Monthly Archives

August 2020

Novavax and Canada Reach Agreement in Principle to Acquire Novavax’ COVID-19 Vaccine

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Novavax and Canada Reach Agreement in Principle to Acquire Novavax’ COVID-19 Vaccine
Aug 31, 2020 at 8:55 AM EDT

•  Canadian government to purchase up to 76 million doses of NVX-CoV2373

GAITHERSBURG, Md., Aug. 31, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it has reached an agreement in principle with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, Novavax’ COVID-19 vaccine.

“We are pleased to work with the Canadian government on supply of our COVID-19 vaccine, an essential step to ensure broad access of our vaccine candidate,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We are moving forward with clinical development of NVX-CoV2373 with a strong sense of urgency in our quest to deliver a vaccine to protect the world.”

“We are pleased to announce this agreement with Novavax, which will give Canadians access to a promising COVID-19 vaccine candidate. This is an important step in our government’s efforts to secure a vaccine to keep Canadians safe and healthy, as the global pandemic evolves,” said The Honourable Anita Anand, Minister of Public Services and Procurement, Government of Canada.

Novavax and Canada expect to finalize an advance purchase agreement under which Novavax will supply doses of NVX-CoV2373 to Canada beginning as early as the second quarter of 2021. This purchase arrangement will be subject to licensure of the Novavax vaccine by Health Canada.

NVX-CoV2373 is currently in multiple Phase 2 clinical trials. The Phase 2 portion of the Phase 1/2 clinical trial to evaluate the safety and immunogenicity of NVX-CoV2373 began in August in the United States and Australia, and expands on the age range of the Phase 1 portion by including older adults 60-84 years of age as approximately 50 percent of the trial population. Secondary objectives include preliminary evaluation of efficacy. In addition, a Phase 2b clinical trial to assess efficacy began in South Africa in August.

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. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 data of the 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. Phase 2 clinical trials began in August. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

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 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 undergoing 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 in order 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:

Novavax

Investors
Silvia Taylor and Erika Trahan
ir@novavax.com
240-268-2022

Media
Brandzone/Speak Life Science
Amy Speak
amy@speaklifescience.com
617-420-2461

Join BHI and Represent the BioHealth Capital Region in the FRAXA Biotech Games™ for Research

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Are you seeking an opportunity to engage your firm in a fun community-building activity?  Register one or more teams for the FRAXA Biotech Games.  The BioHealth Capital Region has been challenged by other clusters to demonstrate the greatest knowledge of biotech trivia. Proceeds benefit FRAXA Research Foundation, supporting Fragile X research projects at institutions around the world, including MIT, Harvard, Stanford and UCSD. Fragile X is the most common inherited cause of autism and intellectual disabilities.  BioHealth Innovation (BHI) is hosting the BioHealth Capital Region (Maryland, DC, and Virginia)’s participation in this exciting new event.

Register one team or multiple teams this month to compete for the Cup in September!

Novavax Initiates Phase 2 Portion of Phase 1/2 Clinical Trial of COVID-19 Vaccine

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  • Primary objectives expand evaluation of immunogenicity and safety
  • Secondary objectives include preliminary efficacy assessment
  • Trial to enroll up to 1,500 volunteers in United States and Australia, with approximately 50 percent between 60 and 84 years of age
  • Interim immunogenicity and safety data expected in fourth quarter of 2020

GAITHERSBURG, Md., Aug. 24, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the first volunteers have been enrolled in the Phase 2 portion of its ongoing clinical trial to evaluate the immunogenicity and safety of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. The Phase 2 clinical trial expands on the age range of the Phase 1 portion by including older adults 60-84 years of age as approximately 50 percent of the trial’s population. NVX‑CoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant.

“We expect this Phase 2 portion of the trial to expand on the encouraging Phase 1 safety and immunogenicity data for NVX-CoV2373, and we will now look for robust immune responses in older adults,” said Gregory M. Glenn, M.D., President, Research and Development at Novavax. “Our Phase 3 trial of NanoFlu, which we reported in March of 2020, provided us with a deep understanding of the unique needs of older adults, who are particularly vulnerable to COVID-19. We know that the world is closely watching all of these trials, and we anticipate interim data from this trial in the fourth quarter of this year.”

