U.S. Pharmacopeia launches suite of resources to detect substandard and falsified COVID-19 treatments

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New methods were created in collaboration with public health organizations, pharmacopeias, regulators, and manufacturers to help ensure quality and improve public trust

Rockville, MD, May 17, 2021 – The U.S. Pharmacopeia (USP) announced the release of a range of tools and resources to help reduce risks from substandard and falsified COVID-19 treatments, and to assist manufacturers, regulators, and quality control laboratories in helping to ensure quality COVID-19 treatments are being procured, produced, and distributed.

“While COVID-19 vaccines are essential to end the pandemic, treatments are a critical component to help patients, particularly those who are hospitalized with COVID-19,” said Jaap Venema, Ph.D., USP’s Chief Science Officer. “It is vital that regulators and manufacturers ensure approved therapeutics, like remdesivir, meet quality expectations. We have already seen the demand versus supply imbalance result in substandard and falsified remdesivir, particularly in low- and middle-income countries. USP is committed to helping to ensure quality throughout the medicines supply chain.”

The antiviral drug VEKLURY® (remdesivir), invented, developed and manufactured by Gilead Sciences, Inc., was the first U.S. Food and Drug Administration (FDA) approved treatment for pediatric and adult patients at least 12 years of age and weighing at least 40 kg who are hospitalized with COVID-19.  It was granted emergency use authorization by the FDA in May 2020 and was approved by the FDA under the tradename of VEKLURY on Oct. 22, 2020.[i] As a standard of care, healthcare providers around the world are using remdesivir not only to treat patients, but also in clinical trials to understand its efficacy and safety in different patient populations and in combination with other investigational treatments.[ii]

The USP Methods to Detect Falsified Remdesivir publication includes procedures developed by USP for determining the identity and strength of the remdesivir active pharmaceutical ingredient (API) and drug product – essential tools for detecting substandard and falsified medicines. The publication includes procedures using infrared spectroscopy (IR), ultra-high performance liquid chromatography (UHPLC), and nuclear magnetic resonance spectroscopy (NMR) technologies along with supporting validation results. It also features USP’s first quantitative NMR (qNMR)-based digital spectra for determining the identity of remdesivir API using either high field or benchtop qNMR instruments.

In addition to the USP Methods to Detect Falsified Remdesivir publication, USP announced other resources to help combat substandard and falsified COVID-19 treatments including:

Minilab’s Screening Tools for Dexamethasone:

In collaboration with USP, the Global Pharma Health Fund developed two new test methods on dexamethasone for the Minilab testing platform. These screening tools complement USP’s compendial standards available in the USP-NF for dexamethasone, a corticosteroid being widely used to treat COVID-19 patients.

IMWP draft monographs for Favipiravir

Pharmacopoeias around the world continue to work together to support the COVID-19 response. As part of the World Health Organization’s (WHO) International Meeting of World Pharmacopoeias (IMWP),  pharmacopeias have developed and made available two IMWP draft monographs for Favipiravir and Favipiravir Tablets to be used on a voluntary basis. Favipiravir is an antiviral approved for COVID-19 treatment in Japan, Russia and India.

Substandard and falsified medicines pose a threat to global health security and hinder the ability of strong and resilient public health systems to prevent, detect, and respond to infectious disease threats.

“Major public health events can increase the vulnerability of medicines to the threat of substandard and falsified products,” said Jeff Moore, Ph.D., Senior Director, Scientific Affairs & Strategy at U.S. Pharmacopeia. “These resources to help combat substandard and falsified COVID-19 treatments were created in collaboration with public health organizations, pharmacopeias, manufacturers, and regulators from around the world and are an important example of the value and importance of collaboration in times of need.”

For over 200 years, USP has supported the development, manufacturing, and distribution of quality medicines through development of standards and other tools that help ensure the quality of medicines. USP is working with government organizations, other pharmacopeias, manufacturers of drugs and other health products, and healthcare professionals in the US and around the world to help build the public’s trust in vaccines and treatments for COVID-19.

These resources are for informational purposes only and intended to provide tools to address substandard and falsified treatments during the COVID-19 pandemic. They are intended to complement standards developed by USP and other organizations by providing validated methods with supporting results to verify the ingredients and quality of these treatments. These tools are not part of the U.S. Pharmacopeia-National Formulary and does not reflect USP’s opinions on future revisions to official text of the USP–NF. Parties relying on these resources bear independent responsibility for awareness of, and compliance with, any applicable federal, state, or local laws and requirements.

