Monthly Archives

April 2020

Immunomic Therapeutics Announces Close of $61.3M Financing

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-Proceeds to support acceleration of Phase II clinical trial for GBM, advancement of pipeline, including development of COVID-19 vaccine candidate and expansion of opportunities for its UNITE nucleic acid platform-


ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”) a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today the close of a $61.3M financing led by HLB Co., LTD, a global pharmaceutical company focused on developing novel cancer drugs. This represents the second closing in the investment process for the HLB Consortium, ($10M was placed in February 2020), and substantially increases their holding in Immunomic Therapeutics to 47.6% of the common stock. HLB also secured an option to make further investment into the company in the months ahead.

“We are pleased to welcome HLB as a significant shareholder of Immunomic Therapeutics and look forward to working with them within the framework of the HLB Bio family of companies. They have a proven track record of success in Asia and share our commitment and passion for developing best-in-class therapies for cancer and other serious diseases,” said Dr. William Hearl, CEO of Immunomic Therapeutics. “With HLB’s support, we are well-positioned to accelerate our efforts in immuno-oncology, in particular glioblastoma multiforme, and rapidly advance other key candidates in our pipeline, including our most recent initiative into infectious diseases with development of our vaccine candidate for COVID-19.”

Proceeds from the financing will support the acceleration of ITI’s Phase II clinical trial of ITI-1000 for the treatment of glioblastoma multiforme (GBM), advance its emerging pipeline, and expand upon the current applications of its UNITE platform. The financing will also enable Immunomic to expand its team and infrastructure to support the future growth of the company.

In addition, ITI and HLB intend to establish an Asian Brain Cancer Research Center in Seoul that will bring together the world’s leading experts and cutting-edge science to advance research in the GBM field and to deploy ITI-1000 to the Asian population. ITI-1000 is a cell therapy powered by ITI’s UNITE platform that is currently being evaluated in a Phase II clinical trial (ATTAC-II) in collaboration with researchers at the University of Florida (Dr. Duane Mitchell) and Duke University (Dr. John Sampson). ITI-1001 is an alternative, cell-free approach to treating GBM. The company held a successful pre-IND meeting earlier this year for ITI-1001 and expects to be able to file an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) by the end of 2020.

Concurrent with the financing, five (5) members from HLB Co., LTD will be joining the Immunomic Therapeutics Board of Directors.


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

About Immunomic Therapeutics, Inc.

Immunomic Therapeutics, Inc. (ITI) is a privately-held, clinical stage biotechnology company pioneering the development of vaccines through its proprietary technology platform, UNiversal Intracellular Targeted Expression (UNITE), which is designed to utilize the body’s natural biochemistry to develop vaccines that generate broad immune responses. UNITE has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy and autoimmune diseases. ITI is primarily focused on applying the UNITE platform to oncology, where it could potentially have broad applications, including viral antigens, cancer antigens, neoantigens and antigen-derived antibodies as biologics. The Company has built a large pipeline from UNITE with six oncology programs and two allergy programs. ITI has entered into a significant allergy partnership with Astellas Pharma and has formed several academic collaborations with leading Immuno-oncology researchers at Fred Hutchinson Cancer Research Institute, Johns Hopkins University of Medicine, and Duke University. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit


ITI Company:
Sia Anagnostou

ITI Media:
Amy Conrad
Juniper Point

AGT CEO Jeff Galvin on the Future of the Gene and Cell Therapy Industry

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The rapid growth of biopharma is causing a shift to a new paradigm for the drug development and delivery model. In the same manner that the personal computing industry grew and developed business models that fit the way products were sourced, constructed and delivered, a business model for biopharma is taking shape.

Jeff Galvin, CEO of American Gene Technologies (AGT), had 30 years of business and entrepreneurial experience in Silicon Valley during the formative years of the personal computing and internet era. He left retirement as an Angel Investor in real estate and high tech in 2008 to found AGT and lead it in developing a bank for Lentiviral vectors with different characteristics for use with its gene delivery platform.

