go into a person’s weight. A new report from the lab of Sekar Kathiresan, MD, director of the Center for Genomic Medicine at Massachusetts General Hospital (MGH), documents a clear biologic basis for the predisposition of obesity. More specifically, that genetics play a role in how heavy a person gets.

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Most Congressional hearings are morality plays designed to reach a predetermined outcome. It wasn’t hard to predict how the second hearing on drug pricing by the House Committee on Oversight and Reform was supposed to go. If the title, “HIV Prevention Drug: Billions in Corporate Profits after Millions in Taxpayer Investments” wasn’t enough of a clue, when Chairman Elijah Cummings (D-MD) said it was because of the “phenomenal leadership” of freshman Rep. Alexandria Ocasio-Cortez (D-NY) that the hearing was being held, any doubts evaporated. In an extraordinary gesture of deference for a new Member of Congress, Rep. Ocasio-Cortez was recognized for an opening statement before senior members of the committee.

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At AURP’s BIO Health Caucus, we will explore trends in life science research, opportunity zone funding resources, the marriage of life science and philanthropy in global partnership opportunities. Discover the unique roles that biomedical innovation cluster and research parks play in innovation ecosystems around the globe. Translating discoveries from the lab to the market has never been more important. Connect with AURP at booth #3955 or One-on-One Partnering! 

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The net proceeds from the IPO, along with NextCure’s cash on hand, will largely be used to drive its lead product, NC318, through clinical trials and testing.

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Viela Bio today announced results from a pivotal study of its anti-CD19 monoclonal antibody, inebilizumab, in patients with neuromyelitis optica spectrum disorder (NMOSD) — a rare autoimmune disease characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis. Results were presented today during the Clinical Trials Plenary Session at the 2019 American Academy of Neurology (AAN 2019) Annual Meeting held in Philadelphia from May 4-10.

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BioHealth Innovation has announced the schedule for the next year’s Entrepreneur-in Residence (EIR) feedback sessions. These 1:1 Sessions with EIRs take place at BioHealth Innovation’s office in Rockville OR by videoconference. There is no charge to participate but entrepreneurs must be working on a biohealth Start-Ups/innovation in the BioHealth Capital Region (MD, DC, VA). The upcoming dates are:

2019: 5/22, 7/24, 9/4, 10/9, 11/20

2020: 1/22, 2/26, 3/25, 4/22, 5/27

Schedule your appointment online here. For questions or more information, contact BHI.

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The Biomedical Advanced Research and Development Authority (BARDA) will begin procuring Emergent BioSolutions’ anthrax vaccine into the Strategic National Stockpile (SNS) to strengthen U.S. preparedness in the event of a public health threat, the company said on Wednesday.

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The Food and Drug Administration (FDA) has approved Qternmet XR (AstraZeneca) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D).

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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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The U.S. government invests a significant amount of money to further research and technology innovation. In 2017, the federal government invested approximately $150 billion in R&D— about one-third at the 17 federal laboratories across the country and two-thirds at universities and private sector R&D institutions, according to government reports. This represents about one-third of all U.S. R&D spending.

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The submission to Arlington County ends months of speculation.

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The angel investor market in 2018 experienced an increase in market participation in more companies, albeit at smaller amounts, according to the Center for Venture Research at the University of New Hampshire. Total angel investments in 2018 were $23.1 billion, a negligible decrease of 3.4% over 2017. A total of 66,110 entrepreneurial ventures received angel funding in 2018, an increase of 7.4% over 2017 investments. The number of active investors in 2018 rose to 334,565 as compared to 288,380 in 2017, a robust increase of 16%. The change in total dollars and the number of investments resulted in a deal size for 2018 that was smaller than in 2017, reflecting lower valuations. The increase in number of investments likely offsets a decline in activity by institutional investors in seed and start-up deals and the smaller deal size may have partially contributed to the increase in angel investors.

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AS A CHILD, Susan Hockfield took apart anything she got her hands on to figure out how it worked. One time it was a watch, another time her mother’s iron. Her interest in the anatomy of the physical world grew over time: She pursued a career in neurobiology, and went on to teach at Yale University, where she eventually became provost. In 2005 she became the first female president of the Massachusetts Institute of Technology — and its first biologist-president.

