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Author: The Wistar Institute

Wistar Receives Merit Extension from the National Cancer Institute

PHILADELPHIA — (August 2, 2022) — The National Cancer Institute (NCI) has granted a Merit Extension Award to The Wistar Institute’s Ellen and Ronald Caplan Cancer Center totaling more than $5 million. The Institute is the first NCI-designated Basic Cancer Center in the nation to receive this prestigious award, which extends its Cancer Center Support Grant (CCSG) for two additional years. Furthermore, Wistar’s Ellen and Ronald Caplan Cancer Center is among the first five NCI-designated Cancer Centers to earn the distinction countrywide.

“The Wistar Institute is the first basic NCI-designated cancer center to earn the prestigious Cancer Center Support Grant Merit Extension,” said Henry P. Ciolino, Ph.D., director of the Office of Cancer Centers at the NCI. “NCI extended the NCI-designation based on Wistar’s continued exceptional performance in uncovering the fundamental aspects of cancer, advancing these basic discoveries to impact patients through translation to clinical applications, and for conducting education and training of future cancer scientists. The seven-year term of the current NCI-designation will allow Wistar to increase its scientific impact through longer-range planning.”

Wistar’s Ellen and Ronald Caplan Cancer Center focuses on research for cancer prevention, diagnosis, and therapy, and the Cancer Center Support Grant (CCSG) facilitates the Institute’s ability to embrace an interdisciplinary approach that merges basic, translational, and disease-relevant research. Having received an “exceptional” rating – the highest possible – in its past two, consecutive CCSG renewal applications, and maintained exceptional research progress, institutional commitment, and leadership, the Merit Extension application was approved by the NCI. This award will enable the Ellen and Ronald Caplan Cancer Center to further advance the initiatives of its 2019 CCSG as well as expand on programmatic initiatives recently launched by the Institute’s Bold Science // Global Impact five-year strategic plan.

“The Wistar Institute is honored to receive this extension,” said Dario C. Altieri, M.D., president and chief executive officer, director of the Ellen and Ronald Caplan Cancer Center, and the Robert and Penny Fox Distinguished Professor at The Wistar Institute. “We are committed to scientific excellence in the face of diseases affecting people across the country, and we are grateful the NCI recognizes our determination and single-mission focus that has propelled forward a deeper understanding of cancer biology. We will continue to invest in promising scientific talent and training programs and pursue innovative solutions to cancer.”

Rugang Zhang, Ph.D., deputy director of the Ellen and Ronald Caplan Cancer Center, Christopher M. Davis Endowed Professor, and program leader of the Immunology, Microenvironment & Metastasis Program shares, “This merit extension not only reflects the NCI’s confidence in our Cancer Center’s remarkable momentum and exceptional trajectory, but also recognizes the excellent leadership of Dr. Altieri and the team at Wistar. This is truly a great achievement for our Cancer Center.”

In 1972, Wistar became the first NCI-designated Basic Cancer Center in the nation and has since been continuously recognized and supported by the NCI. Wistar’s Ellen and Ronald Caplan Cancer Center tackles cancer through multiple lenses, exemplified through the three scientific research programs at the Institute: the Gene Expression and Regulation Program; the Immunology, Microenvironment and Metastasis Program; and the Molecular and Cellular Oncogenesis Program. Recognized as a Basic Cancer Center, Wistar does not treat patients, grant degrees nor does it have an in-house health care system. This opens opportunities to collaborate with regional health care systems and public and private sectors on focused efforts into the science behind the treatments for cancer.

Women & Science Virtual Event: Pancreatic Cancer Is PRIMED to Become an Immunologic Disease

Scientific Seminar
Wednesday, Sept. 14, 2022

Dr. Elizabeth Jaffee, Deputy Director of The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins School of Medicine will discuss her cutting-edge research to develop immune based therapies for pancreatic and breast cancers.

Learn more about Wistar’s Women & Science Program.

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Wistar Hosts Education Career Panel 

Several panelists from varied backgrounds spoke to Wistar trainees about their current positions as education professionals for science departments and institutions.

What was the moment you knew you wanted to teach? How do you balance research and education? What are some skills or qualities in a person that helps them be a strong educator? These are some of the questions trainees asked education professionals at Wistar’s Education Career Panel on Friday, July 22.