The Phase 2 portion of the ongoing Phase 1/2 clinical trial is a randomized, placebo-controlled, observer-blinded study to evaluate the safety and immunogenicity of NVX-CoV2373 with Matrix-M in subjects aged 18 to 84 years. The clinical trial will assess two dose sizes (5 and 25 µg), each with 50 µg of Matrix‑M. Although the trial was designed to confirm immunogenicity and safety in adults, secondary objectives include preliminary evaluation of efficacy. The study is targeting enrollment of up to 1,500 healthy volunteers, with approximately 50 percent of participants ≥60 years of age, at up to 40 sites in the U.S. and Australia

The trial is supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

In the Phase 1 portion of the Phase 1/2 clinical trial, conducted in Australia, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. These data have been submitted for peer-review to a scientific journal and are posted online at the preprint server medRxiv.org.

For further information, including media-ready images, b-roll, downloadable resources and more, click here.

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. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 data of the 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. Phase 2 clinical trials began in August. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

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 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 undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 data of the Phase 1/2 clinical trial. 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 in order 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 8-K 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:

Novavax

Investors and media
Silvia Taylor and Erika Trahan
ir@novavax.com
240-268-2022

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

 

Novavax logo

Source: Novavax, Inc.

QIAGEN to Launch Easy-to-Use Digital Test in the U.S. for Rapid Detection of SARS-CoV-2 Antibodies Following FDA Emergency Use Authorization

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  • Access Anti-SARS-CoV-2 is an easy-to-use 10-minute test on a portable device that provides highly accurate results on Total Ig antibodies (IgA, IgM, IgG)
  • New test based on QIAGEN partner Ellume’s proprietary technology, addresses current test shortfalls in terms of automation and convenient read-out of results
  • Digital eHub and eStick system provides rapid qualitative serological in-vitro detection of total antibodies to SARS-CoV-2 in plasma and serum
  • U.S. launch set to start in late August 2020 after submission for FDA Emergency Use Authorization, European CE-IVD marking and commercialization start planned in coming weeks

GERMANTOWN, Md. & HILDEN, Germany–(BUSINESS WIRE)–QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. launch of the new Access Anti-SARS-CoV-2 Total test, an easy-to-use digital test done on a portable device that provides results in about 10 minutes to detect antibodies in people exposed to the SARS-CoV-2 virus, which is the case of COVID-19.

The launch of this antibody test, which was developed in partnership with the Australian digital diagnostics company Ellume, comes after the submission by QIAGEN of this unique antibody test to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). First shipments are planned for late August 2020. A CE-IVD marking for Europe and other markets is planned in the coming weeks.

The new serological test has been shown to have sensitivity of 100% (CI 88.43–100.00%) and specificity of 100% (CI 95.20–100.00%).

The test is performed on the eHub, a small portable digital device that provides reliable results in 10 minutes. Each eHub can handle up to eight patient samples simultaneously and can perform up to 32 total tests per hour. The nanoparticle fluorescent detection technology uses serum or plasma from patient samples. The same platform is being used for QuantiFERON-TB Access, a new solution in development for diagnosis of latent tuberculosis (TB) infection in low-resource regions with a high TB disease burden.

Please find the full press release here.

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

Contacts

QIAGEN
Investor Relations

John Gilardi +49 2103 29 11711
Phoebe Loh +49 2103 29 11457
ir@QIAGEN.com

Public Relations
Thomas Theuringer +49 2103 29 11826
pr@QIAGEN.com

Nearly 40 Maryland Companies, Universities Working on Vaccines, Therapeutics, Diagnostic Tests, and Clinical Research

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Maryland’s Life Sciences Companies Have Secured More Than $3 Billion For Vaccine Development
Hopkins Commits 260 Scientists and Researchers to COVID-19 Projects
University of Maryland School of Medicine Begins Phase 3 Trials of Vaccine

 

ANNAPOLIS, MD—Governor Larry Hogan today commended the nearly 40 Maryland life sciences companies that are working on developing and manufacturing COVID-19 vaccines and therapeutics, improving diagnostic tests, and providing clinical research and technological support to ensure safe and effective health care delivery.

The University System of Maryland and Johns Hopkins University have also dedicated millions of dollars toward research, testing, and clinical trials. The University of Maryland School of Medicine recently began phase 3 trials of a COVID-19 vaccine.