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Venture capital firms are starting to launch and raise funds to invest in companies located in designated Opportunity Zones, where investors can get ..

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If 2017 was a banner year for biotech venture capital, 2018 blew it out of the water. Last year, private biotech companies reeled in a grand total of $16.8 billion, eclipsing 2017’s then-record $12.1 billion by 39%. And it wasn’t just the total spent that smashed records: The average per financing round increased too, and so did the proportion of enormous megarounds.

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Alexis Borisy, Third Rock Ventures partner, discusses the fund’s biotech investment strategy on “Bloomberg Technology

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Vaccine development has slowed over the past five years, but changes to investment strategies and a shift in focus to more technical and complex vaccines could renew the innovation engine.

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The company will use the funding to grow two business lines.

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The Maryland Stem Cell Research Commission (Commission) has approved funding to its second round of 2019 recipients for a total of $6,622,673.63. The Commission has also issued its Request for Applications (RFAs) for its first round of funding for fiscal year 2020.

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NextStep Robotics Inc., an early-stage company that has developed a personalized robotic therapy to help treat foot drop in recovering stroke patients, announces the closing of its second funding round. The $600,000 round will allow NextStep to transition from prototyping and development to manufacturing and sales. Led by the Abell Foundation, a new investor, this round includes investments from previous private investors from Vancouver, Canada and new investors the Abell Foundation, University of Maryland (UM) Ventures, and Jeff and Brad Quinn of Engineered Medical Systems, Inc. (EMS), a partner company of the newly-formed LaunchPort™ Accelerator.

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Protenus, a Baltimore data security company, has raised $13 million in new equity financing, according to documents filed with the U.S. Securities and Exchange Commission.

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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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Recorded at the National Capital Consortium for Pediatric Device Innovation Competition in College Park in front of a live audience!

Laurie Strongin is Founder and CEO of the Washington, DC-based Hope for Henry Foundation which is reinventing the pediatric patient experience in hospitals around the country. Laurie’s work with Hope for Henry and the memoir she published, “Saving Henry,” have placed her at the forefront of supporting the rights of patients and their families and the responsible use of new medical technologies. Laurie’s advocacy has led her to service on the nation’s preeminent science policy and bioethics panels. Her activism has produced op-eds in national newspapers; appearances on television and radio; collaborations with Congressional leadership; and recognition from the White House. An in-demand inspirational speaker, Laurie has been featured as a People magazine “Heroes Among Us” and was the subject of profiles in the USA Today and the Washington Post and on Good Morning America. Laurie serves on the board of directors of the National Marrow Donor Program/Be the Match; on the Advisory Committee to Disney’s “Team of Heroes,” and on the Advisory Committee of the Association of Child Life Professionals. Learn more athttps://hopeforhenry.org/.

Listen now on Google Play bit.ly/2CzdnA9, iTunes, apple.co/2Arsfze, TuneIn bit.ly/2M60Wmx.

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The 3rd hour of TODAY looks at the Virginia-based biotech company Aperiomics, which says it has technology that could shake up health care and find answers for the millions of people living with chronic and undetected illnesses.

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The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announced five winners of its “Make Your Medical Device Pitch for Kids!” competition who will each receive $50,000 in grant funding and access to the consortium’s first-of-its-kind “Pediatric Device Innovator Accelerator Program” led by MedTech Innovator. A panel of expert judges from business, healthcare, regulatory and legal sectors selected the winners based on the clinical significance and commercial feasibility of their medical devices for children. The competition focused solely on advancing care in pediatric orthopedics and spine, a sector that the FDA identified as an emerging underserved specialty which lacks innovation.

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The University of Vermont Health Network Ventures and legal firm Wilson Sonsini Goodrich & Rosati recently invested in BioFactura’s $6M Series B Financing Round.

“With the commitment from the UVM fund and WSGR, BioFactura is now securing value-added institutional investors who bring significant financial and business resources to bear as we advance our biopharmaceutical products to the clinic,” said Darryl Sampey, BioFactura’s President and CEO.

