CAMBRIDGE, Mass. — Repertoire® Immune Medicines, a biotechnology company pioneering the discovery and development of programmable T cell-targeted immune medicines, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to RPTR-1-201 for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) after progression on, or intolerance to, available standard therapies. RPTR-1-201 is a novel T cell receptor (TCR) bispecific immune medicine that is currently in a Phase 1/2 trial for the treatment of multiple advanced solid tumors.
“Patients with advanced TNBC often face limited options after progression on standard therapies,” said Robert Andtbacka, MD, CM, Chief Medical Officer of Repertoire Immune Medicines. “Fast Track Designation underscores the seriousness of this disease and the unmet needs for new treatment options. RPTR-1-201 is designed to redirect T cells by targeting a tumor-selective epitope on tumor cells in selected patients, and we appreciate the FDA’s engagement as we evaluate its potential in this population.”
“RPTR-1-201 reflects our ability to discover tumor-selective epitopes and intentionally engineer TCR bispecifics designed to engage them with high affinity and specificity,” said Anthony Coyle, PhD, President and Head of Research and Development at Repertoire Immune Medicines. “Derived from our DECODE™ platform, RPTR-1-201 couples an epitope-specific TCR with an anti-CD3 domain to engage and redirect T cells. Fast Track Designation supports closer dialogue with the FDA as we advance the program and continue its clinical evaluation.”
The FDA’s Fast Track program is intended to facilitate the development and expedite the review of investigational therapies that treat serious conditions and address unmet medical needs. The designation may enable more frequent interactions with the FDA and may allow rolling review of a future marketing application if relevant criteria are met.
RPTR-1-201 is a TCR bispecific molecule comprised of an engineered TCR that binds with high affinity and precision to a tumor-selective epitope and an anti-CD3 moiety that engages and redirects T cells to kill tumor cells. RPTR-1-201 is derived from Repertoire’s DECODE™ platform, which maps the immune synapse to identify TCR-epitope pairs and translate these insights into T cell-targeted immune medicines.
RPTR-1-201 is currently being evaluated in a Phase 1/2 clinical trial as monotherapy and in combination with an anti-PD-1 therapy in participants with advanced solid tumors (ClinicalTrials.gov Identifier: NCT07293754). Repertoire plans to discuss development options in the Fast Track indication with the FDA as the program advances.
About Repertoire® Immune Medicines
Repertoire® Immune Medicines is a clinical-stage biotechnology company that harnesses the power of the human immune system to develop novel and potentially transformative therapies for cancer and autoimmune diseases. Using its proprietary DECODE™ platform, which comprehensively maps the immune synapse between TCRs and their cognate antigenic epitopes, Repertoire translates these unique immune system insights into potent and targeted off-the-shelf immune medicines. The company integrates deep protein engineering expertise with artificial intelligence, powered by its proprietary DECODE database, to accelerate discovery and translation of drug candidates into clinical development. In addition to Repertoire’s wholly owned pipeline of immune medicines, the company has ongoing strategic partnerships with Bristol Myers Squibb, Genentech, Pfizer and Eli Lilly.
Repertoire® was founded in 2019 by Flagship Pioneering. Its team operates from sites in Cambridge, Massachusetts and Zurich, Switzerland. To learn more about Repertoire®, please visit our website at www.repertoire.com and follow us on LinkedIn and X.
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