“On the day of our first coronavirus cases, I said that Maryland was home to some of the top health research facilities in the world, and vowed that we would be a part of developing treatments and perhaps even a vaccine for this deadly virus,” said Governor Hogan. “I want to commend our world-class life sciences community, our universities, and federal research labs for working together to fight this unprecedented global pandemic. Our state will continue to lead on the road to recovery.”

To date, Maryland’s life sciences companies have secured more than $3 billion for the development of a vaccine for SARS-CoV-2, the virus that causes COVID-19.

  • Gaithersburg-based Novavax was awarded $1.6 billion through Operation Warp Speed to complete late-stage clinical development, establish large-scale manufacturing, and deliver 100 million vaccine doses as early as late 2020, as well as $388 million from the international Coalition for Epidemic Preparedness Innovations and $60 million through a U.S. Department of Defense contract to support vaccine production.
  • Emergent BioSolutions, with its headquarters and product development facility also based in Gaithersburg and three manufacturing facilities in Baltimore and Rockville, announced it signed contracts with AstraZeneca, Johnson & Johnson, Novavax, and Vaxart as well as with Operation Warp Speed for a total of $1.5 billion to support COVID-19 vaccine candidate development and manufacturing.
  • Bethesda-based Longhorn Vaccines and Diagnostics won a $225 million U.S. Department of Homeland Security contract to transport clinical samples to testing labs.
  • Altimmune, headquartered in Gaithersburg, was awarded a $4.7 million contract from the U.S. Army Medical Research and Development Command and is working with Rockville-based Vigene Biosciences on the development of a single-dose intranasal COVID-19 vaccine.

“Emergent is proud to be a part of Maryland’s efforts to fight the COVID-19 pandemic,” said Robert G. Kramerpresident and CEO of Emergent BioSolutions. “Maryland’s life sciences cluster enhances our ability to partner with pharmaceutical and biotechnology innovators. Along with our longstanding partnership with the federal government in support of its efforts to combat public health threats, we are uniquely positioned to work quickly to help advance vaccine and hyperimmune therapeutic candidates.”

“We are grateful to be part of Maryland’s collaborative life sciences cluster that, together with the state’s superb academic institutions, is making rapid progress in the fight against COVID-19,” said Stanley C. Erckpresident and chief executive officer of Novavax.  “Novavax’s swift response in developing one of the world’s most promising vaccines for this pandemic is a testament to the value of these close relationships, rich local resources, and government support in effectively addressing pressing public health needs.”

The University System of Maryland and Johns Hopkins University both mobilized quickly to develop a comprehensive response to the pandemic. Johns Hopkins dedicated $6 million in funding to support about 260 scientists and researchers working on more than two dozen projects related to COVID-19. In addition, Hopkins’ School of Medicine is conducting more than 100 clinical studies to develop COVID-19 diagnostics and, with $35 million from the U.S. Department of Defense, is working with the Bloomberg School of Public Health to test the efficacy of blood plasma from COVID-19 survivors as a treatment option.

The University System of Maryland faculty are working to develop a rapid COVID-19 test and are conducting a clinical trial of experimental stem cell therapy to reduce death in the sickest patients. The University of Maryland School of Medicine will receive up to $3.6 million over the next year from the Defense Advanced Research Projects Agency to rapidly test hundreds of drugs, approved and marketed for other conditions, to see if any can be repurposed to prevent and treat COVID-19.

“It’s in crises like these that you see why Maryland is one of the country’s top biosciences hubs,” said University System of Maryland Chancellor Jay A. Perman. “Our USM institutions are on the front lines developing COVID-19 diagnostics and therapeutics, testing multiple vaccines, leading dozens of other R&D projects. But they’re also reaching out to our close industry partners, joining our assets and expertise to theirs so we can quickly commercialize COVID-19 solutions. There are few states that have the breadth and depth of our life sciences talent, and fewer still that have an ecosystem like ours that thrives on collaboration.”

“As we confront a global pandemic on a scale not experienced since the 1918 flu, it is remarkable to see the extraordinary depth and breadth of expertise being galvanized against COVID from right here in Maryland,” said Ron Daniels, president of Johns Hopkins University. “Johns Hopkins researchers quickly mobilized to launch an emergency, cross-divisional COVID-19 research program to stem the tide of the virus and save lives. From investigating the underlying biology and developing treatments for the disease to addressing its devastating impact on our local communities, and reporting rigorous data about its spread, Hopkins researchers are at the forefront of the fight to stop COVID-19.”

