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Regarding the June 4 front-page article “Cold War echoes in race for vaccine,” about the “race” among nations, notably the United States, China, and Russia and other European nations for development of a vaccine against the novel coronavirus:

When communicating about vaccines and dates, leaders should be careful to note that this means candidate vaccines. We actually have a vaccine only after it is proved effective and safe over a long period, requiring time (years, not months), durability (e.g., the measles vaccine lasts a lifetime whereas some others are much shorter), a formula that covers all or most strains (especially those recurring seasonally) and feasibility (cost, global availability, etc.).

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As multiple companies work to develop vaccines against the virus that causes Covid-19, it will be important for them to work with the federal government toward an understanding with regard to fair pricing, but outright price controls could risk scaring companies away, a doctor helping lead efforts to develop drugs and vaccines for the disease told biotech industry executives Tuesday.

Image: https://medcitynews.com

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Johns Hopkins University researchers will be permitted to resume on-site laboratory activities beginning next week, the first steps of a gradual resumption of on-campus activities envisioned in the weeks and months ahead as the university emerges from a monthslong period of distancing prompted by the COVID-19 pandemic.

 

Covid 19 roundup Fauci talks pricing disparate impact and the virus s enduring mysteries China to offer experimental vaccines to overseas workers Endpoints News

Multiple vaccines will ultimately be approved for Covid-19, NIAID chief Anthony Fauci told BIO yesterday, and the companies that make them should be allowed to profit, “as long as it’s not in an outrageous way.” Sitting down for a rare extended interview with new BIO chief Michelle McMurry-Heath,

Image: NIAID chief Anthony Fauci (AP Images)Image: https://endpts.com

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Once upon a time, developing a new vaccine was a step-by-step process that went from concept, to design, to tests in humans, to regulatory approval, to manufacturing.

It was a process that could take a decade or more.

But the urgent need for a COVID-19 vaccine has radically changed all that. Now, the hope is the entire process can be completed in a year or less.

Image: Cell culture operators prepare a 2000-liter single-use bioreactor to produce proteins used to make vaccines. Philip Taciak/Emergent Biosolutions

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The National Institutes of Health has launched a $1 million Technology Accelerator Challenge (TAC) to spur the design and development of non-invasive, handheld, digital technologies to detect, diagnose and guide therapies for diseases with high global and public health impact. The Challenge is focused on sickle cell disease, malaria and anemia and is led by NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB). The Bill & Melinda Gates Foundation is cooperating with NIH to help accelerate the transformation of design concepts into products for low-resource settings.

 

Banners and Alerts and Can you catch Covid 19 from someone without symptoms Quartz

On Monday, June 8, an official at the World Health Organization (WHO) made a surprising statement. People who have Covid-19 but are asymptomatic—meaning they never develop symptoms like fever, coughing, or gastrointestinal distress—very rarely gave it to others, stated Maria Van Kerkhove, the WHO’s technical lead on the Covid-19 pandemic, at a regularly-scheduled press briefing.

The very next day, the organization took it back. Some might have taken WHO’s original statement to mean that “stealth transmission” of Covid-19 is unlikely—that if a person isn’t actively coughing and sneezing, you don’t need to worry about getting infected. But that’s not necessarily the case. On June 9, WHO clarified that while most transmission seems to come from people showing symptoms, it’s too soon to know exactly how the virus spreads.

Image: AP PHOTO/PETROS KARADJIAS - https://qz.com/

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The BioHealth Capital Region featured at last week’s Redefining Early Stage Investments Conference (RESI) where speakers from the region discussed a range of topics of interest to early stage companies including:

For more information, check out the RESI Conference site or contact BHI.

 
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ROCKVILLE, Md.--(BUSINESS WIRE)--Creatv Microtech, a privately-held biotechnology company has pioneered a blood test to predict treatment response in patients with stage II-III NSCLC treated with chemoradiation therapy (CRT) and consolidated immunotherapy. Clinical data presented at the ASCO 2020 virtual annual meeting shows the ability to predict which NSCLC patients will benefit from anti-PD-L1/PD-1 immunotherapies. “We are delighted to present a method to stratify patients responding to immunotherapy by a single tube of blood collected after completion of CRT,” said Dr. Cha-Mei Tang, CEO of Creatv. “Early identification of patients that do not respond to immunotherapy will reduce unnecessary patient suffering from ineffective and costly treatment, allowing patients to proceed to alternative therapies.” Currently, no other blood test can predict immunotherapy treatment response for lung cancer.

