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347th Edition – March 26, 2019

By BHI Weekly Newsletter Archives




BioHealth Innovation


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March 26, 2019












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MedImmune spinout Viela Bio raising another $75M – Washington Business Journal

Viela Bio had raised $282 million when it launched at the end of February 2018.

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Interview: Viela Bio Eyes BLA for Lead Asset Only One Year After Launch | BioSpace

One year after spinning out from AstraZeneca’s MedImmune, Viela Bio is already anticipating filing a Biologics License Application with the U.S. Food and Drug Administration (FDA) for its lead asset, inebilizumab.

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2019 Fifth Annual BioHealth Capital Region Forum – Only 2 Weeks Left to Register

April 8 + 9, 2019

One MedImmune Way, Gaithersburg, MD 20878

This invitation-only event is free for executive level biotech leaders and is presented by BioHealth Innovation, VirginiaBio, Maryland Tech Council, University System of Maryland, Children’s National Health Network, HemoShear, GSK, BeneVir, Quality Biological, Johns Hopkins University and AstraZeneca. Maryland, Virginia, and Washington, DC set the bar high for biotech innovation. So please join us for our Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

REGISTER TODAY!

Register at bhcrf2019.eventbrite.com

For more information about our speakers and event schedule, please visit www.bhcrforum.com.

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Emergent BioSolutions Initiates Phase 3 Clinical Study to Evaluate AV7909 for Post-Exposure Prophylaxis of Anthrax | Vaccines | News Channels

Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase 3 trial to evaluate the lot consistency, immunogenicity, and safety of AV7909 (anthrax vaccine adsorbed with CPG 7909 adjuvant) following a two-dose schedule administered intramuscularly in healthy adults. AV7909 is being developed for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure.

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Join us April 4, 2019 – PATHFINDER INNOVATION PROGRAM

Successful Marketing and PR Strategies for Your Startup

  • PR and Marketing – What’s the difference?
  • How do you establish your brand?
  • Are there tips for marketing on a tight budget?
  • What should an effective marketing plan include?
  • How can a strong digital strategy build credibility?
  • How do I get press coverage for my product/service/technology?
  • What type of budget is realistic for marketing/public relations activities?

SPEAKERS

  • Sasha Whitaker – American Gene Technologies
  • Warren Ellis – Montgomery County Economic Dev. Corp.
  • Jennifer Owers and Rachel Wojnilower – Clark Concepts

SCHEDULE

  • 8:15 a.m. – Networking and Coffee
  • 8:30 a.m. – Discussion with Q&A (in person/by videoconference)
  • 9:45 a.m. – One-on-One Meetings with Experts*

 Pre-Registration REQUIRED: RSVP by NOON, 4/3 at BHI@BioHealthInnovation.org

No charge to attend

More Details »

*In person attendance during the discussion is required to participate in 1:1 meeting with experts.

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Altimmune Announces Positive Results from NasoVAX Extension Study

Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, today announced additional positive data from a Phase 2 extension study of its NasoVAX intranasal influenza vaccine candidate. Data from this study demonstrated that 100% of the evaluated subjects remained seroprotected, and the seroconversion rate was unchanged more than one year after vaccination.

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2019 NCI and FNL Technology Showcase – Keynote Speaker: BHI’s Rich Bendis

We are excited to announce that Rich Bendis of BioHealth Innovation will be the keynote speaker at the 2019 Technology Showcase. Now in its third year, the Technology Showcase promises to be a “must attend” event for biotech stakeholders in Maryland/DC/VA region. Check out the event page to learn more about our keynote speaker and some of the great panel sessions that we have planned.

Make sure to reserve time on your calendar for the afternoon of Wednesday, June 12.

The 2019 Technology Showcase is a half-day event that will showcase technologies being developed at the NCI and the Frederick National Laboratory for Cancer Research (FNLCR) to encourage startup company formation, technology licensing and collaborations. Innovators, entrepreneurs, investors and business development professionals should attend.

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Paragon Bioservices Appoints New CTSO, Bolsters Leadership Ranks to Support Late-Stage Clinical and Commercial Biopharmaceutical Manufacturing – Paragon Bioservices, Inc.

Paragon Bioservices, the leading private equity-backed, biologics contract development and manufacturing organization (CDMO) announced today the appointment of Thomas VanCott, Ph.D., as Chief Technology and Strategy Officer (CTSO), along with several key promotions and new hires.

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Johns Hopkins spinout Vixiar gets $1.5M for tablet-based cardiac measurement system | MobiHealthNews

Vixiar, a Johns Hopkins spinout marketing a tablet-based point of care system for assessing cardiac filling pressure, has raised $1.5 million in Series A funding. This brings the company’s total funding to $3 million.

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GSK pancreatic cancer drug heads to phase 1 combo with Merck’s Keytruda after positive mouse trial | FierceBiotech

GlaxoSmithKline’s experimental drug GSK095 is designed to work in tandem with checkpoint inhibiting medicines in the hopes of empowering the immune system to launch a more aggressive attack against tumors than it does with checkpoint inhibitors alone. Early results from a preclinical trial of a related GSK drug suggest that the combo holds promise in treating pancreatic cancer—so much so that the company is launching a phase 1 study of the drug in combination with Merck’s blockbuster PD1 checkpoint inhibitor Keytruda.

