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.

Click here to read more via sciencemag.org

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. www.biofactura.com

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. www.uvmhealth.org

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. www.wsgr.com

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.

Click here to read more via lifescienceleader.com

Gaithersburg-based Sirnaomics closes $47 million funding round

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Gaithersburg-based Sirnaomics closes $47 million funding round
Dr. Patrick Lu is founder, president and CEO of Gaithersburg-based Sirnaomics, which just closed on a $47 million funding round.

Original Post: Washington Business Journal

By: Katishi MaakeDigital Producer

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.

The latest $11 million, also part of the C2 round, was led by CR-CP Life Sciences Fund, a Hong Kong joint venture established by China Resources Group and Charoen Pokhand Group, two Asian conglomerates.

Additional investors for the C2 round include Shanghai-based Rich Yield Capital; Rolling Boulder Investment from Shenzhen, China; and Legend Sky Investment.

 

In three venture rounds, the company has raised a total of $58 million in financing and obtained government funding and corporate partnerships valued at another $10 million, Chief Medical Officer Michael Molyneaux said Friday in an email to the Washington Business Journal. The company, he said, is now valued at more than $200 million.

Sirnaomics develops anti-fibrosis and anticancer therapeutics through RNA interference technology, which shuts down disease-causing genes.

Click here to read more from the WBJ.

Protenus Announces Former Chief Privacy Officer of HHS Office of the National Coordinator to Keynote 3rd Annual PANDAS Conference in Baltimore

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BALTIMOREApril 30, 2019 /PRNewswire/ — 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.

The keynote, “Alexa, why do we need APIs in healthcare,” will focus on how health systems can balance advancing digital health and patient engagement while ensuring the privacy and security of patient data. Savage’s presentation will also highlight best practices healthcare organizations can start using to reduce organizational risk and better protect patient privacy.

“With CMS predicting the increased use of ‘common consumer tools’ to deliver care outside of traditional brick-and-mortar environments, I hope to bring a tech-forward, HIPAA-expert perspective to hospital privacy officers to help them navigate the shift,” stated Savage.

“The volume of health data available electronically has continued to grow with the adoption of consumer-facing applications focused on improving patient care. PANDAS provides our nation’s most innovative privacy officers a forum to address the new and evolving challenges these adoptions bring to healthcare,” said Nick Culbertson, CEO of Protenus, the founding organization of PANDAS. “To that end, we are thrilled to welcome Lucia. Her expertise and experience will provide unique insight as to how the industry can make important strides in protecting patient data as healthcare continues to innovate. We are looking forward to a thought-provoking discussion.”

 

Click here to read the entire press release.

United Therapeutics Announces FDA Approval Of XPS™ And Steen Solution™ Used To Perform Centralized Ex-Vivo Lung Perfusion Services

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SILVER SPRING, Md., April 29, 2019 /PRNewswire/ — 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.

In June 2018, United Therapeutics and XVIVO Perfusion announced a collaboration agreement to incorporate the use of XPS™ and STEEN Solution™ into the Silver Spring, Maryland laboratory of Lung Bioengineering Inc., a subsidiary of United Therapeutics’ public benefit corporation Lung Biotechnology PBC. Since then, Lung Bioengineering has used the XPS™ technology to offer centralized EVLP to transplant centers on a fee-for-service basis, in order to increase the supply of transplantable lungs to address needless patient deaths on the transplant waitlist.

“We are proud to be XVIVO Perfusion’s partner in offering unique centralized EVLP services to expand the supply of transplantable lungs,” said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. “We are grateful to the FDA for approving this technology that enables otherwise discarded lungs, which would be unable to be used in furtherance of their donors’ generous intent, to instead be frequently restored to transplantable and hence life-saving condition. I feel it is a miracle of biotechnology that will benefit thousands of patients who die needlessly awaiting transplant.”

Click here to read the entire release.

Kite to Open Cell Therapy Manufacturing Facility in Frederick County Creating Significant Job Opportunities In Maryland

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Kite Pharma, a California-based biopharmaceutical company that develops innovative cancer immunotherapies, announced plans today to open a new biologics manufacturing facility in Frederick County that will produce innovative cell therapies for people with cancer. A Gilead company, Kite will open the new facility on a 20-acre site in the Urbana Corporate Center, with plans to create a significant number of job opportunities.

Kite Pharma, A Gilead Company.  Car-T Cell Therapy for Cancer

“This new facility in Urbana builds on our substantial technical capabilities and rapid progress in making personalized chimeric antigen receptor T and TCR cell therapies for people with cancer. As we advance our industry-leading cell therapy pipeline and seek to help a growing number of people with cancer, expanding and investing in our manufacturing capabilities is essential,” said Tim Moore, executive vice president of technical operations at Kite. “With the Urbana site, we will have the opportunity to build and design the facility tailored to our own innovative processes and with state-of-the-art features that will enable us to meet the future needs for cell therapies.”

With this new facility, Kite will significantly expand its ability to manufacture commercially available and investigational cell therapies. The new Frederick facility will become part of Kite’s growing commercial manufacturing network that includes sites in California and the Netherlands.

Click here to read more via BioBuzz.

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