ElevateBio inks deal to supply Kyverna’s CAR T-cell therapy for gMG
Experiment treatment miv-cel currently being tested in Phase 2/3 trial
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- Kyverna and ElevateBio signed a supply deal for miv-cel, a CAR T-cell therapy for generalized myasthenia gravis (gMG).
- Miv-cel targets B-cells to reduce self-reactive antibodies, with the aim of easing gMG symptoms.
- A Phase 2 trial showed rapid, sustained symptom reduction in gMG patients.
Kyverna Therapeutics and ElevateBio have signed a manufacturing and supply agreement for mivocabtagene autoleucel (miv-cel), Kyverna’s experimental CAR T-cell therapy for people with generalized myasthenia gravis (gMG).
The new agreement covers both U.S. commercial and global clinical supply of miv-cel, formerly known as KYV-101, which is currently being tested in gMG patients within a registrational Phase 2/3 clinical trial called KYSA-6 (NCT06193889).
Registrational studies are those designed to provide robust data that, if positive, can be used to support applications seeking the therapy’s approval. Recruitment of adults with hard-to-manage gMG is ongoing at sites in the U.S., the U.K., Brazil, Germany, Saudi Arabia, and Australia.
“Kyverna’s highest priority is to bring the transformative potential of miv-cel to patients, and this agreement with ElevateBio further strengthens our commercialization readiness and long-term manufacturing supply,” Mayo Pujols, chief technology officer of Kyverna, said in a company press release. “With ElevateBio’s proven expertise in manufacturing innovation and quality, demonstrated by a clinical manufacturing success rate of more than 98% for miv-cel, as well as their ability to scale production, we’re pleased to continue to advance our partnership.”
Miv-cel designed to eliminate B-cells
In gMG, the immune system produces self-reactive antibodies that mistakenly attack the connection between nerves and muscles, disrupting the signals that trigger muscle movement. This breakdown in communication leads to symptoms like fatigue and muscle weakness.
Miv-cel is designed to target and eliminate B-cells, the immune cells responsible for producing antibodies, including those that drive MG. In this way, the therapy aims to lower self-reactive antibody levels, thereby helping to relieve symptoms.
As a CAR T-cell therapy, miv-cel works by taking T-cells (immune cells with the ability to kill other cells) from the patient’s blood and modifying them in a lab. This modification adds an engineered receptor protein, called CAR, that allows the T-cells to recognize and attack B-cells specifically.
Before receiving the therapy, patients undergo a short course of chemotherapy to clear out existing immune cells and create space for the new ones. The modified T-cells are then infused back into the patient’s bloodstream, where they seek out and destroy B-cells.
Therapy also being developed for stiff person syndrome, MS
The Phase 2/3 KYSA-6 trial is designed to test miv-cel in up to 66 gMG patients who carry self-reactive antibodies against the acetylcholine receptor or muscle-specific kinase proteins, the two most common targets of MG-driving antibodies. Eligible participants have persistent gMG symptoms despite prior treatment with available therapies.
As of late February, seven participants had been treated with a single dose of miv-cel in the trial’s Phase 2 portion and had at least three months of follow-up data.
Results showed that all of these patients experienced rapid, sustained clinically meaningful reductions in disease severity, as assessed with the validated MG Activities of Daily Living (MG-ADL) and the Quantitative MG (QMG) scales. In addition, 57% of these patients achieved minimal symptom expression, reflecting no or minimal impact of the disease on daily life, at last follow-up.
The study’s Phase 3 portion is evaluating whether miv-cel can outperform standard-of-care MG therapies at reducing MG-ADL and/or QMG scores, reflecting less severe disease.
Miv-cel is also being developed as a potential treatment for other autoimmune conditions, including stiff person syndrome (SPS), multiple sclerosis, and rheumatoid arthritis.
By combining our technology and manufacturing expertise with Kyverna’s leadership in autoimmune cell therapies, we are well-positioned to deliver reliable supply that supports patients today and growing demand in the years ahead.
Kyverna and ElevateBio, a development and manufacturing organization, have worked together for three years on process development, quality systems, and manufacturing optimization for miv-cel.
This work has laid the foundation for an application seeking the therapy’s approval in the U.S. for people with SPS, a rare neurological autoimmune disorder that causes progressive muscle stiffness and painful spasms.
This new agreement is meant to give Kyverna flexible, scalable manufacturing capacity as it prepares for a potential commercial launch and further clinical testing.
“This agreement affirms ElevateBio’s commitment to the commercial supply of miv-cel and highlights the quality of our partnership with Kyverna,” said Chris Murphy, CEO of ElevateBio. “By combining our technology and manufacturing expertise with Kyverna’s leadership in autoimmune cell therapies, we are well-positioned to deliver reliable supply that supports patients today and growing demand in the years ahead.”
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