Viela Bio Receives U.S. FDA Breakthrough Therapy Designation for Inebilizumab for Treatment of Neuromyelitis Optica Spectrum Disorder

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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.

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REGENXBIO Appoints Dr. Steve Pakola as Chief Medical Officer

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ROCKVILLE, Md.April 17, 2019 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV®Technology Platform, today announced the appointment of Steve Pakola, M.D., as its Senior Vice President and Chief Medical Officer. Dr. Pakola will report to Kenneth T. Mills, REGENXBIO’s President and Chief Executive Officer.

Dr. Pakola joins REGENXBIO from Aerpio Pharmaceuticals, Inc., where he was Chief Medical Officer. He has held key leadership roles in preclinical and clinical development, regulatory affairs and medical affairs. While Dr. Pakola’s therapeutic area experience encompasses multiple indications, his predominant focus has been the development of treatments for retinal disorders, including clinical development experience in diabetic retinopathy, diabetic macular edema and age-related macular degeneration (AMD). He was the lead inventor and program lead for the Jetrea®(ocriplasmin) program, from inception in 2002 through the therapy’s United States and European regulatory submissions in 2012.

“In this role, Steve will leverage his rich industry experience and expertise in the discovery and development of novel treatments for retinal disease,” said Mr. Mills. “Steve’s background as an innovator in drug development is particularly relevant as we leverage our breakthrough science to advance five current proprietary therapeutic programs that focus on retinal, neurodegenerative and metabolic diseases. We are excited to welcome Steve to the team.”

“I am thrilled to join REGENXBIO at this time of exciting momentum for the company as it advances the development of gene therapies,” said Dr. Pakola. “REGENXBIO’s NAV Technology Platform has the potential to transform the course of treatment for patients with rare diseases as well as in broader applications such as wet AMD. I look forward to working with my colleagues, investigators and the regulatory authorities to bring new and innovative treatments to patients.”

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GlaxoSmithKline CEO talks pharmaceutical industry and leadership

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Emma Walmsley, the CEO of GlaxoSmithKline, discussed the pharmaceutical industry and the role of leadership at the Stanford Medicine Dean’s Lecture on Tuesday. GlaxoSmithKline, commonly known as GSK, is a British-based multinational pharmaceutical company — one of the world’s largest.

Walmsley became CEO of GlaxoSmithKline in 2017, marking her as the first woman to run a major pharmaceutical company. Since taking the helm, Walmsley has instituted significant change in GlaxoSmithKline’s approach to research and development. These include a greater focus on the immune system, further investments into advanced technologies and increased utilization of genetic information and techniques.

“There has never been a more exciting time in terms of the advances in biology and technology, and how the two of them coming together could be absolutely thrilling and impactful to patients around the world,” Walmsley said.

Throughout the talk, Walmsley highlighted GSK’s new business strategies, acquisitions and trajectory, as well as the state of the pharmaceutical industry. Her educational background in Classics and her professional background in consumer products, she explained, is often untraditional in the scientific sector, yet it offers her a unique perspective as chief executive.

Walmsley also discussed the complexities involved in her role as head of a large pharmaceutical company. Throughout her tenure as CEO, she has often had to weigh tough business decisions, putting aside her personal biases and fears in favor of what is directly beneficial for the company.

Read more via the Staford Daily.

Emergent BioSolutions Announces Interim Results From Phase 2 Study Evaluating CHIKV-VLP, Chikungunya Virus Vaccine Candidate

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GAITHERSBURG, Md., April 16, 2019 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced results from the interim analysis of its Phase 2 clinical study evaluating the safety and immunogenicity of the company’s chikungunya virus virus-like particle (CHIKV-VLP) vaccine candidate across a series of dosing regimens. The interim analysis has shown that with a single dose administered, up to 98% of study participants produced a neutralizing antibody response against the chikungunya virus (CHIKV) by Day 7. Further, the immune response was shown to be persistent through the six-month visit, including in the one-dose regimen.

“Emergent is highly encouraged about our vaccine candidate as the interim data suggest that a single dose of the vaccine was able to generate a positive immune response, which persisted through the study participants’ visits at six months,” said Abbey Jenkins, senior vice president and vaccines and anti-infectives business unit head. “Chikungunya virus infection represents a significant unmet medical need – having no vaccine or treatment available – despite its emergence as a global threat because of the highly debilitating nature of the associated disease and unprecedented magnitude of its spread.1 We look forward to completing the data set analysis and finalizing our development plan, which could allow for initiation of a pivotal trial next year.”

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Catalent to acquire gene therapy leader Paragon Bioservices, Inc. for $1.2 billion

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Will provide new expertise and capabilities in one of the fastest-growing areas of healthcare, positioning Catalent for accelerated long-term growth

SOMERSET, N.J. and BALTIMORE, M.D. – April 15, 2019 – Catalent, Inc. (NYSE: CTLT), the leading global diversified provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, and Paragon Bioservices, Inc., a leading viral vector development and manufacturing partner for gene therapies, today announced they have entered into a definitive agreement under which Catalent will acquire Paragon for $1.2 billion.