About USP
U.S. Pharmacopeia (USP) is an independent, nonprofit, scientific organization that sets quality standards for medicines, dietary supplements and food ingredients worldwide. USP’s quality standards are legally recognized in the United States and elsewhere and are used in more than 140 countries. These standards, which are continuously developed and revised by more than 800 volunteer experts in science, industry, healthcare and academia. Learn more at www.usp.org.

For additional information about how USP is working to improve the supply of safe, trusted COVID-19 vaccines, treatments, and preventatives, visit www.usp.org/covid-19

QIAGEN Receives U.S. FDA Emergency Use Authorization for Fast and Easy-to-Use Digital Test to Detect SARS-CoV-2 Coronavirus Antibodies

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  • U.S. authorization gives healthcare professionals access to portable rapid testing device that can monitor immune status in relation to COVID-19
  • Test based on QIAGEN partner Ellume’s proprietary eHub technology and helps ease testing shortfalls by using automation and providing easy-to-read results
  • eHub digital device can handle eight tests at once, all working independently of each other, can process up to 32 samples per hour, can eventually be used simultaneously with the antigen test

GERMANTOWN, Md. & HILDEN, Germany–(BUSINESS WIRE)– QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the fast and easy-to-use QIAreach® Anti-SARS-CoV-2 Total Test.

The authorization means QIAGEN can start making its portable antibody testing device available to health-care professionals in the U.S. Each antibody test takes only about 10 minutes to identify whether a person carries antibodies to the SARS-CoV-2 virus as a result of prior infection. Individual test results are read on a digital eHub device that can process up to 32 tests per hour – and will eventually also run the antigen test.

The QIAreach Anti-SARS-CoV-2 Total Test is a serological test that has been shown to have a sensitivity of 93.85% (CI 84.99–98.30%) and a specificity of 97.83 %–%% (CI 95.00–99.29%). QIAGEN’s technology detects total antibodies (Total immunoglobulin) specific to SARS-CoV-2 immune response – while most other tests currently identify only selected antibodies.

The QIAreach Anti-SARS-CoV-2 Total Test was developed in partnership with Ellume, an Australian digital diagnostics company. It is the first of two QIAGEN COVID-19 tests to make use of Ellume’s digital eHub and eStick system: QIAGEN in early September 2020 presented the QIAreach SARS-CoV-2 Antigen Test to detect active SARS-CoV-2 infection, which has been submitted to the FDA for an EUA.

Research into the SARS-CoV-2 pandemic also requires the monitoring of the immune status of individuals. QIAGEN is the only company that has developed both an antibody and a T-cell test to track immune responses. In November, it also launched the QuantiFERON SARS-CoV-2 test (for research use only) that can detect T-cell responses in people who have had natural infection or vaccination.

“Serological testing for antibodies is central to identifying people who have been recently infected by the virus or have been infected in the recent past, especially those who did not show any symptoms and therefore might not know of an infection,” said Davide Manissero, Chief Medical Officer of QIAGEN. “As societies are now returning to normal daily routines, understanding the COVID-19 immunity in a population can help guide public health measures.”

Traditional rapid lateral-flow antibody tests are hard to automate and results can be hard to read. The QIAreach Anti-SARS-CoV-2 Total Test generates easy-to-read results on the digital eHub platform. Each QIAreach eHub can handle up to eight samples on eight eSticks simultaneously, with each eStick test running independently. QIAGEN is using the same platform to develop QIAreach® QuantiFERON®-TB, a new testing solution for identifying latent tuberculosis (TB) infections in low-resource regions.

Further information on QIAGEN’s response to the coronavirus outbreak can be found here.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of March 31, 2020, QIAGEN employed approximately 5,700 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Forward-Looking Statement

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN’s products, including those products used in the response to the COVID-19 pandemic, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN’s products (including fluctuations due to general economic conditions, the level and timing of customers’ funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors’ products; market acceptance of QIAGEN’s new products and the integration of acquired technologies and businesses; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, including the breadth and duration of the COVID-19 pandemic and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission.

