Kyverna to leverage ElevateBio BaseCamp’s expertise in process development and cell product manufacturing to achieve a lower cost of goods

Ingenui-T is an optimized autologous CAR-T cell manufacturing process for autoimmune diseases

EMERYVILLE, Calif. and WALTHAM, Mass., Sept. 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, today announced a partnership to advance process development and manufacturing to produce industry-leading Ingenui-T-derived chimeric antigen receptor (CAR) T-cell therapies. 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.

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.”

 

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.

 

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.

 

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 (CAR) 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.

 

ElevateBio is a technology-driven company built to power the development of transformative cell and gene therapies today and for many decades to come. The company’s integrated technologies model offers turnkey scale and biotechnological capabilities to power cell and gene therapy processes, programs and companies to their full potential. The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next­generation, full­spectrum gene­editing platform, a proprietary induced pluripotent stem cell (iPSC) platform, and an RNA, cell, protein, and vector engineering platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to power the discovery and development of advanced therapeutics.

In addition to enabling a broad breadth of biopharmaceutical companies in the development of their novel cell and gene therapies, ElevateBio is also building a highly innovative pipeline of cellular, genetic, and regenerative medicines. ElevateBio aims to be the dominant engine inside the world’s greatest scientific advancements harnessing human cells and genes to alter disease. For more, visit www.elevate.bio or follow ElevateBio on LinkedIn or Twitter.

 

Christian Pflaumer
+1 (917) 841-4525
christian.pflaumer@ruderfinn.com

Investor contact:
Catherine Hu
chu@elevate.bio

Media contact:
DJ Webster
dwebster@elevate.bio

¹Brudno et al., Nature Medicine 2020; 26:270-280.