 

AstraZeneca Emergent BioSolutions sign 87M deal to produce U S supply of COVID 19 vaccine FiercePharma

AstraZeneca made waves last week when it signed a massive $750 million deal to ramp production of a University of Oxford COVID-19 vaccine up to 2 billion doses per year. Now, as part of a Trump administration effort to get shots into U.S. hands as soon as possible, AstraZeneca has agreed to another major manufacturing tie-up.

Image: AstraZeneca agreed to dole out $750 million last week to boost its COVID-19 shot capacity to more than 2 billion doses. (AstraZeneca)

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Emergent BioSolutions Inc. will help produce COVID-19 vaccines in Baltimore and Rockville under a federal contract.

Gaithersburg-based Emergent said Tuesday it will manufacture vaccines under an existing contract with a division of U.S. Department of Health & Human Services, assisting government efforts to fast-track the vaccine. Emergent has long worked with the federal health agency’s Biomedical Advanced Research and Development Authority.

 

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Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your complimentary virtual feedback session with BHI Entrepreneurs-in-Residence and Analysts on one of the following dates: 6/24, 7/22, 8/26. (45 minute blocks of time beginning at 9:00 in the morning. Pre-registration is required; sign up www.tinyurl.com/EIRFeedback. For questions/more information, contact This email address is being protected from spambots. You need JavaScript enabled to view it.

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Novavax Inc. just scored even more support for its coronavirus vaccine program.

The Gaithersburg company said late Thursday it won a Department of Defense contract worth up to $60 million to help manufacture its Covid-19 vaccine candidate, NVX‑CoV2373. The funding, from the Defense Health Program, would back the production of multiple pieces of the vaccine, to be manufactured in the U.S., according to Novavax’s (NASDAQ: NVAX) announcement.

 

Ampel Bio Solutions, LLC

Charlottesville, Virginia. June 9, 2020. AMPEL BioSolutions announces genomic analysis and findings that could improve treatment of COVID19 patients with approved drugs such as Embrel and Stelara. Published on bioRxiv as a preprint, the study reveals a gene-based test that will be able to determine those patients who may progress to severe illness with increased likelihood of morbidity. In addition, AMPEL’s CovGENE approach identifies FDA-approved drugs that may be appropriately repositioned to interfere with mechanisms that cause lung damage in severe COVID19 patients. The paper describes gene expression measured in three body compartments (lung, airway and blood) and integrates information from the blood and lung for a “whole body” understanding of the effects of SARS-CoV2 virus.

Banners and Alerts and AstraZeneca Approaches Gilead About Potential Merger

AstraZeneca Plc has made a preliminary approach to rival drugmaker Gilead Sciences Inc. about a potential merger, according to people familiar with the matter, in what would be the biggest health-care deal on record.

The U.K.-based firm informally contacted Gilead last month to gauge its interest in a possible tie-up, the people said, asking not to be identified because the details are private. AstraZeneca didn’t specify terms for any transaction, they said. While Gilead has discussed the idea with advisers, no decisions have been made on how to proceed and the companies aren’t in formal talks, the people added.

Image: Photographer: David Paul Morris/Bloomberg

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GAITHERSBURG, MD, June 1, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has authorized the Company to proceed with a clinical trial of T-COVID, an investigational agent for the treatment of early COVID-19. Patient enrollment in the Phase 1/2 clinical trial is expected to commence in June, with data readout anticipated in Q4 2020. 

T-COVID is based on the same replication-deficient adenovirus 5 (RD-Ad5) vector technology behind Altimmune’s intranasal vaccine candidates, which include NasoVAX for influenza, NasoShield for anthrax, and AdCOVID for COVID-19, but it acts through a different mechanism. In preclinical studies sponsored by the National Institute of Allergy and Infectious Diseases, intranasal administration of RD-Ad5 vectors modulated the innate immune response to lethal challenge with a respiratory virus in mice and protected them from death. The immunomodulatory effects resulted in significantly decreased cellular inflammation and lower concentrations of IL-6 and other inflammatory cytokines in the lungs of treated animals compared to controls.