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Emmes Acquires UK-Based Orphan Reach

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ROCKVILLE, Md., May 12, 2021 /PRNewswire/ — Emmes (the “Company”), a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation and a portfolio company of Behrman Capital, today announced that it has acquired Orphan Reach, a CRO specialized in clinical research related to rare diseases. Financial terms of the transaction were not disclosed.

This marks Emmes’ second acquisition since Behrman’s investment in 2019 and builds on its recent acquisition of Neox S.R.O. (“Neox”) in December 2020. Founded nearly 20 years ago, Orphan Reach has its headquarters in the United Kingdom and offices in Ireland, Germany, India, Canada, and the United States. The acquisition expands Emmes’ geographic presence and complements Neox’s operations in central and eastern Europe. The transaction also bolsters the Company’s efforts with commercial biopharmaceutical clients and further augments its market-leading capabilities in rare diseases.

Grant Behrman, Managing Partner of Behrman Capital, said, “We are thrilled with the addition of Orphan Reach to the Emmes platform, which we believe greatly augments the Company’s BioPharma effort and builds on the recent and successful Neox transaction. Orphan Reach enhances Emmes’ momentum and steepens the Company’s growth trajectory through expansion of its geographic footprint and customer base, and we look forward to continuing to support the Company as it pursues organic initiatives and additional acquisitions.”

Dr. Christine Dingivan, Emmes’ Chief Executive Officer, said, “Our acquisition of Orphan Reach will accelerate our growth, bolstering our industry leadership in clinical research for orphan and rare diseases. Orphan Reach has an outstanding reputation, with longstanding experience in a multitude of rare disease clinical trials with over 50 biopharma customers throughout the world.”

She continued, “We believe that Orphan Reach and Emmes will be highly synergistic; we will combine Emmes’ deep strategic drug development and advanced statistical capabilities with the exceptional patient-centered global operations experience of the Orphan Reach team. With more than 7,000 rare diseases identified and only 400 treatments available, this represents a large research opportunity and demonstrates our commitment to advancing public health and addressing unmet medical needs for all populations.”

Orphan Reach Founder and CEO Thomas Ogorka said, “Orphan Reach and Emmes share a passion for the research we do, a dedication to the patients in our trials, and successful, long-term collaborations with our clients. I look forward to this new chapter in our history and to further extending our leadership in rare and orphan disease research that leads to new treatment options for these patients.”

Mr. Ogorka and the existing management of Orphan Reach will continue in their current roles.

“I am looking forward to working with Thomas and the Orphan Reach team, particularly as we broaden their research opportunities in the United States,” added Dr. Dingivan. “I am also very optimistic about collaboration between Orphan Reach and Neox and the potential for leveraging our growing global footprint and client relationships.”

In April, the Company announced that Rhonda Henry, a 30-year industry veteran, had been hired to become president of Emmes BioPharma, further reinforcing Emmes’ commitment to expansion in this market.

About Orphan Reach
Headquartered in the United Kingdom, Orphan Reach is a global and full-service CRO that has built a reputation for outstanding clinical research addressing rare diseases. Founded in 2002, the company has management teams in Europe, Asia and the U.S., and supports patients with rare diseases in more than 70 countries. The team’s goal is to accelerate access to new treatments in a wide range of orphan therapeutic areas.

About Emmes
Founded in 1977, Emmes is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. The Company’s clients include numerous agencies and institutes of the U.S. federal government and a wide range of biotechnology, pharmaceutical and medical device companies throughout the world. To learn more about how our research is making a positive impact on human health, go to the Emmes website at www.emmes.com.

About Behrman Capital
Based in New York City and San Francisco, Behrman Capital was founded in 1991 by Grant G. and Darryl G. Behrman. The firm invests in management buyouts, leveraged buildups and recapitalizations of established growth businesses. The company’s investments are focused in three industries: defense and aerospace, healthcare services, and specialty manufacturing and distribution. The firm has raised $3.5 billion since inception and is currently investing out of its sixth fund. For more information, please visit www.behrmancap.com.

Contact:
Ross Lovern / Daniel Hoadley
Kekst CNC
ross.lovern@kekstcnc.com / daniel.hoadley@kekstcnc.com

SOURCE Behrman Capital

Adaptive Phage Therapeutics Announces $40.75 Million Series B Financing

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GAITHERSBURG, MD., May 11, 2021 – Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, today announced that the company has closed a $40.75 million Series B investment round led by Deerfield Management Company. Also joining the Series B round are existing investor Mayo Clinic and an additional undisclosed institutional investor. Proceeds of this financing will be used to accelerate clinical development of PhageBank™ phage therapies as well as for general corporate purposes.

