Senza5 CART5 (VIPER-101) is a gene-edited, autologous, dual-population therapy being evaluated for T-cell lymphoma. Senza5 CART5 targets CD5, which is present on cancer cells in >85% of people with T-cell lymphoma. Senza5 CART5 has shown superior efficacy vs classical CART5 therapies in multiple pre-clinical animal models, and a Phase 1 clinical trial is currently enrolling patients (NCT06420089). Anti-CD5 CAR T-cell therapies have shown promise in the clinic with positive data in studies conducted both domestically and internationally.
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OF T-CELL LYMPHOMA
lymphoma
In the US, T-cell lymphoma is diagnosed in ~10,000 people each year. It’s a progressive disease with a poor prognosis and significant unmet needs. There are few available treatments; in the last ten years, only two products have been FDA-approved, and current therapies show only modest responses in a small percentage of patients.
101
This is an open-label Phase I study (NCT06420089) designed to evaluate the safety and to establish the recommended dose of Senza5 CART5 T-cells* in people with T-cell non-Hodgkin lymphoma (NHL). The study will also look at how Senza5 CART5 affects the cancer and how long the therapy survives in the body. This trial may evaluate up to 5 dose levels of Senza5 CART5 given as a single intravenous (IV) infusion.
*The use of Senza5 CART5 is experimental and has not been approved by the Food and Drug Administration (FDA).
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VIPER-102 utilizes CAR T-cells that target a novel, universal solid tumor antigen that is both over-expressed by malignant cells and compartmentalized in healthy tissue. These properties may alleviate the off-tumor, on-target challenges with conventional antigenic targets for solid tumors. This program is being explored to treat multiple types of solid tumors, and we are currently focused on IND-enabling studies.
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VIPER-103 utilizes CAR T-cells that target a novel B-cell antigen highly enriched in cancer and autoimmune diseases. By selectively targeting diseased B-cells, this therapy can kill pathogenic (or malignant) cells while sparing healthy B-cells, thereby mitigating the associated risks of immunosuppression due to B-cell aplasia. This program is being explored for the treatment of B-cell-mediated autoimmune diseases, and we are currently focused on IND enabling studies.