Repertoire Immune Medicines Announces FDA Acceptance of IND for PRIME™ IL-12, an Autologous Multi-Targeted T Cell Candidate for HPV+ Solid Tumors
CAMBRIDGE, Mass. – February 12, 2021 – Repertoire Immune Medicines, a clinical-stage biotech company creating novel immune therapies for cancer, autoimmunity and infectious disease, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for PRIME-IL-12 (RPTR-168). The company expects to initiate a Phase 1/2 trial to characterize the safety, tolerability and proof of biological activity of PRIME IL-12 in patients with relapsed/refractory HPV+ tumors and advanced metastatic melanoma in the first half of 2021.
PRIME IL-12 is an autologous multi-targeted T cell investigational therapy that is tethered with IL-12. It is designed to provide an effective anti-tumor immune response in a broad range of cancer indications by targeting a distinct set of tumor-associated antigens. The importance of IL-12 as a potent immunomodulatory agent has been recognized for over 20 years. However, its therapeutic value has been limited by severe toxicity related to systemic exposure after intravenous administration. Repertoire’s proprietary approach of tethering IL-12 onto the surface of multiclonal T cells is designed to direct and localize delivery of IL-12 to the tumor, potentially enabling a safe and potent anti-tumor response.
In pre-clinical studies, PRIME IL-12 provided both an autocrine signal that promoted T cell activation within the tumor microenvironment, and also stimulated neighboring immune cells in a paracrine manner to engage the endogenous immune system and promoted a broader anti-tumor response. PRIME IL-12 represents a first-in-class therapeutic approach designed to repolarize the microenvironment and reverse the phenotype of immune cells that include myeloid-derived suppressor cells.
About Repertoire Immune Medicines
Repertoire Immune Medicines is a clinical-stage biotechnology company working to unlock and direct the remarkable power of the human immune system to prevent or treat cancer, as well as autoimmune and infectious disease. The company is founded on the belief that the repertoire of T cell receptor (TCR)-antigen codes that drive health disease represents one of the greatest opportunities for innovation in medical science. Repertoire scientists created and developed the DECODE and DEPLOY suite of technologies, which allow in-depth characterization of TCR-antigen pairs, and the ability to rationally design and develop novel targeted immune medicines.
From its sites in Cambridge, Mass., and Zurich, Switzerland, Repertoire’s team of more than 120 is creating a new category of immune medicines enabled from its DECODE discovery platform. The company’s first product in the clinic is a novel multiclonal T cell therapy consisting of naïve, rare T cells derived from the peripheral blood, activated against a curated set of antigens and armed with a proprietary cytokine payload. Repertoire is in clinical-stage immuno-oncology development today, targeting metastatic solid tumors. In the field of autoimmunity, Repertoire is using its proprietary platform to discover novel epitopes and TCRs from patients with type 1 diabetes. The company is also using its DECODE platform to discover infectious disease antigens and responding T cell clones.