Monthly Archives

May 2019

Montgomery County Economic Development Corporation (MCEDC) Launches New Bio Lab Pilot

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Helps Fund Wet Lab Space for Small Biotech Companies

The Montgomery County Economic Development Corporation (MCEDC) launches a year-long pilot program designed to help small biotech companies fund wet lab space in Montgomery County, Maryland. The Bio Lab Pilot project will assist the County’s growth-stage life sciences companies with their infrastructure needs.

The successful applicant must agree to be headquartered in the County for three years, and lease wet lab space that is 5,000 SF or less. The grant award will provide $10 per SF of lab fit-out costs, up to $30,000 per company.

“Young BioHealth companies are not always able to obtain conventional financing. These grants are designed to help fill the funding gap associated with wet lab costs,” said David Petr, President and CEO of MCEDC.

MCEDC will fund the pilot project with $250,000 from its FY19 budget, which includes $50,000 in funding from the Maryland Department of Commerce.

“Maryland Commerce is pleased to support this project, which will help offset the cost of wet lab space and encourage more small biotech companies to grow in Montgomery County,” said Kelly M. Schulz, Maryland’s Commerce Secretary.

Expanding local companies, new start-up companies, and relocating companies are eligible to apply for Bio Lab Pilot funds to fit-out newly leased lab space. Developers and building owners are ineligible to receive pilot program grants. The threshold criteria for a pilot award will be the demonstrated evidence of a funding gap that prevents the company from completing its new lab fit-out.

Click here to read the entire press release.

BioBuzz – Three Examples That Show Why The National Cancer Institute is a Goldmine of Blockbuster Technologies for Commercialization

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The 2019 Tech Showcase Focuses on Partnerships, Entrepreneurship and Business Resources for Commercializing Technologies

May 7, 2019

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?

They are a few recent examples of the many technologies and companies spun out of The National Cancer Institute (NCI) in Frederick, Maryland. For years, NCI and the Frederick National Laboratory for Cancer Research (FNLCR) have been a wellspring of tech innovation that has helped create new companies and develop life-saving medicines.

On June 12th from noon to 5 pm, NCI will host its annual Technology Showcase, offering industry, inventors and entrepreneurs an invaluable opportunity to connect, explore NCI’s tech transfer process and receive expert advice on starting a new business and what it takes to commercialize a product. The event, held in cooperation with the Frederick County and Frederick City governments, will be held at the FNLCR Advanced Technology Research Center in Frederick, Maryland.

The National Cancer Institute and Frederick National Laboratory 2019 Technology Showcase


Rich Bendis, President and CEO of BioHealth Innovation, Inc. will be the keynote speaker and sessions on attracting equity investors, non-dilutive funding sources, leveraging incubators and partnering with NCI/FNLCR highlight the showcase’s increased focus on the strong business case for tech transfer collaboration. What’s more, the showcase provides an excellent opportunity for direct engagement with technology inventors.

NCI’s Tech Transfer Center and FNLCR have an outstanding track record of successful technology licensing, fruitful collaborations and successful startup formations. Here are a few highly notable examples.

Kite Pharma, a successful T-Cell therapeutics company that recently announced its plans to build a manufacturing site in Frederick County, Maryland, was founded on technology transferred out of an NCI lab. Kite, before being acquired by Gilead in 2017, collaborated with NCI to license technology developed by immuno and gene therapy pioneer Dr. Steven A. Rosenberg. This NCI technology, licensed to Kite in 2014, eventually led to the development of FDA-approved YESCARTAⓇ, Kite’s approved CAR-T immunotherapy for a type of non-Hodgkin lymphoma. In addition, a significant segment of Kite’s current pipeline is also based on this same NCI technology. The power and promise of the NCI technology licensed by Kite is evidenced by Gilead paying $11.9 billion to acquire Kite without the company having an approved product at the time.

Lab Owl Transforms Pilot Scale-up lab at top Biotech company

Avelumab, commercially known as BAVENCIO, is a pioneering Merkel cell carcinoma treatment developed as part of a co-development agreement between EMD Serono, the biopharma division of Merck KGaA, and the NCI Tech Transfer Center. In 2017, avelumab was the first checkpoint antibody approved by the FDA for this lethal form of skin cancer. During the phase II trials, NCI and EMD Serono entered into a Cooperative Research and Development Agreement (CRADA) for avelmulab. Just four years after the first NCI-led studies, avelumab received FDA approval for Merkel cell carcinoma and another indication. Merck KGaA and Pfizer entered into a collaboration to jointly develop and commercialize Bavencio® (avelumab) in a deal worth up to $2.85 billion for Merck KGaA. The collaboration has been recognized by GEN as one of the top 10 Immuno-Oncology Collaborations.

miRecule, Inc., a Gaithersburg, Maryland-based early-stage biopharmaceutical company focused on developing microRNA-based therapies for drug-resistant cancers, is another startup company spun out of NCI. The company and NCI entered into a CRADA for microRNA therapeutics for treating head and neck squamous cell carcinomas. miRecule, founded in 2016, is currently raising $1 million in seed capital and has won several grants, including a Small Business Innovation Research (SBIR) grant. As of July 2018, the company had raised $500,000 in grant funds and $250,000 from private investment (Source: Washington Business Journal). miRecule’s founder and CEO Anthony D. Saleh, who is the inventor of the company’s genomics-based drug discovery platform, is also a former NCI postdoctoral fellow and former ‘Entrepreneur in Residence’ at BioHealth Innovation.