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Takeda and HemoShear Therapeutics Extend Exclusive Drug Discovery Partnership in Liver Diseases

HemoShear Therapeutics, LLC, a privately held biotechnology company, today announced an extension of its partnership with Takeda Pharmaceutical Company Limited to discover and develop additional novel therapeutics for liver diseases, including nonalcoholic steatohepatitis (NASH).

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Researchers at Johns Hopkins offer new protocol to potentially cure sickle cell disease

There’s new hope for patients who have blood diseases. Johns Hopkins Kimmel Cancer Center researchers say a new protocol offers the possibility of a cure. One patient who tried the treatment says it didn’t just change her life, it saved it.

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What’s behind sky-high valuations of biopharma startups? – MedCity News

2018 was undoubtedly one of the most important years ever for biopharma, setting records for valuations and dealmaking. But a paper published in January called some of that exuberance into question, noting that many startups over the years have managed to become unicorns – with valuations of $1 billion or more – despite having little or no published, peer-reviewed data.

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Top 10 Immuno-Oncology Collaborations

A sampling of recent reports shows just how much immuno-oncology continues to grow. Last month, GrandView Research projected a more than doubling of the global cancer immunotherapy market, from the $58.1 billion it tallied in 2018, to $126.9 billion by 2026. As GEN noted when it ranked the top immuno-oncology startups in February, market projections range from $124.88 billion (Transparency Market Research) to $173 billion (Market Research Engine) by 2024.

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How Do You Start A Biotech Company?

To launch a company that might attract the investment you need to develop a promising new drug candidate or research tool you need to assemble at least two, but preferably all, of these three things: (a) intellectual property (IP), (b) proof of principle, and (c) team with some biotech experience.

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Flagship Pioneering raises $824M in new fund – MedCity News

A life sciences-focused venture capital firm has raised more than $800 million for its latest fund.

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Initial Results from Autolus Therapeutics’ ALLCAR19 Phase 1/2 Trial in Adult Acute Lymphoblastic Leukemia Presented at the AACR Annual Meeting | Autolus Therapeutics plc

By News Archive

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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 Claire Roddie MB, PhD, FRCPath, honorary senior lecturer, Cancer Institute, University College London (UCL), presented today initial data from the ongoing Phase 1/2 ALLCAR19 trial of AUTO1 in adult acute lymphoblastic B cell leukemia (ALL) as a late-breaking poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2019 in Atlanta, Georgia.

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LRIG Metro DC Spring Show

By News Archive

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April 4, 2019 3pm-6:30pmUniv. Shady Grove Convention Center 9630 Gudelsky Drive, Rockville, Maryland 20850

Welcome to the Spring 2019 Meeting of the Metro DC Chapter of the Laboratory Research Interest Group! Although we have deep roots in Laboratory Automation, we also invite you to learn about other research technologies, new tools, and projects that are available and ongoing in the Capitol Bioscience hub!

This years theme is Emerging Technologies at the Forefront of Bioscience, with emphasis on 3D Cell Printing, Organoids, Tissue-On-Chip models, and Artificial Intelligence in Bioscience.

Attendance is free with your Eventbrite reservation, and we encourage you to register early.

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Bhcr crab trap finalists 2019

Five Innovative BioHealth Companies Selected to Present Technologies at 4th Annual BioHealth Capital Region Crab Trap Competition

By News Archive

Bhcr crab trap finalists 2019

– Winner to be announced during 2019 BioHealth Capital Region Forum –

Five innovative companies focused on the diagnosis or treatment of Multiple Sclerosis, TBI, Autism, Spinal misalignment, and Metastatic Cancer will present their innovative technologies to a panel of judges and industry leaders on April 9th during the 2019 BioHealth Capital Region Forum, at the AstraZeneca campus in Gaithersburg, Maryland. Founded by BioHealth Innovation, Inc. (BHI) and AstraZeneca in 2016, the annual Crab Trap Competition highlights biohealth companies with strong commercial potential. The five finalists were selected from a competitive field of almost fifty entries. The 4th Annual Crab Trap Competition is sponsored by Wilson Sonsini Goodrich & Rosati. The grand prize this year is $10,000.

In 2016, the initial prize was awarded to Sonavex, a commercial stage Johns Hopkins spin-out focused on Empowered Patient Care.  The company’s first technology is a dual-component system comprising an FDA-cleared bioabsorbable implant (EchoMark) and an FDA-cleared custom automated ultrasound (EchoSure) to detect post-operative vascular complications prior to catastrophic surgical failures that represent a $3B annual market and cost hospitals up to $577,000 per instance. The company closed a $4.5M Series A in 2018, recently secured a $3M NIH grant and is currently raising its Series B. In 2017, the winner was another Johns Hopkins (JH*) spinout, LifeSprout, developer of a suite of products to address soft tissue needs in the aesthetic and reconstructive markets. Last year’s winner, Galen Robotics, is developing, in partnership with JHU, a surgical robot to make minimally invasive surgeries faster, safer and more precise. The company plans a 510k submission next year, is raising Series A financing, and will be relocating the HQ team in CA to join their engineering experts in Baltimore.