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Montgomery Co. biotech company receives FDA approval for human trials of HIV Cure program

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A Montgomery County-based biotechnology company has announced it received approval from the FDA to begin human trials for its HIV cure program.

American Gene Technologies has been developing its program for 12 years. The company submitted their request to the FDA in October to begin human trials which are slated to start at the end of September or the beginning of October.

“This is momentous news that we have FDA approval to launch Phase 1 and conduct our first human trials. We are beyond excited to reach this milestone,” Chief Science Officer David Pauza said in a news release. “Based on our successful commercial-scale product manufacturing runs and features of the product observed in our labs, this therapy has a high potential to be effective.”

The company’s work builds off of a previous study by Sangamo Therapeutics which clipped part of the protein that plays a major part in HIV infection.

 

Click here to read more.

5 Questions with Judy Costello, Managing Director of Economic Development for BioHealth Innovation, Inc. (BHI)

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“5 Questions With……” is a weekly BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. This edition features 5 Questions with Judy Costello who is Managing Director of Economic Development for BioHealth Innovation, Inc. (BHI).

Judy Costello is Managing Director of Economic Development for BioHealth Innovation, Inc. (BHI). Prior to joining BHI, she served as Director of the Maryland Department of Commerce’s Office of BioHealth and Life Sciences and as Deputy Director of the department’s BioMaryland Center. In these positions, she has worked to grow the region’s biohealth cluster by supporting industry recruitment and retention, commercialization, workforce, non-dilutive and dilutive fundraising, international soft landing, partnership, and promotion activities. She previously served as Executive Director of the Business Alliance for Innovation and Entrepreneurship.

At the Business Alliance, she managed the organization’s Bootcamp, angel investor forum, tech transfer showcases, educational seminars, and other programs connecting entrepreneurs, faculty innovators, students, and industry leaders in Maryland, DC, and Virginia with each other and with those providing funding and other resources to young companies.

Before joining the Business Alliance, Costello held positions in economic development, financial services marketing, and university public relations. She is a graduate of Georgetown University and holds an MBA from Loyola University in Maryland.

1. What was your first job/role in the biotech/pharma/life-sciences industry? Tell us about it. (How you ended up there. About the role and company).

Though I interacted with a few early-stage biotech companies while running the Business Alliance Entrepreneur Bootcamp and Grubstake Angel Investor programs, I knew little about the unique life cycle of these companies and the industry until I joined the Maryland Biotechnology Center (later known as the BioMaryland Center) as its first Deputy Director in 2011. The Center was the part of the Maryland Department of Business and Economic Development tasked with guiding the implementation of the state’s “Bio2020 plan” involving a $1.3 billion to growing the biotechnology industry in Maryland.  While serving in that role, I had the opportunity to provide economic development (i.e. facilities, financial incentives, workforce, and marketing) support to a wide range of biotech companies.  We worked with industry, academic and government leaders to help build a sense of community, connect the state’s biotechnology assets and business growth resources with each other; and promote them in and outside Maryland.

The Department was rebranded to the Maryland Department of Commerce in 2015 and still works, with TEDCO and other agencies, to support the growth of the bio industry in the state. Maryland has so much to offer in terms of its biotechnology industry that it was a very exciting place to be.   Every day, I learned about new technologies and more about resources provided to innovators by the state in which I have lived since 1986.

2. Tell us about your current role and company/org? (highlight what the company is working on, maybe career opportunities there, location, history)

Since 2017, I have worked as the Managing Director for Economic Development at BioHealth Innovation.  The mission is similar to what I was doing at Maryland –supporting biotech industry growth through initiatives focused on expanding capital, talent, commercialization assistance, and other resources to companies; connecting innovators with resources, and promoting the industry cluster. However, BHI’s geographic footprint is broader—focused primarily on the BioHealth Capital Region (Maryland, DC, and Virginia)—and also assisting a few companies outside the area.

Our Entrepreneurs-in-Residence, analysts, and consultants provide direct commercialization support to a number of companies including several as part of an international soft-landing program.  This varies from non-dilutive funding application development assistance to market research, business strategy, portfolio vetting and packaging, and business development services. We still support queries about space, workforce, capital raising, economic development incentives, and other growth resources. What I most enjoy is continuing to learn while helping others advance their technologies, career paths, and businesses.