The use of these vectors with this platform will save time and money in drug development, Galvin said as he shared his vision for the biopharma industry with BioSpace.

Click here to read more via BioSpace

Emergent BioSolutions Signs Agreement to be U.S. Manufacturing Partner for Johnson & Johnson’s Lead Vaccine Candidate for COVID-19

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  • Emergent will provide contract development and manufacturing services to support Johnson & Johnson’s commitment of one billion doses of vaccine for worldwide emergency pandemic use
  • Agreement valued at approximately $135 million

GAITHERSBURG, Md., April 23, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced an agreement whereby Emergent will deploy its contract development and manufacturing (CDMO) services to support the manufacturing of Johnson & Johnson’s lead vaccine candidate for COVID-19 that leverages the AdVac® and PER.C6® technologies from the Janssen Pharmaceutical Companies of Johnson & Johnson.

Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions, stated, “When mission-driven organizations combine talents and capabilities, potential solutions to serious issues like COVID-19 become more within reach to benefit patients. We are proud of our collaboration with Johnson & Johnson and are equally committed to our longstanding relationship with the U.S. government. At a time like this, we all need to be working together to achieve maximum results for public health. Emergent is committed to our mission – to protect and enhance life – by advancing our own therapies and helping partner companies advance their programs as well.”

Under the agreement, valued at approximately $135 million, Emergent will provide drug substance manufacturing services with its molecule-to-market CDMO offering, supported by investments from Johnson & Johnson beginning in 2020, and will reserve certain large-scale manufacturing capacity to pave the way for commercial manufacturing of Janssen’s adenovirus-based COVID-19 vaccine beginning in 2021.

To support Johnson & Johnson’s goal of supplying one billion doses of a COVID-19 vaccine, a long-term commercial manufacturing agreement is under negotiation for large-scale drug substance manufacturing anticipated to begin in 2021.

Large-scale manufacturing of drug substance for Johnson & Johnson’s vaccine candidate will be done at Emergent’s Baltimore Bayview facility, a Center for Innovation in Advanced Development and Manufacturing (CIADM) designed for rapid manufacturing of vaccines and treatments in large quantities during public health emergencies. Emergent’s CIADM is a result of a public-private partnership with the U.S. Department of Health and Human Services (HHS).

“Eight years ago, HHS invested in novel public-private partnerships to create three Centers for Innovation in Advanced Development and Manufacturing or CIADMs to help strengthen the nation’s biotech infrastructure to prepare and respond to emergencies,” said Gary Disbrow, Ph.D., acting director of the Biomedical Advanced Research and Development Authority. “Leveraging the capacity available at the Bayview CIADM to speed development and manufacturing of COVID-19 vaccine is precisely how we envisioned these centers be used in pandemic response.”

Syed T. Husain, senior vice president and CDMO business unit head at Emergent, stated, “We share with our partners the same urgency to combat COVID-19 and will leverage our talents, capabilities, and capacities up to 300 million doses to advance this much-needed vaccine candidate and ensure ongoing commercial supply through our CDMO services.”

Emergent’s Bayview facility 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.

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 using its decades of experience in vaccine and hyperimmune development and manufacturing, as well as its molecule-to-market contract development and manufacturing (CDMO) offerings to provide comprehensive medical countermeasure solutions in response to the COVID-19 pandemic. Emergent is developing two potential treatments, COVID-Hyper Immune Globulin (COVID-HIG), a human plasma-derived therapy candidate for treatment of COVID-19 in severe hospitalized and high-risk patients, and COVID-Equine Immune Globulin (COVID-EIG), an equine plasma-derived therapy candidate for treatment of severe disease. Both candidates are anticipated to be in Phase 2 clinical studies over the summer.