The panel included Dr. Jason Diaz, Wistar’s new Education Program Director of the Institute’s Hubert J.P. Schoemaker Education and Training Center; Dr. Kate Milani, Assistant Professor at Rowan University’s School of Medicine Molecular Biology Department; and Dr. David Garbe, Director of Outreach and Education for the Pennsylvania Society for Biomedical Research (PSBR).

Panelists spoke about their personal academic and career journeys and what led them to where they are today as well as offered advice on what they wish they knew before transitioning into STEM education career paths.

“It is always an exciting and gratifying experience to witness someone’s understanding expand and puzzle pieces coming together,” Diaz shared about his motivation and favorite part of his role at Wistar. “There is a great synergy around bringing research into the classroom, and having students work on projects tied to real research really enriches the learning experience.”

Wistar Celebrates Promising Scientists at 2022 Ching Jer Chern Memorial Award Ceremony

On June 15, Wistar hosted a hybrid event naming this year’s Ching Jer Chern Memorial Postdoctoral Fellow and bestowing the Ching Jer Chern Memorial Awards, honoring the commitment of the Chern family to advancing scientific careers. The ceremony was attended by Mrs. June Chern and other members of the family.

Established in 2016, the Ching Jer Chern Memorial Postdoctoral Fellowship provides two years in partial salary to an excellent, early-stage, international postdoctoral fellow at The Wistar Institute. Dr. Abdurrahman Elbasir, a postdoctoral researcher in the Auslander Lab, is this year’s recipient of the prestigious fellowship. Elbasir’s research includes leveraging artificial intelligence to identify viruses related to cancer.

Previous 2020 Chern Fellow Dr. Leila Giron presented an update on her work investigating microbial translocation in the gut related to long-COVID. Giron is now a staff scientist in the Abdel-Mohsen Lab.

Two Ching Jer Chern Memorial Awardees were also recognized at this event. This award was established by June Chern in 1989 to honor her late husband Dr. Ching Jer Chern, who was a member of Wistar’s scientific staff from 1974 until his death from cancer in 1987. Co-recipients Dr. Samson Adeniji of the Abdel-Mohsen Lab and Dr. Phillip Wulfridge of the Sarma Lab were both honored for their authorship of the best scientific papers published during the year.

Adeniji’s manuscript focused on protein mechanisms underpinning how HIV infected cells evade immune surveillance and hopes to use this knowledge to harness multiple immune cells and target virus infected cells in the future. Wulfridge’s publication described a novel method of characterizing interactors with R-loops which play roles in cell processes like gene regulation and are associated with DNA damage and diseases like cancer.

“We are appreciative of the Chern family for spearheading awards like this for our Wistar trainees. We hope to continue to celebrate the excellent research the trainees are doing now to honor the memory of Dr. Ching Jer Chern,” said Dr. Kristy Shuda McGuire, Wistar’s dean of Biomedical Studies and chair of the Wistar Training Committee.

Wistar Offers New Quality Science Apprenticeship to Bolster Philadelphia Life Science Workforce

The Hubert J.P. Schoemaker Education and Training Center is adding a new training program uniquely designed to address life science industry needs. Titled the Quality Science Pathway Apprenticeship, this certification program is cost-free and provides on-the-job training and instruction for quality science roles in the biotechnology and pharmaceutical industries. Wistar sat down with David Zuzga, Ph.D., associate dean of Biomedical Studies at the Institute, to discuss what this new program is and why it is important to infuse new talent into the Philadelphia life science workforce.

Q: Can you provide a lay-friendly overview of what Quality Science (QS) is and breakdown the role of a QS officer within the biotechnology or pharmaceutical industries?

A: Quality Science professionals ensure the safety and efficacy of medicines, diagnostics, and medical devices across the continuum of research and development (R&D), clinical trial testing, and commercial production. They are responsible for testing and certifying that these products meet the needs and expectations of doctors and patients and are free from deficiencies.

Q: Describe the demand in the region for these types of STEM-based skills.

A: Although Quality Science is an essential operation within biopharmaceutical companies, people are rarely exposed to the field before being hired into these roles and there are few opportunities for training and education, increasing the onboarding time of new employees.

