Kyverna Therapeutics Announces New Patient Data Highlighting Potential of KYV-101 for Treatment of Lupus Nephritis in Symposium at ACR Convergence 2024
Kyverna Therapeutics presented updated clinical data for KYV-101, their CD19 CAR T-cell therapy for lupus nephritis (LN) treatment. The data shows sustained efficacy and durability in patients treated with the target dose of 1×108 CD19 CAR T cells, with four out of six patients having at least six months of follow-up. Key findings demonstrate deep B cell depletion, immune system reset, stabilized eGFR, preserved kidney function, and improved SLE activity. The treatment allowed elimination of immunosuppressants and reduction of glucocorticoids while maintaining a manageable safety profile with no high-grade CRS or ICANS observed.
Kyverna Therapeutics ha presentato dati clinici aggiornati per KYV-101, la loro terapia CAR T-cell CD19 per il trattamento della nefrite lupica (LN). I dati mostrano efficacia e durabilità sostenute nei pazienti trattati con la dose target di 1×108 cellule T CAR CD19, con quattro pazienti su sei che hanno avuto almeno sei mesi di follow-up. I principali risultati dimostrano una profonda deplezione delle cellule B, un ripristino del sistema immunitario, una eGFR stabilizzata, funzione renale preservata e miglioramento dell'attività del LES. Il trattamento ha permesso l'eliminazione degli immunosoppressori e la riduzione dei glucocorticoidi, mantenendo un profilo di sicurezza gestibile senza CRS o ICANS di alto grado osservati.
Kyverna Therapeutics presentó datos clínicos actualizados para KYV-101, su terapia de células T CAR CD19 para el tratamiento de la nefritis lúpica (LN). Los datos muestran eficacia y durabilidad sostenidas en pacientes tratados con la dosis objetivo de 1×108 células T CAR CD19, con cuatro de seis pacientes teniendo al menos seis meses de seguimiento. Los hallazgos clave demuestran una profunda depleción de células B, reinicio del sistema inmunológico, eGFR estabilizada, función renal preservada y mejoría en la actividad del LES. El tratamiento permitió la eliminación de inmunosupresores y la reducción de glucocorticoides, manteniendo un perfil de seguridad manejable sin observaciones de CRS o ICANS de grado alto.
Kyverna Therapeutics는 루푸스 신염(LN) 치료를 위한 CD19 CAR T세포 요법인 KYV-101의 업데이트된 임상 데이터를 발표했습니다. 데이터는 1×108 CD19 CAR T 세포의 목표 용량으로 치료받은 환자들에서 지속적인 효능과 내구성을 보여주며, 6명의 환자 중 4명이 최소 6개월의 추적 관찰을 받았습니다. 주요 발견은 B 세포의 깊은 감소, 면역 시스템 재설정, 안정된 eGFR, 유지된 신장 기능 및 개선된 SLE 활성을 입증합니다. 이 치료법은 면역억제제의 제거와 글루코코르티코이드의 감소를 가능하게 하였으며, 고등급 CRS 또는 ICANS가 관찰되지 않는 안전한 프로필을 유지했습니다.
Kyverna Therapeutics a présenté des données cliniques mises à jour pour KYV-101, leur thérapie par cellules T CAR CD19 pour le traitement de la néphrite lupique (LN). Les données montrent une efficacité et une durabilité soutenues chez les patients traités avec la dose cible de 1×108 cellules T CAR CD19, quatre patients sur six ayant bénéficié d'au moins six mois de suivi. Les résultats clés démontrent une déplétion profonde des cellules B, un rétablissement du système immunitaire, une eGFR stabilisée, une fonction rénale préservée et une amélioration de l'activité du LES. Le traitement a permis l'élimination des immunosuppresseurs et la réduction des glucocorticoïdes tout en maintenant un profil de sécurité gérable sans observations de CRS ou ICANS de haut grade.
Kyverna Therapeutics hat aktualisierte klinische Daten zu KYV-101 vorgestellt, ihrer CD19 CAR T-Zelltherapie zur Behandlung von Lupusnephritis (LN). Die Daten zeigen eine anhaltende Wirksamkeit und Langlebigkeit bei Patienten, die mit der Ziel-Dosis von 1×108 CD19 CAR-T-Zellen behandelt wurden, wobei vier von sechs Patienten mindestens sechs Monate Follow-up hatten. Die Hauptergebnisse zeigen eine tiefe B-Zell-Depletion, eine Wiederherstellung des Immunsystems, eine stabilisierte eGFR, erhaltene Nierenfunktion und eine verbesserte SLE-Aktivität. Die Behandlung ermöglichte die Elimination von Immunsuppressiva und die Reduktion von Glukokortikoiden, während ein handhabbares Sicherheitsprofil beibehalten wurde, ohne dass hochgradige CRS oder ICANS beobachtet wurden.
- Sustained efficacy and durability observed in LN patients at 6+ months follow-up
- Successful elimination of immunosuppressants and reduction of glucocorticoids
- Strong safety profile with no high-grade CRS or ICANS reported
- Development of Ingenui-T, a 3-day manufacturing process that eliminates need for apheresis
- None.
Insights
The updated clinical data for KYV-101 in Lupus Nephritis (LN) patients shows compelling progress. The target dose of 1×108 CD19 CAR T cells demonstrated sustained efficacy and durability in all four patients with 6+ months follow-up. Key findings include deep B cell depletion, immune system reset and stabilized kidney function (eGFR), while reducing the need for immunosuppressants.