 Click here to read more via BioBuzz

FDA Approves American Gene Technologies (AGT) to Move Forward with Phase 1 Clinical Trial of HIV Cure Program

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ROCKVILLE, Md., Aug. 11, 2020 (GLOBE NEWSWIRE) — American Gene Technologies (AGT) announced today approval by the Food and Drug Administration (FDA) to begin Phase 1, the first human clinical trial for AGT’s lead HIV program. AGT will conduct its Phase 1 study at clinical sites in the Baltimore/D.C. area, and has named Washington Health Institute, University of Maryland, Institute of Human Virology and Georgetown University as its initial trial sites. These sites are expected to begin enrollment in September 2020.  AGT hopes to report initial data before the end of the year.

AGT’s Phase 1 trial will investigate the safety of AGT103-T, measure key biomarkers and explore surrogate markers of efficacy. AGT103-T is a single-dose, lentiviral vector-based gene therapy developed to eliminate HIV from the millions of people globally infected with the disease.

HIV has affected society for more than four decades. Globally, nearly 38 million people have been infected with HIV and over one million people in the United States are living with HIV. So far, efforts to cure the disease have been unsuccessful. AGT developed a new treatment to repair immune system damage done by HIV and allow natural responses to control the virus. From its research, AGT believes a cure is attainable and is now taking the significant step of testing in humans.

The AGT103-T cell product is made from blood cells using an 11-day process that increases the HIV-fighting T cells and uses a gene therapy to help these cells survive in the body. The product demonstrates the ability to clear itself of HIV when challenged with the virus and HIV-infected human cells.

AGT’s characterization of AGT103-T was done in collaboration with government researchers from the National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health.  Under a Collaborative Research Agreement, NIAID provided detailed characterization of CD4 T cells in the company’s AGT103-T cell product and insight into mechanisms of action for this biological drug that may benefit people living with HIV.

A peer-reviewed article co-authored by AGT and NIAID scientists was published in Molecular Therapy in June 2020 (read published article). The publication describes the evolution of the AGT103-T manufacturing process as researchers developed the large-scale production of modified HIV-specific CD4 T cells that resist infection and depletion by HIV. The upcoming Phase 1 study will allow AGT to examine the effect of AGT103-T in a clinical setting which was previously demonstrated in preclinical human cell models.

The levels of potency in the AGT103-T cell product that have been repeated and validated by NIAID have given AGT further confidence that antiretroviral therapy-free HIV remission could be achieved soon. According to AGT founder and CEO Jeff Galvin, “I am confident AGT103-T will be an important step towards an eventual cure for HIV.”

“This is momentous news that we have FDA approval to launch Phase 1 and conduct our first human trials. We are beyond excited to reach this milestone. This brings us closer to our goal of transforming lives with genetic medicines,” said Chief Science Officer David Pauza, Ph.D. “Based on our successful commercial-scale product manufacturing runs and features of the product observed in our labs, this therapy has a high potential to be effective.”

Phase 1 in Maryland

Maryland ranked fifth of all U.S. states and territories in HIV diagnosis rates, with nearly 1,000 new cases in 2018 alone according to the Maryland State Department of Health. The Washington, D.C. metropolitan area, including Baltimore, is a hotspot for HIV/AIDS.  Our clinical trial sites in the metro area will test our new treatment in populations hardest hit by HIV.

FOR MEDIA: Click Here to Register for the Virtual Press Conference.

About HIV

Today, approximately 37.9 million people worldwide and 1.2 million people in the United States are living with HIV/AIDS. The U.S. government has estimated that 38,900 Americans were newly infected with HIV in 2018 and 1.7 million individuals globally were infected with HIV in 2018. Locally, the Washington D.C./Baltimore area is often cited as a ‘hot spot’ for HIV with Washington, D.C. having the highest rate of infection at nearly 48 infections per 100,000 population and Baltimore City with similarly high infection rates of 36 per 100,000.

Since the late 1980s, antiretroviral drugs have restored quality of life to persons living with HIV and, in some cases, have even been used to prevent new infections. However, no approved treatments can cure HIV. This is an unmet medical need that AGT is closer to addressing.

About AGT 103-T

AGT103-T is a genetically-modified cell product made from a person’s own cells. AGT’s approach is unique in that it focuses on repairing the key immune system damage caused by HIV. When HIV infection causes this specific damage, killing of T helper cells required for immunity to HIV, the infected person becomes unable to eliminate the virus and thus, becomes chronically infected. AGT’s approach is designed to repair the T helper cell defect and provide durable virus control that is not compromised by HIV strains that vary in sequence or use alternate ways to enter and infect T cells. AGT’s AGT103-T HIV therapeutic drug should work to remove infected cells from the body and decrease or eliminate the need for lifelong antiretroviral treatment.

