Government Owned Invention Available for License: Method of Manufacturing Papilloma Infiltrating Lymphocyte (PIL) Cell Therapy Products as a Treatment for Patients With Chronic Viral Infection(s)

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services National Institutes of Health AGENCY: National Institutes of Health, HHS. ACTION: Notice. SUMMARY: The National Cancer Institute (NCI) seeks research co-development partners and/or licensees for development of papilloma-infiltrating lymphocytes (PIL) as treatment for patients with chronic human papillomavirus (HPV) 6 or 11 infections. FOR FURTHER INFORMATION CONTACT: Inquiries related to this license opportunity should be directed to: Suna Gulay French, Ph.D., Technology Transfer Manager, NCI, Technology Transfer Center, Email: suna.gulay@nih.gov or Phone: 240-276-7424. SUPPLEMENTARY INFORMATION: Recurrent respiratory papillomatosis (RRP) and anogenital condyloma are caused by chronic infection with human papillomavirus (HPV) types 6 or 11. These conditions lead to the development of papillomatous growths in different regions of the body. RRP affects the upper aerodigestive tract, condylomas the anogenital area. In RRP, growths in the aerodigestive tract can cause dysphonia, dyspnea and—in severe cases—airway obstruction. This may lead to recurrent pneumonia or respiratory failure. Current treatment for RRP primarily involves repeated surgical debulking or laser ablation to manage symptoms. However, the virus often persists in a latent state, resulting in continual papilloma regrowth. The need for frequent procedures exposes patients to cumulative anesthetic and surgical risks, emotional distress, significantly diminished qu…