Monthly Archives

July 2020

The Washington Post Names RoosterBio a 2020 Top Washington-area Workplace

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RoosterBio has been named one of The Washington Post’s 2020 Top Workplaces in the Washington, D.C. area. Winners were selected based solely on employee feedback gathered through an anonymous third-party survey administered by Energage, LLC, which measured several aspects of workplace culture, including alignment, execution, and connection. This award is the third award received by the RoosterBio for its outstanding workplace culture since 2019.

“As our leadership team was transforming RoosterBio from an incubator startup company into a worldwide regenerative medicine products leader, we wanted to build the kind of company we all wanted to work for,” said RoosterBio CEO Margot Connor. “It is gratifying to realize that this effort is paying off. As we navigate the new challenges that COVID-19 has presented this year, we remain nimble and adaptable, but focused on retaining the high-quality workforce that we have.”

The full list of winners along with additional content will run in print in a special Top Workplaces magazine on October 14, 2020 and will be available on The Post’s site. The Washington Post will also host an awards ceremony in October to recognize the 200 top-ranked companies.

“Now in its seventh year, The Post’s Top Workplaces list continues to highlight the companies that are leaders in the Washington-area in terms of employee engagement and satisfaction,” said Washington Post Top Workplaces editor Dion Haynes. “We had a record number of employees participate in the survey this year, making it clear that these organizations have made cultivating an atmosphere of support and respect a priority.”

In 2019, RoosterBio won the Frederick County Best Places to Work award in the medium-sized employer category by Frederick County and City Governments, and the Frederick County Chamber of Commerce. Most recently, Rooster Bio was named a 2020 Top 50 Workplace in Frederick Magazine.

About RoosterBio
RoosterBio, Inc. is a privately held cell manufacturing platform technology company focused on accelerating the development of a sustainable Regenerative Medicine industry, one customer at a time. RoosterBio’s products are high-volume, cost-effective, and well-characterized adult human mesenchymal stem/stromal cells (hMSCs) paired with highly engineered media systems. RoosterBio has simplified and standardized how living cells are purchased, expanded, and used in development, leading to marked time and cost savings for customers. RoosterBio’s innovative products and collaborative relationships are ushering in a new era of productivity and standardization into the field. Visit

About The Washington Post
The Washington Post is an award-winning news leader whose mission is to connect, inform, and enlighten local, national and global readers with trustworthy reporting, in-depth analysis and engaging opinions. It combines world-class journalism with the latest technology and tools so readers can interact with The Post anytime, anywhere.

About Energage, LLC
Headquartered in Exton, PA., Energage (formerly known as WorkplaceDynamics) is a leading provider of technology-based employee engagement tools that help leaders to unlock potential, inspire performance, and achieve amazing results within their organizations. As the research partner behind the Top Workplaces program, Energage has surveyed more than 47,000 organizations representing well over 16 million employees in the United States.

Johns Hopkins Receives $35M in Federal Funding for COVID-19 Blood Plasma Trials

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Researchers will test convalescent blood plasma therapy in two nationwide trials to determine its effectiveness in treating COVID-19 patients

Johns Hopkins researchers have received $35 million in funding from the U.S. Department of Defense for two nationwide clinical trials to test the effectiveness of a convalescent blood plasma outpatient treatment that may help COVID-19 patients’ immune systems fight the virus.

The randomized double blind trials totaling 1,100 people will be conducted at over 20 ambulatory clinics in medical centers across the U.S., including the Navajo Nation, and will help researchers determine whether convalescent blood plasma therapy—a transfusion of a blood product from COVID-19 survivors that contains antibodies—can effectively be used to treat people in the early stage of COVID-19 illness or prevent the infection in those at high risk of exposure to the virus at their home or jobs.

Currently, there are no FDA-approved vaccines to prevent infection with the SARS-CoV-2 virus, which causes COVID-19, nor approved treatments for the illness in its earliest stage. There are also no outpatient therapies to prevent hospitalization or death.

“This is a story of great synergy between researchers and institutions to carry out important studies that will inform our nation and the world on how effective plasma can be to prevent COVID-19 and to treat early disease,” says Arturo Casadevall, a Bloomberg Distinguished Professor who holds joint appointments in Bloomberg School of Public Health and School of Medicine. To initiate the clinical trial, Casadevall and his colleagues assembled a broad collaboration of investigators at Johns Hopkins and at participating medical centers across the U.S.

Image caption:Shmuel Shoham from Johns Hopkins Medicine and David Sullivan from the Bloomberg School of Public Health discuss the blood plasma clinical trials and their potential applications.

Leaders of the trials include Casadevall and his colleagues Shmuel Shoham, associate professor of medicine at School of Medicine, David Sullivan, professor of molecular microbiology and immunology at the Bloomberg School of Public Health, and Daniel Hanley, director for multisite clinical trials in the Institute for Clinical and Translational Research at the School of Medicine.