About American Gene Technologies (AGT)

American Gene Technologies (AGT) is a gene and cell therapy company with a proprietary gene-delivery platform for rapid development of cell and gene therapies to cure infectious diseases, cancers, and inherited disorders. AGT’s mission is to transform people’s lives through genetic medicines that rid the body of disease. AGT has received 3 patents for the technology used to make the AGT103-T cell product and ten patents for its unique immuno-oncology approach to stimulate gamma-delta (γδ) T cells to destroy a variety of solid tumors. The company has developed a synthetic gene for treating Phenylketonuria (PKU), a debilitating inherited disease. AGT’s treatment for PKU has been granted Orphan Drug Designation by the Food and Drug Administration (FDA), and it is expected to reach the clinic in 2020.

FOR MEDIA: Register Now for AGT’s Virtual Press Conference
AGT will be hosting a virtual press conference to provide the media details regarding the AGT103-T autologous cell therapy, pre-clinical results, clinical sites, enrollment plan, and timelines. If you are a member of the media and would like to attend this 1-hour press conference, please register here: (click link)

American Gene Technologies Contacts:

C. Neil Lyons, Chief Financial Officer
Phone: (301) 337-2269
Email: info@americangene.com
www.americangene.com

Sasha Whitaker, Digital Marketing and Communications
Phone: (301) 337-2100
Email: swhitaker@americangene.com
www.americangene.com

Videos are available at the following links:

https://www.globenewswire.com/NewsRoom/AttachmentNg/87674dba-67e6-47ea-b0d7-c7382ed01d90

https://www.globenewswire.com/NewsRoom/AttachmentNg/3ac30894-796a-4444-87f7-533b1172bec6

https://www.globenewswire.com/NewsRoom/AttachmentNg/c2344580-d880-4cb3-a5c4-5c66c3267262

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USM Maryland Momentum Fund Invests $250,000 in $3.5M Seed Round of miRecule Inc.

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Baltimore, MD. (Aug. 10, 2020) — The University System of Maryland (USM) Momentum Fund has invested $250K in miRecule, an emerging biotech company with a cutting-edge discovery platform to create RNA therapeutics alongside theFSHD Society as a co-investor. This investment is complemented by recent funding raised over the past year, which includes lead investor Alexandria Venture Investments as well as Pathway Bioventures, Alumni Ventures Group, and angel investors. In total, miRecule’s seed round raised more than $3.5M in private seed funding. In addition to its private investments miRecule has also been awarded a non-dilutive $2M Phase II Small Business Innovation Research (SBIR) grant from the National Cancer Institute.

miRecule’s DREAmiRTM discovery platform was developed through more than a decade of research in collaboration with the National Institutes of Health in Bethesda, Md. DREAmiR analyzes genomic and outcome data from thousands of patients to identify the underlying genetic abnormalities causing a disease in an individual patient. The company then creates an RNA therapeutic to directly target and fix the abnormality. miRecule is applying this platform to a variety of diseases, developing lifesaving RNA therapeutics for cancer, muscular dystrophy, and even COVID-19.

“We are excited to add another therapeutic company to our investment portfolio. miRecule’s technology has the potential to be incredibly impactful for the health care industry and certainly for individual patients,” said Claire Broido Johnson, managing director of the Momentum Fund. “In addition to an innovative product, miRecule has a strong management team and we have a lot of confidence in their ability.”

miRecule was founded in Biohealth Innovation’s incubator in Montgomery County (Md.) by Chief Executive Officer (CEO) Anthony D. Saleh, PhD, and Chief Operating Officer Ashwin Kulkarni, MS, an alum of University of Maryland, College Park. The majority of miRecule’s seed round funding will be used to advance their lead program, MC-30, which addresses head and neck cancer, towards clinical development. Head and neck cancer is the sixth most common form of cancer worldwide, and for many patients, survival is measured in months not years.

“We are hopeful that MC-30 will be a real game changer,” said CEO Dr. Saleh. “By correcting the underlying mutations that make a patient resistant to treatment, we think we can triple response rates and give years of quality life back to many patients.”

