Kyverna Therapeutics Announces Conference Call on Interim Phase 2 Data of KYV-101 in Generalized Myasthenia Gravis
Breakthrough Clinical Results
Kyverna Therapeutics will host a conference call to discuss interim data from the KYSA-6 Phase 2 clinical trial evaluating KYV-101 in generalized myasthenia gravis (gMG). The data will be presented at the AANEM Annual Meeting. KYV-101 is a fully human, autologous, CD19 CAR T-cell therapy with CD28 co-stimulation, designed for potency and tolerability, and is under investigation for B-cell-driven autoimmune diseases. Kyverna is focused on developing cell therapies for autoimmune diseases.
Key Highlights
- Kyverna Therapeutics to share interim Phase 2 data of KYV-101 in generalized myasthenia gravis.
- Conference call to be held on October 29, 2025, to discuss the KYSA-6 trial results.
- KYV-101 is a fully human, autologous, CD19 CAR T-cell therapy with CD28 co-stimulation.
- KYV-101 is being investigated for B-cell-driven autoimmune diseases with potential for durable drug-free remission.
Incidence and Prevalence
Latest Estimates of Myasthenia Gravis Incidence and Prevalence Globally
Incidence Rates
The annual incidence of myasthenia gravis (MG) globally ranges from 3 to 30 per 1,000,000 people. Since the mid-1980s, an increasing incidence has been reported, mainly attributed to late-onset MG. Recent epidemiological studies show varying rates across different regions:
- In Ferrara, Italy (1985-2007), the mean annual age-adjusted incidence was 18 per 1,000,000, without significant temporal trends
- A study in Croyden found an annual incidence of 9.1 per million (95% confidence limits 5.7-13.8 per million)
- Another study estimated the annual incidence rate at 4.6 per million population, remaining constant over time
- In Australia (2013), there were 545 incident cases, yielding a crude incidence rate of 24.9 per 1 million residents (27.9 per 1 million in women and 21.9 per 1 million in men)
- The most recent data from Turkey (2024) shows incidence rates varying between 2.22 and 3.59 per 100,000 population from 2016-2023, with a rate of 2.82 per 100,000 in 2023
- In children, the mean incidence of antibody-positive autoimmune myasthenia was 1.5 per million children per year
A changing pattern in MG incidence has been observed with an increase in frequency of late-onset and a decrease of early onset MG in recent years. A 2006 study found that while the mean annual incidence rate of early-onset MG remained constant at 3.5 x 10(-6), the rate for late-onset MG increased from 4.7 to 20.8 x 10(-6).
Prevalence Rates
Prevalence estimates also vary considerably across regions:
- Previous studies reported prevalence estimates in Europe ranging from 7.7 to 11.1 per 100,000 inhabitants
- In the province of Pavia, Italy, the overall crude prevalence was 24 per 100,000 inhabitants
- Sardinia showed a prevalence of 11.1 per 100,000 population (12.4 women and 9.9 men)
- A study in Denmark showed the point prevalence rate increased from 41 per million population in 1950 to 77 in 1988, with model calculations predicting a rate of 83 in year 2000
- In North Italy, a study found a prevalence per million of 105.3 (102.3 if standardized for the Italian population), described as "the highest prevalence figure yet found"
- In Kumamoto city, Japan (1982), the prevalence ratio was 6.7 per 100,000 population, while in Kumamoto prefecture (1983), it was 3.9 per 100,000
- For specific subtypes, the detected prevalence of genetically confirmed congenital myasthenic syndrome (CMS) in the UK was 9.2 per million children under 18 years of age
Demographic Patterns
Age- and sex-specific incidence rates show a bimodal appearance for both sexes. The age limit between early onset and late onset of MG is set at 50 years. The median age at onset has steadily increased over time. The total patient population shows a 6 to 4 predominance of females. In children, girls are affected more frequently than boys across all age ranges.
Key Unmet Needs and Target Populations for Myasthenia Gravis
Unmet Treatment Needs
Refractory myasthenia gravis patients (approximately fifteen percent) represent a significant unmet need as they do not respond adequately to standard therapies. Current challenges include unpredictable and variable disease progression, differing response to individual therapies, and substantial longterm side effects associated with conventional treatments, including increased risk of infections, osteoporosis, and diabetes.
Despite advances in treatment options, there is neither a cure nor preventative treatment available, only symptomatic treatment. The field lacks high-quality evidence for rehabilitation approaches, with existing studies showing methodological quality from low to fair. There is also an absence of cross-comparative studies between different rehabilitative modalities.
Target Populations
Several specific patient populations are being targeted for novel treatments:
- AChR-Ab-positive patients with generalized MG and baseline Quantitative Myasthenia Gravis scores ≥12
- Muscle-specific kinase (MuSK) MG patients, which are relatively rare and have higher incidence of myasthenic crisis
- Thymoma-associated MG patients complicated with hypertension and/or diabetes post thymectomy
- Elderly patients and males who showed higher susceptibility to LTBI
- Patients with moderate to severe AChR-Ab-positive generalized MG
Emerging Therapeutic Approaches
Molecular therapies represent a significant advance, offering more selective, rapid, and safer alternatives to traditional immunosuppressants. These include:
- B-cell depletion therapies (rituximab)
- Neonatal Fc receptor inhibitors (rozanolixizumab, batoclimab)
- Complement inhibitors (eculizumab, zilucoplan)
Recent clinical trials have shown promising results: - Belimumab improved MG-ADL scores - Batoclimab enhanced QMG and MGC scores - Eculizumab improved MG-QoL 15r scores
Research Gaps
The clinical efficacy of novel biologics remains debated, with a need for further validation through rigorous research regarding safety profiles and adverse reactions. For refractory MG patients, HSCT-related mortality may be high, indicating a need for safer treatment options.
Additional research needs include: - Prospective studies investigating HSCT efficacy and safety - Improved laboratory medicine for rapid diagnosis - Better understanding of serological biomarkers - Investigation of CAR T-cell therapies for durable responses - More personalized treatment approaches due to variable patient responses - Studies on emerging immunomodulators that dampen autoreactivity without affecting general immunity
These unmet needs highlight the importance of continued research and development of targeted therapies for myasthenia gravis patients who currently have limited effective treatment options.
Information on KYV-101 and Related Drugs
Insufficient information is available regarding KYV-101, its mechanism of action, or its therapeutic indication. Without this foundational information, it is not possible to identify other drugs being trialed for the same indication using the same MoA as KYV-101.
Similarly, without knowledge of KYV-101's mechanism of action or the specific condition it targets, information about intervention models used in clinical trials for similar drugs cannot be determined.
The lack of data on KYV-101 prevents identification of:
- Comparable drugs with similar mechanisms
- Clinical trial designs for related therapeutics
- Intervention models being employed
- Treatment protocols in development
- Patient populations being studied
Further information about KYV-101 would be required to provide a comprehensive analysis of drugs with similar mechanisms of action and their associated clinical trial intervention models.