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Wed, May 8, 2019, 6:00 PM – 8:00 PM EDT

Inova Center for Personal Health, 8100 Innovation Park Drive, Conference Center, Fairfax, VA 22031

The Titanic represents to many of us the iconic tale of what happens when an unstoppable force meets an immovable object. The tragedy is embodied in that instant when The Ship struck The Iceberg, killing over 1,500 passengers and crew—and the hubris of thinking we can build something too big to fail. But while the iceberg may have represented the killing blow, what many do not realize is that the demise of the Titanic was in fact a result of a series of small decisions and missteps across a number of dimensions.

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Startups may spring from pure academics or from a healthy and heterogenous mixture of science, business experience, and inspired thinking. Rachel King, CEO of GlycoMimetics, and others brought experience to the company. Her cofounder, Dr. John Magnani, brought original science, and an expert team soon joined in response to the inspiration created by the company’s concept. The germ idea was to make a formerly “undruggable” set of disease targets druggable. Deep, careful studies of molecular structures were required, followed by rational drug design to achieve the goal of small molecule therapy mimicking natural carbohydrates critical to the “glycosylation” of cellular proteins.

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Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation (NASDAQ: XON) and a clinical stage biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, today announced the official opening of its new manufacturing facility. Precigen commenced the build-out of the nearly 5,000 square foot manufacturing facility in 2018 to support gene therapy manufacturing. The good manufacturing practices (GMP) facility was designed with agility and control in mind, focusing on rapid manufacturing and the ability to scale production appropriately to meet early stage clinical trial needs.

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LifeSprout, makers of synthetic tissues for aesthetic and reconstructive medicine, is moving from Johns Hopkins‘ East Baltimore innovation hub into a manufacturing accelerator for medical device companies in South Baltimore’s Port Covington.

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Car crashes, battle wounds, and surgeries can leave people with gaping holes in soft tissue that are often too large for their bodies to repair. Now, researchers have developed a nanofiber-reinforced injectable gel that can rebuild missing muscle and connective tissues by serving as a scaffold and recruiting the body’s wound-healing cells. So far, the team has tested the material only in rats and rabbits. But if it performs as well in humans, it could give reconstructive surgeons a fast and easy way to help patients regenerate lost tissues without scarring or deformity.

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The University of Maryland has opened a 215,600-square-foot computer science facility on its College Park campus.

The university says the Brendan Iribe Center for Computer Science and Engineering will support team-based, interdisciplinary research in virtual and augmented reality, artificial intelligence, robotics, computer vision, algorithms, programming languages and systems.

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Available life science space is dwindling in Maryland’s traditional life science core.

• Only six buildings currently offer space larger than 20,000 s.f.
• Space with high ceilings and utility capacity are scarce.
• Investor demand has increased in the last plots of vacant and underutilized land.

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For the past five years, Jigar Patel and a group of fellow Roche employees have been quietly developing drug discovery technology at the global pharma company’s outpost in Madison, WI. Now, they’re setting out on their own to see if their approach to identifying promising peptide-based therapies can have an impact on the sector.

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On Tuesday, May 7, the Center for Biotechnology Education will hold its 14th annual research symposium. During the event at the Johns Hopkins University Montgomery County Campus, biotechnology students and some high school students will participate in a poster session devoted to their research.

Following the poster session, Barry O’Keefe, a scientist at the National Cancer Institute, will give a keynote address about natural product-based drug discovery. O’Keefe is acting chief of the Molecular Targets Program at the Center for Cancer Research and chief of the Natural Products Branch, Developmental Therapeutics Program at the Division of Cancer Treatment and Diagnosis.

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Venture capital dollars are flooding into biotech, totaling $8.5 billion in 2017 alone. But there’s no one way to fund a startup.

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The privacy and security of patient data continues to be increasingly important as access to this data increases and threats to this sensitive information continue to grow. At the same time, several new federal health information policies will make electronic health information about individuals more widely available to individuals and their caregivers and health care professionals. Lucia Savage, Former Chief Privacy Officer of HHS Office of the National Coordinator, will provide the opening keynote for the Privacy and Analytics (PANDAS) conference, focusing on innovation that equips privacy teams to effectively navigate the shift that occurs when organizations begin to more frequently utilize consumer tools to deliver healthcare.

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In February 2019, the French immuno-oncology diagnostics company HalioDx opened its first laboratory in North America. The five-year-old company, a Qiagen spin-off, selected Richmond, VA, as the location of the lab, in part, because the state’s capital city is only a two-hour drive from the FDA’s headquarters in Maryland.

