Two patients were treated with KYV-101, a
fully human anti-CD19 CAR T-cell product candidate, in Germany as part of a named patient program
after failure to respond to conventional therapies
The treatment resulted in an acceptable safety
profile, with no observed clinical signs of early neurotoxicity,
warranting larger clinical studies in subjects with multiple
sclerosis
EMERYVILLE, Calif., March 29,
2024 /PRNewswire/ -- Kyverna Therapeutics, Inc.
(Kyverna), a patient-centered, clinical-stage biopharmaceutical
company focused on developing cell therapies for patients suffering
from autoimmune diseases, announces today the publication in
Med1, of a report describing the first use of
KYV-101, a fully human anti-CD19 chimeric antigen receptor (CAR)
T-cell product candidate, in two patients suffering from
progressive multiple sclerosis (MS) as part of a named patient
program for critically ill patients after both patients failed to
respond to conventional therapies.
"We are very pleased about offering this potentially
paradigm-shifting treatment opportunity to patients that have
exhausted other medical recourses," said Christoph Heesen, M.D., professor for clinical
and rehabilitative MS research at the University Medical Center
Hamburg-Eppendorf in Hamburg,
Germany, and senior co-author. "Emerging findings indicating
that this approach may affect disease biology in the central
nervous system are promising, as preventing disease progression
remains one of the most difficult challenges in MS therapy."
"Exploring the safety profile of CAR T administration in this
population and hopefully establishing that it compares favorably to
hematopoietic stem cell transplant may bring the cell therapy
approach to a larger number of patients in need," said Nicolaus
Kröger, M.D., professor of Medicine and medical director,
Department of Stem Cell Transplantation at the University Medical
Center Hamburg-Eppendorf in Hamburg,
Germany, and senior co-author. "If safe administration can
be replicated in other patients and efficacy be formally
established in clinical trials, this may bring a relevant
therapeutic option to patients with MS."
"We are committed to transforming the standard of treatment for
patients living with multiple sclerosis," said Peter Maag, Ph.D., chief executive officer of
Kyverna. "The pioneering work done with KYV-101 by medical teams in
Hamburg and in our trials in the
U.S. helps build the data backbone needed to further advance our
knowledge and hopefully accelerate development of CAR T-cell
therapies in autoimmune diseases."
CAR T-cell therapy involves modifying a patient's T cells to
recognize and remove B cells in the patient's body. CD19 CAR T-cell
therapy specifically targets CD19, a protein expressed on the
surface of B cells, which are involved in various types of
autoimmune diseases.
About Multiple sclerosis (MS)
Multiple sclerosis is a chronic neurodegenerative autoimmune
disease affecting over 2.8 million individuals
worldwide2. 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
Medicine3.
KYV-101 is currently being evaluated in sponsored,
open-label, Phase 1/2 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 1/2 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.
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. Fischbach et al., Med (2024),
https://doi.org/10.1016/j.medj.2024.03.002
2.
Walton C, et al., Mult Scler. 2020; 26:1816-1821.
3. Brudno et al., Nature Medicine 2020; 26:270-280.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/first-in-disease-use-of-kyverna-therapeutics-kyv-101-in-patients-with-progressive-multiple-sclerosis-published-in-med-302103748.html
SOURCE Kyverna Therapeutics