On September 26, 2023 Kyverna Therapeutics ("Kyverna"), a clinical-stage cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases and ElevateBio, LLC ("ElevateBio"), a technology-driven company focused on powering transformative cell and gene therapies, reported a partnership to advance process development and manufacturing to produce industry-leading Ingenui-T-derived chimeric antigen receptor (CAR) T-cell therapies (Press release, ElevateBio, SEP 26, 2023, View Source [SID1234635425]). Ingenui-T is an optimized autologous manufacturing platform developed by Kyverna to specifically address the needs of patients with autoimmune diseases, enabling a lower cost of goods and an improved patient experience.
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ElevateBio and Kyverna will implement Kyverna’s Ingenui-T platform into their process development and cell product manufacturing efforts at ElevateBio BaseCamp. BaseCamp is ElevateBio’s end-to-end genetic medicine current Good Manufacturing Practice (cGMP) manufacturing and process development business with capabilities for research, clinical, and commercial cell and gene therapies.
Building and improving on the learnings from CAR T-cell therapy in oncology, Kyverna is seeking to revolutionize the way patients with autoimmune diseases are treated. "We are excited by the potential to not only provide dramatic benefit to patients by eliminating the underlying disease pathology using CAR T-cell therapy, but also to bring innovation to other aspects of the patient journey," said Karen Walker, chief technology officer at Kyverna. "Together with ElevateBio, we aim to deliver radical benefits to patients in less time, with lower impact, and at substantially reduced cost."
"At ElevateBio, we have combined multiple next-generation technology platforms with industry-leading expertise to transform the current cell and gene therapy development paradigm," said Michael Paglia, chief operating officer at ElevateBio BaseCamp. "We are delighted to build a long-term relationship with Kyverna to optimize manufacturing processes and accelerate the development of their therapies."
About KYV-101
KYV-101 is an autologous version of a novel, fully human clinical-stage anti-CD19 chimeric antigen receptor (CAR) T-cell 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.
About Ingenui-T
Ingenui-T is Kyverna’s proprietary cost-efficient autologous CAR T-cell therapy manufacturing process, designed specifically to meet the needs of autoimmune disease patients. The process incorporates components to enhance the patient experience, to accelerate product availability, as well as to reduce cost of goods associated with personalized CAR T-cell therapy manufacturing.