APT’s PhageBank™ technology is a growing collection of hundreds of bacteriophage, collectively providing broad spectrum coverage against six of the highest priority multi-drug resistant bacterial pathogens.  APT plans to use the proceeds from this Series B financing to fund the company’s clinical-stage therapeutic programs in prosthetic joint infection (PJI) and diabetic foot osteomyelitis (DFO), as well as for general corporate purposes including further development of a proprietary PhageBank™ Susceptibility Test (PST) to rapidly identify phage therapies required to eradicate specific bacterial infections.

“We are thrilled to announce this financial support from Deerfield, a prominent healthcare-focused investment firm, and Mayo Clinic, one of the world’s most distinguished nonprofit healthcare organizations,” said Greg Merril, APT’s CEO and Co-Founder. “This Series B funding round positions APT to continue aggressively expanding PhageBank’s coverage spectrum and advancing our clinical development pipeline of new therapeutic options to patients suffering from bacterial infections, many of which are notably difficult-to-treat multi-drug resistant and/or biofilm-mediated infections.”

“Adaptive Phage Therapeutics is taking a unique and differentiated approach to the therapeutic treatment of bacterial infections,” said Jonathan Leff, Partner at Deerfield. “We are excited to be working with the APT team on their unique PhageBankTM platform, which has shown significant promise in patients treated for a variety of multi-drug resistant bacterial infections under compassionate use allowance from the FDA. Together, we believe we can bring PhageBank™ therapy into the mainstream, and work to solve one of the key challenges facing modern medicine, the growing problem of antibiotic-resistant bacteria.”

Adaptive Phage Therapeutics, Inc.

Adaptive Phage Therapeutics is a clinical-stage company advancing therapies to treat multi-drug resistant infections. Prior antimicrobial therapeutic approaches have been “fixed,” while pathogens continue to evolve resistance to each of those therapeutics, causing those drug products to become rapidly less effective in commercial use as antimicrobial resistance (AMR) increases over time.

APT’s PhageBank™ approach leverages an ever-expanding library of bacteriophage (phage) that collectively provide evergreen broad spectrum and polymicrobial coverage. PhageBank™ phages are matched through a proprietary phage susceptibility assay that APT has teamed with Mayo Clinic Laboratories to commercialize on a global scale.

APT’s technology was originally developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under FDA emergency Investigational New Drug allowance, APT has provided investigational PhageBank™ therapy to treat more than 40 critically ill patients in which standard-of-care antibiotics had failed.

For more information, visit http://www.aphage.com.

About Deerfield

Deerfield is an investment management firm committed to advancing healthcare through investment, information and philanthropy.

For more information, please visit www.deerfield.com

Adaptive Phage Therapeutics

Investor Relations:

Gilmartin Group, LLC.:

Laurence Watts

laurence@gilmartinir.com

619-916-7620

Deerfield Contact:

Deerfield Management Company

Karen Heidelberger

karenh@deerfield.com

212-583-7298

Global Biotech Company, Ellume, to Open Manufacturing Facility in Frederick

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BALTIMORE, MARYLAND (May 10, 2021) – Governor Larry Hogan today announced that Ellume, an Australia-based digital diagnostics company, will establish its first U.S. manufacturing operation in Frederick County and create more than 1,500 new jobs by the end of 2022. Ellume, based in East Brisbane in Queensland, will lease about 200,000 square feet in two new buildings to accommodate demand for its diagnostic products targeting infectious diseases. The company signed a $231.8 million agreement in February 2021 with the U.S. Department of Defense, in coordination with the U.S. Department of Health and Human Services, to accelerate domestic production of its COVID-19 home tests and support ongoing U.S. pandemic preparation and response.

The project is a result of strengthening ties between Australia and Maryland, which were reinforced by Governor Hogan’s infrastructure and trade mission to Australia in September 2019. While there, he toured Sydney, Adelaide, and Melbourne, visited various infrastructure projects, and met with Australian officials and businesses.