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Kilpatrick Townsend & Stockton and GreyB Services released today their findings from The First Annual Kilpatrick Townsend & GreyB Services Patenting Trends Study (Study). The Study provides clear and actionable information that assists decision makers in envisioning the technological future of their respective industries and setting their companies’ strategies over the coming years and decades in an increasingly globalized economy.

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The newly published document, “2018: Evidence and Opportunity: Impact of Life Sciences in North Carolina,” is a fascinating story of transformation for a state that once held the unfortunate reputation as the second-poorest in the nation.

It marks the 10th anniversary of the North Carolina Biotechnology Center’s contract with TEConomy Partners to track and evaluate the state’s life science landscape.

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The company is seeking to go public just three years after its founding.

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United Therapeutics Corporation (Nasdaq: UTHR) today announced that its collaborator, XVIVO Perfusion, Inc., a subsidiary of XVIVO Perfusion AB (STO: XVIVO), has received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the products XPS™ and STEEN Solution™. This approval means that STEEN Solution, XPS and the accompanying single-use articles are the only medical device products that are approved in the United States for ex-vivo lung perfusion (EVLP) of initially unacceptable donated lungs at body temperature.

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GSK today announced that the US Food and Drug Administration (FDA) has approved, under priority review, the use of the intravenous (IV) formulation of Benlysta (belimumab), a B-lymphocyte stimulator (BLyS)-specific inhibitor, in children with lupus from as young as five years of age.

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

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With an FDA approval for its pricey CAR-T therapy Yescarta under its belt and more treatments in the pipeline, Gilead’s Kite Pharma was on the hunt for a new manufacturing site to fuel those hopes. The company found it in Maryland.

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Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation (NASDAQ: XON) and a clinical stage biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, today announced the official opening of its new manufacturing facility. Precigen commenced the build-out of the nearly 5,000 square foot manufacturing facility in 2018 to support gene therapy manufacturing. The good manufacturing practices (GMP) facility was designed with agility and control in mind, focusing on rapid manufacturing and the ability to scale production appropriately to meet early stage clinical trial needs. The new facility adds to Precigen’s existing footprint in Germantown, Maryland, which supports more than 95 employees. To mark the official opening, the company held a ribbon cutting ceremony attended by elected officials and local community members with remarks from Randal J. Kirk, Chairman and Chief Executive Officer of Intrexon, Helen Sabzevari, PhD, President of Precigen, United States Congressman David Trone representing Maryland’s 6th Congressional District and Jeffrey Schlom, PhD, Chief of the Laboratory of Tumor Immunology and Biology at the Center for Cancer Research, National Cancer Institute. Dr. Schlom is the principal investigator of a Cooperative Research and Development Agreement (CRADA) between the National Cancer Institute and Precigen. Under this CRADA, the National Cancer Institute and Precigen are collaborating to evaluate Precigen’s proprietary adenoviral vaccines in preclinical and clinical studies for the treatment of cancer.

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Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to autologous enriched T-cells genetically modified with a retroviral vector to express two chimeric antigen receptors targeting CD19 and CD22 (AUTO3) for the treatment of acute lymphoblastic leukemia (ALL).

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Today, the U.S. Department of Commerce’s National Institute of Standards and Technology announced 15 key findings from a final version of a new “green paper” on maximizing U.S. innovation from government-funded research.

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GlycoMimetics, Inc. (NASDAQ: GLYC) announced today dosing of the first patient in a Phase 3 clinical trial being conducted under the auspices of a Cooperative Research and Development Agreement (CRADA) between GlycoMimetics and the National Cancer Institute (NCI), part of the National Institutes of Health. The second in a series of trials designed to evaluate uproleselan across the continuum of care in AML, this NCI-sponsored study is evaluating the addition of uproleselan to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated AML who are suitable for intensive chemotherapy. A third trial, to be conducted by the European HOVON consortium, is expected to initiate later this year.

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CoapTech LLC, a medical device company focused on delivering transformative solutions for minimally-invasive surgery, announced today that the U.S. Food and Drug Administration (FDA) on April 10, 2019 granted the company 510(k) clearance for its PUMA-G System, which enables ultrasound-based placement of percutaneous gastrostomy feeding tubes.

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