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.

Description of Technology:

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, while condylomas involve the anogenital area. In RRP, growths in the aerodigestive tract can cause dysphonia, dyspnea, and, in severe cases, airway obstruction, which 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, and significantly diminished quality of life. Despite progress in localized treatments such as surgery and laser ablation, there are no approved systemic therapies for chronic HPV 6 or 11-related conditions. This highlights a clear unmet need for effective, curative therapy options.

Researchers at the National Cancer Institute (NCI) have developed a novel adoptive cell therapy approach to target conditions driven by HPV types 6 or 11. They have successfully identified and preferentially expanded HPV 6 and/or 11-specific T cells from papilloma tissue obtained from patients with RRP. These papilloma-infiltrating lymphocytes (PILs) have demonstrated the ability to eliminate papillomatous tissue. This T cell manufacturing method holds promise for developing cell-based therapies for chronic HPV 6/11-related conditions, including RRP and potentially anogenital condyloma. Notably, the ability to isolate and expand antigen-specific lymphocytes from non-cancerous growths represents an exciting advancement in the field of adoptive cell therapy – potentially paving the way for treating a broader range of non-malignant diseases.

This technology is available for licensing and offers a compelling opportunity for companies developing next-generation immunotherapies. The Center for Immuno-Oncology and the Surgical Oncology Program of the NCI, Center for Cancer Research are actively seeking industry partners to support the clinical development and commercialization of this approach. It is particularly well-suited for biotech firms focused on T cell therapies or addressing HPV-related diseases. Strategic collaboration could accelerate market entry and unlock significant value in an area with high unmet medical need.

Potential Commercial Applications:

• Immunotherapy for chronic HPV-related conditions such as recurrent respiratory papillomatosis (RRP) and anogenital condyloma.
• Development of personalized T cell therapies targeting HPV 6 or HPV 11 infections.
• Generation of T cell receptor (TCR) libraries for research and therapeutic purposes.

Competitive Advantages:

• Selective expansion of T cells with high specificity for HPV 6 or HPV 11 antigens.
• Potential to treat both non-cancerous and cancerous HPV-related conditions.
• Ability to produce oligoclonal T cell populations, increasing the efficacy of the therapy.
• Methodology applicable to both therapeutic and preventative treatments for chronic HPV infections.
• Drug development for RRP may qualify for regulatory incentives due to the rarity of the disease.