Emergent has announced collaborations with three fellow innovators to develop and manufacture their COVID-19 vaccine candidates. Most recently, Emergent was selected as U.S. manufacturing partner for a vaccine candidate expected to be in a Phase 1 human study by September in support of a goal to produce 1 billion doses of vaccine worldwide. Earlier partnerships include a vaccine candidate expected to be in a Phase 1 study in May and an oral vaccine candidate expected to be in a Phase 1 study in the second half of 2020. For the COVID-19 vaccine collaborations, 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 facility, 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, as well as the negotiation of another contract related to the second phase of 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, Corporate Communications

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

Emergex Signs Agreement with George Mason University for Highly Pathogenic RNA Virus Studies

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Abingdon, UK, 22 April 2020 – Emergex Vaccines Holding Limited (‘Emergex’), a biotechnology company developing CD8+ priming set-point vaccines to prevent serious infectious diseases, today announced that it has entered into an agreement with the George Mason University, based in Virginia, in the United States.

The agreement specifies that George Mason University’s National Center for Biodefense and Infectious Diseases will provide their unique expertise and resources as a partner in the development of Emergex’s vaccines against highly pathogenic RNA viruses. In particular, George Mason University’s Biosafety 3 capabilities, coupled with their experience in dealing with RNA viruses, means that they are a well-suited collaborator on the vaccine validation studies, as well as the optimization of vaccine design.

Professor Thomas Rademacher, CEO and co-founder of Emergex, commented, “Everyone in the world today has or will be affected by highly pathogenic RNA viruses such as bird flu, Ebola, COVID-19, etc. These viruses have caused significant morbidity and mortality, especially in high-risk groups such as the immunocompromised or elderly. We are therefore very excited to announce today this agreement with George Mason University, which adds an important capability to Emergex’s vaccine program.”

Dr Aarthi Narayanan, Associate Professor of Systems Biology in George Mason University’s College of Science, added, “My colleagues and I are looking forward to partnering with Emergex and we are especially pleased to be lending our expertise to efforts to create a vaccine during these challenging times. As members of the faculty of a premier research university, we work with other thought leaders to address global threats. This is how we make progress, and collaboration is the top priority for the College of Science, the Institute for Biohealth Innovation, and the University as a whole.

Emergex’s set-point vaccines have been designed to offer advantages compared to traditional vaccines. These vaccines modify the initial immune status of the recipients in a way that ‘primes’ their immune systems to recognise subsequent infectious agents much like a natural infection would do, and thus preventing an acute or severe manifestation of the disease. They do this by providing a cell-mediated immune response (a T-cell response) rather than a humoral immune response (an antibody based immune response) which should stimulate longer lasting immunity. They are self-adjuvanted and limit or eliminate the allergic, autoimmune or antibody mediated side effects associated with the traditional vaccines. They are also 100% synthetic and do not contain any RNA or DNA – do not use inactivated or live-attenuated pathogens – and therefore should be inherently safer to develop and use.

About Emergex
Emergex, a UK-based biotechnology company headquartered in Abingdon, UK, is pioneering the development of set-point vaccines to address some of the world’s most immediate health threats such as Dengue Fever, Zika, Ebola, pandemic flu and serious intra-cellular bacterial infections.

These set-point vaccines are population based and modify the initial immune status of recipients in a way that ‘primes’ their immune systems to recognise subsequent infectious agents much like a natural infection would do, preventing an acute or severe manifestation of the disease.

Emergex combines validated technologies together with the very latest scientific insights to develop its vaccines, including using synthetic peptide codes determined on actual infected cells and using a proprietary gold nanoparticle carrier system for programming.

The Company has a growing pipeline of vaccine candidates. The most advanced development programme is a vaccine for Dengue Fever, which may also be disease modifying for other Flaviviruses such as the Zika and Yellow Fever viruses. Emergex also has programmes in development for a universal Influenza vaccine and a universal Filovirus vaccine (including viruses such as Ebola and Marburg) and discovery programmes for a Yellow Fever Booster vaccine and a Chikungunya vaccine.

