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

JLABS @ Washington, DC Incubator Opens for Business with Diversity at its Core

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The pandemic wasn’t going to slow JLABS down. Two years after announcing a new location, Johnson & Johnson’s incubator arm opened its doors in the nation’s capital on Monday, right on time.

The new hub, dubbed JLABS @ Washington, D.C., will host up to 50 startups spanning pharmaceuticals, medical devices, consumer and health tech companies, including those working on pediatric care. The first group of companies moving in includes spinouts from the Children’s National Hospital, J&J’s partner in running the site, startups local to the D.C. area, and those from other parts of the country.

“We’ve selected companies that are here in the [D.C., Maryland and Virginia] region and we’ve also selected a company from New York and one from Alabama that are looking specifically to expand in the D.C. area,” said Sally Allain, head of JLABS @ Washington, D.C. “We have two international companies coming in as part of the first group of companies.”

Though it’s home to the National Institutes of Health and federal agencies like the FDA, the D.C. area doesn’t always spring to mind as a biotech hub the way Boston, San Diego or the Bay Area do.

“It’s unfortunate, because the capital region has so much here. I think it’s untapped,” said Allain, who figures that with the growth in manufacturing and investing in the area, the region could catapult into the top five biotech hubs pretty soon.

Click here to read more via FIERCE Biotech.

Mason Start-up Ceres Nanosciences Experiences Big Wins and Increases Footprint in Prince William County

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Ceres Nanosciences, a Northern Virginia bioscience company spun out of George Mason University that specializes in diagnostic products and workflows, has opened a 12,000-square-foot advanced particle manufacturing plant in Prince William County’s Innovation Park. The new facility increases the manufacturing capacity of Ceres’ Nanotrap® Magnetic Virus Particles, which improve diagnostic testing for viruses like SARS-CoV-2, influenza, and respiratory syncytial virus.

The completion of the new facility also reflects the partnership between Mason and the Prince William County Department of Economic Development (PWCDED).

“The PWCDED has a long-standing relationship with Mason, specifically with the Science and Technology Campus that anchors our bioscience hub in Innovation Park,” said Christina Winn, executive director of PWCDED. “Ceres was the first company to graduate our Science Accelerator, and we are invested in their growth as a leader, collaborator and innovator in our life sciences industry cluster.”

The construction of the facility, which was completed in under four months, was funded by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative to expedite the production and commercialization of diagnostic tests for the SARS-CoV-2, the virus that has become known as COVID-19. Prince William County also supported the swift development of the site.

“We’re immensely grateful for the NIH funding that supported this new facility,” said Ross Dunlap, Ceres Nanosciences CEO. “Not only are we now able to deliver a robust supply of this critical reagent that the industry needs, but the facility also is a major element of Ceres’ long-term growth plan.”

Click here to read more via George Mason University.

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