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Phase 1 open-label clinical trial in LN in U.S. is actively recruiting patients at multiple sites
KYV-101 is a novel, fully human anti-CD19 chimeric antigen receptor T-cell therapy designed to deplete B cells, including autoreactive B cells in autoimmune disease patients
Lupus nephritis (LN) is a serious complication of lupus; nearly half of adults diagnosed with lupus develop LN
EMERYVILLE, Calif.,June 1, 2023/PRNewswire/ -- Kyverna Therapeutics ("Kyverna"), a cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KYV-101 for the treatment of patients with refractory lupus nephritis (LN). KYV-101 is a novel anti-CD19 chimeric antigen receptor T-cell (CAR T) therapy designed to deplete B cells, including autoreactive B cells, in autoimmune disease patients.
"The FDA granting us Fast Track designation for KYV-101 means we can move more quickly toward bringing this potentially transformative and life-saving medicine to patients with lupus," said Peter Maag, Ph.D., chief executive officer (CEO) of Kyverna. "We believe KYV-101 has the potential to drive greater and more rapid reduction of disease activity in patients with LN, and we look forward to sharing clinical data on patients in the second half of 2023."
Kyverna's Phase 1 open label, multi-center clinical trial of KYV-101 in the US is actively recruiting patients at multiple sites in the US. Kyverna also filed its first European Union (EU) Clinical Trial Application (CTA) to the Paul Ehrlich Institut (PEI) inGermanyfor a parallel Phase 1/2 clinical trial of KYV-101 in LN.
Fast Track designation is designed to facilitate the development and expedite the review of new therapeutics intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs, thus enabling drugs to reach patients sooner. Therapies granted Fast Track designation are given the opportunity for more frequent interactions with the FDA and may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.
About Lupus Nephritis (LN)Lupus nephritis (LN) is a serious complication of systemic lupuserythematosus(SLE), more commonly known as lupus. Approximately 40 percent of adults diagnosed with lupus eventually developLNand 60 percent ofLNpatients will fail standard of care and approved treatments1. Aside from modest efficacy, current treatments expose these young adults to the well-demonstrated detrimental consequences of chronic treatment withcorticosteroidsand other powerfulimmunosuppressants. Up to 10 percent of patients withLNand 40 percent with diffuseLN(class IV) will ultimately develop kidney failure, requiring dialysis or a kidney transplant to stay alive2.
About KYV-101KYV-101 is anautologousversion of a novel, fully human clinical-stage anti-CD19 chimeric antigen receptorT-cell(CART) construct with properties well suited for use in B cell-drivenautoimmunediseases such as lupus nephritis and other B-cell drivenautoimmunediseases. In a 20-patient Phase 1/2 study in oncology, expected anti-lymphoma activity was associated with a significant reduction ofcytokinesreleased that translated into a strong reduction ofcytokine-drivenside effects such as the rate of immuneeffectorcells-associatedneurotoxicitysyndrome (ICANS)3. The fully human anti-CD19 CAR also translated into reducedimmunogenicitythat favorably impacted cell persistence.Kyvernarecognized that these properties singled out KYV-101 as a product ideally poised for use inautoimmunedisease patients, and the company obtained exclusive, worldwide licenses from the National Institutes of Health (NIH) to use this CD19 construct in bothautologousandallogeneicCART-celltherapies.
About Kyverna TherapeuticsKyvernaTherapeutics is a cell therapy company with the mission of engineering a new class of therapies forautoimmuneand inflammatory diseases. TheKyvernatherapeutic platform combines advancedT-cellengineering and synthetic biology technologies to suppress and eliminate theautoreactiveimmune cells at the origin ofautoimmuneand inflammatory diseases.Kyverna'spipeline includes next-generation chimeric antigen receptorT-cell(CART) therapies in bothautologousandallogeneicformats with properties well suited for use in B cell-drivenautoimmunediseases. By offering more than one mechanism for tamingautoimmunity,Kyvernais positioned to act on its mission of transforming howautoimmunediseases are treated. For more information, please visit https://kyvernatx.com.
| 1E. Carter et al., Nature Reviews Rheumatology, 12, Oct. 2016, 605-620. |
| 2Adv Chronic Kidney Dis. 2019;26(5):313. |
| 3Brudno et al., Nature Medicine 2020; 26:270-280. |
1E. Carter et al., Nature Reviews Rheumatology, 12, Oct. 2016, 605-620.
2Adv Chronic Kidney Dis. 2019;26(5):313.
3Brudno et al., Nature Medicine 2020; 26:270-280.