“Blood plasma therapy may have the most potential in providing immediate immunity to people at high risk of COVID-19 exposure and treating COVID-19 early to prevent hospitalization or death,” says Sullivan. “For definitive proof of this, we need a rigorous randomized clinical study to evaluate it.”

The prevention trial will include 500 people who have been exposed to COVID-19 in their home or at work as health care providers. The companion trial will have another 600 participants who have early COVID-19 disease, meaning they are within eight days of their first symptoms but are not sick enough to be in a hospital. All participants will be over age 18. The researchers aim to complete recruitment of participants to the trial in early fall 2020.

Convalescent blood plasma therapy involves transfusing a portion of blood called plasma from people who have recovered from the virus. When separated from red and white blood cells and platelets in the blood, plasma is the yellow-tinged liquid that includes proteins called antibodies, which glom on to foreign substances such as viruses and either mark them for destruction by the immune system or disrupt a virus’ ability to multiply and grow.

Physicians have used the treatment for severe diseases in hospitals for more than a century, often during epidemics such as the influenza pandemic of 1918 and the more recent outbreak of severe acute respiratory syndrome in 2003. Laboratory experiments in the past have shown that the therapy neutralizes many viruses. However, the treatment is often used in the chaotic phases of a crisis without the rigors of a large clinical trial.

There is very little clinical data proving the effectiveness of using the therapy in outpatient clinics, according to the researchers. Currently, only hospitalized patients have access to any type of therapy for COVID-19.

“Because plasma from recovering patients is widely available, it may be a rapid low-cost treatment of major value in early stages of epidemics. A randomized trial is needed to clearly demonstrate these historical and laboratory proven benefits,” says Hanley.

The blood plasma used in these trials is being collected from many organizations, including the New York Blood Center and the American Red Cross. One donor can provide plasma for up to three people. Trial participants will receive one IV infusion of the plasma at an outpatient facility, which usually takes about an hour.

As part of the trials, participants with COVID-19 will be monitored over four weeks to determine the course of the disease and its severity. Participants who have been exposed to the virus will be evaluated over four weeks for development of COVID-19 infection, including symptom checks and laboratory testing for the virus and antibodies. The researchers will examine the long-term immunity of both groups at three months after infusion with convalescent plasma.

From the trials, Shoham says, the researchers hope to learn if blood plasma can prevent infection or squash it where it begins. “There are also biological implications,” he says, adding that blood plasma therapy could expand treatment options for viral diseases. “We’re reviving an old approach to fight pathogens, and it may be useful for other viruses or parasites such as malaria.”

Image of virus and cells
Johns Hopkins responds to COVID-19

Coverage of how the COVID-19 pandemic is affecting operations at JHU and how Hopkins experts and scientists are responding to the outbreak

Johns Hopkins research into convalescent blood plasma therapy was previously funded by $3 million from a Bloomberg Philanthropies gift and $1 million from the state of Maryland. Johns Hopkins also received a $1 million award supplement from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases. Additionally, the researchers used the National Center for Advancing Translational Sciences Trial Innovation Network and the National COVID-19 Convalescent Plasma Project at Michigan State University to develop interest in the trial among participating centers.

Jason Roos, deputy joint program executive officer for chemical, biological, radiological and nuclear defense, says, “We’ve seen that convalescent plasma can benefit patients suffering from some of the worst effects of COVID-19. The JPEO-CBRND is excited to be working with Johns Hopkins University to determine whether that same plasma could help protect our Joint Forces from COVID-19, either by preventing infection altogether or drastically reducing their symptoms. Those types of beneficial outcomes would help us make sure our servicemen and women stay healthy so they can complete their mission.”

Other key faculty supporting this project include virologists Andy Pekosz and Sabra Klein of the Johns Hopkins Bloomberg School of Public Health and transfusion medicine experts Evan Bloch and Aaron Tobian of the School of Medicine.

BioFactura Awarded $1 Million SBIR Contract for Development of a Marburg Virus Therapeutic

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Contract awarded by the Joint Science & Technology Office–Chemical and Biological Defense of the Department of Defense

FREDERICK, Md.July 29, 2020 /PRNewswire-PRWeb/ — BioFactura, Inc. today announced a $1 million Small Business Innovation Research (SBIR) Phase II contract awarded by the Joint Science & Technology Office—Chemical and Biological Defense (JSTO-CBD) of the Department of Defense (DoD). The goal of this project is to develop, optimize, and scale-up a highly efficient mammalian cell culture-based bioprocess suitable to meet surge requirement needs for rapid manufacture of a monoclonal antibody (mAb) therapeutic against the Marburg virus (MARV) biothreat.