Regionally, the demand for quality science professionals is expected to skyrocket as more of Philadelphia’s biotechnology companies transition from R&D to the commercial stage. In fact, the Chamber of Commerce recently established the Life Science Talent Pipeline Collaborative to ensure the region’s life science sector is supported by a talented workforce. The Collaborative identified access to quality science professionals as vital to sustaining and expanding the region’s life science industry. We have this emergent need for quality science professionals and training infrastructure, which Wistar’s Quality Science Pathway Apprenticeship (QSPA) is designed to meet.

Q: What inspired Wistar to create this apprenticeship program in collaboration with Pathway for Patient Health? Can you speak more about their role in the program?

A: I previously worked with Pathway for Patient Health (P4PH) to establish a quality science certificate program at La Salle University. I believe that combining the certificate program with the innovative biomedical apprenticeship model Wistar pioneered with its Fox Biomedical Research Technician (BRT) Program provides more equitable access to training and careers in the life sciences.

P4PH recruited industry subject matter experts to develop a curriculum that produces Certified Quality Science Professionals. The program addresses the lack of exposure to quality science and training opportunities, and helps employers access a unique talent pipeline of quality science professionals. Wistar’s Quality Science Pathway Apprenticeship combines the P4PH certificate with on-the-job training at employer sites. Online, evening courses are taught by subject matter experts from companies, connecting participants to potential future employers.

P4PH supports the Program by providing access to industry mentors and an online global hiring portal. The first course, Global Regulatory and Legal Requirements of Quality, begins in early September, and the remaining courses – Product Development and Validation, and Risk and Failure Analysis – will run in the spring. Once certified, participants will be eligible to begin full-time employment with employer partners in roles such as quality control analyst and quality control microbiologist.

Q: What career opportunities are available for those who complete the Quality Science program including reasonable salary expectations?

A: Average starting salaries for jobs supported by the program, such as quality control analysts, are ~$60,000 annually. But this is just the start. These positions are an entry point into the life science industry and a steppingstone to lucrative careers and management roles in regulatory affairs, quality assurance, and manufacturing site management.

Q: What are some of the differences between the Quality Science Pathway Apprenticeship and the existing workforce development programs at Wistar? What makes Quality Science a unique opportunity?

A: The QSPA is complementary to Wistar’s existing Biomedical Technician Training (BTT) Pre-apprenticeship Program. The BTT Program develops and hones laboratory research skills and provides internships in academic and industry settings. On the other hand, the QSPA provides an understanding of the regulatory landscape in which industry R&D operates and complies. Together, these Programs provide broad and deep training to accelerate careers in both R&D and Quality Science.

Q: How does completing this certification program particularly through Wistar benefit participants?

A: Wistar’s QSPA Program is unique in that it combines an industry certificate program with a state-registered apprenticeship offering full-time employment and 2,000 hours (one year) of on-the-job training. It has been developed in response to life science companies in the Greater Philadelphia region expressing an increasing, critical need for employees with quality science training and experience. Unlike other programs, the QSPA is a cost-free, open-access program available to diverse learners at different stages in their academic and professional careers and may include current undergraduates at two- or four-year institutions, non-current college students (some college coursework, but not currently enrolled), and recent college graduates.

Q: Why is the unique collaboration with industry partners like Pathway for Patient Health important to this Program and Wistar’s Hubert J.P. Schoemaker Education & Training Center? What does this mean for our Institute to offer these career pathways in science?

A: Our commitment to workforce training initiatives is reflected in Wistar’s 2021-2026 Bold Science // Global Impact Strategic Plan. Notably, education and training comprise one of the plan’s three pillars, with the specific goal of expanding Wistar education and training programs to create a diverse, inclusive life science talent pipeline. The QSPA enables Wistar to meet its strategic education goals by creating an innovative public-private partnership that aligns workforce needs constraining the regional biotechnology industry with a novel STEM work-based learning and training model that provides career pathways to traditionally underserved populations– ultimately increasing diversity, equity, and inclusion in the life sciences.

For more information about course details and eligibility, please visit our Quality Science Apprenticeship webpage.

