Monthly Archives

November 2020

Novavax Announces COVID-19 Vaccine Clinical Development Progress

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GAITHERSBURG, Md., Nov. 30, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. NVX‑CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix‑M™.

“Novavax is in a leading position to significantly contribute to the need for safe and efficacious vaccines that will ultimately end the worldwide COVID-19 pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide.”

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. The primary efficacy endpoints for these trials have been harmonized and reviewed by global regulatory agencies in order to facilitate regulatory approval and ensure that the results are generalizable across global populations. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

United Kingdom (U.K.) pivotal Phase 3 trial update

Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K. to determine efficacy and safety of NVX-CoV2373. The U.K. Vaccines Taskforce and National Institute for Health Research played pivotal roles in the rapid recruitment and enrollment of volunteers.

Interim data in this event-driven trial are expected as soon as early first quarter 2021, although the timing depends on the overall COVID-19 rate in the region. These data are expected to serve as the basis for licensure application in the U.K., European Union and other countries. More than 25 percent of enrollees in the trial are over the age of 65, while a large proportion of volunteers had underlying co-morbid medical conditions generally representative of the population.

South Africa Phase 2b trial update

The Phase 2b trial taking place in South Africa to evaluate safety and provide an early indication of efficacy is now fully enrolled. A total of 4,422 volunteers are taking part in the trial, which includes 245 medically stable, HIV-positive participants.

This trial is expected to increase the body of efficacy data of NVX-CoV2373 in racially and geographically diverse populations as well as in older adults. As in the U.K., availability of efficacy data depends on the illness rate in South Africa and may be available as soon as the first quarter 2021. The trial is being conducted in collaboration with Professor Shabir Mahdi and Wits University and is funded in part by the Bill & Melinda Gates Foundation. The Coalition for Epidemic Preparedness Innovations (CEPI) funded the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial.

U.S./Mexico pivotal Phase 3 trial update

Novavax expects its pivotal Phase 3 clinical trial in the United States and Mexico to begin in the coming weeks. More than 100 trial sites have been selected with some alternate sites in place, should they be needed.

Preliminary blinded data on NVX-CoV2373 in older adults needed to proceed to Phase 3 has previously been positively reviewed by the Food and Drug Administration (FDA). Additional clinical data from the Phase 2 trial conducted in the U.S. and Australia are expected to be unblinded in Q1 and will be targeted for publication.

Novavax will use vaccine material produced at commercial scale for this trial. Therefore, the Company has been working closely with the FDA to complete trial-initiation gating activities related to its commercial-scale production at FUJIFILM Diosynth Biotechnologies in Research Triangle Park, North Carolina.

Novavax was awarded $1.6 billion in funding from the U.S. government to meet its Operation Warp Speed goals to expedite the delivery of millions of doses of safe, effective vaccines for COVID-19. The award is funding the U.S. and Mexico pivotal Phase 3 trial and manufacturing scale-up.

About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence 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 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 block binding of spike protein to cellular receptors and provided protection from infection and disease. NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is being evaluated in a Phase 3 trial in the U.K. and two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $399 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and more than $1.6 billion from the U.S. Government’s Operation Warp Speed program.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undertaking 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. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

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, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 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
Erika Trahan ir@novavax.com
240-268-2022

Media
Edna Kaplan media@novavax.com
617-974-8659

Novavax logo

Source: Novavax, Inc.

BioBuzz: Maryland Company Poised to Produce Millions of Point-of-Care COVID-19 Tests that Deliver Accurate Results in 15 Minutes

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Rockville, Maryland’s Maxim Biomedical (MaximBio) is on the cusp of bringing 3 million of its new and effective point-of-care COVID-19 tests to the fight against the coronavirus pandemic in early 2021, with a scale up to 15 million tests per month expected by Q2 2021.

The company’s brand new point-of-care (POC), ready out-of-the-box antigen test is based on a Lateral Flow Assay technology (LFA) that produces visually interpreted results within 15 minutes.

