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434th Edition, December 15, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


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December 15, 2020












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AstraZeneca to acquire Alexion for $39 billion in blockbuster deal

AstraZeneca on Saturday said it was acquiring Alexion Pharmaceuticals for $39 billion, marking a significant expansion into the treatment of rare diseases of the immune system.

The deal — a mix of cash and stock — values Alexion at $175 per share, a 45% premium to Friday’s closing stock price.

Image: KRISTOFFER TRIPPLAAR/SIPA/AP

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Qiagen, producer of COVID tests, to expand in Germantown, add 300 jobs – Maryland Daily Record

Qiagen, an international life sciences company that provides molecular sample and assay technologies, is expanding its United States headquarters in Germantown to accommodate increased production of testing products for COVID-19 and other diseases. The company, which is based in the Netherlands, has already spent over $7 million on new equipment and improvements to its 146,000-square foot …

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EIR Feedback (BHI) – Wednesday, December 16, 2020 – Biohealth Innovation

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

 

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COVID-19 Strategic Renewal Task Force Report | ConnnectedDMV

COVID-19 STRATEGIC RENEWAL TASK FORCE REPORT

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2020: The Human Immunome: Small Moves Become a Movement — The Golden Goose Award

The Human Immunome: Small Moves Become a Movement

“We’re basic scientists. We did not set out initially just to make drugs. That’s not what it was about when we started. I’ve just always been interested in how the human immune system even recognizes a virus,” says James E. Crowe, Jr., a well-known infectious disease expert who directs the Vanderbilt Vaccine Center in Nashville, Tennessee. “Now we can study how the body works and have curiosity about that, but also have drugs in the pipeline. It’s the unexpected benefit we get by delving deeply into the human immune system.” Crowe is one of the recipients of the 2020 Golden Goose COVID-19 Recognition for his decades-long pursuit of a better understanding of the human immune system, which is now paying dividends in the fight against COVID-19.

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United Therapeutics Receives FDA Orphan Drug Designation For Treprostinil For The Treatment Of Idiopathic Pulmonary Fibrosis

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 9, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF). United Therapeutics intends to initiate a phase 3 study, called TETON, to evaluate the use of Tyvaso® (treprostinil) Inhalation Solution in patients with IPF. FDA recently cleared United Therapeutics’ investigational new drug application (IND) for the TETON study, and the company expects to commence enrollment in 2021. Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. This exclusivity would also benefit Treprostinil Technosphere®, United Therapeutics’ next-generation dry powder inhalation form of treprostinil, upon FDA approval of that product for the IPF indication.

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USM COVID Research & Innovation Task Force Launches Student PSA Public Health Challenge – USM

Baltimore, Md. (Dec. 11, 2020) – The University System of Maryland (USM) COVID Research and Innovation Task Force is bringing together people, expertise, and resources from its 12 universities to rapidly advance solutions to challenges presented by the COVID-19 pandemic. With the generous support of several local organizations, the Task Force is inviting members of the USM community to take part in a multimedia, Public Health Challenge seeking creative submissions that highlight ways for USM students, members of the broader university community, and all Marylanders to stay safe and healthy while waiting for a vaccine to become available.

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Funding Opportunities | MSCRF – 1/14 Deadling to Apply

We offer six programs to accelerate discovery and commercialization of human stem cell-based technologies. Please verify eligibility, read the appropriate RFA below and apply here.

Companies or Universities/Research Institutes that wish to conduct human stem cell-based clinical trials in the State of Maryland. 1:1 match of non-state money is required. IND required

 

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Novavax Appoints Vaccine Industry Expert Margaret G. McGlynn to Board of Directors | Novavax Inc. – IR Site

GAITHERSBURG, Md., Dec. 09, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Margaret G. McGlynn, R. Ph. to its board as an independent director. Ms. McGlynn brings extensive pharmaceutical industry, vaccine and non-profit experience to her role on the Novavax Board of Directors.