Wistar’s Joseph Trainor is a 2022 CFO of the Year Honoree by the Philadelphia Business Journal

The Crystal Tearoom at the Wanamaker Building was an elegant backdrop for the Philadelphia Business Journal’s 2022 CFO of the Year Awards. Wistar Institute Chief Financial Officer (CFO) Joseph Trainor, CPA, was celebrated among top honorees representing for- and non-profit health care, financial, academic, communications, sports, and other industry sectors across the region. Trainor’s outstanding leadership, especially through the tumultuous two plus years of the pandemic contributed to the immense growth and success of Wistar science.

Trainor started his Wistar career nine years ago and since then has worked to grow the Institute’s funding and endowments through careful innovative financial planning, analysis, and management. Since Wistar is a non-profit biomedical research institute, primary funding comes through federal grants and its endowment. In the last six years, Wistar has doubled its grant funding and tripled its endowment – all under the financial leadership of Trainor.

When Trainor accepted his award on stage, he answered one question: What is his guiding philosophy as CFO? Trainor said, “Surround yourself with great people, listen to them, and follow the mission. The best decisions I’ve made were those decisions made with others.”

Wistar Scientists Reveal New Function of Enzyme ADAR1 Linking it to Age-Related Diseases via a Role Independent of RNA-editing During Aging

PHILADELPHIA — (July 18, 2022) — Aging and age-related disorders pose a complex challenge to the biomedical research community. To better understand how senescence is regulated is of high significance to promote healthy aging and treat age-associated disorders. In a research paper published today in Nature Cell Biology, Rugang Zhang, Ph.D., deputy director of the Wistar Ellen and Ronald Caplan Cancer Center, Christopher M. Davis Endowed Professor, and program leader of the Immunology, Microenvironment & Metastasis Program, and his team revealed a novel ADAR1-SIRT1-p16INK4a axis in regulating cellular senescence and its potential implications in tissue aging.

“Understanding the basic mechanism underlying tissue aging is challenging and cellular senescence offers an angle into the complex biology that drives tissue aging. These mechanistic insights gained by studying senescence regulation during tissue aging can in turn be used to promote healthy aging and combat age-associated disorders.” states Zhang.

Central to this quest is a protein called p16INK4a because its expression both increases during tissue aging and it drives senescence. Prior studies established that depletion of p16INK4a expressing cells is sufficient to delay age-associated disorders. Thus, approaches that prevent age-associated increase in p16INK4a expression may have important implications in designing intervention strategies to promote healthy aging.

The research team’s findings center around a protein called ADAR1. ADAR1 is a specialized enzyme involved in RNA editing and is now revealed in senescence. Postdoctoral researcher in the Zhang lab and first author on the paper Xue Hao, Ph.D., explains that this research was largely inspired by prior independent research carried out in model organisms such as fruit flies and worms showing that depletion of the equivalent of human ADAR1 in these organisms reduces lifespan and causes age-dependent changes such as neurodegeneration.

This story also benefits from a highly collaborative Wistar Institute culture. In fact, the previous work of Kazuko Nishikura, Ph.D., professor in the Gene Expression & Regulation Program at Wistar’s Ellen and Ronald Caplan Cancer Center – and a pioneer in ADAR1 biology – showed that stressed cells utilize ADAR1 as protection from apoptosis, programmed cell death. “As senescent cells are stressed cells and are resistant to apoptosis, the first question we set out to ask was whether ADAR1 is related to cellular senescence and secondly, how does it regulate senescence and what is its’ potential implication in tissue aging.” Hao explains.

The team first examined the expression of ADAR1 in vitro in human fibroblasts and in vivo in multiple tissues from young and aged mice. Then, they experimentally altered ADAR1 expression in multiple cell types in petri-dish and mouse tissues to establish ADAR1 as a critical regulator of p16INK4a expression. Intriguingly, the team discovered that ADAR1 loss promotes p16INK4a expression through SIRT1, another protein known to regulate both senescence and tissue aging. Interestingly, this function of ADAR1 does not depend on its biological role in RNA editing.