MARV is a member of the same family as Ebola virus, causes lethal viral hemorrhagic fever, and is classified as a Category A priority pathogen by the NIH, due to high case fatality rates and suspected weaponization. There are currently no MARV vaccines or therapeutics approved for human use. With so much focus on Ebolavirus over the last few years, MARV antibody development efforts have lagged considerably and few MARV-specific mAbs have been described. This problem leaves the U.S. in a vulnerable situation to treat and manage a MARV outbreak. Under the contract, BioFactura will use its proprietary StableFastTM Biomanufacturing Platform to develop a process for this crucial therapy against MARV that is easily scalable for production at large manufacturing cGMP (current Good Manufacturing Practices) facilities.

Dr. Darryl Sampey, President and CEO of BioFactura, stated, “This Chem-Bio Defense Phase II award builds upon our successful early development of a highly productive StableFast cell line during the SBIR Phase I contract. We look forward to working with our partners at the DoD to develop the drug manufacturing process for advanced testing and clinical readiness to meet threats to the warfighter.”

“This government contract for the development of a novel Marburg virus therapeutic countermeasure is the
result of continued efforts to create highly effective therapeutics that can be deployed in the event of a biological threat. The current COVID pandemic has taught us a valuable lesson: Strategic preparedness in conjunction with an organized effort at containment and treatment, can mitigate the effects of these deadly pathogens. We applaud the JSTO-CBD and DoD for their foresight,” said Jeffrey Hausfeld MD. MBA., Chairman and Chief Medical Officer of BioFactura, Inc.

This project is supported by the Defense Threat Reduction Agency under Contract No. HDTRA1-20-C-0033. Any opinions, findings and conclusions or recommendations expressed in this press release are those of the
authors and do not necessarily reflect the views of Defense Threat Reduction Agency.

About BioFactura, Inc.

BioFactura, Inc. (Frederick MD) develops and commercializes high-value biodefense medical countermeasures and biosimilars (i.e., follow-on biologics or generic biopharmaceuticals) using its patented StableFast™ Biomanufacturing Platform, the optimal system for bringing these drugs to market with faster, lower cost, superior-quality manufacture. For over 15 years, BioFactura has been advancing life-saving medicines from the research bench to the patient using its innovative drug development and manufacturing technologies. Current and past programs include biodefense drugs against smallpox and Ebola, novel medicines for cancer, and low-cost/high-quality biosimilars for autoimmune and infectious diseases.

Thrive Earlier Detection Closes $257 Million Series B Financing

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Proceeds to Advance CancerSEEK, a Liquid Biopsy Test Designed to Detect Multiple Cancers at Earlier Stages of Disease, into Registrational Trial

Financing Co-Led by Casdin Capital and Section 32 and Includes Multiple New Top-Tier Investors

Cambridge, MASS., July 29, 2020 – Thrive Earlier Detection Corp., a company dedicated to extending and saving lives by incorporating earlier cancer detection into routine medical care, today announced that it has raised $257 million in a Series B financing. The round was led by Casdin Capital and Section 32, with participation from new investors Bain Capital Life Sciences, Brown Advisory, Driehaus Capital Management, Intermountain Ventures, Janus Henderson Investors, Lux Capital, Moore Strategic Ventures, Perceptive Advisors, Rock Springs Capital, Sands Capital, funds and accounts advised by T. Rowe Price Associates, Inc., and other undisclosed investors. All of Thrive’s Series A investors returned to participate in the Series B financing. Thrive also announced that Eli Casdin has been appointed to the board of directors.

“Since our founding in 2019, Thrive has continued to make tremendous progress in our pursuit towards changing the face of cancer,” said David J. Daly, chief executive officer of Thrive. “In April, we published data from the first ever prospective and interventional study of a multi-cancer screening test in an asymptomatic population. Our blood test more than doubled the number of cancers first detected by screening, enabling better outcomes and, in some cases, potential cure for these patients. With this financing, we are well-positioned to advance our test into a robust registrational trial and continue to work closely with key stakeholders to remove barriers to ensure timely access, including future reimbursement for CancerSEEK.”

Thrive’s vision is to incorporate its blood test, CancerSEEK, into routine medical care and detect more cancers at earlier stages when they can be more effectively treated and, in many cases, cured. Today, the vast majority of people are diagnosed only after symptoms appear, often coinciding with late stage, metastatic disease, and poor outcomes. CancerSEEK, used in combination with standard-of-care screening tests has the potential to shift this paradigm to a new reality where the majority of cancers, including many with no screening options today, are diagnosed through screening and at earlier stages.

“We are proud to partner with a diverse group of world class investors who share in our vision to make earlier detection of cancer an accessible and affordable part of our healthcare system,” said Steven J. Kafka, Ph.D., chairman of Thrive and managing partner at Section 32. “We are also thrilled to welcome Eli Casdin to our board of directors. Eli has deep and broad expertise in diagnostics and biotech, and he will provide tremendous value to Thrive.”

Mr. Casdin has spent the last 17 years focused on and investing in disruptive technologies and business models across life sciences and healthcare. In 2011, he founded Casdin Capital, a life science technology investment firm to provide growth equity to private and public companies throughout the industry continuum.