“Margie’s deep experience in vaccine commercialization and understanding of global public health will be invaluable as we move closer to collecting Phase 3 clinical data and submitting NVX-CoV2373, our COVID-19 vaccine candidate, for regulatory authorization and approval,” said Stanley C. Erck, Novavax President and Chief Executive Officer.

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REGENXBIO Announces Positive Interim Data and Update for Phase I/II Trial of RGX-121 for the Treatment of MPS II | BioSpace

ROCKVILLE, Md., Dec. 8, 2020 /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 interim data from Cohorts 1 and 2 of the ongoing Phase I/II trial of RGX-121 for the treatment of patients up to 5 years old diagnosed with Mucopolysaccharidosis Type II (MPS II). In addition, REGENXBIO announced plans to evaluate a higher dose of RGX-121 in a third cohort of patients at an increased dose of 2.0×1011 GC/g brain mass. REGENXBIO expects to begin enrolling patients in Cohort 3 in the first quarter of 2021.

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Liquid Biopsy Predicts Esophageal Cancer Patient Response to Treatment | Business Wire

ROCKVILLE, Md.–(BUSINESS WIRE)–Creatv MicroTech, a privately-held biotechnology company has pioneered a blood test to predict treatment response in patients with newly diagnosed Stage I-III esophageal cancer (EC) treated with chemoradiation therapy (CRT). The results were published in the Journal of Translational Medicine. Creatv’s collaborator MD Anderson Cancer Center recruited patients for the study under standard of care CRT and IRB approved protocol. “We are delighted to present a method to stratify patients with EC who are responding to CRT using a single tube of blood,” said Dr. Cha-Mei Tang, CEO of Creatv. “Now, patients who are not responding to CRT can be identified quickly for alternative therapy.” Currently, no other blood test predicts treatment response for Stage I-III esophageal cancer therapies.

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Avoid these 5 real-world data pitfalls when planning your patient registry, cohort study, or observational clinical study

When clinical investigators and study coordinators start planning a new study design, speed and efficiency are paramount.

Running a clinical study takes careful planning. Whether this is your 1st clinical study or your 21st, the last thing you probably want to do is waste time and resources on data collection delays that are easy to prevent.

Traditionally, major bottlenecks occur during study startup, eligibility screening, the informed consent period (including assent in pediatric studies), and patient travel to the clinical site(s). Researchers eager to get the ball rolling on their study can save time and ease logistical burdens by stopping data gridlock before it begins.

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Vaccitech, Future Planet backed Oxford Spinout, Offers Global Path to End of COVID-19 — Future Planet Capital

This week, interim Phase III data was released for the Oxford / AstraZeneca Vaccine, co-invented by our portfolio company Vaccitech. From late December, assuming the full dataset has been analysed and confirmed to meet formal regulatory requirements, AstraZeneca has announced that they believe they will be in a position to provide a vaccine for a quarter of the world’s population. The vaccine will not just benefit the UK, EU and US who have ordered millions of doses, but the developing world, too. The Serum Institute of India has already begun producing 1 billion doses for the global south.

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Emmes Announces its Contribution to Second Remdesivir Clinical Trial for COVID-19 | BioSpace

ROCKVILLE, Md., Dec. 14, 2020 /PRNewswire/ — Emmes today announced that it has conducted the data and statistical analysis for the second iteration of the Adaptive COVID-19 Treatment Trial (ACTT-2). The ACTT-2 trial assessed the efficacy and safety of a 4-mg dose of baricitinib with remdesivir, versus remdesivir alone, in hospitalized COVID-19 patients.

Baricitinib, produced by Eli Lilly and Company, has been used to treat adults with moderate to severe rheumatoid arthritis. Baricitinib, in combination with remdesivir for COVID-19 patients, received Emergency Use Authorization on November 19.

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COVID-19 — The Disease That Is Reshaping Manufacturing | NIST

Unless you’ve been living on private island (send invite immediately!), it’s no secret that the pandemic has changed the way manufacturers operate and run their businesses in order to survive these challenging times.