“Paragon’s unparalleled expertise in the rapidly growing market of gene therapy manufacturing will be a transformative addition to our business that we believe will accelerate our long-term growth. Paragon brings to Catalent a complementary capability that will fundamentally enhance our biologics business and our end-to-end integrated biopharmaceutical solutions for customers,” said John Chiminski, Catalent’s Chair & Chief Executive Officer. “We look forward to working with Paragon’s incredibly talented team and world-class customers to complete the significant ongoing investments into expanded state-of-the-art facilities and deliver revolutionary, lifesaving treatments to patients.”

Paragon’s differentiated scientific, development and manufacturing capabilities have positioned it to capitalize on strong industry tailwinds in the potentially $40 billion addressable market for gene therapy. Paragon brings specialized expertise in adeno-associated virus (AAV) vectors, the most commonly used delivery system for gene therapy, as well as unique capabilities in GMP plasmids and lentivirus vectors.

For over 25 years, Paragon has partnered with some of the world’s best biotech and pharma companies to develop and manufacture products based on transformative technologies, including AAV and other gene therapies, next-generation vaccines, oncology immunotherapies (oncolytic viruses and CAR-T cell therapies), therapeutic proteins, and other complex biologics.

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Floreo Inc. Wins BioHealth Capital Region 4th Annual Crab Trap Competition

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– Winning company focused on learning solutions for those with Autism.

Other finalists presented innovative technologies related to Multiple Sclerosis, Spine Alignment, TBI and Oncolytic Immunotherapeutics 

Competition sponsored by Wilson Sonsini Goodrich & Rosati held during 2019 BioHealth Capital Region Forum –

Floreo 2019 crab trap image

Judges of the 2019 Crab Trap competition present Floreo Inc. CEO and Co-Founder, Vijay Ravindran their award 

ROCKVILLE, MARYLAND, April 9, 2018 – Floreo Inc., an early stage startup founded in 2016 which is leveraging the power of virtual reality to deliver immersive, fun, and affordable lessons for children and adults with autism spectrum disorder (ASD), was chosen from five finalists as the firm with the most commercial potential at the 4th Annual Crab Trap Competition. This year’s judges included industry leaders John Rubin of JP Morgan Private Bank, Charles J. Andres of Wilson Sonsino Goodrich & Rosati’s, Raghav Bhargava of New Enterprise Associates (NEA), Ethel Rubin of NIH/BHI, John Trainer of AstraZeneca, and Norm Marcus, MD. Of Sanderling Ventures.

The Judges were impressed with Floreo’s CEO and Co-Founder, Vijay Ravindran, presentation of his company’s technology which was inspired by his autistic son’s reaction to virtual reality. Floreo’s library of lessions are currently used in schools, therapy, and homes while providing a supervising adult the opportunity to monitor and track the learner’s progress. Floreo joins previous Crab Trap winners Galen Robotics (2018), LifeSprout (2017) and Sonavex (2016).

In addition to Floreo, the judges and 2019 BioHealth Capital Forum audience viewed presentations by  four other finalists – BeCareLinkBRAINBox SolutionsSpine Align, and Unleash Immuno Oncolytics. “Every year the Crab Trap competition has brought some of the most exciting science and technology to the BioHealth Capital Region Forum. Most people know somebody who has been impacted by challenges of Autism. The technology that Floreo has developed and is continuing to improve makes them a very worthy award winner.” said Richard Bendis, BHI President & CEO.  “The congratulate all the companies and presenters on their progress to date and wish them great success in the future.  The judges made clear this was a particularly competitive group of finalists.”

Founded by BioHealth Innovation, Inc. (BHI) and MedImmune (now AstraZeneca) in 2016, the Crab Trap Competition focuses on companies in therapeutics, diagnostics, medical devices, healthcare services, e-health, mobile health, electronic medical records, health informatics, and biohealth cyber security. The grand prize this year is $10,000 plus $10,000 worth of legal consultive services provided by Crab Trap Sponsor Wilson Sonsini.

About the BioHealth Capital Region

The BioHealth Capital Region (BHCR) consisting of Maryland, Virginia, and Washington, DC is the prominent BioHealth cluster in the Mid-Atlantic. The BHCR encompasses more than 800 life sciences companies, over 70 federal labs and world-class academic and research institutions. According to Genetic Engineering News in 2018, the BHCR is ranked 4th in Top Biopharma Clusters in the country. The BHCR brand represents collaboration among leading stakeholders with a collective goal to make the BHCR a top 3 biohealth cluster by 2023. http://www.biohealthcapital.com/

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Media contacts:
Richard Bendis
Phone: 301-637-6439, e-mail: rbendis@biohealthinnovation.org

Johnson & Johnson Innovation and Children’s National Health System* to Launch JLABS @ Washington, DC at the new Children’s National Research and Innovation Campus in 2020

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WASHINGTON, April 9, 2019 /PRNewswire/ — Johnson & Johnson Innovation LLC and Children’s National Health System (Children’s National) today announced a collaboration to launch JLABS @ Washington, DC, a 32,000-square foot facility to be located at the new Children’s National Research and Innovation Campus in Washington, DC. This Children’s National expansion is set on a nearly 12-acre portion of the former Walter Reed Army Medical Center campus in the nation’s capital. The co-location of the Research and Innovation Campus with key partners in the areas of public health research, innovation and incubator space is critical to accelerating the translation of potential breakthrough discoveries into new treatments and technologies. The JLABS @ Washington, DC site will be open to pharmaceutical, medical device, consumer and health technology companies that are aiming to advance the development of new drugs, medical devices, precision diagnostics and health technologies, including applications in pediatrics.