“We look forward to building the foundation for Ellume’s long-term vision in the U.S. and recruiting the highly skilled talent in Maryland’s Biotech Corridor needed to fuel our flagship U.S. facility,” said Jeff Boyle, PhD, Ellume U.S. president. “Frederick is the ideal location for Ellume as we continue to work closely with the U.S. government in delivering COVID-19 tests to communities across the country. The facility will serve as a foundation for Ellume to support the domestic response to the COVID-19 pandemic and better prepare the U.S. for future public health crises.”

“It is outstanding news that Ellume has chosen Maryland for this significant expansion and will create more than 1,500 new life sciences jobs in our state at a time when they are needed the most,” said Governor Hogan. “We had a highly successful mission to Australia, and I am pleased that the partnerships and connections we created during that mission have resulted in bringing this world-class company to Maryland.”

Ellume’s focus is on the detection of common infectious diseases which affect the global population across all diagnostic settings: at home, point-of-care, and in-laboratory. Ellume has a global consumer health partnership with GlaxoSmithKline; a global COVID-19 and latent tuberculosis partnership with QIAGEN; and a range of professional products under its ellume·lab brand.

The Ellume COVID-19 Home Test was the first rapid self-test for COVID-19 detection authorized by the U.S. Food and Drug Administration for asymptomatic and symptomatic use without a prescription. With the Centers for Disease Control reporting that at least 50% of COVID-19 cases are transmitted asymptomatically, Ellume’s test will play a crucial role as one of the only diagnostic tools authorized for non-prescription use as a screening tool in the United States. Further information can be found at ellumehealth.com.

“This is great news for Frederick County. Ellume is on the cutting edge, making products that will help the world to overcome this health pandemic,” said Frederick County Executive Jan Gardner. “We are excited to welcome Ellume to our thriving life science and biopharma family. Frederick County has delivered on our fast-track permitting process to accelerate this project so production can begin in the second half of 2021. Frederick County is a great place to do business.”

“We are thrilled to have attracted a global leader like Ellume, which is at the forefront of diagnostic testing for a host of infectious diseases, including coronavirus,” said Maryland Commerce Secretary Kelly M. Schulz. “Being in Maryland will not only bring the company closer to their existing key federal partners, but will also provide access to our highly-educated workforce, research labs, and critical mass of resources that make our state an ideal place for a life sciences company to succeed.”

To assist with costs related to the development project, the Maryland Department of Commerce is working with the company on a conditional loan through Advantage Maryland, formerly the Maryland Economic Development Assistance Authority and Fund (MEDAAF), contingent on job creation and capital investment. Frederick County approved the project for Turbo Fast Track Permitting to meet the company’s timeline and the project is eligible for county tax credits over the next six years. The company is also eligible for local workforce services.

About Maryland Commerce

The Maryland Department of Commerce stimulates private investment and creates jobs by attracting new businesses, encouraging the expansion and retention of existing companies, and providing financial assistance to Maryland companies. The Department promotes the State’s many economic advantages and markets local products and services at home and abroad to spur economic development and international investment, trade and tourism. Because they are major economic generators, the Department also supports the Arts, film production, sports and other special events. For more information, visit commerce.maryland.gov.

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Novavax Announces Positive Preclinical Data for Combination Influenza and COVID-19 Vaccine Candidate

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GAITHERSBURG, Md., May 10, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced data from a preclinical study of the company’s combination quadrivalent seasonal flu vaccine (NanoFlu™) and COVID-19 vaccine candidate (NVX-CoV2373). The NanoFlu/NVX-CoV2373 combination vaccine demonstrated positive immune responses to both influenza and SARS-CoV-2. A pre-print of the manuscript is available at bioRxiv.org.

The manuscript, titled ‘Combination Respiratory Vaccine Containing Recombinant SARS-CoV-2 Spike and Quadrivalent Seasonal Influenza Hemagglutinin Nanoparticles with Matrix-M™ Adjuvant,’ studied a combination vaccine comprising a quadrivalent nanoparticle influenza vaccine formulated together with a recombinant SARS-CoV-2 spike protein vaccine and Matrix-M™ adjuvant. The combination vaccine elicited robust responses to both influenza A and B and protected against the SARS-CoV-2 virus. Clinical studies of the combination vaccine are expected to begin by the end of the year.