The 2019 BioHealth Capital Region Crab Trap Finalists presenting at the forum at 9:30 a.m. on Tuesday, April 9th, are:

BeCareLink – Predictive Artificial Intelligence Digital Therapeutic Mobile Platform for Multiple Sclerosis and other neurological conditions.

BRAINBox Solutions – Multi-Modality capability to diagnose and provide prognostic information for mild Traumatic Brain Injury. 

Floreo Inc. Leveraging the power of virtual reality to develop a subscription platform that delivers immersive, fun, and affordable lessons for children and adults with autism spectrum disorder (ASD). 

Spine Align – Spine Align is a medical device company developing technologies that enable spine surgeons to make real-time intraoperative measurements of spinal alignment.

Unleash Immuno Oncolytics – Developing armed, oncolytic viruses to treat metastatic cancers.  Our platform combines tissue-specific control of both viral replication and the expression of human cytokines to provide a dual punch in cancer cells.

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Noble Life Sciences’ CEO Srujana Cherukuri, Ph.D. joins Rich Bendis for a New Episode of BioTalk!

By BioTalk with Rich Bendis Podcast, News

Cherukuri-noble-sciences-biotalk-article-image.jpgA very interesting episode of BioTalk where Srujana Cherukuri, Ph.D. discusses her path from Intern to CEO and where the company is headed next

Before becoming CEO, Dr. Cherukuri served in multiple roles at Noble Life Sciences including Chief Operations Officer, Chief Scientific Officer, Vice President of Product Development and Operations, and Director of Scientific Affairs.  In her previous roles at Noble, Dr. Cherukuri was instrumental in optimizing new preclinical animal models and streamlining operations to achieve operational efficiency.  In addition, Dr. Cherukuri led the successful consolidation of Noble operations at the Spring Valley Laboratories site. Prior to joining Noble, Dr. Cherukuri held positions at the Cleveland Clinic Foundation, National Cancer Institute and University of Maryland where she led projects focused on understanding the basic biology and mechanistic actions in cancer cells. Dr. Cherukuri has expertise in diverse areas of Biology and has 12+ years of research experience in the areas of oncology and stem cell biology.  Dr. Cherukuri completed her PhD in biology at Cleveland State University.

Listen now on iTunesGoogle Play, and TuneIn

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AstraZeneca and Daiichi Sankyo Sign $6.9 Billion Deal for a Single Cancer Drug | BioSpace

By News Archive

astrazeneca-logo

AstraZeneca signed a global development and commercialization deal with Daiichi Sankyo for trastuzumab deruxtecan (DS-8201), an antibody-drug conjugate (ADC).

An ADC is a chemotherapy agent attached by a molecular linker to an antibody focused on a specific cancer marker. This way, the antibody delivers the toxic chemical directly to the tumors, minimizing the effects of the chemotherapy on healthy cells.

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Innovators – Deadline Extended to April 9th for $250K Pediatric Device Competition

By News Archive

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Pediatric orthopedic and spine medical device innovators –good news—the deadline has been extended until Tues., April 9 at midnight EST to apply for the NCC-PDI “Make Your Medical Device Pitch for Kids!” competition with $250K in awards.

This is your chance to capture up to $50,000 in funding and gain access to the first-ever NCC-PDI “Pediatric Device Innovator Accelerator Program” led by MedTech Innovator.

Innovators earning a spot at this one-of-a-kind pediatric accelerator will receive mentorship and support from NCC-PDI’s network of medtech executives, investors, specialty pediatricians and FDA regulatory and business consultants. All finalists will be offered pitch perfect coaching by Entrepreneurs-In-Residence at BioHealth Innovation.

The competition will be held April 30, 2019 at the University of Maryland, College Park. Be part of it!

Jump start your journey to commercialization. The first step is applying here before the April 9, 2019 midnight EST deadline.

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Creatv MicroTech’s Liquid Cell Biopsy and CAML cancer biomarker featured at AACR 2019 – Press Release

By News Archive

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Creatv MicroTech, detecting and diagnosing cancer when it matters most, will present its latest findings on cancer diagnosis and treatment at the Annual American Association for Cancer Research (AACR) Meeting at Atlanta, Georgia, March 29 – April 3, 2019.  Two posters will showcase the clinical utility of cancer-associated macrophage-like cells (CAMLs) biomarker.

Abstract No. 437 / 9: “Combining circulating stromal cells with cell free DNA for increased sensitivity in profiling oncogenic mutations and indicates highly aggressive non-small-cell lung cancer,” investigating the clinical potential of Circulogene’s Patient Mutation Load (PML) analysis from matched cfDNA, CAMLs, and tumor tissue to evaluate progression free survival (PFS) and overall survival (OS) in non-small-cell lung cancer (NSCLC).

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