On October 11, 2021 Repertoire Immune Medicines reported that the first patient has been dosed in the company’s Phase 1 study of RPTR-168 (PRIME IL-12) in patients with select relapsed or refractory human papillomavirus (HPV)-16-positive tumors (Press release, Repertoire, OCT 11, 2021, View Source [SID1234591080]).

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RPTR-168 is an autologous multi-targeted T cell (MTC) therapeutic candidate derived from rare peripheral blood T cells. The T cells are collected from each patient through apheresis and are primed and expanded by a set of five tumor-associated antigens known to be expressed on HPV-16-positive tumors. RPTR-168 is designed to deliver interleukin-12 (IL-12), a potent immunomodulatory agent that has been shown to improve anti-tumor activity by promoting T cell function inside the tumor microenvironment.

The use of IL-12 has been limited because of dose-related toxicities observed in other settings. To address this, Repertoire utilizes its proprietary technology to tether IL-12 to the surface of RPTR-168 MTCs. This approach is designed to allow direct and localized delivery of IL-12 to the tumor, which may support an anti-tumor immune response.

"We have developed RPTR-168 to target five distinct antigens known to play a role in HPV-16-positive tumor development and armed it with the potent immunomodulatory agent IL-12 using Repertoire’s proprietary tethering technology," said John Cox, chief executive officer, Repertoire Immune Medicines. "RPTR-168 is Repertoire’s second investigational candidate to advance to Phase 1 clinical study. This milestone reflects our team’s commitment to advancing our programs from early research and discovery to the clinical study stage."

The Phase 1 study is being conducted at trial centers in the United States. The first patient was dosed at HonorHealth Research and Innovation Institute in Scottsdale, Arizona.

"The ability to safely deliver IL-12 with a multi-targeted cell therapy would be a significant advancement in the treatment of solid tumors," said Ted Reiss, M.D., MBE, chief medical officer, Repertoire Immune Medicines. "We believe the use of cell-tethered IL-12 has the potential to enhance T cell responses in the microenvironment of solid tumors. We are grateful to the patients, caregivers and healthcare providers who are participating in and supporting this study of RPTR-168."

About the Phase 1 Clinical Study of RPTR-168

The Phase 1 clinical study is an open-label, multi-center trial to characterize the safety and tolerability of RPTR-168 in adult patients with relapsed or refractory metastatic or locally advanced human papillomavirus-16-positive tumors. The primary endpoints are safety and tolerability.

For more information about the clinical study visit: clinicaltrials.gov and use study identifier NCT04762225.