MaximBio is a family-owned business that was founded in 2005; it is part of the Maxim family of businesses. The company operates out of its 26,000 square foot fully FDA-registered, cGMP compliant, and ISO13485 certified facility in Rockville that houses 13 labs. MaximBio offers a suite of FDA and CDC approved products, as well as customizable CDMO services.

Click here to read more via BioBuzz

Altimmune Announces Submission of Investigational New Drug Application for AdCOVID™ a Single-dose Intranasal COVID-19 Vaccine; On Track to Commence Phase 1 Clinical Study in December

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GAITHERSBURG, Md., Nov. 25, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company advancing proprietary intranasal vaccines and peptide therapeutics, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to commence a Phase 1 clinical study of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID. AdCOVID is designed to stimulate a broad immune response including both systemic immunity (neutralizing antibody) and local immunity (mucosal IgA and resident memory T cells) in the nasal cavity and respiratory tract.

“We’ve made exceptional progress advancing AdCOVID and are on track to begin a Phase 1 clinical study this year, with a data readout anticipated in the first quarter of 2021,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “While the progress being reported with current vaccines is very encouraging, many in the scientific and medical communities agree that there is continued need for next-generation vaccines that offer significant enhancements. AdCOVID has the potential to provide many benefits not offered by current vaccines, including simple intranasal administration (particularly well-suited for use in children), the ability to be transported at room temperature and conveniently stored in refrigerators for years, and the stimulation of nasal mucosal immunity with the potential to provide sterilizing immunity and block transmission of the SARS-CoV-2 virus. In addition to testing in adults, our IND included a preliminary proposal for evaluation of children as young as 2 years of age, and we look forward to further discussions around our pediatric program with the FDA in the near future.”

“It’s not widely known or appreciated that nasal mucosal immunity may be essential in preventing the spread of the SARS-CoV-2 virus to other individuals by stopping replication and transmission of the virus at the site of infection – the nose and respiratory tract,” said Frances E. Lund, the Charles H. McCauley Professor and Chair for the University of Alabama at Birmingham, Department of Microbiology. “Several recent studies have shown that in the absence of mucosal immunity, the nasal cavity may become a reservoir for the coronavirus, particularly in children, potentially allowing for disease transmission even after an intramuscular vaccination. A vaccine that prevents transmission by children would allow them to return to school and their parents to return to work. We are excited to collaborate with Altimmune on the advancement of this important next-generation vaccine and look forward to seeing data from the upcoming clinical study.”

In a recent pre-IND meeting, the FDA agreed to the overall Phase 1 study design and patient population, as well as plans for manufacturing and product testing of AdCOVID. The FDA also confirmed that additional nonclinical studies were not required and that the toxicology data previously submitted and reviewed for Altimmune’s NasoShield™ and NasoVAX™ intranasal vaccine candidates support the clinical development of AdCOVID, with no additional toxicology studies required before initiation of the Phase 1 trial.

About AdCOVID

In recently published preclinical studies (www.biorxiv.org/content/10.1101/2020.10.10.331348v1) conducted in collaboration with the University of Alabama at Birmingham, potent serum neutralizing antibody and T cell responses were induced in mice in addition to a robust induction in mucosal immunity against the spike protein of the virus. Importantly, the mucosal immunity was characterized by IgA antibody and resident memory T cell responses in the respiratory tract, both are believed to be important in fighting infection.

Based on data from Altimmune’s other intranasal platform vaccines (NasoVAX and NasoShield) AdCOVID is expected to have extended stability at room temperature allowing for cold chain-free shipment of the vaccine, where it can then be stored in common refrigerators found in community-based doctor’s offices and pharmacies for two years or more. The simple and convenient handling requirements may greatly increase the number of people willing to take the vaccine.

Altimmune anticipates commencing a Phase 1 safety and immunogenicity trial of AdCOVID in the fourth quarter of 2020 with a data readout in the first quarter of 2021.