About the USM Momentum Fund 
The Maryland Momentum Fund is an initiative of the University System of Maryland (USM) to provide late seed investment funding for promising technology ventures that come out of any of the 12 constituent USM institutions, its research parks, and its students, faculty, or graduates. With a $10M commitment from the USM already in place, the Fund co-invests with venture capitalists, foundations, and angel investors.

The Maryland Momentum Fund, which was established by the USM Board of Regents to support promising commercial opportunities arising from advances in research and intellectual property at USM campuses, has invested in 15 startups to date:  MF FireNextStep Roboticsthe North American Wave Engine CorporationZest TeaPaverGuideRetriumVeralox TherapeuticsGemstone BiotherapeuticsNeoprogenMinnowtechARMR SystemsInfercabuaryDatakwippathOtrakKaloCyte, and miRecule. The Fund is designed to create returns and support USM’s most innovative ideas as they enter the marketplace. Learn more at www.momentum.usmd.edu.

About miRecule

miRecule, Inc. is a pre-clinical biotechnology company focused on the development of RNA therapeutics to treat a variety of diseases. miRecule has developed DREAmiR, a genomics-based discovery platform that identifies critical RNA targets in specific subsets of patients that would benefit from treatment. The company then creates proprietary chemically modified RNA therapeutics with improved pharmacology and utilizes antibodies for targeted delivery to the diseased tissue. miRecule’s business model is to develop a pipeline of RNA therapeutics through human proof-of-concept and then out-license the candidate drug to larger biopharma companies. miRecule’s lead candidate, MC-30 for head and neck cancer, addresses a market of greater than $1B with high unmet need. This therapeutic replaces the potent tumor suppressor activity of microRNA-30, which is lost in half of head and neck cancer patients. MC-30 has over 50x improved half-life and 10x improved efficacy over the natural microRNA, and has demonstrated curative potential with low toxicity in animal models. miRecule’s second program, MC-DX4 for the treatment of Facioscapulohumeral muscular dystrophy (FSHD), addresses a market worth over $1B in the U.S. alone with over 40,000 patients and no approved treatment. MC-DX4 eliminates expression of the DUX4 gene, the cause of the disease in 95% of FSHD patients.

Contact-miRecule
Anthony Saleh
anthony@mirecule.com

Contact: Mike Lurie
Phone: 301.445.2719
Email: mlurie@usmd.edu

BioForward Wisconsin’s Lisa Johnson Virtually joins Rich Bendis on BioTalk

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The BioHealth Capital Region and BioForward Wisconsin come together as Lisa Johnson joins Rich Bendis on BioTalk to discuss her career, the industry, and growing biohealth in the Midwest.

Listen now via Google https://bit.ly/2DtF6Y1, Apple, https://apple.co/3fJU0q3, Spotify https://spoti.fi/3fFpb5H, TuneIn https://bit.ly/3iqNAh9, and YouTube Audio https://bit.ly/2PERPcH

Lisa Johnson is CEO of BioForward Wisconsin which serves as the collective voice of the state’s robust and comprehensive biohealth cluster. BioForward Wisconsin represents more than 220 member organizations and focuses on initiatives to strengthen the talent pipeline, enable collaborations and enhance professional development.

Appointed as CEO of BioForward Wisconsin in May 2015, Johnson brought entrepreneurial, international and government experience to the organization building its statewide focus on integrated health solutions. Her expertise in general management, operations, business development, and leading results-oriented teams powers a positive, action-oriented ecosystem that significantly contributes to the biohealth industry and the state’s economy.

Johnson started her bioscience career in 1989 by partnering to launch Novagen, a successful life science reagents company focused on protein expression and purification. As Finance and Business Development Manager responsible for administration, sales, and business development functions, she led teams in managing licensing and OEM agreements, distributor relations, and the integration process during the 1998 buyout with CN Biosciences & Merck KGaA.

At Merck KGaA, Johnson held a variety of positions as General Manager for EMD Biosciences, managing teams to achieve global sales of $80M. She was promoted to Vice President of Operations for EMD Biosciences and later to Vice President of Corporate Development for EMD Chemicals North America.

In June 2009, she joined Semba Biosciences, Inc. as Chief Business Officer. In 2011, Johnson left the bioscience world to join state government as Vice President, Entrepreneurship and Innovation for the Wisconsin Economic Development Corporation.

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