“Despite low rates during the COVID-19 pandemic, influenza remains a significant risk to global public health and the need for versatile, more effective vaccines is as important as ever, including against the flu. This study’s results build on our success to-date with NVX-CoV2373, and with NanoFlu, which successfully achieved all of its objectives in a pivotal Phase 3 trial announced last year,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “We believe that this novel combination vaccine candidate, which leverages Novavax’ technology platform and Matrix-M™ adjuvant, could be an important future tool in the long-term fight against both of these harmful respiratory viruses.”

Immunogenicity Results

The preclinical study found that the combination NanoFlu/NVX-CoV2373 (qNIV/CoV2373) vaccine induced functional influenza and COVID antibodies in ferrets. Hemagglutination inhibition (HAI) and ACE2 receptor-inhibiting titers were comparable between immunization with the combination vaccine and with its respective component vaccines. Antibody titers were elevated two weeks after a single dose and increased even further two weeks following a second immunization.

Hamsters that received the combination NanoFlu/NVX-CoV2373 vaccine had elevated levels of SARS-CoV-2 anti-S IgG two weeks after the first immunization, which increased significantly after a second dose, with levels comparable to animals that received the NVX-CoV2373 vaccine alone. Human ACE2 receptor inhibiting antibody levels responded similarly. The immune responses to influenza A and B strains elicited by NanoFlu/NVX-CoV2373 were comparable to immunization with NanoFlu alone. Further, the combination vaccine induced antibodies against SARS-CoV-2 neutralizing epitopes, including at hidden or cryptic sites, that are common between USA-WA1 and the B.1.351 variant.

Protection after SARS-CoV-2 challenge

When hamsters were challenged with SARS-CoV-2, animals immunized with NanoFlu/NVX-CoV2373 retained their body weight comparably to non-infected animals and those immunized with NVX-CoV2373 alone. An examination of viral load in the upper and lower respiratory tract showed that little or no virus was detected four days after COVID-19 infection in animals immunized with NanoFlu/NVX-CoV2373 or with just NVX-CoV2373. Microscopic and macroscopic observations of the lungs showed no remarkable findings in animals immunized with either the combination vaccine or with NVX-CoV2373 alone.

“Seasonal influenza and COVID-19 combination vaccines will likely be critical to combating emerging COVID-19 variants,” said Russell ‘Rip’ Wilson, Executive Vice President and NanoFlu General Manager, Novavax. “Millions of people are affected by influenza each year in the U.S., and despite our vaccination efforts, currently available flu vaccines are only partially effective. Our NanoFlu vaccine Phase 3 clinical trial achieved all of its primary endpoints, and we expect this combination vaccine will help control both COVID-19 and influenza illness.”

About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated 100% protection against severe disease, efficacy of 96.4% against the original virus strain, 86.3% against the B.1.1.7/501Y.V1 variant and 89.7% overall; and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 100% protection against severe disease and 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

About Matrix-M™
Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About NanoFlu™
NanoFlu™ is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M™ adjuvant.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Novavax Forward Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

Investors
Novavax, Inc.
Erika Schultz | 240-268-2022
ir@novavax.com

Solebury Trout
Alexandra Roy | 617-221-9197
aroy@soleburytrout.com

Novavax Media
Amy Speak | 617-420-2461
Laura Keenan | 202-709-7521
media@novavax.com

Montgomery County to spend $500,000 on push for global pandemic center – Washington Post

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An ambitious push to create a “Global Pandemic Center” in suburban Maryland got a $500,000 boost Tuesday from the Montgomery County Council, which said the project could help drive the county’s post-pandemic economic recovery and foster resilience against the next major health crisis.

Spearheaded by the regional nonprofit Connected DMV, the center would involve scientists and policymakers from across the globe but operate primarily from the D.C. region, with a likely headquarters in Montgomery.

It would “identify and launch strategic projects needed to advance pandemic avoidance and preparedness,” Connected DMV said in its pitch to the council, including a $2 billion flagship initiative, titled “AHEAD 100,” that would stockpile monoclonal antibodies — laboratory-made treatments — for 100 pathogens most likely to cause global pandemics.

“We were the first place [in Maryland] hit by this covid-19 initially, and we paid a heavy price,” Montgomery County Executive Marc Elrich (D) said in an interview Tuesday, citing the county’s high death toll during the first part of the pandemic. “Anything we can do to avoid being that off-guard is going to be worthwhile.”

The county dollars, which are coming out of its general reserves, will go toward Connected DMV’s $2.5 million “strategy phase” to secure federal support, private- sector partnerships and other resources needed to launch “AHEAD 100.”

