429th Edition, October 28, 2020

Scott Carmer, CEO of NexImmune, joins BioTalk to discuss his career in the BioHealth Capital Region, recent Milestones, and his Long-Term Vision for the company

Listen now via Apple https://apple.co/3kxdC3J, Google https://bit.ly/31FlUPB, Spotify https://spoti.fi/3kuVszD, or TuneIN https://bit.ly/2TqqD3f

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– Winning company has FDA cleared device to rapidly and objectively assess brain injury at point of care.

ROCKVILLE, MARYLAND, October 26, 2020 – BrainScope, a medical neurotechnology company that is a pioneer in the use of A.I. and machine learning in the creation of biomarkers of brain injuries and disease was selected from five finalists as the company with the most commercial potential at the 5th Annual BioHealth Capital Region Crab Trap Competition. The Bethesda, Maryland based company is helping hospital Emergency Departments (EDs) objectively triage the almost five million patients that present each year with suspected mild traumatic brain injuries. BrainScope’s FDA-cleared decision support tool provides a rapid and accurate assessment of the likelihood of a brain bleed and a concussion, at the point of care.

BrainScope’s outstanding 99% sensitivity to a head CT scan is performed without the use of radiation, in a fraction of the time, and can improve ED efficiency and increase patient satisfaction. Clinical studies have demonstrated that when BrainScope is used in triage, hospitals can reduce the number of patients being sent for head CT by about a third. According to BrainScope CEO Susan Hertzberg, “We are honored to have been chosen from this exceptional group of companies and are very excited by the early reception we are receiving from the emergency medical community.  Now more than ever in this COVID-19 world, emergency departments need to have fast, accurate, objective tools to rapidly assess patient status and needed care.”

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After posting positive results from a midstage test for its RNAi candidate back in the spring, Sirnaomics has grabbed a $105 million series D round.

The cash boost, co-led by existing investor Rotating Boulder Fund, new investor Walvax Biotechnology Co. Ltd. and Sunshine Riverhead Capital, will go toward the biotech seeking to push deeper into the clinic and one day follow rival and RNA pioneer Alnylam to regulatory approval.

The $105 million will be put toward that R&D process for its RNAi therapeutics, which are on tap to treat a diverse range of diseases including cancers, fibrosis diseases, metabolic diseases and viral infections.

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What happens when you fund Black Founders? With $100K funding & support from Google for Startups Black Founders Fund, TruGenomix plans to further advance its efforts to bring earlier diagnosis & treatment for behavioral health disorders like PTSD to military, veterans, first responders, healthcare workers & trauma-exposed communities at large. This is why the initiative matters: https://goo.gle/2SqjS10

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Rockville, Md.—Autonomous Therapeutics, Inc. (ATI), a rapidly growing antivirals company, has chosen Montgomery County’s Rockville, Maryland, for its new headquarters. ATI chose to relocate from New York City to take advantage of Rockville’s proximity to leading U.S. researchers, regulators, and funders. Their new 17,700 SF home at 1530 E. Jefferson Street is also in an Opportunity Zone, which offers an advantage for the company in attracting future investment.

ATI is developing a suite of first-in-class “Therapeutic Interfering Particles” (TIPs) to prevent respiratory pandemics, including influenza and COVID-19. The company’s lead candidates include therapeutics that are designed to prevent infections by any coronavirus strain—from COVID-19 to the next pandemic. ATI has raised millions of dollars in capital from public and private partners to transition its antiviral candidates into first-in-human clinical trials.

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She said the Rockville research company is set to grow and details Covid’s larger impact on research.

Image: Dr. Christine Dingivan took over as president and CEO of Rockville contract research organization Emmes at the end of September. COURTESY EMMES

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It will support pediatric research at the health system.

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MARSEILLE, France, Oct. 23, 2020 (GLOBE NEWSWIRE) — Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that AstraZeneca (LSE/STO/Nasdaq: AZN) has dosed the first patient in its Phase 3 clinical trial, INTERLINK-1, evaluating monalizumab in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors (“IO-pretreated”). Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

Dosing of the first patient in this trial has triggered a $50 million milestone payment from AstraZeneca to Innate.

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What is BARDA Industry Day?

BARDA Industry Day is the annual meeting held to increase potential partner’s awareness of U.S. Government medical countermeasure priorities, interact with BARDA and ASPR staff, and network with public and private sector colleagues working in the Health Security space. This year, BARDA Industry Day 2020 will be virtual and will feature one day of exciting speakers, breakout sessions, and valuable networking opportunities!

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The biotech behind AstraZeneca and the University of Oxford’s late-stage pandemic vaccine has hired Margaret (Meg) Marshall, M.D., as its new chief medical officer.

Marshall joined as a consultant to Oxford spinout Vaccitech in the summer, but she now jumps on board full time. This comes two months after it nabbed U.K. government funding for a COVID-19 vaccine it thinks can improve on first-generation prospects, including the AstraZeneca vaccine it helped develop.

Image: Vaccitech’s headquarters in Oxford, England (Jun via Flickr/CC-by-SA 2.0)

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The startup is now looking for a lead investor for its Series A round to fund the company’s go-to market roadmap.

Image: Sam Owen is founder and CEO of D.C.-based Otolith Labs ALEXANDRA WHITNEY PHOTOGRAPHY

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America’s long-term economic growth demands a stepped-up commitment to promoting the innovation impact of the nation’s top-tier universities and other research institutions.

For research institutions themselves, this commitment means prioritizing research, empowering great researchers, building efficient and outcomes-focused technology transfer operations, instilling cultures of innovation and entrepreneurship, and engaging with surrounding business and innovation communities. For America as a whole, it means funding more research resources and paying more attention to the worldwide competition for human talent, including high-skilled immigrants.