“In the collective search to bend the mortality curve on cancer, the disruptive potential of earlier detection has long been a promise. But now, in a real-world study of 10,000 individuals, Thrive’s blood test integrated with standard-of-care, has delivered on this potential and shows the power of detecting cancers before they spread. While there is more work ahead, it is clear that the future has now arrived. I’m excited to join the board and help in my small way to usher in this new era,” said Eli Casdin, chief investment officer of Casdin Capital.

About Casdin Capital

Casdin Capital, LLC was founded in 2011 and brings a deep understanding, expertise and long-term perspective to financing the next generation of life science innovation. Specific only to the firm’s diagnostics and molecular information portfolio, Casdin Capital has invested in many of the leading pioneers, including but not limited to Foundation Medicine, Invitae, Adaptive Biotechnologies, Flatiron Health and 23andMe. In addition, Eli Casdin currently serves on the board of directors of Exact Sciences, a leader in the field of molecular screening for cancer. For more information, please visit

About Section 32

Section 32 is a venture capital fund investing at the frontiers of technology, healthcare and the life sciences with the goal to improve the human condition by accelerating the discovery, development, adoption and distribution of important technologies and lifesaving medicines. Founded by Bill Maris, the firm’s focus areas include biotechnology, therapeutics, advanced diagnostics, precision medicine, software, cybersecurity, machine learning and artificial intelligence. For more information, please visit

Thrive Earlier Detection Corp. is a healthcare company focused on incorporating earlier cancer detection into routine medical care to extend and save lives. Thrive is developing CancerSEEK, a liquid biopsy test that is designed to detect many cancers at earlier stages of disease. CancerSEEK will serve as the core of Thrive’s integrated cancer information offering. For more information, please visit

BioFactura, Inc. Co-Founder, President & CEO, Darryl Sampey, PH.D., Virtually Sits Down with Rich Bendis for BioTalk

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BioFactura, Inc. Co-Founder, President & CEO, Darryl Sampey, PH.D., joins BioTalk to discuss his background with the University of Maryland, the BioHealth Capital Region, and the creation of his company in Frederick.

Listen now via Google, Apple, Spotify, TuneIn, and YouTube (Audio Only)

Darryl Sampey co-founded BioFactura in 2004 and has guided the venture over the past 15 years from start-up through incubator stages to become a significant biopharmaceutical product development and clinical manufacturing company. As President and CEO, Dr. Sampey manages all strategic and scientific endeavors of the Company. Before BioFactura, he led both process development and manufacturing teams at Human Genome Sciences, Inc. (HGS) honing his skills developing and scaling up new biologics processes and control strategies. During his tenure with HGS, Dr. Sampey played key roles in the start-up, commissioning, and validation of the company’s first cGMP manufacturing facility and associated development laboratories. Prior to his work at HGS, Dr. Sampey gained industrial experience in the commercial research laboratory designing and optimizing fermentation and product recovery processes for novel vaccines at North American Vaccine, Inc. His work in vaccine research has since progressed to internationally-approved vaccines for whooping cough in infants and meningitis in adults. Darryl Sampey began his career in biotechnology at the University of Maryland graduating first in his class with a Bachelor of Science in Chemical Engineering, Magna Cum Laude, and, subsequently earned a Ph.D. in Bioengineering.

Emergent BioSolutions Signs Agreement with AstraZeneca to Expand Manufacturing for COVID-19 Vaccine Candidate

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  • Emergent will provide contract development and manufacturing services beginning in 2020 to produce drug substance at large scale for commercial supply
  • Agreement is valued at approximately $174 million through 2021 and brings the total AstraZeneca commitment to $261 million
  • Parties may enter into additional commercial manufacturing commitments as the candidate progresses over three years through Emergent’s flexible capacity deployment model

GAITHERSBURG, Md., July 27, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has signed an agreement to provide contract development and manufacturing (CDMO) services for large-scale commercial drug substance manufacturing for AstraZeneca’s COVID-19 vaccine candidate, AZD1222. The agreement is valued at approximately $174 million through 2021 and follows an $87 million contract in June for development services, performance and process qualification, raw materials and an initial capacity reservation.

“Emergent is driven by our desire to advance solutions that will make an impact on this pandemic,” said Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions. “Sharing a passion for science, we are encouraged by AstraZeneca’s investigational COVID-19 vaccine and look forward to supporting its continued progress.”

The adenovirus vector-based vaccine candidate, AZD1222, was co-invented by the University of Oxford and its spin-out company, Vaccitech, and licensed by AstraZeneca. The vaccine candidate is currently in clinical trials. It is one of the candidates funded and supported by Operation Warp Speed (OWS), the U.S. government’s program to accelerate the development, manufacturing, and distribution of COVID-19 medical countermeasures that aims to have substantial quantities of a safe and effective vaccine available.