About Altimmune

Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an intranasal immune modulating therapeutic for COVID-19 (T-COVID™); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™). For more information on Altimmune, please visit www.altimmune.com.

About UAB

Known for its innovative and interdisciplinary approach to education at both the graduate and undergraduate levels, the University of Alabama at Birmingham is an internationally renowned research university and academic medical center, as well as Alabama’s largest employer, with some 23,000 employees, and has an annual economic impact exceeding $7 billion on the state. The pillars of UAB’s mission include education, research, innovation and economic development, community engagement, and patient care. Learn more at www.uab.edu.

Forward-Looking Statement

Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, the initiation and timing of the AdCOVID Phase 1 clinical trial in Q4 2020 and data readout in Q1 2021, the potential immunization effects of AdCOVID, the shipping and storage requirements for AdCOVID, the willingness of the general public to use AdCOVID, and the prospects for regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: potential impacts due to the COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to secure regulatory approval for its AdCOVID investigational new drug application submission to the U.S. Food and Drug Administration, the Company’s ability to manufacture clinical trial materials on the timelines anticipated; the Company’s ability to secure manufacturing approval from its SARS-CoV-2 cell licensor on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company’s business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2019 and quarterly report on Form 10-Q for the quarter ended March 31, 2020 filed with the SEC, which are available at www.sec.gov.

Investor Contacts:
Will Brown Ashley R. Robinson
Chief Financial Officer LifeSci Advisors, LLC
Phone: 240-654-1450 617-430-7577
wbrown@altimmune.com arr@lifesciadvisors.com
Stacey Jurchison
Sr. Director, Investor Relations
Phone: 410-474-8200
sjurchison@altimmune.com
Media Contact:
Warren Rizzi
Sard Verbinnen & Co.
Phone: 212-687-8080
altimmune-svc@sardverb.com

Merck acquires OncoImmune to ramp supply of promising Covid drug

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Pharmaceutical giant Merck said it plans to acquire privately held OncoImmune for $425 million in cash, gaining rights to an under-the-radar drug that has shown striking results in hospitalized patients with Covid-19.

The medicine, CD24Fc, was shown in a late-stage clinical study in September to reduce the risk of respiratory failure or death by more than 50% in patients hospitalized with Covid-19 and requiring oxygen, Merck said Monday.

The drug was given as an intravenous infusion in addition to standard-of-care, which could include remdesivir and dexamethasone, and was compared to standard-of-care alone. The data, in 203 patients, also showed that patients receiving CD24Fc had a 60% higher probability of seeing improved clinical status.

“The results are remarkable,” Merck’s research chief, Dr. Roger Perlmutter, said in a telephone interview.

Click here to read more via CNBC

Dr. Carol Nacy, CEO of Sequella Incorporated, joins BioTalk to discuss her career, the evolution of their science, and vision for the future.

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Listen now via Apple https://apple.co/374aOFI, Google https://bit.ly/3pTGqqj, Spotify https://bit.ly/3nIl7WO, and TuneIn https://bit.ly/3nIl7WO

Dr. Nacy co-founded our Sequella in 1997 and has served as our CEO and Chairman of the Board since 1999. Prior to Sequella, Dr. Nacy served during 1997 and 1998 as Chief Scientific Officer (CSO) for Anergen, Inc., a California company acquired by Corixa Corporation in December 1998. From 1993 through 1997, Dr. Nacy was Executive Vice President and CSO at EntreMed, Inc. and participated in its successful initial public offering in June 1996. Previously, Dr. Nacy was Career Scientist (GS-15) at the Walter Reed Army Institute of Research, Washington, DC. Dr. Nacy currently serves on the board of directors of companies and non-profit agencies.