Find out more online at

About George Mason University
George Mason University is Virginia’s largest public research university. Located near Washington, D.C., Mason enrolls more than 37,000 students from 130 countries and all 50 states. Mason has grown rapidly over the last half-century and is recognized for its innovation and entrepreneurship, remarkable diversity, and commitment to accessibility.

The Institute for Biohealth Innovation (IBI) promotes and supports biohealth-related research activities of faculty, staff, and students at George Mason University. The IBI connects Mason researchers in biohealth with potential collaborators, both within the university and externally, to advance human health research. Learn more and hear more from our researchers at

The College of Science at Mason is a leader in scientific discovery creating innovative solutions for the rapidly-changing needs of today’s world. Mason’s College of Science blends traditional science education with sought-after programs in disciplines as diverse as personalized medicine, infectious diseases, geoinformatics, climate dynamics, materials science, astronomy, forensic science, and applied mathematics. The College encourages meaningful education and research at all levels offering innovative undergraduate programs, minors, certificates, and graduate degree opportunities, as well as global, transfer-focused, and online, or hybrid, programs that allow professionals the opportunity to reskill or change careers. Learn more at

George Mason University Biomedical Research Laboratory is one of thirteen Regional Biocontainment Laboratories constructed with funding support from the National Institute of Allergy and Infectious Diseases/National Institutes of Health (NIAID/NIH). The BRL is a state-of-the-art laboratory with biosafety level 3 and aerosolization capabilities where scientists perform pioneering research of infectious diseases, both emerging and potential bio threat agents. Learn more at

BioBuzz: Industry Leaders Outline Best Strategies for Attracting Talent in the BioHealth Capital Region

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Recruiting and attracting talent is one of the top priorities and challenges for biotech and life science companies, even amid the current coronavirus pandemic. To help address those challenges, WorkForce Genetics organized a virtual panel of HR and talent acquisition leaders and local CEO’s to share their insights and best practices.

On April 15th over 125 attendees joined the online panel event which was co-hosted by the Society of Physician Entrepreneurs (SOPE), entitled “Attracting Talent in the BioHealth Capital Region.” Panelists included Marty Rosendale, CEO of the Maryland Tech Council (MTC); Kate Surdez, VP, Human Resources at Viela Bio; and Matthew Levy, Associate Director, Talent Acquisition at Kite Pharma, a Gilead Company. Dr. Jeffrey Hausfield, Chairman of the Board and Chief Medical Officer at BioFactura and the Co-founder and President of SoPE, acted as the panel’s moderator.

Topics covered during the discussion included regional branding, employer branding, small versus large company recruiting strategies, competition for talent and workforce development.  However, an important topic that was addressed early on was how the panelists and their respective organizations have pivoted to adapt to the coronavirus pandemic.

Click here to read more via BioBuzz

Medcura, Inc., a Commercial-Stage Medical Device Company, Announced Today That It Has Moved Into a New Purpose-Built Facility in Riverdale, Maryland That Will Support the Manufacture and Commercialization of Its Growing Product Line

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Medcura chose the Discovery District, a growing center for technology and innovation, where high-tech companies can build businesses that develop, manufacture and commercialize disruptive new products. The Company worked with Terrapin Development and St. John Properties to design and deliver a facility that can house product development, manufacturing and leadership functions that will support commercialization of consumer, clinical, surgical and military applications of its proprietary platform. The Company intends to manufacture core cGMP compliant hemostatic and wound treatment materials at a scale necessary for commercial launch and in support of the clinical development of implantable devices.

“Expanding into this new plant is just the next stage in our growth arc,” said Larry Tiffany, Chief Executive Officer. “These new headquarters give the Company state-of-the art manufacturing and R&D labs, while providing a new corporate home where our growing team can build a successful business. By co-locating our product development and manufacturing, we can now more effectively integrate innovations in our chemistry, product design, and means of delivery across our commercial product lines.”