Syed T. Husain, senior vice president and CDMO business unit head at Emergent, stated, “As COVID-19 vaccine candidates progress through the pipeline, Emergent stands ready alongside leading innovators to rapidly deploy our CDMO services to help meet the substantial demand for a vaccine – anchored on our foundational expertise in development and manufacturing and propelled by our commitment to our mission – to protect and enhance life.”

This agreement follows and is in addition to the landmark public-private CDMO partnership between Emergent and the Biomedical Advanced Research and Development Authority (BARDA) announced in June to pave the way for OWS high-priority innovators.

Activities under this agreement will be performed at Emergent’s Baltimore Bayview facility, where certain manufacturing capacity reserved by BARDA through the CDMO task order issued to Emergent under OWS will be used. Emergent’s Baltimore Bayview facility is a designated Center for Innovation in Advanced Development and Manufacturing (CIADM) by the U.S. Department of Health and Human Services (HHS) designed for rapid manufacturing of large quantities of vaccines and treatments during public health emergencies.

The CIADM has unique capabilities across four independent suites to produce at clinical scale to get candidates rapidly into the clinic, while at the same time scaling up to enable large-scale manufacturing to up to 4000L to prepare for production of commercial volumes to meet customer demand. The CIADM has the capacity to produce tens to hundreds of millions of doses of vaccine on an annual basis, based upon the platform technology being used.

Financial Considerations
The company will provide an update to its 2020 financial outlook incorporating expectations related to this agreement and any other relevant information when it reports its second quarter financial results on July 30, 2020.

About Emergent BioSolutions
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

Emergent’s Response to COVID-19
Emergent BioSolutions is deploying its decades of experience in vaccine and hyperimmune development and manufacturing, as well as its molecule-to-market contract development and manufacturing (CDMO) services to provide comprehensive medical countermeasure solutions in response to the COVID-19 pandemic.

Using its established hyperimmune platforms, Emergent is developing two investigational plasma-based treatments – COVID-Human Immune Globulin (COVID-HIG) and COVID-Equine Immune Globulin (COVID-EIG). COVID-HIG is being developed as a human plasma-derived therapy candidate with $14.5 million in HHS funding and will be evaluated in two studies of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, for potential treatment of COVID-19 in severe hospitalized and high-risk patients. With $34.6 million in funding from the Department of Defense and in collaboration with the Mount Sinai Health System and ImmunoTek Bio Centers, COVID-HIG will also be evaluated for post-exposure prophylaxis in populations at high risk of COVID-19, such as front-line health care workers and the military. COVID-EIG is being developed as an equine plasma-derived therapy candidate for potential treatment of severe disease in humans. Both candidates are anticipated to be in Phase 2 clinical studies in 2020. These investigational products are not approved by the U.S. Food and Drug Administration and their safety and effectiveness have not been established.

Emergent is deploying its CDMO capabilities, capacities, and expertise to support the U.S. government’s Operation Warp Speed to pave the way for innovators to advance COVID-19 programs. The company is working with four innovators to develop and manufacture COVID-19 vaccine candidates. For the COVID-19 vaccine response, Emergent’s integrated CDMO network provides development services from its Gaithersburg facility, drug substance manufacturing at its Baltimore Bayview facility, and drug product manufacturing at its Baltimore Camden and Rockville facilities, all in Maryland.

For 22 years Emergent has focused on advancing public health, and its multi-pronged approach to tackling COVID-19 demonstrates its commitment to its mission – to protect and enhance life.

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our ability to produce viable COVID-19 vaccine candidates at the prescribed scale and on the anticipated timeline and pave their potential pathway to licensure, the total value and anticipated duration of activities under the announced AstraZeneca contract as well as the negotiation of any further commitments or contracts related to the collaboration and deployment of capacity toward future commercial manufacturing, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including the success of the planned development programs; the timing of and ability to obtain and maintain regulatory approvals for the product candidates; and our commercialization, marketing and manufacturing capabilities. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.

Media Contact:
Miko B. Neri
Senior Director, Global Communications & Public Affairs

Investor Contact:
Robert G. Burrows
Vice President, Investor Relations


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Source: Emergent BioSolutions

Altimmune Announces Manufacturing Agreement With Vigene Biosciences For AdCOVID™, Its Single Dose Intranasal Vaccine Candidate For COVID-19

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GAITHERSBURG, Md., July 22, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the Company has entered into an agreement with Vigene Biosciences (“Vigene”) to manufacture AdCOVIDTM, Altimmune’s single-dose intranasal vaccine candidate for COVID-19. Vigene, a Rockville, Maryland-based award-winning Contract Development and Manufacturing Organization (CDMO), specializes in viral vectors and will deploy its capabilities to manufacture AdCOVID. Following recent positive pre-clinical data, Altimmune plans to start a Phase 1 clinical trial of AdCOVID in Q4 2020.