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By Brian Darmody 

Seventy-five years ago, Vannevar Bush, an electrical engineer who directed government research during the Second World War, authored Science—The Endless Frontier. His report called for a centralized approach to government research, which led to the creation of the National Science Foundation in 1950 and is credited as a path breaking roadmap for US science policy.  

Over the next 75 years, the federal government invested billions of dollars of research, creating the world’s leading research universities, while places like Stanford University and state of North Carolina launched research parks; tech transfer programs stimulated by the Bayh-Dole Act flourished; and reforms in SEC regulations created the venture capital sector. 

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A few months ago, we all woke up to a new reality as COVID-19 changed everything. Personally, I shut down one of my startups while one of my portfolio’s startups boomed and a close friend — who had closed a large Series B in January — fired a third of her employees.

Then I saw community members rise to the occasion, taking action to help others, and governments acting faster than ever to enact bold and effective policy. Clearly, we are the ones we’ve been waiting for. It’s in our hands as a global community to shape how this will play out.

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In this issue, we discuss how real-world evidence can be an important component of satisfying drug approval and post-approval study requirements and also, can provide other tangible advantages to drug sponsors. We also look at COVID-19’s impact on Medicare telehealth. Other articles include: the next installment in the series of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for entrepreneurs; the Bayh-Dole Act turns 40; and the lack of public guidance available regarding COVID-19 related apps.

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Real estate investment trusts (REITs) have done an excellent job creating outsized wealth for their investors over the years. From 1972 through the end of last year, REITs generated an average annual total return of 13.3%, which outperformed the S&P 500’s 12.1% total return. Those higher long-term returns mean REITs have turned small initial investments into big-time paydays at a faster pace than the S&P 500.

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Johns Hopkins moved up a spot to No. 10 in the annual U.S. News & World Report Best Global University Rankings released today, a year after moving up to No. 11 from No. 12 in the 2020 rankings.

Johns Hopkins also ranks among the top 10 universities in the world in 15 subject areas and among the top 20 in 19 subject areas. Ten new subject area rankings were added to the list this year, bringing the total to 38.

Image: https://hub.jhu.edu

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New Enterprise Associates Inc., one of the world’s largest venture capital firms, is in talks to sell a minority stake in itself, according to people with knowledge of the matter.

The Silicon Valley firm has held discussions with several potential investors, said the people, who requested anonymity because the talks are private. No deal has been reached, and it’s possible one won’t materialize. Representatives for NEA didn’t immediately respond to requests for comment.

Image: NEA’s Scott Sandell Photographer: David Paul Morris/Bloomberg

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In a long-awaited meeting on America’s crash program to deliver vaccines against the Covid-19 coronavirus, leaders of the program reviewed the measures they have taken to assure the effectiveness and safety of the vaccines. The U.S. Food and Drug Administration convened a panel of independent vaccine experts to ask questions during the Thursday online session. The meeting was designed to reassure the public on the integrity and transparency of the FDA’s vaccine oversight, as the agency has wrestled with political pressure and pockets of public vaccine hesitancy.

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Introduction

The UK formally left the EU on 31st January 2020 and the transition period, as set out in the withdrawal agreement, will come to an end on 31st December 2020. During this transition period the UK has continued to remain under EU pharmaceutical law.

From 1st January 2021 the UK will be able to adopt an independent regulatory framework with the Medicines and Healthcare products Regulatory Agency (MHRA) positioned as the stand-alone regulator for medicines and medical devices.

Negotiations between the EU and UK are still ongoing to define the future relationship and with only a matter of months left before the end of the transition period there has been no formal agreement. For the pharmaceutical industry this presents numerous challenges as companies prepare to continue supply of medicines that comply with new legislation. The preferred outcome for many within the industry will be to implement a mutual recognition agreement for areas such as GMP certification, batch testing, etc. between the UK and EU. It is unclear at this stage if an encompassing mutual recognition agreement is achievable so all involved parties should be preparing for a ‘no deal’ scenario and review existing guidance to understand risk exposure and mitigating actions.

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Last week, the Department of Defense (DOD) announced a seven-year award of $87 million for a new Manufacturing USA institute: BioMADE. The BioIndustrial Manufacturing and Design Ecosystem (BioMADE) institute joins a network of 8 other DOD institutes, making for a total of 16 institutes supported across the federal government in the Manufacturing USA program. ASME has been a long-time supporter and advocate of the Manufacturing USA program.

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Different geographies and jurisdictions play different roles in the global economy. Some specialize in what economists call “seedbed” functions—generating new products and firms, often through cutting-edge innovation. Others specialize in corporate functions by offering attractive environments for company headquarters or other management activities. Still others specialize in more routine production functions for goods or services, handling aspects of the work that involve less innovation and have lower skill requirements. Finally, some regions specialize in resource production tied to geographical endowments, such as minerals, arable land, or lumber.

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BLUEPRINT FOR ECONOMIC RECOVERY BEYOND THE TRIANGLE: Most experts agree Raleigh and Durham are well positioned for a strong recovery from the pandemic, but what about the areas well beyond the Triangle’s core?

A new report released Wednesday from RTI International is meant to address that very question. The Innovation Corridor Blueprintincludes 12 areas of focus for leaders and stakeholders to tackle in a 100-mile radius around the Triangle. Topics range from digital infrastructure and affordable housing to biohealth technology and addressing systemic racism.

Image: An illustration of the Raleigh-Durham skylines. SEANPAVONEPHOTO

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