They also found that downregulation of ADAR1 by a process called autophagy (the degradation and recycling of damaged or unneeded cell components) during senescence decreased the stability of SIRT1 mRNA, which in turn upregulated the translation of p16INK4a to induce senescence. Hao elaborates, “Our study revealed a novel ADAR1-SIRT1- p16 INK4a axis that plays an important role in cellular senescence at translational level, and this newly defined function of ADAR1 is independent of its RNA editing function.”

Zhang says, “Our study starts to reveal the missing link between ADAR1 and tissue aging through p16INK4a expression during senescence. In addition, these findings provided a scientific rational to explore whether this newly discovered mechanism can be leveraged for therapeutic development regarding age-associated disorders.”

“One of the ways to potentially restore ADAR1 expression as a means to suppress p16INK4a and senescence observed during tissue aging is by inhibiting autophagy.” Hao details. She adds about next research steps, “Our study raises some interesting questions. For example, what is the relative contribution of this mechanism to p16INK4a expression during aging of different tissues? In addition, it would be interesting to determine whether intervention of this pathway can alleviate the age-associated disorders that are linked to p16INK4a expression in previous published animal models.”

Co-authors: Xue Hao, Yusuke Shiromoto, Masayuki Sakurai, Martina Towers, Qiang Zhang, Shuai Wu, Bin Tian, Andrew Kossenkov, Kazuko Nishikura, Pingyu Liu from The Wistar Institute; Aaron Havas, Peter D. Adams from Sanford Burnham Prebys Medical Discovery Institute; Lu Wang, Shelley Berger from the University of Pennsylvania.

Work supported by: This work was supported by US National Institutes of Health grants (R01CA160331 to R.Z., P01AG031862 to P.D.A., S.L.B and R.Z., R01GM040536 and R01GM130716 to K.N., and R50CA211199 to A.V.K.). K.N. was supported by a grant from Emerson Collective. Support of Core Facilities was provided by Cancer Center Support Grant (CCSG) CA010815 to The Wistar Institute.

Publication Information: ADAR1 downregulation by autophagy drives senescence independently of RNA editing by enhancing p16INK4a levels. Nature Cell Biology, 2022. Online publication.

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The Wistar Institute is an international leader in biomedical research with special expertise in cancer research and vaccine development. Founded in 1892 as the first independent nonprofit biomedical research institute in the United States, Wistar has held the prestigious Cancer Center designation from the National Cancer Institute since 1972. The Institute works actively to ensure that research advances move from the laboratory to the clinic as quickly as possible. wistar.org

The Wistar Institute Collaborates with University of Buea in Cameroon to Expand Antiviral and Drug Discovery

Dr. Ian Tietjen, Research Assistant Professor in the Montaner Lab, recently returned from Cameroon where he is collaborating with scientists who are developing a new drug discovery research facility that will study medicinal plants, natural product compounds, and locally-synthesized chemical compounds to treat infectious diseases.

Dr. Tietjen’s international collaboration with his colleague Dr. Fidel Ntie-Kang of the University of Buea began in 2015. Ntie-Kang, a computational chemist, specializes in drug and protein interactions to make predictions about how natural product compounds might interact with therapeutic targets. Tietjen has collaborated in conducting computational chemical screens across huge libraries of millions of compounds to find which ones might be interacting the best for future clinical use.

Ntie-Kang approached Tietjen to forge a new collaboration around capacity building and knowledge exchange. When finished, this new drug discovery facility now under construction at the University of Buea will have about a dozen African researchers working on natural medicinal products and other chemical compounds for antiviral drug discovery and development.

This past trip, Tietjen traveled to Cameroon to assess the University’s plans and help create a strategy that would best apply Wistar’s resources to their needs. Beginning in September 2022, Wistar will host three scientists from the University of Buea for a year, including Ntie-Kang, for immersive training in the many laboratory techniques that Wistar researchers carry out so they may bring this expertise and capacity back to the University of Buea. Next year, Tietjen intends to return to Cameroon with the University of Buea research team to train local students and new staff at the drug discovery facility in molecular and cell biology and drug discovery techniques.

“This collaboration gives us the unique chance to share our research and education expertise with researchers and students that might otherwise not get a chance to work with us,” Tietjen says. “However, because Dr. Ntie-Kang and his colleagues are already established scientists in computational chemistry, natural product chemistry, and infectious diseases that disproportionately affect people in low-income countries, we have just as much to learn from them, if not more, than they do from us.”