Click here for the Transcript

Immunomic Therapeutics and CoImmune Therapeutics Enter into Partnership to Manufacture ITI-1020, a Novel Experimental Cell Therapy for Glioblastoma

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ROCKVILLE, Md. & DURHAM, N.C.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, and CoImmune, Inc. (“CoImmune”), a privately held clinical-stage immuno-oncology company developing cell-based therapeutics to treat unmet medical needs in blood-borne and solid tumor indications, announced today that the companies have entered into a license agreement for ITI to use CoImmune’s proprietary dendritic cell process for certain ITI cell therapy vaccine programs. The partnership highlights the oncology pipeline of ITI and CoImmune’s expertise and technology in the development and manufacture of cell-based therapeutics.

Under the terms of the license agreement that supports this partnership, ITI will employ CoImmune’s process for manufacturing and cGMP work for the advancement of ITI-1020, ITI’s autologous dendritic cell (DC) investigational vaccine loading with mRNA encoding LAMP: pp65 for the treatment of newly diagnosed glioblastoma (GBM). CoImmune is eligible to receive milestone payments from ITI upon the successful achievement of certain agreed-upon programmatic goals, including initiation of clinical studies and regulatory submissions. In addition, CoImmune will be eligible to receive royalty payments based upon net sales of ITI-1020, if the product were to be approved in the future.

“We are excited to work with CoImmune, an emerging leader in the development and manufacture of cell-based immunotherapies,” said Dr. Tim Coleman, Senior Vice President of Operations at Immunomic Therapeutics. “This agreement supports our immediate and long-term goals for developing and commercializing cancer immunotherapies designed from our investigational UNITE nucleic acid platform. We look forward to collaborating with CoImmune and harnessing their expertise in cell therapies to bring our innovative products to patients in need.”

“Our industry is experiencing an increase in the emergence of cell-based therapeutics based on encouraging clinical results to date. Our team at CoImmune has a great deal of expertise in developing and manufacturing these products to efficiently stimulate the immune system against cancer and we are excited to partner with ITI,” said Charles Nicolette, CEO of CoImmune. “By combining our team’s know-how with the unique approach to immune system stimulation by UNITE™, we believe ITI is well positioned to move into advanced clinical development, initially targeting GBM.”

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing target antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

About Immunomic Therapeutics, Inc.

Immunomic Therapeutics, Inc. (ITI) is a privately-held, clinical stage biotechnology company pioneering the development of vaccines through its investigational proprietary technology platform, UNiversal Intracellular Targeted Expression (UNITE), which is designed to utilize the body’s natural biochemistry to develop vaccines that have the potential to generate broad immune responses. The UNITE platform has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy and autoimmune diseases. ITI is primarily focused on applying the UNITE platform to oncology, where it could potentially have broad applications, including targeting viral antigens, cancer antigens, neoantigens and producing antigen-derived antibodies as biologics. In early 2020, an investment of over $60M by HLB Co., LTD, a global pharmaceutical company, enabled ITI to accelerate application of its immuno-oncology platform, in particular to glioblastoma multiforme, and rapidly advance other key candidates in the pipeline, including the most recent initiative into infectious diseases with development of its vaccine candidate for COVID-19. The Company has built a large pipeline from UNITE with eight oncology programs, multiple animal health programs and a SARS-CoV-2 program to prevent and treat COVID-19. ITI has entered into a significant allergy partnership with Astellas Pharma and has formed several academic collaborations with leading Immuno-oncology researchers at Duke University and the University of Florida. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit www.immunomix.com.

About CoImmune, Inc.

CoImmune specializes in the development of immuno-oncology therapies based on its two proprietary platform technologies. The autologous RNA-loaded dendritic cell technology for solid tumors specifically targets each patient’s unique tumor antigens. The allogeneic CAR-CIK technology is a variation on CAR-T therapy with greatly reduced toxicity while retaining strong efficacy based on an on-going clinical trial in pediatric and adult acute lymphoblastic leukemia patients. For more information, please visit www.coimmune.com

Contacts

Company Contact:

Sia Anagnostou
AAnagnostou@immunomix.com
717-327-1822

Media Contact:

Amy Conrad
Juniper Point
amy@juniper-point.com
858-366-3243

Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA

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GAITHERSBURG, Md., Nov. 09, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM™ adjuvant.