Other early contributors include the state of Maryland and the Bill & Melinda Gates Foundation, said Connected DMV chief executive Stu Solomon. The organization hopes to nail down a strategic plan by the end of August.

Click here to read more via the Washington Post.

Novavax Initiates Pediatric Expansion for Phase 3 Clinical Trial of COVID-19 Vaccine

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GAITHERSBURG, Md., May 3, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has initiated a pediatric expansion of its Phase 3 clinical trial for NVX-CoV2373, the company’s recombinant protein vaccine candidate against COVID-19. The additional arm of the ongoing PREVENT-19 pivotal trial will evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 in up to 3,000 adolescents aged 12-17 across up to 75 sites in the United States.

Participants will randomly receive either the vaccine candidate or placebo in two doses, administered 21 days apart. Two-thirds of volunteers will receive intramuscular injections of the vaccine and one-third will receive placebo. A blinded crossover is planned to take place six months after the initial set of vaccinations to ensure that all trial participants receive active vaccine. Participants will be monitored for safety for up to two years following the final dose.

“Through the expansion of our PREVENT-19 clinical trial, we hope to build upon the encouraging safety and efficacy data generated to-date in adults for our vaccine candidate and to play a significant global role in offering vaccination to as many people as possible across age groups to end the suffering caused by the pandemic,” said Gregory M. Glenn, M.D., President, Research and Development, Novavax.

Dr. Glenn will share an update regarding this arm of the PREVENT-19 trial during the 21st annual World Vaccine Congress taking place online, May 4-6. He will participate in two sessions during the congress, including a presentation and a panel discussion. Details are as follows:

Morning Plenary:

Date: Tuesday, May 4
Time: 9:10am – 10:40am EST
Title: Safety, efficacy, and uptake of COVID-19 vaccines
Moderator: Jakob Cramer, M.D., Head of Clinical Development, CEPI

Afternoon Session: COVID-19: Vaccine Response & Approaches

Date: Tuesday, May 4
Time: 3:30pm – 3:45pm EST
Title: Novavax COVID-19 Program Update

To register, please visit the World Vaccine Congress website here. Dr. Glenn’s presentation slides will be posted to the company’s website following the presentation here.

About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated 100% protection against severe disease, efficacy of 96.4% against the original virus strain, 86.3% against the B.1.1.7/501Y.V1 variant and 89.7% overall; and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 100% protection against severe disease and 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

About Matrix-M™
Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Novavax Forward Looking Statements
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

Investors
Novavax, Inc.
Erika Schultz | 240-268-2022
ir@novavax.com

Solebury Trout
Alexandra Roy | 617-221-9197
aroy@soleburytrout.com

Novavax Media
Laura Keenan | 202-709-7521
media@novavax.com

Children’s National Research & Innovation Campus Welcomes New Resident Company, AlgometRx to JLABS @ Washington, DC Site

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On April 26, 2021, AlgometRx Inc., a Children’s National spinout company developing a handheld device to objectively measure pain by pupillary response, will relocate to Johnson & Johnson Innovation – JLABS @ Washington, DC on the Children’s National Research & Innovation Campus. The AlgometRx move comes following the company being awarded the JLABS @ Washington, DC Children’s QuickFire Challenge, which includes a one-year residency at the newly opened JLABS @ Washington, DC – a 32,000-square-foot incubator located at the new Children’s National Research & Innovation Campus in northwest Washington, D.C. As an awardee, AlgometRx also receives access to research and development space, capital equipment, mentorship, resources and programming.

Located on a nearly 12-acre portion of the former Walter Reed Army Medical Center campus, the Children’s National Research & Innovation Campus is the nation’s first campus dedicated to pediatrics, which formally opens in September 2021. This campus aims to help address a significant problem: the development of medical and surgical devices for children has long lagged behind that for adults. Over the past decade, only one in four medical devices approved by the Food and Drug Administration (FDA) were indicated for use in children, and the majority were for those ages 12 and up.

By bringing together public and private partners, the campus is a one-of-a-kind innovation ecosystem that aims to accelerate breakthrough discoveries into new treatments and technologies.

AlgometRx was founded by pediatric anesthesiologist Julia C. Finkel, M.D., and originated at the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National.

