The US Food and Drug Administration (FDA) has given clearance for Kyverna Therapeutics’ investigational new drug (IND) application to begin a Phase II clinical trial of KYV-101 for myasthenia gravis.
The KYSA-6 trial will analyse KYV-101’s ability to treat adults with the autoimmune disease.
Go deeper with GlobalData
KYV-101 is a fully human CD19 chimeric antigen receptor (CAR) T-cell therapy that is designed to act on the CD19 protein.
This protein is expressed on the B cell surface and is associated with myasthenia gravis and several other autoimmune diseases
The US National Institutes of Health (NIH) designed the CAR in KYV-101 to enhance tolerability and the product candidate is specifically intended for the treatment of B cell-driven autoimmune diseases.
Kyverna Therapeutics intends to evaluate KYV-101 for further indications and establish a pipeline of immunotherapies for autoimmune diseases.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataKyverna Therapeutics CEO Peter Maag said: “We are grateful that the FDA’s decision to clear the IND for our Phase II KYSA-6 trial will allow Kyverna to offer this potentially paradigm-shifting investigational treatment to patients that may benefit from a deep B cell depletion and possibly durable reset of their immune system.”
KYV-101 is currently being analysed for active lupus nephritis in the Phase I KYSA-1 trial in the US and Phase I/II KYSA-3 trial in Germany.
Another Phase I/II KYSA-5 trial is evaluating the CART cell therapy’s efficacy in treating cutaneous systemic sclerosis in the US.
Otto-von-Guericke University Neurology department director Prof Aiden Haghikia said: “We have seen firsthand the transformative effects of KYV-101 in MG patients treated with the investigational therapy in our clinic.
“I welcome the FDA’s decision and look forward to more clinical data to further our knowledge about CAR T-cell therapy in patients with severe neurological autoimmune diseases.”
Earlier this year, Kyverna Therapeutics began enrolling subjects in a Phase I trial to evaluate KYV-101’s ability to treat lupus nephritis.
Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.
Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