“The FDA’s decision to grant Fast Track Designation for NVX-CoV2373 reflects the urgent need for a safe and effective vaccine to prevent COVID-19, and we look forward to working closely with the agency to accelerate access to this vaccine,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. and globally.”

Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. Data from the event-driven trial could support global authorization and approval, including in the U.S. The Company’s ongoing Phase 3 clinical trial in the UK to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 is expected to be fully enrolled by the end of November. Depending on the overall COVID-19 attack rate, interim data in the UK trial, which is also event-driven, are expected as soon as early first quarter 2021.

About NVX-CoV2373

NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence 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 contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $399 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and almost $1.7 billion from the U.S. government.

About Fast Track Designation

Fast Track Designation by the U.S. FDA is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, with the intent of getting important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. Specifically, Fast Track Designation facilitates meetings with FDA to discuss all aspects of development to support licensure and provides the opportunity to submit sections of a BLA on a rolling basis as data become available.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undertaking 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. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

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, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 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
Erika Trahan ir@novavax.com
240-268-2022

Media
Brandzone/KOGS Communication
Edna Kaplan kaplan@kogspr.com
617-974-8659

Genetron Health Inc. Relocates U.S. HQ to Montgomery County, Maryland

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Received coveted FDA Breakthrough Device designation for its NGS test for early detection of hepatocellular carcinoma

 

Rockville, Md.—Citing proximity to leading U.S. regulators and researchers, fast-growing precision oncology company, Genetron Health Inc. (Genetron), is moving its U.S. headquarters to Montgomery County, Maryland from North Carolina’s Research Triangle. The China-based company is relocating to a 6,000 SF hybrid space for Research & Development and a state-of-the-art lab in Gaithersburg, Maryland for its planned rapid growth.

Genetron’s blood-based next generation sequencing (NGS) test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), designed for early detection of hepatocellular carcinoma due to chronic HBV infection and/or liver cirrhosis. Genetron believes they are one of the first China-based, cancer molecular diagnostic companies to receive this critical FDA designation.

The company is planning for exponential growth following clinical trials, with the goal of hiring 30 to 50 people within two years and continued expansion thereafter. Genetron will be seeking workers at the crossroads of health and biotech, including professionals with expertise in bioinformatics. Learn more here about the FDA designation and the success of their study to date.

“Montgomery County is historically the first place for human genomics,” said Sizhen Wang, Genetron’s co-founder and CEO. “The county offers great advantages to us, including proximity to the U.S. evaluating authority, the FDA. We also have a perfect opportunity here for collegial interconnection with hospitals, pharma and tech companies, as well as a great talent pool to draw from as we grow.”

The company’s Chief Scientific Officer, Hai Yan, and Chief Technology Officer, Yuchen Jiao, have a Maryland connection as well, with both having been Post-Doctoral Fellows at Johns Hopkins University.

“On behalf of the State of Maryland, we are thrilled to serve as the new U.S. headquarters home for Genetron Health Inc.,” said Maryland Commerce Secretary Kelly M. Schulz. “With a bustling biohealth and life sciences sector, Genetron will fit perfectly in Montgomery County, surrounded by some of the state’s most innovative medical companies and the top researchers from across the nation.”

“We’re so pleased that Genetron has chosen to join the growing list of international companies making their home here. This innovative company’s choice of Montgomery County for its global expansion further highlights our county’s strengths in cell and gene therapy, bioinformatics and access to a highly-educated workforce,” said Montgomery County Executive Marc Elrich.

Montgomery County has approved Genetron for a MOVE grant of $46,848 to assist with their relocation, and the company is working to obtain additional State incentives for its relocation. The Montgomery County Economic Development Corporation (MCEDC) worked with the company to provide introductions to partners, incentives and available space.

“We welcome Genetron Health as yet another international company to have chosen Montgomery County. More global companies are making their home in our diverse community with the right set of assets that will help them be successful,” said Benjamin H. Wu, MCEDC President and CEO. “We congratulate Genetron on their exciting FDA Breakthrough Device designation, which is expected to be a catalyst for their rapid expansion.”

