May 2020

In 2009, a remarkable partnership started with an unsolicited email and a “cold call.”

Ten years later, Rockville, Maryland’s Sanaria and the Bioko Island Malaria Elimination Project (BIMEP) consortium won the P3 Impact Award from a pool of nearly 2,000 applicants, marking a milestone for a unique and remarkable global health consortium that’s turning the tide in the global fight against malaria.

BIMEP, which is the fusion of two impactful malaria programs, started its mitigation efforts in Equatorial Guinea’s (EG) Bioko Island in 2004. Since that time, “BIMEP has succeeded in reducing the rate of transmission of malaria by mosquitoes on Bioko Island by 99%, reducing the prevalence of malaria infection in children 2-14 years old by 76%, and reducing all-cause mortality among children under 5, largely attributable to malaria, by 63%,” according to Sanaria’s website.

The award, which was bestowed at the 2019 Concordia Summit held in New York City at the time of the UN General Assembly, was the latest achievement of the collaboration between Sanaria, Medical Care Development International (MCDI), the government of EG, Marathon Oil, Noble Energy, the Atlantic Methanol Production Company (AMPCO) and a host of other public, private and leading scientific subject matter expert partners. The Concordia Foundation, the University of Virginia’s Darden School of Business in Society, and the U.S. Department of State’s Office of Global Partnerships created the P3 Impact Award to honor leading public-private partnerships that improve communities and the world.

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The trial at the university’s Center for Vaccine Development and Global Health and three other sites in the United States and Germany is for four separate but similar vaccines developed by the pharmaceutical giant Pfizer Inc. and the German biotech company BioNTech. Pfizer planned to announce the U.S. trials Tuesday morning.

“We’re not skipping any steps, but we are speeding them up quite a bit,” said Dr. Kirsten Lyke, an infectious disease expert and the study’s lead investigator in Baltimore. “This vaccine is actually four different vaccines, with testing moving rapidly, head-to-head. … We’re hoping one rises to the top.”

Lyke, a professor of medicine and faculty member at the university’s vaccine development center, said she and other researchers learned a lot from work on quick-moving threats such as the Ebola virus about how to expedite the vaccine trial process.

There are no vaccines or even specific treatments for COVID-19, the disease caused by this coronavirus. With almost 250,000 deaths globally and more than 68,000 in the United States, federal and international regulators have moved with urgency and allowed several vaccine trials to move ahead at unprecedented speed. More than one vaccine likely will be approved and needed to protect billions of people across the globe.

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COLUMBIA, Md., May 4, 2020 (Newswire.com) – ​Intralytix, Inc. announced today that it has received a multimillion-dollar grant (AI 148054) from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), for the clinical development of its bacteriophage therapy preparation for managing infections caused by the bacterial pathogen Shigella. Dr. Alexander Sulakvelidze, Executive Vice President of Intralytix and the Program Director of the multi-PI grant, commented, “We are very pleased to have this collaborative opportunity with NIAID. The project will address a significant public health issue, as it is expected to help reduce the burden of disease caused by Shigella. It will also help enhance our program on developing bacteriophage-based therapeutic preparations as complementing modalities to other anti-infectives, such as vaccines and antibiotics, for managing bacterial diseases, including those caused by multi-drug resistant bacterial pathogens.” Dr. Sulakvelidze concluded, “This award paves the way for an important clinical study, and also shows that Intralytix continues to demonstrate innovative leadership in successfully developing bacteriophage products for various applications.”

This NIAID-funded project will assess the safety and efficacy of the Shigella bacteriophage preparation developed by Intralytix in Phase 1/2a clinical trials. “We believe that our bacteriophage preparation will help reduce the severity or incidence of disease caused by Shigella,” commented Dr. Jennifer Schwartz, Director of Clinical Development at Intralytix. She noted that “Shigella infections affect approximately 125 million people worldwide each year, with the majority of the 14,000 associated deaths occurring in young children. Bacteriophage therapy has been and is used in Eastern Europe and Asia but has not been approved by the U.S. Food and Drug Administration due to the lack of adequate clinical trials. Not only are these Phase 1/2a trials expected to have a public health impact on Shigella infections, but they will also help pave the way for the development of bacteriophage therapies against other important bacterial pathogens, including those having epidemic potential, such as cholera. We look forward to starting this important project in collaboration with the NIAID and our academic collaborators.”

The content of this press release is solely the responsibility of Intralytix and does not necessarily represent the official views of the NIAID or the NIH.

About Intralytix Inc.

Intralytix, Inc. is a privately held company headquartered in Columbia, Maryland. The Company is focused on using its core bacteriophage technology platform to improve human health through the development and commercialization of innovative products for food safety, animal health, human therapeutics, oral care, cosmetic, and dietary supplements/probiotic applications.

Intralytix was the first company in the world to receive FDA-approval for a bacteriophage-based product for food safety applications. The Company currently has the world’s largest portfolio of FDA-approved bacteriophage-based products on commercial markets and is the largest producer of bacteriophage preparations for food safety applications worldwide. Intralytix is currently sponsoring a clinical trial at the Mount Sinai Hospital in New York, for which it is IND-holder (https://clinicaltrials.gov/ct2/show/NCT03808103?term=Intralytix&rank=1), and the Company also has several additional human therapeutic bacteriophage products in various stages of development. To learn more, please visit www.intralytix.com or contact Dr. Alexander Sulakvelidze (410-625-2533, asulakvelidze@intralytix.com).

