On January 7, 2021 Repertoire Immune Medicines, a clinical-stage biotech company creating a new category of immune therapies for cancer, autoimmunity and infectious disease, reported that John Cox, Chief Executive Officer, will participate in the 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2021 at 8:05 a.m. EST (Press release, Repertoire, JAN 7, 2021, View Source [SID1234573655]). Mr. Cox will provide an update on progress and plans for its lead clinical programs and advancement of its immune medicines platform.

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Repertoire has initiated enrollment of the next cohort of patients in a Phase 1/2 study of PRIME IL-15 in patients with advanced metastatic solid tumors. PRIME IL-15 (RPTR-147) is a novel, autologous, non-genetically modified multiclonal T cell product designed to release IL-15 in a local and sustained manner, limiting systemic exposure and thus improving tolerability. In the initial stage of this study, following administration of PRIME IL-15, 10 of 17 patients with advanced metastatic disease had stable disease, of which four were stable for more than six months.

In analyses performed in this initial set of patients, persistence of T cell clones derived from PRIME IL-15 was observed in blood and within tumors by tracking T Cell Receptor (TCR) beta sequences. Additional evidence generated through the company’s DECODE platform demonstrates the expansion of rare lymphocytes derived from peripheral blood. Moreover, study data confirm that these T cells specific for tumor-associated antigens infiltrate into solid tumors when administered to patients.

In the continuing Phase 1/2 study, patients will receive PRIME IL-15 produced using a second-generation manufacturing process that generates T cells enriched for a stem-like memory phenotype. Cells with this phenotype have been previously associated with more effective anti-tumor responses. Additional clinical data from the PRIME IL-15 study are anticipated in the second half of 2021.

Repertoire also expects to initiate a clinical study with PRIME IL-12, an additional cytokine-tethered autologous T cell product. IL-12 has previously been studied as a potential treatment for cancer but severe toxicity has limited its potential. PRIME IL-12 is designed to limit systemic exposure and to allow tumor-infiltrating antigen-specific T cells to deliver IL-12 to the tumor microenvironment. PRIME IL-12 will be studied in patients with human papillomavirus (HPV) 16+ solid tumors, including patients with head and neck cancer. PRIME IL-12 study initiation is expected in the first half of 2021.

"We are highly encouraged by the ability of our PRIME IL-15 tumor antigen-specific peripheral T cells to infiltrate solid tumors, which has been a major hurdle in the development of cell therapies for solid tumors," said Anthony Coyle, Ph.D., President, Research and Development, Repertoire. "Now that we have expanded our platform with our tethered IL-12 approach, we are sharply focused on evaluating the ability of our therapeutic candidates to modify the tumor microenvironment and affect clinical outcomes."

Repertoire will also present new data from its discovery programs, which demonstrate the broad applicability of the company’s DECODE platform to identify targets not only in cancer but also new therapeutic opportunities in multiple autoimmune disorders including type 1 diabetes as well as infectious diseases. Repertoire’s DECODE platform allows the in-depth characterization of TCRs and their cognate antigens in the context of specific major histocompatibility complex (MHC) molecules. By understanding relevant immune synapses and identifying pathogenic T cells and their antigens, Repertoire plans to continue to design and develop new therapeutic modalities for important immune diseases of high unmet medical need.

"In less than a year since Repertoire was formed, we have made remarkable progress in the clinical programs we have underway and in our foundational DECODE and DEPLOY platforms," said Mr. Cox. "We look forward to an eventful year that includes biological validation of our approach of activating peripheral blood-derived T cells, arming them with our novel cytokine technologies, and directing them to solid tumors. We will continue to leverage our ability to decode the immune synapse as we build an integrated discovery and drug development engine to create differentiated immune medicines."