The Biopharmaceutical Development Program filled, stoppered, capped, and sealed the ch14.18 antibody prior to its labeling and distribution to the NCI Cancer Therapy Evaluation Program.
The Federal Laboratory Consortium (FLC) presented an Excellence in Technology Transfer award to the group that collaborated to bring Unituxin (dinutuximab, also known as ch14.18), an immunotherapy for neuroblastoma, to market.
Beverly Keseling and Samir Shaban, manufacturing managers in the Biopharmaceutical Development Program (BDP), are part of the team that received this national award on April 27. The team also includes Donna Bialozor, technology transfer specialist, NCI Technology Transfer Center; Sherry Ansher, Ph.D., associate chief of the Agreement Coordination Group, Regulatory Affairs Branch, Cancer Therapy Evaluation Program (CTEP), NCI; Jan Casadei, Ph.D., chief, Regulatory Affairs Branch, CTEP, NCI; Karen Muszynski, Ph.D., program director, Biological Resources Branch, NCI; Malcolm Smith, M.D., Ph.D., associate branch chief, Pediatrics Oncology, Clinical Investigations Branch, CTEP, NCI; Alice Yu, M.D., Ph.D., professor of Pediatrics, Division of Hematology/Oncology, University of California San Diego School of Medicine; and L. Mary Smith, Ph.D., vice president of Product Development, United Therapeutics Corporation (UTC).
The FLC announced its selection of “Discovery to Commercialization: New Immunotherapy for Rare Childhood Cancer, Neuroblastoma” for national honors in January.
The ch14.18 group previously received another Excellence in Technology Transfer award during the FLC Mid-Atlantic Region’s annual meeting in November 2015.
On March 10, 2015, the U.S. Food and Drug Administration (FDA) approved ch14.18 as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a rare cancer that most often occurs in young children. And on August 17, 2015, the European Commission granted marketing authorization for ch14.18 for the treatment of high-risk neuroblastoma in patients ages 12 months to 17 years.
Those two approvals are the result of a collaborative effort between BDP, NCI, the Children’s Oncology Group, and UTC, which together created the first approved immunotherapy for pediatric high-risk neuroblastoma.
The BDP actively supported this project from 1996 to 2015, specifically by producing ch14.18. The BDP worked directly with NCI, the FDA, and Health Canada on issues of patient safety and product characterization, while members of BDP’s manufacturing teams managed all aspects of the production, from manufacture to vialing. The BDP also worked to ensure that the supply of ch14.18 met the demand needed for patients enrolled in clinical studies during the transitional period prior to FDA and European Commission approval.
Additionally, the BDP’s Regulatory Affairs group worked with NCI’s CTEP, the FDA, and Health Canada to develop and submit regulatory submissions in a timely manner. Following definitive evidence of efficacy, the BDP worked with NCI’s Technology Transfer Center on a Cooperative Research and Development Agreement (CRADA) announcement seeking a collaborator to assume responsibility for production and regulatory approval of ch14.18. The eventual CRADA between NCI and UTC allowed the BDP to transfer the drug production process to UTC, the company that led the product to licensure.
Both the regional and national Excellence in Technology Transfer nominations were submitted by NCI’s Technology Transfer Center.
Update: In the new video below, hear from the team that received the Excellence in Technology Transfer award, as they discuss the new immunotherapy and its commercialization.