 

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In a bid to boost its global vaccine manufacturing abilities, Gaithersburg biotechnology firm Novavax has paid roughly $167 million to buy a biologics manufacturing plant in the Czech Republic.

The company paid cash for Praha Vaccines a.s., part of the Cyrus Poonawalla Group.

Novavax expects its newly acquired plant in Bohumil, Czech Republic to provide an annual capacity of over 1 billion doses of antigen for its COVID-19 vaccine candidate starting in 2021.

Image: In this photo released by Nucleus Network/ABC, technicians prepare for a clinical trial of a coronavirus vaccine in Melbourne, Australia, Tuesday, May 26, 2020, with hopes of releasing a proven vaccine this year. Novavax will inject 131 volunteers in the first phase of the trial testing the safety of the vaccine and looking for signs of its effectiveness. (Patrick Rocca/Nucleus Network/ABC via AP)

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Editor’s Note: This post was originally published on April 7, 2020. As updates are discovered and advancements are announced regarding the work below, details will be published for accuracy.

As the U.S. continues to find its way through a tough fight against this global pandemic, a number of BioHealth Capital Region (BHCR) biotech companies are making significant contributions to stem the COVID-19 pandemic. With people across the U.S. and the world making sacrifices to flatten the curve — along with nurses, doctors and first responders who stand heroically at the front lines — life science companies in our region are doing everything in their power to make COVID-19 vaccine progress with celerity, safety and efficacy top-of-mind.

 

U S gives AstraZeneca 1 billion for COVID 19 vaccine candidate UPI com

May 21 (UPI) -- European pharmaceutical company AstraZeneca said Thursday it has received more than $1 billion from the U.S. government to develop its coronavirus vaccine candidate.

The drugmaker has partnered with the University of Oxford on its "AZD1222" vaccine, one of several candidates worldwide in clinical trials.

The funding came from the the Biomedical Advanced Research and Development Authority, a branch of the Department of Health and Human Services.

Image: AstraZeneca plans at least 400 million doses and has lined up manufacturing capacity for one billion doses with first deliveries set for September. File Photo by Drago Prvulovic/EPA

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AstraZeneca (AZN) was ranked the most the most inventive pharmaceutical company for the second year in a row by IDEA Pharma's Invention and Innovation Index for 2020. Meanwhile, Roche (RHHBY) jumped seven places from its 2019 ranking to capture the top spot in the list of most innovative pharma firms.

IDEA is an international consulting firm that works with pharma companies to position their products in the early phase to maximize market success and consult on innovation. The firm bases its Innovation Index on the answer to the following question: "If two companies had the same molecule, who would be more successful with it?" It also considers their ability to bring products from phases 1 and 2 to market and commercialize them successfully, according to CEO Mike Rea.

 

Jay A. Perman

Amid a wrenching series of crises that have riven the nation, particularly over matters of race and law enforcement, corporate leaders throughout Maryland have voiced support for the social justice movement that has become more urgent and grown after the death of George Floyd.

Over the last few days, corporate CEO’s, university leaders and others have acknowledged the pain that Americans of all stripes are experiencing, and have pledged to be part of the solution.

 

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Financing round led by Novo Ventures and includes new investors Cowen Healthcare Investments and Sanofi Ventures, as well as existing investors 5AM Ventures, F-Prime Capital, Sofinnova Partners and founding investor Epidarex Capital

Proceeds to support advancement of pipeline of small molecule NLRP3 inflammasome inhibitors, including continued progression of NT-0167 through clinical development

CAMBRIDGE, UK, BOSTON & SEATTLE – June 3, 2020 – NodThera, a clinical stage biotechnology company developing a new class of medicines that inhibit the NLRP3 inflammasome to treat diseases driven by chronic inflammation, today announced that it has secured $55 million (£44 million) in a Series B financing. NodThera's lead candidate, NT-0167, is being evaluated in a Phase 1 clinical trial in healthy volunteers.

