Extending Company's leadership position in
autoimmune CAR T with prioritized indication strategy; pivoting to
late-stage development and commercialization
First-to-market opportunity with KYV-101 in
stiff person syndrome; 40% enrolled in pivotal Phase 2 trial with
first BLA filing targeted for 2026; fast-follow indications in
myasthenia gravis and lupus nephritis
Efficiently expanding into broader autoimmune
indications and increasing patient reach with KYV-102 using whole
blood rapid manufacturing
Cash runway into 2027 to deliver key
milestones
EMERYVILLE, Calif., Jan. 13,
2025 /PRNewswire/ -- Kyverna Therapeutics, Inc.
(Kyverna, NASDAQ: KYTX), a clinical-stage biopharmaceutical company
focused on developing cell therapies for patients with autoimmune
diseases, announced it will present its 2025 strategic priorities
and key milestones during a presentation that will be made by Chief
Executive Officer, Warner Biddle, at the 43rd
Annual J.P. Morgan Healthcare Conference today, Monday, January 13, 2025.
"2025 will be a transformational year for Kyverna as we
accelerate our next wave of growth and pivot to late-stage
development and commercialization with our differentiated CD19 CAR
T construct, KYV-101," said Warner
Biddle, Chief Executive Officer, Kyverna. "Building upon our
leadership position, we have sharpened our focus and execution on a
prioritized set of opportunities – stiff person syndrome,
myasthenia gravis and lupus nephritis – each with a clear and rapid
path to market, where we can deliver a profound patient impact.
Importantly, these indications serve as a beachhead to other
neuroinflammatory and rheumatologic diseases, which we will
continue to pursue in a capital-efficient manner alongside
next-generation innovations, starting with KYV-102, designed to
broaden access to CAR T."
Mr. Biddle added, "We are pleased with our clinical progress to
date, having 40% of patients enrolled in KYSA-8, our pivotal
KYV-101 Phase 2 trial in stiff person syndrome, which enables us to
target a BLA filing in 2026 and puts us on track to deliver the
first approved CAR T therapy in an autoimmune disease. Our
fast-follow indication, myasthenia gravis, has already enrolled
patients in a company-sponsored trial, KYSA-6, and we expect to
report interim Phase 2 data in the second half of 2025."
Strategic priorities for the upcoming year
include:
- Focused execution on company-sponsored KYSA studies
evaluating KYV-101 in priority indications that offer a clear and
rapid path to market. This includes advancing ongoing clinical
studies in stiff person syndrome (KYSA-8), myasthenia gravis
(KYSA-6), and lupus nephritis (KYSA-1 and KYSA-3).
- Continue regulatory interactions leveraging the U.S.
Food and Drug Administration's Regenerative Medicine Advanced
Therapy and Orphan Drug designations for stiff person syndrome and
myasthenia gravis.
- Evaluate additional opportunities in a capital-efficient
manner, harnessing investigator-initiated trials (IITs) and
other KYSA studies – including multiple sclerosis, systemic
sclerosis, and others – to inform the next priority indications for
the Company to advance into late-stage development.
- Advance next-generation innovations, including KYV-102,
incorporating the Company's whole-blood rapid manufacturing
approach, which aims to improve the CAR T patient experience,
eliminate apheresis and ultimately broaden CAR T access.
Anticipated Milestones:
Based on these strategic priorities, Kyverna has issued the
following guidance on upcoming program milestones:
- Stiff Person Syndrome:
- Complete pivotal Phase 2 enrollment mid-2025
- Report topline pivotal Phase 2 data 1H 2026
- BLA filing in 2026
- Myasthenia Gravis:
- Confirm registrational path with regulators 1H 2025
- Report interim Phase 2 data 2H 2025
- Lupus Nephritis:
- Report Phase 1 data 2H 2025
- Future pipeline:
- File KYV-102 investigational new drug application 2H 2025
The Company has a cash runway into 2027 to deliver on these key
inflection points, with $321.6
million of cash, cash equivalents, and marketable securities
as of September 30, 2024.
Presentation at the J.P. Morgan Healthcare
Conference
Warner Biddle will
present a company overview at the 43rd Annual J.P.
Morgan Healthcare Conference today, January
13, 2025, at 5:15 PM PT.
A live webcast of the presentation will be available on the
Investors section of Kyverna's website, www.kyvernatx.com. A
replay of the webcast will be available on Kyverna's website for
approximately 30 days following the conference.
About KYV-101
Uniquely designed, KYV-101 is an
autologous, fully human CD19 CAR T-cell product candidate with
highly potent CD28 co-stimulation and designed for tolerability,
which is under investigation for B-cell-driven autoimmune diseases.
With KYV-101, Kyverna is pioneering a durable
disease-clearing approach aiming for deep B cell depletion, an
immune system reset, and long-term remission in autoimmune
diseases.
It is currently being evaluated in company sponsored,
open-label, Phase 2 trials in stiff person syndrome and myasthenia
gravis and Phase 1/2 trials for lupus nephritis, as well as in
investigator-initiated trials and company-sponsored trials for
multiple indications. The clinical experience to date with KYV-101
highlights the potential for transformative clinical outcomes in
autoimmune patients.
About KYV-102
KYV-102 leverages
the same fully human, clinically validated CD19 CAR-T
construct as KYV-101. It incorporates the Ingenui-T
platform, a proprietary, next-generation process that utilizes
whole blood with a rapid manufacturing approach.
Kyverna intends to broaden CAR T patient access with KYV-102 by
eliminating the need for apheresis starting material and reducing
the manufacturing turnaround time from conventionally manufactured
CAR T products.
About Kyverna Therapeutics
Kyverna Therapeutics, Inc.
(Nasdaq: KYTX) is a clinical-stage biopharmaceutical company
focused on liberating patients through the curative potential of
cell therapy. Kyverna's lead CAR T-cell therapy candidate,
KYV-101, is advancing through clinical development with Phase 2
trials for stiff person syndrome and myasthenia gravis, and two
ongoing multi-center Phase 1/2 trials for patients with lupus
nephritis. The Company is also harnessing
investigator-initiated trials and other KYSA studies, including in
multiple sclerosis and systemic sclerosis, to inform the next
priority indications for the Company to advance into late-stage
development. Its 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. For more information, please
visit https://kyvernatx.com.
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:
Kyverna's strategic priorities and focus; the status of its Phase 2
trial in stiff person syndrome as a pivotal trial; the potential
for KYV-101 to be the first-to-market in stiff person syndrome or
the first approved CAR T therapy in autoimmune; the potential for
KYV-102 to shorten the manufacturing process and increase patient
reach and CAR T access; anticipated milestones and timing thereof,
including anticipated timing for the first intended BLA submission
for KYV-101 and timing for reporting data as well as expected
completion of enrollments; Kyverna's anticipated cash runway; and
Kyverna's clinical trials, investigator initiated trials and
named-patient activities. 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, the possibility that the FDA or other regulatory
agencies may conclude that Kyverna's Phase 2 trial in stiff person
syndrome is not sufficient to be registration-enabling and may
require additional trials or studies to support its intended BLA
submission; 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.
Contact:
Investors: InvestorRelations@kyvernatx.com
Media: media@kyvernatx.com
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SOURCE Kyverna Therapeutics