At least that’s what we at the National Institute of Standards and Technology’s Manufacturing Extension Partnership (NIST MEP) have heard from manufacturers over 11 virtual listening sessions we call the “National Conversation with Manufacturers.”

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Reflecting on 2020 and Wishing You Happy Holidays

Though it began like any other year, 2020 has proven to be one of the most difficult and frustrating periods of our lifetime. This was especially true for our business community, which faced numerous new obstacles including shifting consumer needs, new safety requirements and a general uncertainty about what lay ahead.

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George Washington University, US Patent Innovations targeting cancer and Covid in $3.2M corporate research agreement – Washington Business Journal

The university licenses its original patent to the company to develop the product and conduct early-stage clinical trials.

Image: Michael Keidar, a mechanical engineer by training, is a professor of engineering at George Washington University. WILLIAM ATKINS

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The Enactment of Bayh-Dole, An Inside Perspective – IPWatchdog.com | Patents & Patent Law

We caught the tide– but just barely. That the Bayh-Dole Act passed was amazing. That it passed in a lame duck session of Congress with its principal author defeated, the US Senate changing hands, and a sitting president thrown out, was a miracle. Even then success was not assured. The bureaucracy was waiting to undermine the implementing regulations. Yet the new law survived, strengthening the economy while improving public health and well-being.

Image: U.S. Senator Birch Bayh (ret.)

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Where In The World Should I Conduct My Pivotal Clinical Trial? · BioBuzz

The COVID pandemic has certainly forced us to re-think the whole paradigm of conducting clinical trials. From design, site and CRO selection, patient recruitment, data management, to execution, the world of clinical trials has been altered significantly in 2020… and most likely beyond.

Here are some relevant questions you should be asking yourself and that we will be asking our panelists in today’s webinar:

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Novo Holdings: the world’s largest biotech investor | Sifted

What’s the world’s largest charitable foundation? Nope, its not the Bill and Melinda Gates Foundation. Not even the Wellcome Trust.

It’s Novo Nordisk Foundation, a $65bn endowment headquartered in Copenhagen.

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AUTM 2021 Conference

Top Reasons to Attend:

  • The world may have stopped, but your professional development doesn’t have to.
  • Education and networking from the comfort of your own couch.
  • Loads of partnering opportunities.
  • The programming is tops in the industry.
  • It’s a great value — in fact it’s a great year for the whole office to attend.
  • It’s an important investment in your future.

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novavax logo

Novavax Announces Initiation of PREVENT-19 Pivotal Phase 3 Efficacy Trial of COVID-19 Vaccine in the United States and Mexico | Novavax Inc. – IR Site

By News Archive

novavax logo

GAITHERSBURG, Md., Dec. 28, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced initiation of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, the Company’s COVID-19 vaccine candidate. The trial builds on research from Phase 1/2 studies demonstrating that the vaccine provoked a robust immune response, generated highly neutralizing antibodies against the virus and was generally well-tolerated.

 

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REGENXBIO Logo

REGENXBIO Announces Agreement to Monetize Portion of Zolgensma® Royalties for $200 Million | BioSpace

By News Archive

REGENXBIO Logo

ROCKVILLE, Md., Dec. 22, 2020 /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 that it has entered into an agreement to sell a portion of the royalty rights due to REGENXBIO from Novartis Gene Therapies from the net sales of Zolgensma® to entities managed by Healthcare Royalty Management, LLC (HCR) for a gross purchase price of $200 million. This transaction provides immediate, non-dilutive capital to REGENXBIO for continued innovation in the development of potential breakthrough gene therapies for patients and completion of its internal manufacturing capabilities.