Tietjen also has other research collaborations underway in South Africa, Botswana, Ghana, and Guinea centered around identifying chemical compounds from traditional medicinal plants used for COVID-19 and HIV management and elucidating their mechanisms of action.

Dr. Ian Tietjen Visit to University of Buea in Cameroon

The Wistar Institute Names Gelvina Rodriguez Stevenson, Esq. as Vice President, General Counsel, Secretary and Government Relations

PHILADELPHIA — (July 13, 2022) — The Wistar Institute, an international biomedical research leader in cancer, immunology, and infectious diseases, is pleased to announce the appointment of Gelvina Rodriguez Stevenson, Esq., as vice president, general counsel, secretary and government relations.

With more than 20 years of experience as a health law leader and strategist, Stevenson has served across top clinical, research, academic, and government settings. Most recently, she was associate general counsel and senior director for The Children’s Hospital of Philadelphia while simultaneously teaching as an adjunct professor at Drexel University College of Medicine in Philadelphia, PA.

Previously, Stevenson served as an associate university counsel at Weill Cornell Medical College in New York, NY. She began her legal career at Chadbourne and Parke LLP in New York, NY., progressed to law clerk in the US District Court in Los Angeles, CA., and to the legislative branch of local government as a legislative attorney for the New York City Council, in New York, NY. Stevenson is the co-chair of the Health and Life Sciences Section of the Hispanic National Bar Association and a board member of the American Health Law Association.

“The Wistar Institute is delighted to welcome Gelvina,” said Dario C. Altieri, M.D., Wistar president and chief executive officer, director of Wistar’s Ellen and Ronald Caplan Cancer Center and the Robert and Penny Fox Distinguished Professor. “We are fortunate to have her outstanding leadership skills and rich background of experience acquired in so many professional venues. This is an ideal match to Wistar, where our basic and translational research is highly collaborative and interfaces daily with a diverse portfolio of partnerships in industry, academia and state and federal government. I am thrilled that the Institute will be able to rely on Gelvina’s vast experience and insight to advance our diverse mission and fulfill transformative strategic goals.”

In this position, Stevenson’s responsibilities primarily include identifying, assessing, and managing Wistar’s legal and regulatory affairs; assisting with transactions and contracts relating to business development and intellectual property; managing litigation matters; and providing counsel to the Institute on legal, compliance, and policy matters. She also will lead government relations and the corporate secretary function as well as manage governance issues related to the Board of Trustees.

“I have always admired the science and innovation generated at The Wistar Institute and am excited to join the committed team at Wistar to advance scientific and medical breakthroughs that will change and improve the course of healthcare.” Stevenson says.

Stevenson earned a J.D. from New York University School of Law, received an M.P.A. from Princeton University School of Public and International Affairs, and graduated cum laude from New York University College of Arts and Sciences.

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The Wistar Institute is an international leader in biomedical research with special expertise in cancer research and vaccine development. Founded in 1892 as the first independent nonprofit biomedical research institute in the United States, Wistar has held the prestigious Cancer Center designation from the National Cancer Institute since 1972. The Institute works actively to ensure that research advances move from the laboratory to the clinic as quickly as possible. wistar.org.

Collaboration Advances DNA-delivered Antibodies to Prevent COVID-19

PHILADELPHIA — (July 7, 2022) — Under a Defense Advanced Research Projects Agency (DARPA) and Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) funded program, a novel COVID-19 antibody delivery approach has advanced to clinical trials. The collaborative team was led by David Weiner, Ph.D., The Wistar Institute executive vice president, director of the Vaccine & Immunotherapy Center, and W.W. Smith Charitable Trust Professor in Cancer Research, and included colleagues at the University of Pennsylvania, AstraZeneca, INOVIO Pharmaceuticals, and Indiana University.

This team was awarded $37.6 million to fund the rapid pre-clinical development of DNA-encoded SARs-CoV-2 monoclonal antibodies (DMAbs) to prevent COVID-19. DMAbs use a person’s own cells as a factory for making the protective antibodies, simplifying the development and the production process for biologics—which could broaden the use of such novel medicines to the global community.

