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

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

BALTIMORE, April 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.

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 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.

“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.

LONDON, April 23, 2019 (GLOBE NEWSWIRE) — 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).

According to the National Institute of Health’s National Cancer Institute, in the United States, there will be an estimated 5,930 new cases of ALL and an estimated 1,500 related deaths in 2019. Patients are predominantly children; approximately 60% of cases occur at age < 20 years.  ALL occurs when the bone marrow makes too many immature lymphocytes, which are a type of white blood cell. Despite a high rate of response to induction chemotherapy, only 30–40% of adult patients with ALL will achieve long-term remission. Similarly, pediatric patients typically respond well to first-line treatment (combination chemotherapy) but 10 to 20% of total patients relapse with chemotherapy-resistant disease, leading to a significant unmet need in pediatric patients with high-risk relapsed or refractory ALL.

“We are pleased to receive orphan drug designation for AUTO3 for acute lymphoblastic leukemia,” said Dr. Christian Itin, chairman and chief executive officer of Autolus. “Earlier this year, we presented encouraging updated data from the AMELIA phase 1/2 trial of AUTO3 in pediatric ALL patients.  We believe that AUTO3 has the potential to be a best in class therapy in pediatric ALL by addressing antigen escape, a common cause of relapse in these patients.  AUTO3 may also provide an improved safety profile over currently marketed CAR T therapies with low levels of severe CRS and neurotoxicity observed in clinical studies.”

Click here to read the entire press release.

• Evaluating previously untreated newly diagnosed adults with acute myeloid leukemia (AML) who are fit for intensive chemotherapy
• Second initiation among three late-stage uproleselan clinical trials

ROCKVILLE, Md.–(BUSINESS WIRE)–Apr. 23, 2019– 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.

“The initiation of the NCI-sponsored trial is an important milestone for our uproleselan program, a drug candidate with the potential to address significant unmet treatment needs across the spectrum of AML,” noted Helen Thackray, M.D., FAAP, GlycoMimetics Senior Vice President, Clinical Development, and Chief Medical Officer. “Along with our global pivotal Phase 3 clinical trial testing the investigational drug in patients with relapsed/refractory acute myeloid leukemia, this trial will facilitate our growing understanding of how uproleselan may fit into the continuum of care for individuals living with AML.”

GlycoMimetics is collaborating with both the NCI and the Alliance for Clinical Trials in Oncology to conduct the trial, which is led by Geoffrey Uy, M.D., Associate Professor of Medicine, Bone Marrow Transplantation and Leukemia, Washington University School of Medicine in St. Louis. The primary endpoint will be overall survival, with a planned interim analysis based on event-free survival (EFS) after the first 250 patients have been enrolled in the study. More information on this clinical trial can be found at www.clinicaltrials.gov.

Click here for the entire press release.

Viela Bio (PRNewsfoto/Viela Bio)

Gaithersburg, MD—April 18, 2019 – Viela Bio today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the Company’s anti-CD19 monoclonal antibody inebilizumab, an investigational monotherapy for neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, life-threatening autoimmune disease affecting the central nervous system.

“The Breakthrough Therapy Designation for inebilizumab is based on results from the largest monotherapy study ever conducted in NMOSD,” said Jorn Drappa, M.D., Ph.D., Chief Medical Officer and Head of Research & Development at Viela Bio. “Inebilizumab is a humanized monoclonal antibody designed to bind with high affinity to CD19 and deplete a broad range of B cells, including autoantibody-secreting plasmablasts and CD19-expressing plasma cells. We continue our efforts to bring inebilizumab to patients suffering from this devastating disease for which there are currently no approved medicines.”

Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines intended to treat a serious condition that have shown encouraging early clinical results which may demonstrate substantial improvement on a clinically significant endpoint over available medicines. The designation for inebilizumab is based on data from the pivotal N-MOmentum study evaluating inebilizumab as monotherapy.

Click here to read the entire release.