The non-exclusive, multi-year license and supply agreement enables use of LentiVector® with any Kyverna product

Agreement supports Kyverna’s scalability and reliability of CAR T cell manufacturing goals

EMERYVILLE, Calif., Sept. 20, 2023 – Kyverna Therapeutics (“Kyverna”), a clinical-stage cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases, today announced a non-exclusive, multi-year license and supply agreement with Oxford Biomedica plc (LSE:OXB) (“Oxford Biomedica”), a quality and innovation-led viral vector Contract and Development Manufacturing Organization (CDMO), enabling the use of LentiVector® with any Kyverna product.

The LentiVector® platform is the first commercially approved lentiviral-based gene delivery system. The platform enables the successful development of breakthrough gene and cell-based medicines.

Kyverna’s anti-CD19 chimeric antigen receptor (CAR) T-cell therapies, KYV-101 and KYV-201, specifically target CD19, a protein expressed on the surface of B cells which are involved in various types of autoimmune diseases, including lupus nephritis. These novel therapies have the potential to offer new hope to patients who have exhausted current treatment options. Kyverna’s KYV-101 CAR T-cell product is currently being tested in a Phase 1 clinical trial in lupus nephritis in the U.S. and a Phase 1/2 trial in Germany.

“We are committed to quality and innovation. As a world-leading CDMO with expertise across all key viral vector types, we are committed to enabling our biopharma customers to discover and deliver transformative therapies”, said Dr. Sebastien Ribault, chief commercial officer of Oxford Biomedica. “We are excited to work with Kyverna as an innovative leader in cell therapy for autoimmune diseases and look forward to a fruitful partnership.”

“We are delighted to be working with Oxford Biomedica, a recognized leader in reliable, quality vector supply. We value Oxford Biomedica’s extensive capabilities and technologies to enable efficient and cost-effective manufacturing, which is critical in the vast market of B cell-driven autoimmune diseases that our therapies address,” commented Karen Walker, chief technology officer at Kyverna.

 

Oxford Biomedica is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world.

One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies, and collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. Oxford Biomedica’s world-class capabilities span from early-stage development to commercialization. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.

Oxford Biomedica, a FTSE4Good constituent, is headquartered in Oxford, UK. It has locations across Oxfordshire, UK and near Boston, MA, US. Learn more at www.oxb.com, www.oxbsolutions.com.

 

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 cell-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.

 

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.

 

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

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