Genetron Health is committed to providing a one-stop, multi-scenario genomic profiling solutions in areas including early cancer screening, diagnosis and monitoring, as well as biopharmaceutical services.


ABOUT MCEDC

The Montgomery County Economic Development Corporation (MCEDC) is the official public-private economic development organization representing Montgomery County, Maryland. Created in 2016, MCEDC is led by a Board of Directors of business executives. Its mission is to help businesses start, grow and relocate in Montgomery County by helping them gain access to top talent, business and market intelligence and prime locations. For more information, visit our website. Follow us on TwitterFacebook and LinkedIn.

ABOUT GENETRON HOLDINGS LIMITED

Genetron Holdings Limited (“Genetron Health” or the “Company”) is a leading precision oncology platform company based in China that specializes in cancer molecular profiling and harnesses advanced technologies in molecular biology and data science to transform cancer treatment. The company has more than 700 employees in China with two manufacturing facilities and five clinical laboratories. For more information, please visit ir.genetronhealth.com.

BioBuzz: Seeking Funding During a Pandemic: Panel Discusses Recent Trends in Life Science Capital Investment

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COVID-19 has created significant challenges for the Venture Capital (VC) market and life science companies seeking funding during the pandemic. While the pandemic has undoubtedly added a new layer of risk to an inherently risky field, the fundamentals for what makes a company attractive to a VC have remained steady. However, the way deals get done has changed.

At the recent BioHealth Capital Region (BHCR) Forum, which was held virtually, a panel of life science and VC experts came together to discuss what they want to see from a potential partner before pulling the trigger to invest and how companies seeking funding during a pandemic can better market and position themselves with VCs.

The world of VC funding has always been grounded in strong networks, “warm” introductions, and personal relationships developed over dinners, conference meetings, and boardroom table discussions.

All of this changed in the age of COVID-19. Life science companies seeking funding during a pandemic and VCs searching for the right organization to invest in have had to shift quickly to virtual interactions. Initially, this shift caused significant disruption for an industry rooted in trust built through face-to-face relationship building.

Arti Santhanam, the Executive Director of TEDCO’s Maryland Innovation Initiative (MII) moderated an all-star panel that explored seeking funding during a pandemic. The panel included Benjamin Britt, General Partner of Route 66 Ventures; David Hilbert, President and CEO of Arcellx, a clinical-stage cell therapy company; Sara Nayeem, Partner at New Enterprise Associates (NEA); and Bill Snider, Partner at BroadOak Capital Partners, LLC.

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BioBuzz: Top Biopharma Talent Acquisition Experts Share Strategies for Hiring and Retaining Employees in 2020

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The biotech industry continues to grow rapidly across the nation, especially in the BHCR. The region’s strategy for hiring and retaining employees is a key driver of the BHCR’s steady, sustained growth. The workforce development strategy and infrastructure that supplies the skilled and experienced workers needed for innovation and expansion is a key factor as well.

The region has always been known as a leading vaccine development hub, but in recent years personalized medicine, including cell and gene therapybacteriophage therapy, and a booming advanced biomanufacturing cluster has added to the region’s already strong and diverse biopharma portfolio. The BHCR is evolving and so are its talent needs, which begs the question, what strategic and tactical adjustments need to be made to ensure the BHCR talent pipeline can meet the region’s future workforce requirements?

A 2020 BHCR Forum virtual panel session, hosted by BioHealth Innovation’s (BHI) Managing Director of Economic Development Judy Costello, took a deep dive into the subject. The “Growing and Retaining Your Workforce” breakout session included panelists Diana Elias, Director of HR, ABL Inc.Ellen MacMahon, VP Human Resources Global Operations/IT at AstraZeneca; and Ed Radwinsky, Head of People Operations at RoosterBio, Inc.

Here some of the highlights from the lively and insightful panel discussion on hiring and retaining employees in 2020:

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