The first dosing with this new investigational agent occurred in a first-in-human clinical trial being led by Pablo Tebas, M.D., professor of Infectious Diseases at the Perelman School of Medicine at the University of Pennsylvania, and his team. The clinical trial will assess the overall safety and tolerability of this novel approach to enable the body to produce multiple full-length monoclonal antibodies through advanced DNA technology in people.

“This development is the culmination of the many steps taken working together with our DARPA/JPEO leadership team and members of the consortium advancing this product at this important time. We look forward to seeing the initial outcome from this first-in-human clinical trial studying this novel concept,” Weiner shares. He elaborates on the goals of the trials, explaining “In addition to assessing safety and tolerability, we will also look for important insights into biological expression and activity in our trial subjects and if these can be shown to impact viral infection.”

“Despite all of the progress made on COVID-19 treatments and management, this disease continues to kill three times more Americans than the flu,” says Tebas. “We need better methods to prevent complications of this disease particularly in immunocompromised patients. Our study will test a new way to deliver antibodies against COVID-19 that have been proven to decrease hospitalizations and deaths from this terrible disease.”

This work is enabled through a unique public-private collaboration. The team brings together important and diverse scientific and technical strengths to create this new tool to address vulnerable patient needs. Over the past several years, Weiner and collaborators’ advances in the nucleic acid delivery space led to the developments that underpin this program. The study takes advantage of pioneering nucleic acid approaches advanced by longtime collaborator Tebas, important new tools for nucleic acid delivery developed in concert with INOVIO and is built on the collaboration with AstraZeneca to recreate protein biologics into this innovative DNA medicine approach.

Mark Esser, vice president, Early Vaccines and Immune Therapies, AstraZeneca, said, “Dosing the first patient with a COVID-19 DMAb candidate is the culmination of hard work from a collaborative public-private partnership. This trial provides an important opportunity to evaluate an innovative technology that could potentially transform how we deliver antibodies and protect against severe infections.”

The novel approach utilizes the genetic blueprints for antibodies encoded into DNA plasmids. After delivery into the arm, DMAbs instruct the body to assemble functional antibodies and secrete these into the blood as fully formed specific monoclonal antibodies against pathogens such as the SARS-CoV-2 virus. This approach bypasses the need for immunization to generate protective immunity.

Weiner says, “This project is an important example of team science and the value of working together to tackle difficult problems. The team’s mission was to advance and study a new way to deliver lifesaving therapies in a short time frame. We are hopeful that this clinical study will likely offer insight into the development of new therapeutic approaches for vulnerable patients.”

Together, the research collaboration has successfully shown evidence of SARS-CoV-2 protection in both laboratory and animal model studies with the DMAbs exhibiting the potential for both prevention and treatment of infection. In theory, this nucleic acid medicine approach has potential advantages when compared to traditional methods of monoclonal antibody treatment in aspects of cost, specificity, production, storage, and delivery, thus boosting its availability to patients more globally.

INOVIO Pharmaceuticals Chief scientific officer Laurent Humeau, Ph.D., says, “Advancing this human clinical study was made possible through the dedication of all parties involved in this consortium. We look forward to continuing to develop this promising monoclonal antibody delivery platform with our collaborators.”

This work is supported by the Office of the Assistant Secretary of Defense for Health Affairs with funding from the Defense Health Agency.

This research was developed with funding from the Defense Advanced Research Projects Agency (DARPA).

Disclaimer: The views, opinions and/or findings expressed are those of the author and should not be interpreted as representing the official views or policies of the Department of Defense or the U.S. Government.

Grant information: Synthetic DNA-encoded monoclonal antibodies (DMAbs) targeting COVID-19, 2020-2022, Contract #HR0011-21-9-0001.

Approved for Public Release, Distribution Unlimited

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The Wistar Institute is an international leader in biomedical research with special expertise in cancer research and vaccine development. Founded in 1892 as the first independent nonprofit biomedical research institute in the United States, Wistar has held the prestigious Cancer Center designation from the National Cancer Institute since 1972. The Institute works actively to ensure that research advances move from the laboratory to the clinic as quickly as possible. wistar.org