This collaboration marks the second time Johnson & Johnson and Children’s National have teamed up to emphasize the importance of investing in the health and well-being of babies and children around the world. Through either sponsorship or membership, both entities founded Safe Kids Worldwide, a nonprofit organization aiming to help families and communities keep kids safe from injuries.

“The vision we pursued for this campus required a global innovation partner with a strong commitment to pediatric health and a clear understanding of the next big areas of opportunity for improving human health. We believe the JLABS model is exactly what is needed to help us drive discoveries that are then rapidly translated into new treatments and technologies,” said Kurt Newman, M.D., President and Chief Executive Officer, Children’s National.

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MaxCyte® Launches ExPERT™ Family of Instruments, Providing a Unifying Technology Platform from Concept to Commercialization for the Next Generation of Cellular Therapies

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Gaithersburg, Maryland – April 8, 2019: MaxCyte, the global clinical-stage cell-based medicines and life sciences company, announced today the launch of the new ExPERT™ technology platform. This family of instruments – the ATx, STx and GTx – represents the next generation of the industry’s leading, clinically validated Flow Electroporation® technology for complex cellular engineering. With these additions to the product portfolio, MaxCyte continues its uncompromising focus on high performance cellular editing, while delivering feature enhancements that will enable customers to use a single unifying technology, from concept to commercialization.

“The ExPERT instrument family is the result of extensive customer research into feature design, functionality and performance that are considered critical to enabling the next generation of cellular therapies,” said Brad Calvin, Executive Vice President of Global Commercial Operations for MaxCyte. “Creating cellular editing platforms standardized on a single, scalable, high performance technology can assist the industry in accelerating timelines, reducing costs and achieving milestones critical to the translation of this promising new generation of cellular therapies.”

The ExPERT ATx, STx and GTx build on the solid technology foundation that has been the core of MaxCyte’s historical instrument platforms, which are broadly used by leading companies across the biopharmaceutical industry who are developing increasingly sophisticated biological and cellular-based therapeutics.

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Immunomic Therapeutics Presents Late-Breaking Preclinical Data on DNA Vaccine ITI-7000 at AACR 2019

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ROCKVILLE, Md.–(BUSINESS WIRE)–Apr 2, 2019–Immunomic Therapeutics, Inc. will present late-breaking preclinical data which shows that its’ investigational nucleic acid platform, UNITE, may enhance antitumor immunity when used in connection with its investigational DNA vaccine, ITI-7000. In preclinical studies, ITI-7000, an investigational DNA vaccine targeting ErbB2/HER2, demonstrated robust activation of known anti-tumor CD4 and CD8 cells in vivo and promoted tumor infiltration with activated CD8 T cells. These data will be presented at the American Association for Cancer Research (AACR) 2019 meeting in Atlanta, Georgia.

“There’s no doubt that DNA vaccines are attractive immunotherapies to treat cancer and infectious diseases. However, research in this field has been met with many challenges, one of the most complex being low levels of immunogenicity and the inability to provoke an immune response and demonstrate favorable clinical outcomes,” said Teri Heiland, Ph.D., Senior Vice President of Research and Development at Immunomic Therapeutics. “These late-breaking data at AACR suggest that our proprietary UNITE platform has the potential to enhance the immunogenicity of DNA vaccines by activating T cell responses and increasing tumor infiltration. We are highly encouraged by this data and look forward to continuing to advance ITI-7000 toward the clinic.”

In addition to observing activation of known anti-tumor CD4 and CD8 cells in vivo, Immunomic scientists observed the overexpression of PDL1 in the tumor microenvironment. This pathway has shown clinical relevance as a cancer immunotherapy target of the tumor microenvironment. PDL1 overexpression upregulated by ITI-7000 suggests that a combination of ITI-7000 with an anti-PD1/PDL1 therapy may increase the therapeutic potential of either agent on its own. This data also supports the prevailing belief in the immunotherapy community that cancer vaccination could synergize with anti PD1 and PDL1 and other immunotherapies, as well as support the viability of the UNITE platform as a means to do so. In summary, these findings support the potential of ITI-7000 as a cancer vaccine and highlight that UNITE, Immunomic’s nucleic acid platform, may have the potential to enhance immunity of investigational cancer therapies.

Click here to read the entire release.

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