This IND clearance expands the use of KYV-101
CAR T-cell therapy in a Phase 2, open-label KYSA-8 clinical trial
targeting a devastating neuroimmunological autoimmune
disease
KYV-101 is a fully human anti-CD19 CAR T-cell
therapy designed for use in patients with B cell-driven autoimmune
diseases
EMERYVILLE, Calif., June 20,
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 clearance of its
Investigational New Drug (IND) application by the U.S. Food and
Drug Administration (FDA) for its autologous, fully human anti-CD19
chimeric antigen receptor (CAR) T-cell product candidate, KYV-101,
to be used for the treatment of stiff-person syndrome (SPS) in
Kyverna's trial, named KYSA-8.
"CAR T-cell therapy has already shown preliminary but promising
results in patients with SPS treated outside of the US," said
Marinos Dalakas, M.D., FAAN, Professor of Neurology, Director of
the Neuromuscular Division at Thomas Jefferson
University School of Medicine in Philadelphia, PA, and a leading physician and
researcher on SPS. "I find the KYSA-8 trial of extraordinary
importance as a promising novel therapy for patients with stiff
person syndrome who do not respond to current therapies, with
implications in providing potentially long-lasting benefits."
"The IND clearance gives us confidence in our dedication to
bringing a potential paradigm shift in the treatment of patients
suffering from SPS and reaffirms a target dose of 100 million cells
for KYV-101," said Sham Dholakia, M.D., business unit head rare
diseases at Kyverna. "We are also very grateful to the FDA for the
collaborative approach and timely vetting of our clinical trial
design."
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 disorder1.
There is no cure for SPS, but only treatments focused on
treating the symptoms.
About KYV-101
KYV-101 is an autologous, fully human
anti-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 Medicine2.
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 stiff person syndrome, 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, the
potential that the results of the KYSA-8 trial could usher in a
transformational event in the treatment of SPS patients; 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.Dalakas, M.C., Neurotherapeutics 2022; 19,
832–847.
2 Brudno et al., Nature Medicine 2020;
26:270-280.
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SOURCE Kyverna Therapeutics