Pfizer

Pfizer Inc. (NYSE: PFE) today announced the establishment of the Pfizer Breakthrough Growth Initiative, through which Pfizer will invest up to $500 million in biotechnology companies to help provide funding and access to Pfizer’s scientific expertise to ensure continuity of the biotechnology companies’ most promising clinical development programs.

“There has never been a more important moment to pursue new collaborations in our industry," said John Young, Pfizer's Chief Business Officer. “The Pfizer Breakthrough Growth Initiative seeks to do just this by injecting crucial capital into biotechnology companies that share our commitment to delivering transformative therapies for patients.”

 

VCs Cautious of COVID 19 Contortionists and Telemedicine Gold Rush BioBuzz

COVID-19 is fundamentally changing how we live, how we do business, and how we approach and deliver our healthcare. In the past 14 weeks, there has been unprecedented growth for a segment of companies who were positioned to meet these rapidly sweeping changes to our lives, while so many others have had to close their doors or are fighting to stay in business. COVID-19 has sparked millions of job losses.

Image: https://biobuzz.io

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SARS-CoV-2 is known to infect cells of the respiratory tract. A deeper understanding of which cells support the infection, and to what extent, could lead to insights into disease progression and severity. Scientists at the UNC School of Medicine sought to understand which cells in the airway the virus infects, and how it gets into the lungs in the patients who develop pneumonia. To this end, they have characterized some of the ways in which SARS-CoV-2 infects the nasal cavity and infects and replicates progressively less well in cells lower down the respiratory tract—including the lungs.

Image: SARS-CoV-2 (red) infected ciliated cells in the COVID-19 patient's bronchi. (Takanori Asakura, PhD, UNC School of Medicine)

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GAITHERSBURG, Md., June 04, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the company has been awarded a contract by the U.S. Department of Defense (DoD) for the manufacturing of NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate. NVX‑CoV2373 consists of a stable, prefusion protein antigen made using its proprietary nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant.

 

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With the LSN Digital RESI Conference approaching quickly, Event Gold Sponsor, BioHealth Innovation (BHI), is stepping up to help lead five panels with some heavy hitters from the BioHealth Capital Region (BHCR) on June 8-10, 2020.

Great Investment Opportunities in the BioHealth Capital Region

While we adjust to a COVID-19 world, there continue to be great investment opportunities in the BioHealth Capital Region. Join BHCR CEOs as they make short introductions about themselves and companies. Join CEOs from American Gene Technologies International Inc., miRecule, Adaptive Phage, Healion Bio, KaloCyte, Emocha, Tailored Therapeutics, Inc., DEKA, and Ashvattha Therapeutics, Inc.

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NEWARK, Del., May 26, 2020 /PRNewswire/ -- Today, the National Institute for Innovation in Biopharmaceutical Manufacturing (NIIMBL) announces that they have received $8.9 million from the U.S. Department of Commerce's National Institute of Standards and Technology (NIST). This award will fund high-impact projects that will support the nation's response to the COVID-19 pandemic. The funding is part of the first round of funding made available to NIST through the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

 

emergent biosolutions

GAITHERSBURG, Md., June 01, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has been issued a task order under an existing contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services (HHS), to deploy its contract development and manufacturing (CDMO) capacities, capabilities, and expertise to support the U.S. government’s efforts to accelerate delivery of COVID-19 vaccines.

“Emergent is proud of this expanded BARDA partnership that symbolizes confidence in our development and manufacturing capabilities that have served the U.S. government’s needs for more than two decades,” said Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions. “Our longstanding record of delivering safe and effective medical countermeasures for public health positions us to continue to help at this critical moment by advancing COVID-19 vaccine programs of our fellow innovators in the industry.”

 

INVESTOR RELATIONS GlycoMimetics Inc

GlycoMimetics, Inc. (Nasdaq: GLYC) today announced that Chief Executive Officer Rachel King will provide a company overview at the upcoming Jefferies Virtual Healthcare Conference. The presentation will be available on the company’s website at the “Investors” tab for 30 days, beginning Thursday, June 4 from 1:00 – 1:25 p.m. EDT.