At the 2018 Tech Showcase, Kedar Narayan, Ph.D. from the Center for Molecular Microscopy, FNLCR gave a presentation on “Nanoscale 3-D imaging of cells and tissue by FIB-SEM (focused ion beam scanning electron microscopy)”. Since that presentation, NCI has entered into an early agreement to co-develop the FIB-SEM technology. This technology provides 3D, high-resolution electron microscopic imaging of cells and tissues. The technology can scan a block of tissue layer-by-layer, for example, capturing hi-resolution images, which can then be recombined into a 3D shape without 2D data compression challenges. FEB-SEM could potentially help researchers locate drug targets and loading vehicles more quickly to accelerate R&D for life-saving treatments. This technology has received strong interest recently from a major pharmaceutical company, according to NCI.

The aforementioned success stories are just a few examples of powerful NCI/FNLCR collaborations that have led–and could lead to–powerful treatments for patients in need.

The 2019 Tech Transfer Showcase is not limited to scientists talking to scientists. This year’s showcase will feature technologies, inventors and educational sessions designed to help startup businesses navigate tech transfer, attract the right investment capital and leverage available incubator/accelerator resources to be successful.

The Technology Showcase is unique in that technical innovation is directly tied to the commercial opportunity. If you’re an entrepreneur or in industry and are looking to better understand the market landscape, economic opportunity and commercial potential associated with NCI/FNCRL technologies, mark the 2019 Technology Showcase on your calendar today.

Click here to learn more via BioBuzz.

FDA clears RemUnity drug pump co-developed by Deka, United Therapeutics

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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.

“We developed the RemUnity system to address safety and patient convenience problems with current subcutaneous infusion pumps,” said Martine Rothblatt, chairman and CEO of United Therapeutics. “We believe the RemUnity system reduces the risk of bolus dosing due to pump failures and provides wider arrays of notifications, alerts and alarms than current pumps. Most importantly, the acoustic volume sensing technology and solid-state actuator of the RemUnity system enables it to control Remodulin flow rates without the use of a motor.”

RemUnity features a small, lightweight, durable pump that has a service life of at least three years, according to the company. It uses disposable cartridges that are connected to the pump.

“We are excited to be launching this innovative delivery technology with United Therapeutics. We are confident that it will substantially improve the lives of patients who depend on UT’s unique pharmaceutical advances,” said Dean Kamen, founder and president of Deka. “We look forward to continuing to deliver advanced solutions for patients in need.”

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With promising pivotal data, Viela Bio’s lead autoimmune drug heads for FDA filing

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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.

Viela tested the drug, a CD19-targeting antibody called inebilizumab, in patients with neuromyelitis optica spectrum disorders (NMOSD), a disease in which the immune system attacks the optic nerves, spinal cord and brain. Current treatments fall into two groups: those used when a patient is having an attack and those used to ward off attacks. There is no treatment approved specifically for NMOSD, so the steroids and immunosuppressants prescribed to prevent attacks are used off-label.

The data, presented Tuesday at the annual meeting of the American Academy of Neurology, showed the treatment reduced the risk of attacks by 73%.

“Neuromyelitis optica attacks can be quite devastating. They can result in a rapid loss of vision up to and including blindness and paralysis. The key is to stop attacks from happening,” Viela Bio Chief Medical Officer Jorn Drappa, M.D., Ph.D., told FierceBiotech.

“None of the currently used drugs have been studied in a rigorous fashion in NMOSD—there has not been a controlled clinical trial that establishes these treatments are effective. Ours is the largest clinical trial done in neuromyelitis optica,” Drappa said.

The study enrolled 231 patients with varying severities of disease, said Viela Bio CEO Bing Yao. Most of the patients had autoantibodies against a protein called aquaporin-4 (AQP4), while a small number of them did not. These AQP4 antibodies are a biomarker of NMOSD and are believed to trigger NMOSD attacks when they bind to the nervous system.

Click here to read more via FierceBiotech.

Five winners to receive share of $250K NCC-PDI grant funding and access to unique pediatric device accelerator program

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WASHINGTONMay 1, 2019 /PRNewswire/ — 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.

