Patient received KYV-101, a fully human
anti-CD19 CAR T-cell product candidate, as part of a named-patient
treatment option after failure to respond to conventional
therapies
Significant improvement in walking distance
and 40% reduction in GABAergic medications were among the reported
results
Well-tolerated treatment with low-grade CRS
and no ICANS supports continued exploration of KYV-101 in
neuroimmunological disease
EMERYVILLE, Calif., June 17,
2024 /PRNewswire/ -- Kyverna Therapeutics, Inc.
(Kyverna), a patient-centered, clinical-stage biopharmaceutical
company focused on developing cell therapies for patients suffering
from autoimmune diseases, announced today the publication in
Proceedings of the National Academy of Sciences (PNAS)1
of a report describing the first use of KYV-101, a fully human
anti-CD19 chimeric antigen receptor (CAR) T-cell product candidate,
in a 69-year-old patient suffering from treatment-refractory
stiff-person syndrome (SPS) as part of a named-patient use in
Germany for critically ill
individuals who fail conventional therapies.
"It is extremely encouraging to see this patient improving the
self-reported, uninterrupted walking distance from less than 50
meters to several kilometers within three months after
treatment," said Simon Faissner, M.D., professor for translational
neuroimmunology at the Department of Neurology, Ruhr University
Bochum, St. Josef Hospital, in Germany, and lead co-author. "These dramatic
improvements – if confirmed by further studies – may eventually
provide renewed hope for a much-needed paradigm shift in the
treatment of debilitating autoimmune diseases."
"It is remarkable to observe the transformational effects in a
patient deemed refractory to available standard treatments. With
the disease progressing over several years despite the best medical
treatment, I recommended the CAR T-cell therapy approach," said
Ralf Gold, M.D., professor of
Medicine, chair of Neurology at Ruhr University Bochum, St. Josef
Hospital, in Germany, and senior
co-author. "The absence of observed neurotoxicity and the measured
impact on the pathogenic anti-GAD65 autoantibodies pave the way for
additional studies to confirm the initial, promising
findings."
"On the heels of recent case reports of the use of KYV-101 in
multiple sclerosis and myasthenia gravis, we are excited to see
positive outcomes of KYV-101 in a patient suffering from SPS," said
Peter Maag, Ph.D., chief executive
officer of Kyverna. "These data underscore the dedication of the
Kyverna village to patient care and scientific advancement."
About Stiff Person Syndrome (SPS)
SPS is a rare, progressive neurological autoimmune disorder causing
debilitating muscle stiffness in the torso, arms, and legs,
impacting the ability to walk or move. Patients typically present
with muscle spasms and stiffness, resulting in difficulty turning
and bending. When stiffness is severe, the patient's walking
resembles a statue. Muscle spasms and stiffness can be precipitated
by unexpected stimuli, including sounds, like a phone ring or a
siren, sudden touches or conditions triggering anxiety and
emotional upset which, when severe, are misdiagnosed as a primary
anxiety disorder2. There is no cure for SPS, but
only treatments focused on the symptoms.
About KYV-101
KYV-101 is an autologous, fully human
CD19 CAR T-cell product candidate for use in B cell-driven
autoimmune diseases. The CAR in KYV-101 was designed by the
National Institutes of Health (NIH) to improve tolerability and
tested in a 20-patient Phase 1 trial in oncology. Results were
published by the NIH in Nature Medicine3.
KYV-101 is currently being evaluated in sponsored, open-label,
Phase 1/2 and Phase 2 trials of KYV-101 in the United States and Germany across two broad areas of autoimmune
disease: rheumatology and neurology.
With 50 patients treated so far with the CAR in KYV-101 in both
oncological and autoimmune conditions at more than 15 locations in
Europe and the U.S., we believe
that the differentiated properties of KYV-101 are critical for the
potential success of CAR T cells as autoimmune disease
therapies.
KYV-101 is also being evaluated in investigator-initiated trials
for multiple indications in multiple geographies.
About Kyverna Therapeutics
Kyverna Therapeutics, Inc.
(Nasdaq: KYTX) is a patient-centered, clinical-stage
biopharmaceutical company focused on developing cell therapies for
patients suffering from autoimmune diseases.
Our lead CAR T-cell therapy candidate, KYV-101 is advancing
through clinical development with sponsored clinical trials across
two broad areas of autoimmune disease: rheumatology and neurology,
including Phase 2 trials for multiple sclerosis and myasthenia
gravis, a Phase 1/2 trial for systemic sclerosis, and two ongoing
multi-center, open-label Phase 1/2 trials in the United States and Germany for patients with lupus
nephritis.
Kyverna's pipeline includes next-generation CAR T-cell therapies
in both autologous and allogeneic formats with properties intended
to be well suited for use in B cell-driven autoimmune diseases.
Forward-Looking Statements
Statements in this press
release about future expectations, plans and prospects, as well as
any other statements regarding matters that are not historical
facts, may constitute "forward-looking statements." The words,
without limitation, "anticipate," "believe," "continue," "could,"
"estimate," "expect," "intend," "may," "plan," "potential,"
"predict," "project," "should," "target," "will," "would" and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these or similar identifying words. Forward-looking statements in
this press release include, without limitation, those related to:
the potential efficacy of KYV-101 in patients with SPS, or that the
results of any named patient activities may be repeated in any
clinical trials; the potential impact of named-patient case
reports; Kyverna's goals to develop certain paradigm-shifting
treatment options; Kyverna's beliefs about the differentiated
properties of KYV-101; and Kyverna's clinical trials. Actual
results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including: uncertainties related to market conditions, and
other factors discussed in the "Risk Factors" section of Kyverna's
most recent Annual Report on Form 10-K and Quarterly Reports on
Form 10-Q that Kyverna has filed or may subsequently file with the
U.S. Securities and Exchange Commission. Any forward-looking
statements contained in this press release are based on the current
expectations of Kyverna's management team and speak only as of the
date hereof, and Kyverna specifically disclaims any obligation to
update any forward-looking statement, whether as a result of new
information, future events or otherwise.
For more information, please
visit https://kyvernatx.com.
Kyverna Media Contact:
Consort Partners for Kyverna
kyvernatx@consortpartners.com
1 Faissner S, et al. PNAS. 2024;121:
e2403227121. doi.org/10.1073/pnas.2403227121
2 Dalakas, M.C., Neurotherapeutics 2022; 19,
832–847.
3 Brudno et al., Nature Medicine 2020;
26:270-280.
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