“Vigene is a fantastic partner to advance AdCOVID into Phase 1 clinical testing and beyond,” said Dr. Vipin K. Garg, President and CEO of Altimmune. Dr. Garg continued, “We believe Vigene’s deep experience in viral vector production and their collaborative, client focused approach will help facilitate Altimmune’s timeline for clinical development of AdCOVID.”

“With our new state-of-the-art manufacturing facility and our expertise in viral vector production, we are well positioned to support Altimmune in their COVID-19 vaccine development efforts,” said Dr. Zairen Sun, Vigene’s President and CEO. “In addition to our existing facility, we are in the process of expanding our capacity so that we can support Altimmune beyond clinical development into commercial scale manufacturing.”

Altimmune is also initiating scale up of manufacturing of its AdCOVID vaccine for advanced clinical trials and commercial production. The Company is actively engaged in discussions with additional strategic manufacturing partners with the goal of producing at least 100 million doses of AdCOVID in 2021.

AdCOVID is an intranasal vaccine candidate designed to block viral infection and to provide protection against viral spread through stimulation of both mucosal and systemic neutralizing antibodies (IgA and IgG) as well as cell-mediated immunity. By stimulating mucosal immunity in the nasal cavity, a key point of entry and replication for SARS-CoV-2, AdCOVID has the potential to defend against both infection in the recipient as well as spread of the virus to others. Intranasal administration can also be accomplished more simply than an injection and may eliminate the need for highly trained medical personnel. In addition, since it is expected to have extended stability at room temperature, AdCOVID may avoid the need for costly cold chain logistics.

In preclinical studies conducted in collaboration with the University of Alabama at Birmingham (UAB), AdCOVID stimulated both strong serum neutralizing activity and potent mucosal immunity (IgA) in the respiratory tract. Additionally, vaccination of mice with AdCOVID caused the rapid recruitment of immune cells into the respiratory tract, draining lymph nodes and spleen consistent with induction of potent local and systemic immunity. Increases in CD8+ and CD4+ T cells, dendritic cells and NK cells were observed in the respiratory tract, and germinal center and memory B cells as well as T follicular helper cells were observed in regional lymph nodes and the spleen. Importantly, the latter cell types have been associated in prior vaccine development research with long-lived antibody responses.

About Vigene Biosciences
Vigene Biosciences, Inc. is an award-winning leader in viral vector-based gene delivery for both life science research, gene therapy and cell therapy purposes. Headquartered in Rockville, Maryland, Vigene features 10 fully equipped GMP clean room suites for AAV, lentivirus, retrovirus, adenovirus and plasmids GMP production, respectively.  In addition, Vigene also develops and owns a panel of intellectual properties including proprietary high productivity cell lines (suspension and adherent cells) for viral vector packaging and patents for increasing viral vector packaging efficiency.  Vigene offers FDA and EMA compliant cGMP production for viral vector and plasmid production with the mission of making gene therapy affordable.  For more information on Vigene, please visit

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 treatment 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

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, the initial immunogenicity results of our AdCOVID preclinical studies,  the potential immunization effects of AdCOVID, our ability to manufacture 100 million doses of AdCOVID in 2021, and the prospects for regulatory approval, commercializing or selling AdCOVID or any of our other 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, adverse effects on healthcare systems and disruption of the global economy the reliability of the results of the studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; 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; the Company’s ability to secure additional manufacturing partners; the Company’s ability to obtain potential regulatory approvals on the timelines anticipated, or at all; and the Company’s ability to expand its pipeline of products and the success of future product advancements, including the success of future clinical trials, and the Company’s ability to manufacture and commercialize its products. 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



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ROCKVILLE, Md. — In the critical race for a COVID-19 vaccine, the United States has its eyes squarely set on Montgomery County, Maryland. In addition to being the home of the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), over $3 Billion of public and private coronavirus vaccine research and manufacturing funding has been invested over the past four months in local Montgomery County life sciences companies, including Novavax, Inc. and Emergent BioSolutions. These large-scale investments continue the County’s rich history as the epicenter of many of healthcare’s greatest achievements, including the location where the human genome was first sequenced.

Gaithersburg’s Novavax was awarded $1.6 Billion, one of the largest Operation Warp Speed federal funding awards to date, for its late stage coronavirus vaccine development. This government funding is intended to complete late-stage clinical development, including a pivotal Phase 3 clinical trial, as well as establish large-scale manufacturing and deliver 100 million doses of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate, as early as late 2020. Novavax has also received $388 Million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and $60 Million through a Department of Defense Contract to fund the development of NVX-CoV2373.

“The Covid-19 pandemic highlights the need for industry, government and funding entities to join forces to defeat this and other public health threats. We feel fortunate to be in resource-rich Montgomery County as we continue the important work of developing a vaccine to defeat Covid-19 and other serious threats to public health,” said Stanley C. Erck, President and Chief Executive Officer of Novavax.