“Pain is the only vital sign that is not objectively measured,” Finkel said. “The current standard of measuring pain is the 0-10 scale, which is based on observations and subjective assessment. This technique increases the likelihood for inaccuracies, especially for infants and children who cannot clearly communicate their pain.”

Click here to read more via Innovation District.

Biotech Innovation Company Aditxt to Establish State-of-the-Art Immune Monitoring Center in Richmond, VA

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AditxtScore™ Center is the first of a planned immune monitoring network and will initially monitor COVID-19 immunity status;
New facility expects to target more than 300 jobs over three years to the area

Mountain View, CA and Richmond, VA – May 3, 2021— Aditxt (Aditx Therapeutics, Inc.) (Nasdaq: ADTX), a biotech innovation company focused on improving the health of the immune system, today announced plans to build a high-capacity AditxtScore™ Center in Richmond, VA in the second half of 2021. Aditxt is targeting a capital investment of $31.5 million over three years to scale up its state-of-the-art immune monitoring center, including projected new jobs, laboratory equipment, and construction. The announcement was made at a joint press conference with Governor Ralph Northam, Richmond Mayor Levar Stoney and other local business executives and political officials.

The new immune monitoring center is being developed to increase processing capacity for the company’s flagship AditxtScore™, a pioneering new approach to immune health monitoring that provides a comprehensive profile of the immune system. By assessing an individual’s immune biomarkers, AditxtScore™ will be able to measure indications of immunity to specific disease. AditxtScore™ applications include the recently commercialized AditxtScore™ for COVID-19, developed for use in detecting antibodies and neutralizing antibodies against SARS-CoV-2 antigens. Other applications under development include, among others, predicting dynamic monitoring of the immune system in infectious and autoimmune diseases, organ transplantation, and allergy.

Amro Albanna, co-founder and CEO of Aditxt, commented, “Richmond is an ideal location for our first high-capacity AditxtScore Center given its skilled workforce, location, and infrastructure. As we begin rolling out the AditxtScore platform and applications for immune monitoring, the establishment of an AditxtScore Immune Monitoring Network is vital to realizing our full vision for AditxtScore, which is to transform how we monitor the immune system from reactive testing to proactive monitoring. We look forward to working with the community to complete this important step in the execution of Aditxt’s strategic plan, and we are grateful to the Commonwealth of Virginia, Governor Northam, his team, and all involved for their support and welcoming reception.”

Aditxt expects to create more than 300 new jobs over the next three years to increase AditxtScore™ processing capacity up to a projected 10 million reports annually in efforts to provide more access to individuals to monitor and understand their immune profiles. The company will occupy 25,000 square feet of BioTech 8 in the Virginia Bio+Tech Park, a campus of Activation Capital, with plans for future expansion.

“The Richmond region has emerged as a hub for cutting-edge biotech companies, and this thriving industry will be bolstered by the addition of Aditxt’s Immune Monitoring Center,” said Governor Northam. “The Virginia Bio+Tech Park is an ideal location for the company to continue its groundbreaking work to improve the health of our communities and help us better understand our own immune systems—something that has become extremely important over the past year. We are honored to welcome Aditxt to the Commonwealth, and we thank the company for creating more than 300 well-paid jobs for the people of Virginia.”
View the Governor’s Press Release

Support for Aditxt’s job creation will be provided through the Virginia Talent Accelerator Program, a workforce initiative created by VEDP in collaboration with the Virginia Community College System and other higher education partners, with funding support from the Northam Administration and the Virginia General Assembly. Launched in 2019, the program accelerates new facility start-ups through the direct delivery of recruitment and training services that are fully customized to a company’s unique products, processes, equipment, standards, and culture. All program services are provided at no cost to qualified new and expanding companies as an incentive for job creation.

About Aditx Therapeutics
Aditxt is developing technologies specifically focused on improving the health of the immune system through immune monitoring and reprogramming. The immune monitoring technology is designed to provide a personalized comprehensive profile of the immune system. The immune reprogramming technology is currently at the pre-clinical stage and is designed to retrain the immune system to induce tolerance with an objective of addressing rejection of transplanted organs, autoimmune diseases, and allergies. For more information, please visit: www.aditxt.com

Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of federal securities laws. Forward looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product and business development; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section titled “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s other filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Media and Investor Relations Contact:
Sunny Uberoi
Chief Communications Officer
Aditxt
917-747-2018
ir@aditxt.com

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