The Investigator-Initiated Trial will assess
the safety, tolerability, and clinical activity of KYV-101, a fully
human anti CD19 CAR T-cell therapy in up to 12 study
participants
The clinical study will be supported by
cutting edge correlative studies funded through a parallel research
collaboration between Kyverna and Stanford
University
The agreements further expand the scale of
ongoing clinical studies assessing the potential therapeutic
effects of KYV-101 in multiple diseases and locations around the
world
EMERYVILLE, Calif., March 7,
2024 /PRNewswire/ -- Kyverna Therapeutics, Inc.
(Kyverna), a patient-centered, clinical-stage biopharmaceutical
company focused on developing cell therapies for patients suffering
from autoimmune diseases, today announced the signature of a
collaboration agreement with Stanford
University to allow the use of KYV-101, an investigational,
anti-CD19 CAR T-cell therapy in an open label, phase 1
investigator-initiated trial (IIT) in nine to twelve adult subjects
with non-relapsing and progressive forms of multiple sclerosis.
Each participant will receive a single dose of KYV-101.
A parallel agreement will support the development of correlative
studies thoroughly investigating disease biology upon KYV-101
infusion in MS patients, including the definition of predictors of
response and the potential for immune reset.
The investigator-initiated trial adds to the Kyverna-sponsored
KYSA-7 Phase 2 study in MS and other sponsored KYSA trials in other
rheumatological and neurological autoimmune disorders.
"We foresee great therapeutic potential for CAR T-cell therapy
for immune-mediated disease of the nervous system. This phase 1
trial is a first-in-human study that will assess safety,
feasibility, and tolerance in patients with non-relapsing multiple
sclerosis for which there is no proven treatment," said
Jeffrey Dunn, M.D., the Lily Sarafan
director of Neuroimmunology and clinical professor and chief of
Neuroimmunology within the Department of Neurology and Neurological
Sciences at Stanford University in
Palo Alto, California. "We are
grateful for the opportunity to join forces with Kyverna to explore
what may prove to be paradigm-changing immunotherapy.".
"As CAR T-cell therapies are entering the field of B cell-driven
autoimmunity, leveraging on our knowledge and expertise in oncology
will provide a faster option to address an unmet medical need and
make these potentially life-changing therapies available to
non-cancer patients," said Robert
Lowsky, M.D., professor of medicine, Division of Blood and
Marrow Transplantation and Cellular Therapy at Stanford University in Palo Alto, California.
"We are excited about the interest shown by world-class
institutions like Stanford to evaluate
the clinical performance of KYV-101 in patients suffering from
multiple sclerosis," said Peter
Maag, Ph.D., chief executive officer of Kyverna. "We look
forward to enriching our collective knowledge about the potential
paradigm-shifting value of CAR T-cell therapy through these
dedicated collaborations between Industry and Academia."
CAR T-cell therapy involves modifying a patient's T cells to
recognize and remove B cells in the patient's body. Kyverna's CD19
CAR T-cell therapy, KYV-101, specifically targets CD19, a protein
expressed on the surface of B cells, which are involved in various
types of autoimmune diseases. Kyverna plans to continue to explore
additional indications for KYV-101 and develop a robust pipeline of
promising product candidate immunotherapies aimed at
addressing unmet medical needs in autoimmune diseases.
About Multiple sclerosis (MS)
Multiple sclerosis is a chronic neurodegenerative autoimmune
disease affecting over 2.8 million individuals
worldwide1. It affects more frequently women, people of
Northern European descent, and is also associated with certain
environmental and genetic factors. Patients with MS can experience
a range of symptoms including blurred vision, slurred speech,
tremors, numbness, extreme fatigue, problems with memory and
concentration, and, in severe cases, the inability to walk or
stand.
Current disease-modifying treatments for MS aim to reduce the
frequency of disease relapses and delay progression of disability,
but the disease remains a chronic condition that will progressively
worsen for most patients.
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 Medicine2.
KYV-101 is currently being evaluated in sponsored, open-label
trials of KYV-101 in patients with lupus nephritis, an autoimmune
disease in which more than half of patients do not achieve a
complete response to current therapies and are at risk of
developing kidney failure. Additionally, FDA's IND clearance has
been obtained for Phase 2 trials of KYV-101 for multiple sclerosis
and myasthenia gravis, and a Phase 1/2 trial for systemic
sclerosis.
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 (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 trials in the United States and Germany for patients with lupus nephritis.
Kyverna's pipeline includes next-generation chimeric antigen
receptor (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.
By advancing more than one mechanism for taming autoimmunity,
Kyverna is positioned to act on its mission of transforming how
autoimmune diseases are treated.
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. 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 the final prospectus. 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. Walton C, et al. Mult Scler. 2020;
26:1816-1821.
2. Brudno et al., Nature Medicine 2020;
26:270-280.
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