“We’re thrilled that Medcura has joined a growing group of innovative and entrepreneurial companies that are creating jobs in multiple high-tech industries and are the foundation of our thriving Discovery District,” said Ken Ullman, Chief Strategy Officer for Economic Development at the University of Maryland. “Our goal is to foster the rapid growth of companies like Medcura that are started at the University of Maryland and mature to commercialize disruptive new technologies while helping to transform our community.”

This new plant provides an ideal footprint for the Company’s expanding business. The manufacturing lab (see pictures enclosed), is over four times larger than the Company’s prior accommodations and provides strict isolation for the manufacture of commercial materials while the Company continues to innovate across the hall in an advanced R&D lab.

Moving into this new facility is quite timely, as the Company evaluates co-development opportunities with some of the world’s largest healthcare companies. These relationships are based on coating Medcura’s high-performance materials onto, or infusing them into, market-leading products. By improving the performance of a partner’s product line, particularly in bleeding environments where the patient’s own clotting ability is compromised, these relationships can deliver increased clinical productivity and patient outcomes through decisive and cost-effective bleeding management in an antibacterial environment.

GSK, AstraZeneca in talks for joint U.K. COVID-19 diagnostics project: Bloomberg

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GlaxoSmithKline and AstraZeneca are considering forming a joint laboratory to help the U.K. government stretch and expand its supplies for COVID-19 diagnostic tests, according to a report from Bloomberg.

Even though diagnostics are not their core efforts, the plan is for the two Big Pharmas to test a range of different reagents, chemical mixtures and other materials for new ways to help detect the spreading novel coronavirus. Successes would be provided to other manufacturers or the U.K.’s National Health Service.

An AstraZeneca spokesperson told Bloomberg the company has contacted the government about using “in-house scientific capabilities to increase the effectiveness of the national testing effort” but did not provide specifics. Meanwhile, GSK said it has provided lab equipment and scientific advice, according to the report.

Click here to read more via FierceBiotech

Emergent BioSolutions Executive Vice President, Manufacturing and Technical Operations, Sean Kirk Guests on BioTalk

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Sean M. Kirk, Executive Vice President, Manufacturing and Technical Operations at Emergent BioSolutions joins Rich Bendis to discuss the COVID-19 Health Crisis, Emergent’s Capabilities in Manufacturing in the BioHealth Capital Region and Beyond


Listen now via Apple Podcasts (, Google Podcasts (, Spotify (, and TuneIn (


Mr. Kirk joined Emergent BioSolutions in 2003 and has served as executive vice president, manufacturing and technical operations since April 2019. Prior to this position, Mr. Kirk has held various senior leadership roles including senior vice president, manufacturing operations and contract development and manufacturing operations (CDMO) business unit lead from April 2017 to March 2019, senior vice president, biodefense operations from November 2015 to March 2017, senior vice president, biosciences operations from February 2014 to November 2015 and senior vice president, biodefense vaccines and therapeutics development from March 2012 to February 2014. Mr. Kirk also served in multiple roles of increasing responsibility at Emergent’s manufacturing operations site in Lansing, Michigan.


Before joining Emergent, Mr. Kirk worked at Merial, a multinational animal health company, serving in various positions from 1996 to 2001. Mr. Kirk received both an M.B.A. and B.S. in Microbiology from the University of Georgia.

Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding

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The NIH is deeply concerned for the health and safety of people involved in NIH research, and about the effects on the biomedical enterprise in the areas affected by the HHS declared public health emergency for COVID-19. Due to the potential exceptional impact, we want to assure our recipient community that NIH will be doing our part to help you continue your research.

This is a rapidly evolving situation and we will provide updated guidance and information as it becomes available.

See page update history.


Proposal Submission & Award Management

Human Subjects & Clinical Trials

Animal Welfare

Peer Review

  • Based on NIH Guidance on Travel and Meetings Link to Non-U.S. Government Site - Click for Disclaimer, in-person NIH peer review meetings are being held in alternate formats. Scientific review officers will be in contact with peer reviewers about these changes.

FAQs – FAQs last updated on March 30, 2020 (history).

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