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Through a CRADA with EMD Serono, NCI played an instrumental role in developing and expediting regulatory approval of EMD Serono’s checkpoint inhibitor, avelumab. Avelumab received FDA approval in 2017, only four years after EMD Serono and NCI added the study of avelumab to their CRADA. This was a remarkably fast developmental and regulatory approval timeline.
NCI: 
• James Gulley, M.D., Ph.D., Branch Chief, Genitourinary Malignancies Branch, Center for 
Cancer Research (CCR)

Through a CRADA with EMD Serono, NCI played an instrumental role in developing and 
expediting regulatory approval of EMD Serono’s checkpoint inhibitor, avelumab. Avelumab 
received FDA approval in 2017, only four years after EMD Serono and NCI added the study of 
avelumab to their CRADA. This was a remarkably fast developmental and regulatory approval 
timeline.

The Foundation for the National Institutes of Health (FNIH) besto

In 2011, NCI and Iovance Biotherapeutics entered into a CRADA for the development of Adoptive Cell Therapy (ACT) using Tumor Infiltrating Lymphocytes (TIL). Technology licenses between NCI and Iovance were established to grant Iovance rights to the NIH’s TIL patent estate. By 2019, Iovance began conducting two pivotal multi-center trials of TIL technology in advanced cervical cancer and metastatic melanoma and has achieved Breakthrough Therapy and Fast Track designations from the FDA in these indications, respectively.

The National Institute for Allergy and Infectious Diseases (NIAID) has been recognized by the FLC for their impact on the public through their technology transfer work. On February 21, 2020 NIAID’s Division of Microbiology and Infectious Diseases (DMID) started an Adaptive COVID-19 Treatment Trial (ACTT) to test Gilead’s antiviral drug remdesivir, in a phase 3 trial. Remdesivir is an inhibitor of the viral RNA polymerase, so it became an early therapeutic candidate for COVID-19. This was the first clinical trial in the U.S. for an experimental treatment for COVID-19.

Originally established to study influenza, a partnership between NIAID and biotechnology company AbCellera quickly pivoted to become a major player in the development of antibodybased COVID-19 therapies. One of those therapies, bamlanivimab, has been authorized to treat mild to moderate COVID-19 symptoms in patients who are at risk for more severe disease, when combined with another antibody.

The Licensing Executives Society (LES) has recognized with its “Deals of Distinction” Award licenses granted by the NIH intramural research program to uniCure N.V. based in Amsterdam along with its global partner CSL Behring.   As a result of these licenses on November 22, 2022, the U.S. Food and Drug Administration approved Hemgenix®, the world’s first gene therapy for hemophilia B.  It represents an historic achievement based on more than a two decades of research and clinical development through a government /industry partnership and license agreements.

For the development of gene therapy as a clinically useful procedure for training genetic diseases.

Awardee

National Human Genome Research Institute 

• Dr. R. Michael Blaese

Thus far the progress in our fight against cancer has come at a heavy price in the form of devastating side effects. While they are meant to kill cancer cells, most cancer drugs also destroy normal tissues. Mucositis (painful sores and ulcers in the lining of the mouth) is a common complication of chemotherapy and/ or radiation, affecting approximately 80% of patients who undergo this intensive treatment prior to bone marrow transplantation.

Cancer is the second largest cause of mortality in the U.S., but researchers have made tremendous progress in developing new and effective treatments to reduce these mortalities. The National Cancer Institute’s 2015 challenge goal is to turn cancer from a killer into a chronic disease in the next ten years. Thus far, progress in the fight against cancer has come at a heavy price in the form of devastating side effects. While meant to kill cancer cells, most cancer drugs also destroy normal tissue.