Krystal Biotech Announces First Patient Dosed in Phase 1 Clinical Trial of Inhaled KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors of the Lung
22 April 2024 - 1:00PM
Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a
commercial-stage biotechnology company, announced today that the
first patient was dosed in its Phase 1 clinical trial (KYANITE-1)
evaluating inhaled KB707, a modified HSV-1 vector designed to
deliver genes encoding both human interleukin-12 (IL-12) and
interleukin-2 (IL-2) to the lung, for the treatment of patients
with locally advanced or metastatic solid tumors of the lung.
“Cytokine therapy holds significant potential for the treatment
of solid tumors but its utility has been limited by a lack of safe
and effective delivery options,” said David Chien, M.D., Senior
Vice President of Clinical Development at Krystal Biotech.
“Cytokine delivery via inhalation is a first-of-its-kind
therapeutic approach made possible by the unique attributes of
Krystal’s HSV-1-based vector platform. Together with intratumoral
KB707, inhaled KB707 has the potential to significantly expand the
clinical utility of cytokine therapy to treat a wide range of
otherwise difficult-to-treat and standard of care refractory solid
tumors. Dosing the first patient in KYANITE-1 is an exciting step
toward our goal of delivering a new class of cancer
immunotherapies.”
The KYANITE-1 clinical trial is an open-label, multicenter, dose
escalation and expansion study to evaluate inhaled KB707
monotherapy in patients with advanced solid tumor malignancies
affecting the lungs. Details of the KYANITE-1 study can be found
at www.clinicaltrials.gov under NCT identifier:
NCT06228326.
“Dosing the first patient in our inhaled KB707 trial is another
important milestone for our oncology program and for Krystal,” said
Suma Krishnan, President, Research & Development, Krystal
Biotech. “KYANITE-1 is our second active clinical trial evaluating
KB707 and along with KB407 and KB408, our inhaled genetic medicine
candidates for the treatment of cystic fibrosis and alpha-1
antitrypsin deficiency, respectively, KB707 is our third clinical
stage drug candidate delivered via inhalation. With a deep pipeline
of active clinical trials, we are looking forward to data readouts
starting later in 2024, which we expect will showcase the breadth
and potential of our proprietary, HSV-1 based gene delivery
platform.”
In February 2024, the U.S. Food and Drug
Administration (FDA) granted Fast Track Designation for
inhaled KB707 for the treatment of patients with solid tumors with
pulmonary metastases that are relapsed or refractory to standard of
care therapy. This is the second Fast Track Designation for the
KB707 program. In July 2023, the FDA granted intratumoral KB707
Fast Track Designation for the treatment of anti-PD-1
relapsed/refractory locally advanced or metastatic melanoma.
About Fast Track Designation Fast Track
Designation is designed to facilitate the development and expedite
the review of drugs to treat serious conditions and treat a serious
or unmet medical need, enabling drugs to reach patients sooner.
Clinical programs with Fast Track Designation may benefit from
early and frequent communication with the FDA throughout the
regulatory review process, and such clinical programs may be
eligible to apply for Accelerated Approval and Priority Review if
relevant criteria are met.
About IL-2, IL-12, and KB707IL-2 and IL-12 are
secreted cytokines with complementary functions promoting
cell-mediated immunity in humans. Both IL-2 and IL-12 have been
shown to elicit anti-tumor immune responses in preclinical models
and in clinical settings and have been extensively studied for
their potential in cancer immunotherapy. Despite promising signs of
efficacy, it has proven difficult to effectively harness IL-2 and
IL-12 for therapeutic benefit, as systemic administration is often
poorly tolerated, and their inherently short half-lives necessitate
high dose levels and extremely frequent dose intervals. KB707 is a
modified HSV-1 vector designed to deliver genes encoding both human
IL-12 and IL-2 directly to a patient’s tumor(s) and promote
systemic immune-mediated tumor clearance. KB707 targets solid
tumors that are accessible via intratumoral injection or
inhalation.
About Krystal Biotech, Inc.Krystal Biotech,
Inc. (NASDAQ: KRYS) is a commercial-stage biotechnology company
focused on the discovery, development and commercialization of
genetic medicines to treat diseases with high unmet medical needs.
VYJUVEK® is the Company’s first commercial product, the first-ever
redosable gene therapy, and the first medicine approved by the FDA
for the treatment of dystrophic epidermolysis bullosa. The Company
is rapidly advancing a robust preclinical and clinical pipeline of
investigational genetic medicines in respiratory, oncology,
dermatology, ophthalmology, and aesthetics. Krystal Biotech is
headquartered in Pittsburgh, Pennsylvania. For more information,
please visit http://www.krystalbio.com, and follow @KrystalBiotech
on LinkedIn and X (formerly Twitter).
Forward-Looking StatementsAny statements in
this press release about future expectations, plans and prospects
for Krystal Biotech, Inc., including statements about the
clinical utility of KB707 and its potential therapeutic
capabilities, the Company’s expectations regarding the timing and
results of data readouts from the Company’s clinical trials, the
Company’s beliefs about its proprietary, HSV-1 based gene delivery
platform, and other statements containing the words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “target,” “potential,” “likely,” “will,”
“would,” “could,” “should,” “continue,” and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including:
uncertainties associated with regulatory review of clinical trials
and applications for marketing approvals, the availability or
commercial potential of product candidates, including KB707, and
such other important factors as are set forth under the caption
“Risk Factors” in the Company’s annual and quarterly reports on
file with the U.S. Securities and Exchange Commission. In
addition, the forward-looking statements included in this press
release represent the Company’s views as of the date of this press
release. The Company anticipates that subsequent events and
developments will cause its views to change. However, while the
Company may elect to update these forward-looking statements at
some point in the future, it specifically disclaims any obligation
to do so. These forward-looking statements should not be relied
upon as representing the Company’s views as of any date subsequent
to the date of this press release.
CONTACTInvestors and
Media:Stéphane Paquette, PhDKrystal
Biotechspaquette@krystalbio.com
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