EMERYVILLE, Calif., January 3, 2022 – Kyverna Therapeutics (“Kyverna”), a cell therapy company engineering a new class of therapies for autoimmune and inflammatory diseases, today announced that the company has entered into exclusive, worldwide licenses with the National Institutes of Health (NIH) for intellectual property related to a novel clinical-stage anti-CD19 chimeric antigen receptor T-cell (CAR T) construct with properties uniquely suited for use in autoimmune diseases. Kyverna has obtained rights to use the construct in both autologous and allogeneic CAR T-cell therapies.

This next-generation CAR T construct was designed to improve the tolerability profile of conventional CD19 CAR Ts and developed in the laboratory of James N. Kochenderfer, M.D., at the National Cancer Institute, part of the NIH, the same laboratory that discovered axicabtagene ciloleucel. The rational design was geared to minimize cytokine release and improve clinical tolerability, yielding a construct that combines a fully human anti-CD19 CAR with rationally assembled costimulatory domains.¹ In a 20-patient Phase 1/2 study in oncology, expected anti-lymphoma activity was associated with a significant reduction of cytokines released. Of note, in patients who received the new construct, a ten-fold reduction in the rate of severe neurological toxicity was observed compared to patients who received T cells transduced with an earlier generation, murine-based construct. Kyverna intends to advance the autologous version of this novel CD19 construct, KYV-101, into clinical development for autoimmune diseases in the first half of 2022.

Preclinically, CD19-targeted CAR T-cell therapies have been shown to induce deep and complete B cell depletion in both the circulation and tissues resulting in striking efficacy in disease models supporting the promise of a transformative impact for the approach in patients with B-cell driven autoimmune diseases.² B cells are important for disease pathogenesis, and tissue-based B cells are resistant to depletion by existing agents. Overall, existing approaches to address B-cell driven autoimmune diseases are often limited by either modest effects, leading to resistant and uncontrolled disease, or significant treatment-related morbidity and mortality.

“This licensing agreement with the NIH is an important milestone for Kyverna, as it empowers us to rapidly start exploring the transformative potential of cell therapy for autoimmune diseases with a clinical-stage construct with demonstrated properties making it ideal for use in patients with autoimmunity,” said Dominic Borie, M.D., Ph.D., President and CEO of Kyverna. “KYV-101, with its differentiated safety profile, holds great promise to transform the care and outcomes for patients with B-cell-driven autoimmune diseases.”

“Targeting B cells has shown promise in treating many autoimmune diseases, but much room for improvement in efficacy remains,” said James Chung, M.D., Ph.D., Kyverna’s Chief Medical Officer. “We believe that a more complete depletion of circulating and tissue resident B cells expected with our CAR T therapy KYV-101 will translate to significantly greater efficacy. The improved safety profile and the fully human anti-CD19 scFv of KYV-101 confers advantages over the prior generation CD19 CAR Ts and we look forward to starting clinical trials in the first half of 2022.”

Kyverna Therapeutics is a cell therapy company engineering a new class of therapies for autoimmune and inflammatory diseases. The Kyverna therapeutic platform combines advanced T-cell engineering and synthetic biology technologies to suppress or eliminate the autoreactive immune cells at the origin of autoimmune and inflammatory diseases. In addition to developing next-generation chimeric antigen receptor T-cell (CAR T) therapies in both autologous and allogeneic settings, Kyverna is creating synReg T cells, a synthetic version of Regulatory T cells (Tregs), powerful natural immune cells that control immune homeostasis through multiple immunosuppressive mechanisms. By offering more than one mechanism for taming autoimmunity, Kyverna is positioned to transform how autoimmune diseases are treated. For more information, please visit https://kyvernatx.com.

Kyverna Therapeutics
Ryan Jones
media@kyvernatx.com

Greig Communications, Inc.
Kathy Vincent
kathy@greigcommunications.com

1. Brudno J et al. Safety and feasibility of anti-CD19 CAR T cells with fully human binding domains in patients with B-cell lymphoma. Nat. Medicine 2020;26:270-280.
2. Kansal R et al. Sustained B cell depletion by CD19-targeted CAR T cells is a highly effective treatment for murine lupus. Sci. Transl. Med. 2019; 11(482):eaav1648