The 2019 NCC-PDI “Make Your Medical Device Pitch for Kids!” competition winners are:

  • AMB Surgical, LLC, Dayton, Ohio – FLYTE, a device designed to reduce invasive and repetitive surgery in children and teens with orthopedic illnesses such as scoliosis and limb abnormalities
  • Auctus Surgical, Inc., San Francisco, Calif. – Auctus Surgical Dynamic Spinal Tethering System, a mechanism used to correct the scoliotic spine in pediatric patients through a tethering procedure
  • ApiFix Ltd, Boston, Mass. – ApiFix’s Minimally Invasive Deformity Correction (MID-C) System, a posterior dynamic deformity correction system for surgical treatment to provide permanent spinal curve correction while retaining flexibility
  • Children’s National Health System, Washington, D.C.– Babysteps platform to improve initial assessment of clubfoot deformity and predict the magnitude of correction
  • nView Medical, Salt Lake City, Utah – Surgical scanner using AI-based image creation to provide instant 3D imaging during surgery to improve imagery speed and accuracy

The competition was held at the University of Maryland, College Park by NCC-PDI, one of five FDA Pediatric Device Consortia grant programs that support the development and commercialization of pediatric medical devices. NCC-PDI is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System and the A. James Clark School of Engineering at the University of Maryland. The consortium recently added new accelerators BioHealth Innovation and MedTech Innovator and design firm partner, Smithwise.

Through the inaugural NCC-PDI “Pediatric Device Innovator Accelerator Program,” MedTech Innovator is providing winners with virtual in-depth, customized mentorship from some of the industry’s leading executives and investors. With its prestigious Showcase & Accelerator program, MedTech Innovator has a proven track record of identifying early-stage medical device companies with the key characteristics required for commercial success and accelerating their growth through its vast ecosystem of resources.

Click here to read the entire press release.

This injectable gel could one day rebuild muscle, skin, and fat

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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.

“Soft tissue losses are a ubiquitous problem in clinical medicine,” says Sashank Reddy, a reconstructive surgeon at the Johns Hopkins University School of Medicine in Baltimore, Maryland. Surgeons can transplant tissue from another body region to the injury site. But that involves trauma for patients and tissue loss from another part of the body. Surgeons can also insert synthetic implants. But immune cells typically just wall off those implants, leaving behind thick, fibrous scars.

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University of Vermont Health Network Ventures and Wilson Sonsini Goodrich & Rosati Invest in BioFactura, Inc.

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Frederick, Maryland, April 29, 2019:  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.

Dr. Jeffrey Hausfeld, Chairman of the Board and Chief Medical Officer, stated, “We are excited to work with the University of Vermont Health Network Ventures and WSGR and view them as important strategic investors in BioFactura. Both our Biosimilars and Biodefense drugs promote the health and safety of our patients using innovative, state of the art, biopharmaceutical manufacturing techniques. Improving access to highly effective biologic therapeutics, while bending the cost curve downwards in a meaningful way, are shared goals.”

Chris Jones, Director of Venture Investments for the UVM Health Network, commented, “Investments into biosimilars are directly aligned with the mission of improving access to care and reducing costs. There are additional benefits that BioFactura has revealed, such as improved quality and emergency preparedness, and I predict we will be seeing a lot of interest in this space and in this company going forward.”

Charles Andres Ph.D., RAC, Associate Attorney specializing in Intellectual Property states, “WS Investments, the investment fund of Wilson, Sonsini, Goodrich & Rosati, was pleased to participate in the round.”

About BioFactura, Inc.

BioFactura, Inc. (Frederick MD) develops and commercializes high-value, highly similar biosimilars (i.e., follow-on biologics or generic biopharmaceuticals) using its patented StableFast™ Biomanufacturing Platform, the optimal system for bringing these drugs to market with faster, lower cost, superior-quality manufacture.  For over 10 years, BioFactura has been advancing life-saving medicines from the research bench to the patient using its innovative drug development and manufacturing technologies. Current and past programs include biodefense drugs against smallpox and Ebola, novel medicines for cancer, and low-cost/high-quality biosimilars for autoimmune and infectious diseases.

About University of Vermont Health Network Ventures

University of Vermont Health Network Ventures is the highly selective, mission-led ventures arm of Vermont’s 8-hospital healthcare system.

About Wilson Sonsini Goodrich & Rosati

Wilson Sonsini Goodrich & Rosati is a law firm in the United States that specializes in business, securities, and intellectual property law. WSGR provides legal services to technology, life sciences, and growth enterprises worldwide, as well as the venture capital firms, private equity firms, and investment banks that finance them. The firm’s clients operate in a range of technology industries, including the biotech, communications, digital media, energy, financial services, medical devices, mobile, semiconductor, and software sectors.

GlycoMimetics Aiming At Tough Targets

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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.

GlycoMimetics is developing a drug, uproleselan, designed to mimic a glycan in blocking E-selectin, which may have several results when used with chemotherapy, potentially forcing tumor cells out of the marrow and back into the bloodstream, reducing the effective chemo dose, and lowering chemo-caused side effects such as neutropenia and digestive-tract mucositis.

Another lead compound is rivipansel, which inhibits a wide range of selectins to treat some of the worst symptoms of sickle cell disease (SCD). Uproleselan and rivipansel are both in Phase 3 clinical trials. Earlier candidates for oncology indications, some with other new mechanisms of action (MoAs), are also in the pipeline. It is a formidable lineup and a correspondingly large challenge for a small company such as GlycoMimetics.

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