 

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REGENXBIO Logo

REGENXBIO Announces Agreement to Monetize Portion of Zolgensma® Royalties for $200 Million | BioSpace

By News Archive

REGENXBIO Logo

ROCKVILLE, Md., Dec. 22, 2020 /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 that it has entered into an agreement to sell a portion of the royalty rights due to REGENXBIO from Novartis Gene Therapies from the net sales of Zolgensma® to entities managed by Healthcare Royalty Management, LLC (HCR) for a gross purchase price of $200 million. This transaction provides immediate, non-dilutive capital to REGENXBIO for continued innovation in the development of potential breakthrough gene therapies for patients and completion of its internal manufacturing capabilities.

 

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United Therapeutics Logo

Genetically Modified Pigs May Save Your Life: FDA Allows GMO Pigs

By News Archive

united therapeutics corporation logoThe U.S. Food and Drug Administration (FDA) has approved the second-ever genetically modified subtype of pig for human consumption. But there are no plans to raise this pig for meat or other foodstuffs—the use case is actually much, much cooler.

Get unlimited access to the weird world of Pop Mech. LET’S GET WEIRD. By adjusting the pig’s genes so it doesn’t produce a particular sugar called galactose-alpha-1,3-galactose (alpha-gal), scientists can make medicines that are safe for a group of people who suffer from a peculiar, little-understood allergy. And while this certification isn’t planned for meat, that could be next.

Image: TIM MACPHERSON

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United Therapeutics Logo

Genetically Modified Pigs May Save Your Life: FDA Allows GMO Pigs

By News Archive

united therapeutics corporation logoThe U.S. Food and Drug Administration (FDA) has approved the second-ever genetically modified subtype of pig for human consumption. But there are no plans to raise this pig for meat or other foodstuffs—the use case is actually much, much cooler.

Get unlimited access to the weird world of Pop Mech. LET’S GET WEIRD. By adjusting the pig’s genes so it doesn’t produce a particular sugar called galactose-alpha-1,3-galactose (alpha-gal), scientists can make medicines that are safe for a group of people who suffer from a peculiar, little-understood allergy. And while this certification isn’t planned for meat, that could be next.

Image: TIM MACPHERSON

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Gates Notes Cover Image from Linkedin

These breakthroughs will make 2021 better than 2020 | LinkedIn

By News Archive

Gates Notes Cover Image from Linkedin

The latest on the innovations that will let us go back to normal. This has been a devastating year. More than 1.6 million people have died in the COVID-19 pandemic, with more than 75 million cases and tens of trillions of dollars in economic damages. Millions of people are out of work and struggling to pay their bills, and more than a billion children are missing out on crucial time in school. In the U.S., this year also saw the horrifying killings of George Floyd and Breonna Taylor, ruinous wildfires, and a presidential election unlike any other in modern times.

 

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Virginia Biotech Logo

Virginia Bio Will Direct New “Virginia Bio-Connect” Statewide Consortium to Strengthen Competitiveness of Virginia’s Life Science Ecosystem | Business Wire

By News Archive

Virginia Biotech Logo

RICHMOND, Va.–(BUSINESS WIRE)–Governor Northam and the Virginia Biotechnology Association announced today that GO Virginia has approved a competitive grant request to help fund Virginia Bio-Connect, a $3.2 million Statewide industry cluster scale up initiative. The project, directed by the Virginia Biotechnology Association, is a multi-regional collaboration designed to increase connectivity and awareness of the existing programs, resources, and communities in the Commonwealth that support the life sciences industry.

 

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Washington Memorial from the Steps of the Lincoln Memorial.

Task force report outlines steps to build stronger post-pandemic economy in Maryland, Virginia, D.C. – The Washington Post

By News Archive

Washington Memorial from the Steps of the Lincoln Memorial.

More than 50 local leaders have mapped out an economic recovery strategy for the Washington area that they say would leave it more unified, resilient and prosperous than before the novel coronavirus upended the region.

Connected DMV — a group representing the local academic, nonprofit, public and private sectors — initially came together in March 2019 to drive economic growth in the D.C. area. When the pandemic struck a year later, the group pivoted to creating what it calls a “strategic renewal” task force, which issued a report this month with 12 initiatives to remedy the region’s social and economic challenges.

 

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