The development of Ingenui-T, a 3-day manufacturing process using whole blood instead of apheresis, could be a significant advancement. This innovation could substantially reduce treatment complexity and costs while maintaining product quality comparable to KYV-101. For a disease affecting up to
This clinical progress significantly strengthens Kyverna's market position in the autoimmune disease treatment space. The successful development of KYV-101 addresses a critical unmet need in LN treatment, where current options are and often inadequate. The Ingenui-T manufacturing innovation could provide a important competitive advantage by potentially reducing production costs and improving accessibility.
The company's collaboration with Verily Life Sciences (an Alphabet company) adds credibility and technological depth to their research efforts. With positive clinical outcomes and manufacturing improvements, Kyverna is positioning itself as a leader in CAR T-cell therapy for autoimmune diseases, a market with substantial growth potential given the high unmet medical need.
Positive Sustained Efficacy and Durability at >6-month Follow-Up Observed in Patients With Severe Lupus Nephritis (LN) Treated With KYV-101 Target Dose
KYV-101 Treatment Continues to Demonstrate Robust Safety and Tolerability With No High-Grade CRS or ICANS Observed
These updates will be presented at a company symposium titled, "KYV-101 Anti-CD19 CAR T-Cell Therapy: The Future of Autoimmune Disease Treatment," to be held at 5:45 pm ET on November 18, 2024. Slides from the presentation will be posted to the company website following the symposium.
"Lupus nephritis patients encounter a tremendous burden of disease associated with high morbidity and mortality, with up to
"As our KYV-101 clinical datasets mature, we are increasingly able to focus on the right patients, treated at the right dose, with the right protocol. We are excited to share these new data, which continue to reinforce KYV-101's potential for durable and life-changing outcomes in lupus nephritis patients, including those with high chronicity and disease severity," said Warner Biddle, Chief Executive Officer at Kyverna.
Additional Updates:
Also at ACR Convergence 2024, Kyverna will present data on next-generation approaches, most notably with a poster on Ingenui-T, the Company's preclinical 3-day manufacturing process using autologous whole blood as starting material. Ingenui-T is designed to improve the patient experience by eliminating apheresis, leading to a potential for improved convenience, access and overall cost reduction. As the poster highlights, drug product from the Ingenui-T process manufactured with whole blood from patients with SLE or healthy donors displayed product characteristics similar to KYV-101.
In addition, results from collaborative work on the molecular mechanisms underlying immune reset through deep B-cell depletion with CD19 CAR T-cell therapy performed in collaboration with Verily Life Sciences, an Alphabet precision health company, and the University of Erlangen will be shared as an oral presentation.
The posters and slides from the oral presentation at ACR Convergence 2024 will be available on the publications page of Kyverna's website.
About Lupus Nephritis (LN)
Lupus nephritis (LN) is a serious complication of systemic lupus erythematosus (SLE), more commonly known as lupus. Approximately 40 percent of adults diagnosed with lupus eventually develop LN and 60 percent or more of LN patients will fail standard of care and approved treatments1,2. Aside from modest efficacy, current treatments expose these young adults to the well-demonstrated detrimental consequences of chronic treatment with corticosteroids and other powerful immunosuppressants. Up to 30 percent of patients with LN will develop kidney failure, requiring dialysis or a kidney transplant to stay alive3.
About KYV-101
KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate for use in B cell-driven autoimmune diseases. The CAR in KYV-101 was designed by the National Institutes of Health (NIH) to improve tolerability and tested in a 20-patient Phase 1 trial in oncology. Results were published by the NIH in Nature Medicine4. KYV-101 is currently being evaluated in sponsored, open-label, Phase 1/2 and Phase 2 trials in
About Kyverna Therapeutics
Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Our lead CAR T-cell therapy candidate, KYV-101 is advancing through clinical development with sponsored clinical trials across two broad areas of autoimmune disease: rheumatology and neurology, including Phase 2 trials for stiff-person syndrome, multiple sclerosis and myasthenia gravis, a Phase 1/2 trial for systemic sclerosis, and two ongoing multi-center Phase 1/2 trials in
For more information, please visit https://kyvernatx.com.
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." The words, without limitation, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: the potential impact of the clinical outcomes from the ongoing clinical programs; the potential impact of the new data on the treatment efficacy and safety profile of KYV-101; the potential that the results of the ongoing trials could drastically change the treatment landscape for the targeted autoimmune diseases; Kyverna's goals to develop certain paradigm-shifting treatment options; the potential for KYV-101 to provide durable, immunosuppressant-free remission for autoimmune disease patients; Kyverna's beliefs about the differentiated properties of KYV-101; and Kyverna's clinical trials and named-patient activities. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, and other factors discussed in the "Risk Factors" section of Kyverna's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the
Contact:
Consort Partners for Kyverna: kyvernatx@consortpartners.com
Investors: InvestorRelations@kyvernatx.com
Media: media@kyvernatx.com
1Anders et al., Nat Rev Dis Primers. 2020; 6:7.
2Parodis et al., Autoimmun Rev. 2024; 23:103418.
3Lateef and Petri, Arthritis Res & Ther. 2012; 14(Suppl 4):S4.
4Brudno et al., Nature Medicine. 2020; 26:270-280.
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