Today we hear phrases such as “In these difficult times” to highlight the challenges of the world with COVID-19 which is on all of our minds. Many industries have been adjusting via telecommuting employees if possible, while others cut back hours, furlough staff, or letting employees go. In the biotech industry and, more specifically, the BioHealth Capital Region (BHCR), we have seen a call to action and new collaborations by local key players in our shared mission to find a test, vaccine, and treatment for COVID-19. Before the current healthcare crisis, the BHCR had become the 4^th largest biopharma hub in the United States as ranked by Genetic Engineering News in their annual study. We have over 1,000 biohealth companies in the such as AstraZeneca, Emergent, GSK, Qiagen, Novavax, and others, many of which are making valuable contributions during this COVID-19 pandemic as well as what they do in their everyday operations. The region is also the home of National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) and their Director, Dr. Anthony S. Fauci, who has become a Trusted National Treasure. NIH also has 6,000 scientist and 16,000 overall workers in Bethesda, Md. Which makes it the largest basic research institution in the world. We are also home to the U.S. Food and Drug Administration (FDA) which has accelerated approvals in this time of crisis. We also have leading educational and healthcare institutions like the University System of Maryland, John’s Hopkins, George Mason, and Children’s National Health System and many more.

The May 4^th edition of the Washington Post features an article titled “Maryland plays an outsized role in worldwide hunt for a coronavirus vaccine” by senior regional correspondent covering government and politics, Robert McCartney. This article highlights the efforts over half-a-dozen companies in the region focused on different aspects of the COVID-19 crisis and how some have begun working together to find solutions faster.

The BioHealth Innovation Team, along with the BioHealth Capital Region Community, are proud of the hard work and research taking place and find that in the face of adversity, the BHCR is coming together and is forgetting about how artificial boundaries like State and County lines, Bridges and Rivers have prevented collaboration in the past.

We will all get through this together.

• Rich Bendis, President and CEO

He joins BioTalk host Rich Bendis to discuss their recent successes in funding, research, and their growth in the BioHealth Capital Region

Dr. William Hearl is the founder of Immunomic Therapeutics, Inc. and is an experienced and successful life science businessman and entrepreneur. Dr. Hearl is adept at brokering mutually beneficial partnerships and identifying non-traditional collaborations and investment opportunities.

The advent of the commercial development of LAMP technology came from discussions between Dr. Hearl and Dr. Tom August at Johns Hopkins University. Based on their mutual vision of the value of LAMP, ITI emerged and began operations in 2006. Dr. Hearl’s extensive experience in intellectual property management and business development led to the reward of a sub-license of the LAMP technology to Geron Corporation within 30 days of initiating operations and subsequent license agreements, valued at over $300 million, in 2015 with Japan-based Astellas for next generation allergy vaccines based on the LAMP platform.

Dr. Hearl is also a founder of Capital Genomix, Inc. (CGI), a Maryland-based biomarker and drug discovery Company and served as its first chief executive officer from inception in 2000 to late 2002 when he assumed the role of chief scientific officer. Dr. Hearl raised seed funds and Series A & B funding for CGI (approximately $5 million in cash/debt). He also acquired the Dynex Technologies division of Thermo Scientific in a leveraged acquisition deal. Dynex was subsequently divested and yielded a remarkable tenfold return to the Company.

Dr. Hearl is also responsible for the acquisition and development of the core technologies of Capital Genomix: GeneSystem320TM was licensed exclusively from MD Anderson Cancer Center and the ImmunoMouseTM was invented by Dr. Hearl. Dr. Hearl also has an established record of scientific productivity over his 20 years of work in the biotech industry. He started his career as a bench scientist at Electro-Nucleonics, Inc. and developed blood based diagnostics for HIV, HTLV-I and Hepatitis C. He later worked at Life Technologies and directed the immunodetection group. Under Dr. Hearl’s direction, the lab developed a number of innovative antibody-based detection kits and reagents. He moved into scientific management when he became the director of research and development at Kirkegaard & Perry Laboratories, Inc. in 1994.

Dr. Hearl earned his Ph.D. in biochemistry from the University of Tennessee and B.S. from East Tennessee State University.

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Scientists at George Mason University are working to develop an easy-to-administer COVID-19 antibody test, which could mean using a simple swab in the mouth for saliva.

Dr. Lance Liotta works for the Applied Proteomics and Molecular Medicine Center at GMU. He said they’ve been working on saliva testing for many years and already had a collection device that would work.

“We thought let’s apply our expertise on that topic to that new challenge,” Liotta said.

To use it, you put the swab inside of the mouth and rub it around the cheeks and the gum. You hold it under the tongue and then when it changes color that’s when you know enough saliva was collected, Liotta said.

Once the diagnostic technology is developed the next stop is another specialized lab for patient testing on volunteers.

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