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Kyverna Therapeutics, Inc. (NASDAQ: KYTX) is a pioneering patient-centered, clinical-stage biopharmaceutical company dedicated to developing innovative cell therapies for patients suffering from autoimmune diseases. The company's primary focus is on advancing chimeric antigen receptor (CAR) T-cell therapies to address the unmet medical needs in autoimmune conditions.
Their lead product candidate, KYV-101, is an autologous CD19 CAR T-cell therapy designed to treat B cell-driven autoimmune diseases. This therapy specifically targets CD19, a protein found on the surface of B cells, which play a crucial role in various autoimmune conditions. KYV-101 is currently being evaluated in multiple clinical trials, including Phase 1 trials for lupus nephritis in the United States and Germany, and Phase 2 trials for multiple sclerosis (MS), myasthenia gravis, and systemic sclerosis.
Kyverna has also developed KYV-201, an allogeneic therapy using the same CAR as KYV-101, with the potential to treat multiple autoimmune diseases. The company's pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats, which are designed to be effective in B cell-driven autoimmune diseases.
Recently, Kyverna announced a collaboration with Stanford University to use KYV-101 in a Phase 1 investigator-initiated trial (IIT) for non-relapsing and progressive forms of MS. This collaboration aims to explore the safety, feasibility, and tolerance of KYV-101 in MS patients, and to understand the disease biology and potential for immune reset following the infusion.
Kyverna's robust clinical development program is supported by a solid financial foundation, with recent business highlights indicating significant progress. For the year ended December 31, 2023, Kyverna reported a net loss of $60.4 million due to substantial investments in its clinical programs. However, the company raised approximately $366.9 million in gross proceeds from its initial public offering in February 2024, bolstering its cash reserves and enabling continued advancements in its therapeutic pipeline.
The company operates on the forefront of medical research, collaborating with leading academic institutions like the National Institutes of Health (NIH) and the University Medical Center Hamburg-Eppendorf in Germany. These partnerships help Kyverna leverage cutting-edge scientific knowledge to push the boundaries of CAR T-cell therapy for autoimmune diseases.
At its core, Kyverna Therapeutics aims to transform the treatment paradigm for autoimmune diseases, providing new hope to patients through groundbreaking CAR T-cell therapies. For more information, visit Kyverna Therapeutics.
Kyverna Therapeutics announced the U.S. FDA has cleared its Investigational New Drug (IND) application for KYV-101. This CAR T-cell therapy aims to treat stiff-person syndrome (SPS) in a Phase 2, open-label KYSA-8 clinical trial. KYV-101, an anti-CD19 CAR T-cell product, targets B cell-driven autoimmune diseases. Preliminary results outside the U.S. suggest promising outcomes. The trial will involve a target dose of 100 million cells, offering a potential new treatment for patients unresponsive to current therapies. Kyverna's collaboration with the FDA has been pivotal in advancing this trial.
Kyverna Therapeutics has announced the first use of its anti-CD19 CAR T-cell product, KYV-101, in a patient with severe stiff-person syndrome (SPS), published in the Proceedings of the National Academy of Sciences (PNAS). The 69-year-old patient saw significant improvements, including an increase in walking distance and a 40% reduction in GABAergic medications, following failure to respond to conventional therapies. The treatment was well-tolerated, showing low-grade cytokine release syndrome (CRS) and no immune effector cell-associated neurotoxicity syndrome (ICANS). These promising results support further exploration of KYV-101 for neuroimmunological diseases.
Kyverna Therapeutics has co-authored a review with the National Institutes of Health on the application of CAR T-cell therapy for autoimmune diseases, published in Nature Reviews Immunology.
The review discusses the promising clinical outcomes of anti-CD19 CAR T cells in autoimmune patients, emphasizing optimal CAR construct design for safety and lasting immune reset.
Kyverna is recruiting for multiple trials using their candidate KYV-101 to treat myasthenia gravis, multiple sclerosis, and lupus nephritis.
With over 30 ongoing clinical trials, the review underscores the potential of CAR T-cell therapy in this field.
Kyverna Therapeutics will present data on the largest set of patients treated with KYV-101, an anti-CD19 CAR T-cell therapy, at EULAR 2024. The data covers 50 patients from more than 15 centers in the US and Europe, addressing 12 indications. Highlights include early efficacy and safety data, with a 12-month follow-up on a myasthenia gravis patient. The symposium, scheduled for June 14, will feature leading experts in rheumatology and neurology. Additionally, Kyverna will showcase preclinical development data for KYV-201 and proteomic markers associated with CAR T therapy response.
Kyverna Therapeutics (Nasdaq: KYTX) reported its Q1 2024 financial results, highlighting progress in autoimmune disease therapies. The company treated 30 patients by May 14, 2024, including those with myasthenia gravis, lupus nephritis, and multiple sclerosis. KYV-101, their CD19 CAR T-cell therapy, showed promising early clinical data and received Orphan Drug Designation for myasthenia gravis. Kyverna's balance sheet was strengthened by $366.9 million from their February IPO. However, the company reported a net loss of $26.7 million for Q1 2024, up from a $11.1 million loss in Q1 2023, with operating expenses increasing significantly.
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