Kyverna Therapeutics - KYTX STOCK NEWS

Kyverna Therapeutics (KYTX) has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for KYV-101, its autologous CD19 CAR T-cell therapy for progressive myasthenia gravis. This designation was based on positive clinical outcomes from patients treated in Germany under a named-patient program. The RMAT status allows Kyverna to benefit from expedited meetings and senior FDA leadership involvement throughout KYV-101's development cycle.

Dr. Srikanth Muppidi, a principal investigator in the KYSA-6 trial, emphasized that this designation highlights the FDA's interest in potentially transformative therapies for severe autoimmune diseases. Kyverna's CEO, Peter Maag, expressed satisfaction with the company's scientific rapport with the FDA and hopes this rigorous approach will benefit patients most in need.

Kyverna Therapeutics (KYTX) has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for KYV-101, its autologous CD19 CAR T-cell therapy, in treating refractory stiff-person syndrome. This designation, based on positive clinical outcomes in Germany, allows Kyverna to receive expert guidance on efficient drug development and use of surrogate endpoints from senior FDA officials. The company is set to begin its sponsored trial, KYSA-8, which could potentially revolutionize SPS treatment by offering a durable, immunosuppressant-free remission through an immunological reset of the patient's immune system.

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.