Montgomery County’s Emergent BioSolutions has also been an Operation Warp Speed recipient, securing $628 Million for manufacturing capability for vaccines. Emergent has two COVID-19 agreements totaling $615 Million to manufacture drug substances for Johnson & Johnson’s lead vaccine candidate, as well as partnerships with Novavax, AstraZeneca and Vaxart to develop and manufacture their vaccine candidates. Leading biotech companies in the U.S. and around the world are recognizing and utilizing Emergent BioSolutions’ incredible ability to rapidly scale up and produce vaccines for global pandemics.

“Montgomery County, Maryland truly is the nation’s vaccine capital. Our biotech companies are a major force in fighting this pandemic,” said Benjamin H. Wu, the Montgomery County Economic Development Corporation (MCEDC) President and CEO. “The County and the world can benefit from our local talent and ingenuity. We are leading the way to help save lives with our unparalleled vaccine research and manufacturing capabilities.”

In addition to Novavax and Emergent BioSolutions, there are close to 40 companies helping to fight the pandemic in Montgomery County, including GlaxoSmithKline, Sanaria and Zalgen Labs, among others. See more local Montgomery County COVID-19 contributions here.

“Montgomery County is at the epicenter of global healthcare. Three of the top federal agencies are nearby, including the world’s largest researcher (NIH), regulator (FDA) and payor (CMS). The County has an abundant and incredibly diverse workforce providing access to 40,000 life science workers,” said Brad Stewart, MCEDC’s SVP of Business Development. “You’ll also find 20% of the world’s top vaccine development influencers right here in Maryland. There’s no better place to be for vaccine development.”


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.

Novavax and FUJIFILM Diosynth Biotechnologies Initiate Large Scale Manufacturing of COVID-19 Vaccine Candidate

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GAITHERSBURG, Md. and MORRISVILLE, N.C., July 23, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, and FUJIFILM Diosynth Biotechnologies (FDB), a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies, announced today an agreement to manufacture bulk drug substance for NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. FDB’s site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373.

This arrangement falls under Novavax’ recent $1.6 billion award by the federal government as part of Operation Warp Speed (OWS), a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population. The OWS funding is being used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373 beginning as early as late 2020. NVX-CoV2373 consists of a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant. The batches produced at the FDB site in North Carolina will be utilized in a future pivotal Phase 3 clinical trial of up to 30,000 subjects which is expected to begin in the fall of 2020 and which will determine the safety and efficacy of NVX-CoV2373.

“We are grateful to partner with the team at FUJIFILM Diosynth Biotechnologies to ensure the large-scale manufacture of our COVID-19 vaccine candidate,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We are committed to working together with unprecedented speed to deliver a vaccine to protect our nation’s population.”

“We are delighted to bring our leading technical expertise in baculovirus systems and our proven manufacturing excellence to support Novavax’ response to this global crisis,” said Martin Meeson, Chief Executive Officer of FUJIFILM Diosynth Biotechnologies. “As a critical partner to Novavax, our focus is to advance the delivery of a vaccine that can have a profound impact.”

Novavax’ Phase 1/2 clinical trial of NVX-CoV2373 in 130 healthy participants 18 to 59 years of age began in Australia in May.  Novavax will announce the Phase 1 data, which will consist of preliminary immunogenicity and safety results, during the first week of August. The Phase 2 portion to assess immunity, safety, and COVID-19 disease reduction is expected to begin shortly thereafter. The Phase 1/2 clinical trial is being supported by an up-to $388 million funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI).

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

About Operation Warp Speed

Operation Warp Speed is facilitating, at an unprecedented pace, the development, manufacturing, and distribution of COVID-19 countermeasures, between components of Department of Health and Human Services (HHS), including the Centers for Disease Control and Prevention (CDC), FDA, the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA, part of the HHS Office of the Assistant Secretary for Preparedness and Response); the Department of Defense. OWS is coordinating existing HHS-wide efforts, including the NIH’s ACTIV partnership for vaccine and therapeutic development, NIH’s RADx initiative for diagnostic development, and work by BARDA.

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. A Phase 1 clinical trial of NVX‑CoV2373 initiated in May 2020, with preliminary immunogenicity and safety results expected to be announced during the first week of August. The Coalition for Epidemic Preparedness Innovations (CEPI) is investing up to $388 million, and Department of Defense (DoD) is investing up to $60 million of funding to advance clinical development of NVX‑CoV2373.

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 recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with preliminary immunogenicity and safety results expected to be announced during the first week of August. 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 and connect with us on Twitter and LinkedIn.


FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract  Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerød, Denmark.  FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation.  For more information, go to:

FUJIFILM Holdings Corporation, Tokyo, Japan, brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2020, the company had global revenues of $21 billion, at an exchange rate of 109 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit:

Forward-Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the manufacturing of vaccine antigen dose amounts and timing, 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, as filed with the Securities and Exchange Commission (SEC) and updated by any Quarterly Report on Form 10-Q, particularly the risks inherent to developing novel vaccines. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at, 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.

