South San Francisco and Emeryville, CA – September 07, 2023 – Verily, an Alphabet precision health technology company, and Kyverna Therapeutics (“Kyverna”), a clinical-stage cell therapy company engineering a new class of therapies for autoimmune diseases, today announced a multi-year collaboration to identify novel biomarkers and innovate clinical trial design and execution.
The initial phase of the collaboration focuses on deploying Verily’s state-of-the-art immune mapping platform (Immune Profiler) to elucidate biomarkers of treatment response in autoimmune patients treated with Kyverna’s KYV-101, an autologous Chimeric Antigen Receptor (CAR) T-cell therapy currently in Phase 1 clinical trials in the US and Europe.
“B cell depletion using CAR T-cells represents a new frontier with curative potential for autoimmune patients, and together we will be uncovering the biological basis of the immune reset that confers durable therapeutic response in these patients,” said Charlie Kim, head of molecular science at Verily.
Immune Profiler’s high-resolution molecular phenotyping and advanced computational analytics enables interrogation of a broad range of immune functions over the time course of CAR T-cell therapy, providing an unparalleled view of biological activity. Kyverna brings a network of research-ready participants and a growing sample library from treating autoimmune patients in multiple indications and geographies with KYV-101, its fully human anti-CD19 CAR T-cell therapy.
“We are excited to explore our emerging patient data set, which will enable us to generate a first look into the biology underlying immune reset after administration of CAR T-cell therapy,” said James Chung, chief medical officer at Kyverna.
Additionally, as part of the collaboration, Verily and Kyverna will implement digital tools and technology solutions to reframe evidence generation, using a participant-centered study design that draws conclusions from data collected in real-world settings in addition to data collected directly from study sites. The companies will also develop solutions specifically designed for the needs of autoimmune patients treated with CAR T-cell therapy.
“We are pleased to partner with Verily based on our shared vision to create the future landscape of clinical research, and to enable broader data collection from real-world settings that may contribute to regulatory decision-making,” said Peter Maag, chief executive officer of Kyverna.
“This collaboration links Verily’s deep molecular capabilities with its extensive suite of tools for real-world evidence generation, providing a comprehensive and detailed understanding of the biology and participant experience with this new therapeutic modality in autoimmune disease,” said Amy Abernethy, president of product development and chief medical officer at Verily.
Verily is an Alphabet health technology company focused on research, care, and health financing to deliver on the promise of precision health and help people live healthier lives. We are uniquely positioned at the intersection of technology, data science, and healthcare to create tools to accelerate evidence generation, products to enable more personalized care, and approaches to make costs more predictable. For more information, please visit: verily.com or contact firstname.lastname@example.org.
Immune Profiler is a next generation discovery tool leveraging high-resolution immune measurements and advanced analytics to accelerate and enhance biomarker and target discovery. By combining cytometry, whole genome sequencing, genetics, transcriptomics, epigenomics, and proteomics workflows and integrating high-resolution molecular phenotypes in powerful and efficient analytical workflows, the platform yields a deep and broad view of immune function with valuable translational insights.
Kyverna Therapeutics is a clinical-stage cell therapy company with the mission of 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 and eliminate the autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Kyverna’s pipeline includes next-generation chimeric antigen receptor T-cell therapies in both autologous and allogeneic formats with properties well suited for use in B cell-driven autoimmune diseases. By offering more than one mechanism for taming autoimmunity, Kyverna is positioned to act on its mission of transforming how autoimmune diseases are treated. For more information, please visit https://kyvernatx.com.
KYV-101 is an autologous version of a novel, fully human clinical-stage anti-CD19 chimeric antigen receptor T-cell (CAR T) construct with properties well suited for use in B cell-driven autoimmune diseases such as lupus nephritis and other B-cell driven autoimmune diseases. In a 20-patient Phase 1/2 study in oncology, expected anti-lymphoma activity was associated with a significant reduction of cytokines released that translated into a strong reduction of cytokine-driven side effects such as the rate of immune effector cells-associated neurotoxicity syndrome (ICANS)1. The fully human anti-CD19 CAR also translated into reduced immunogenicity that favorably impacted cell persistence at one month. Kyverna recognized that these properties singled out KYV-101 as a product ideally poised for use in autoimmune disease patients, and the company obtained exclusive, worldwide licenses from the National Institutes of Health (NIH) to use this CD19 construct in both autologous and allogeneic CAR T-cell therapies.
1 Brudno et al., Nature Medicine 2020; 26:270-280.