Investors and Media
Silvia Taylor and Erika Trahan

Brandzone/KOGS Communication
Edna Kaplan

Joe Metzger

Liza M. Rivera

TEDCO Appoints Troy LeMaile-Stovall As New CEO/Executive Director

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COLUMBIA, Md. (July 22, 2020)— TEDCO, Maryland’s economic engine for technology companies, announced today that its Board of Directors has appointed Troy LeMaile-Stovall as Chief Executive Officer/Executive Director, effective September 7, 2020.

“Troy’s depth and breadth of experience in finance, investments, economic development and operational leadership will be a tremendous asset to the organization and to the diverse stakeholders we serve across the state of Maryland,” stated Myra Norton, TEDCO’s Chair of the Board and President of Arena.  “Troy’s most compelling strengths go well beyond his impressive background and experience.  He is a galvanizing, inspiring and inclusive leader with a track record of delivering outcomes in challenging times.  We are delighted to welcome Troy, and look forward to supporting his leadership and the TEDCO team.”

Troy has over 25 years of experience in the fields of investment management, higher education, telecommunications, information/communication technology, management consulting, and non-profit leadership/management.

“I am fortunate, honored and humbled to be selected as TEDCO’s next CEO/Executive Director,” said Troy LeMaile-Stovall.  “In these times of uncertainty brought on by public health, economic and racial concerns, TEDCO should continue to be the voice of innovation that can help Maryland address these concerns for all her citizens.  I look forward to serving.”

Troy serves as Chief Operating Officer at the University of the District of Columbia and he founded and serves as Managing Member of LeMaile Stovall LLC, a management consulting firm focused on strategy, operational performance and capital stack formation. Troy was Interim President for Zenith Education Group, a $400M+, 56-campus career education system. Additionally, Troy was a Principal at Butler Snow Advisory Services, serving not only higher education clients but also senior levels in higher education as EVP/COO at Howard University and Sr. VP/CFO at Jackson State University. He co-founded and operated as the first President/CEO of GulfSouth Capital, Ambassador John N. Palmer’s (Skytel founder) multi-million dollar family investment office; he served global technology and telecommunications clients as a Sr. Engagement Manager at McKinsey & Co.; and held positions at Southwestern Bell Telephone (now AT&T), Bell Labs and Rockwell International. He holds a bachelor’s degree in Electrical Engineering from Southern Methodist University cum laude, a master’s degree in Computer Science from Stanford University, and an MBA from Harvard Business School.

“I want to congratulate TEDCO’s Board of Directors on their appointment of their new CEO Troy LeMaile-Stovall,” said Governor Larry Hogan. “TEDCO provides essential tools and resources to our entrepreneurs during critical company growth stages. Their mission to provide access to capital and advisory support and utilize federal and state programs to assist tech and life science startups benefits our economy amidst our current challenges and helps to create more jobs in communities all across Maryland.”

TEDCO’s Board of Directors enlisted Korn Ferry, in January 2020, to assist the organization with a national search for the selection of a permanent CEO/Executive Director.

“TEDCO has been an innovative organization that has kept Maryland at the forefront of emerging technologies on the East Coast,” said Speaker Adrienne A. Jones. “I am pleased with the rigorous process that the Board of Directors undertook to select Troy Stovall. As we look at a shifting economy coming in to 2021, I look forward to working together with Troy to invest in Maryland companies and new job opportunities so that every Marylander is a part of the 21st century economy.”

“TEDCO serves an important role in the innovation ecosystem of Maryland,” stated Senate President Bill Ferguson.  “Mr. Stovall adds a new, yet experienced, voice to Maryland’s economic development landscape.  I offer my congratulations to Mr. Stovall and to the TEDCO Board and I look forward to working together on legislative solutions to the challenges facing the entrepreneur community in Maryland.”

TEDCO has carried the “innovation to market” banner for 22 years and has added tremendous value to the state’s evolving entrepreneurial ecosystem. Recognized as one of the most active seed/early-stage investors in the nation, TEDCO has a diverse portfolio of more than 400 investments. TEDCO’s initial $22 million awarded to startups led to $1.6 billion in follow-on funding; 7,800 jobs created at an average salary of $74,700; nearly $67 million in annual government revenues attributed to TEDCO activities. TEDCO has also supported more than $157 million in 465 stem cell research grants through Maryland Stem Cell Research Fund, keeping Maryland at the forefront of research in this critical future growth area.

“We also want to recognize and offer our sincere gratitude to Linda Singh, our interim CEO/Executive Director, whose strong leadership during this period has laid a foundation for the organization to thrive in the months and years to come.  We are pleased she will continue to lead the organization in preparation for Troy’s arrival,” stated Norton.


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