Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a
commercial-stage biotechnology company focused on the discovery,
development and commercialization of genetic medicines to treat
diseases with high unmet medical needs, announced today that it has
expanded its R&D pipeline to oncology and that the US Food and
Drug Administration (FDA) has accepted its Investigational New Drug
(IND) application of its lead oncology drug candidate KB707 for the
treatment of locally advanced or metastatic solid tumor
malignancies. The Company will host an investor conference call and
webcast, Thursday, July 27, 2023, at 8:00 am ET, to discuss the
KB707 program. To join the investor conference call, please see the
instructions below. The presentation for the investor conference
call is attached to the Company’s Form 8-K.
“The KB707 program leverages our learnings and clinical
experience in two tissue areas, the skin and the lung, and
underscores the broader potential of our HSV-1 platform to deliver
all types of exogenous genetic material and improve outcomes for
patients with debilitating diseases,” said Krish S. Krishnan,
Chairman and CEO of Krystal Biotech.
KB707 is a modified HSV-1 vector designed to deliver genes
encoding both human IL-12 and IL-2 to the tumor microenvironment
and promote systemic immune-mediated tumor clearance. Two
formulations of KB707 are in development, a solution formulation
for transcutaneous injection and an inhaled (nebulized) formulation
for lung delivery.
“We believe KB707 is a unique and highly differentiated drug
candidate with the potential to unlock the capabilities of
cytokine-based immunotherapy,” said Suma Krishnan, President of
Research & Development at Krystal Biotech. “By enabling
localized and sustained cytokine expression within a treated tumor,
KB707 has the potential to maximize therapeutic efficacy while
avoiding the tolerability challenges of systemic cytokine
treatments.”
The FDA has accepted the Company’s IND to evaluate intratumoral
KB707 in patients with solid tumors accessible by transcutaneous
injection, and the Company expects to initiate a Phase 1 study in
the second half of 2023. The Company is planning to file an
amendment to the KB707 IND in the second half of 2023 to evaluate
inhaled KB707 in a clinical trial in the first half of 2024.
Interleukin-2 (IL-2) and interleukin-12 (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 or clinical models 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 leverages the Company’s
modified HSV-1 vector – and its ability to efficiently deliver a
durable DNA payload without active replication and minimal
cytotoxicity – to drive local and sustained cytokine expression
within the tumor microenvironment and maximize the therapeutic
window and benefit of IL-2 and IL-12.
“There remains an urgent unmet need for new therapies in
cutaneous oncology, including for patients that do not respond to
current first-line options and for the many who eventually progress
on available therapy,” said Jason Luke, MD, Associate Professor of
Medicine in the Division of Hematology/Oncology and Director of the
Cancer Immunotherapeutic Center within UPMC Hillman Cancer Center
Immunology and Immunotherapy Program in Pittsburgh, PA. “As
the lead investigator on multiple practice changing immunotherapy
trials, I have seen first-hand the benefits that can be realized
through effective immune modulation and am excited about the
potential of Krystal's approach for localized, sustained cytokine
delivery.”
In preclinical studies, KB707 has been shown to efficiently
transduce mammalian cells in vitro leading to the secretion of
bioactive IL-2 and IL-12 and can drive localized, durable cytokine
expression in mouse skin after intradermal injection. Furthermore,
in stringent checkpoint inhibitor refractory ‘cold’ syngeneic mouse
models, HSV-1 vector based delivery of murine equivalent IL2 and
IL12 elicited robust antitumor responses and survival benefits,
including via intratumoral injection in single and dual flank
B16F10 melanoma models, as well as via intratracheal delivery in a
metastatic K7M2 osteosarcoma model, with evidence of protection
from tumor rechallenge in both models suggestive of prolonged
adaptive immunity.
The intratumoral KB707 Phase 1/Opal 1 study is an open-label,
multi-center, monotherapy, dose escalation and expansion study,
enrolling patients with locally advanced or metastatic solid
tumors, who relapsed or are refractory to standard of care, with at
least one measurable and injectable tumor accessible by
transcutaneous route. The primary objective of the study is to
evaluate safety and tolerability of KB707. Efficacy will also be
assessed by multiple measures including overall response rate,
progression free survival, and overall survival, and the immune
effects of KB707 monotherapy will be assessed in tumor tissue,
lymph nodes, and blood.
Investor Conference Call, Webcast and Presentation
Information
The Company will host an investor conference call and webcast,
Thursday, July 27, at 8:00 am ET, to discuss the KB707 program.
The conference call will include management’s
overview of the Company’s expanded pipeline and research and
development focus in oncology and discuss potential target
indications as well as a summary of preclinical data and clinical
development plans. External speakers will include Samuel Broder,
M.D., former Director of the National Cancer Institute where he
oversaw the development of numerous anti-cancer therapeutic agents,
and Jason Luke, M.D., F.A.C.P., Associate Professor of Medicine in
the Division of Hematology/Oncology and Director of the Cancer
Immunotherapeutic Center within UPMC Hillman Cancer Center
Immunology and Immunotherapy Program in Pittsburgh, PA.
To register and join the conference call, please go to:
https://www.netroadshow.com/events/login?show=6a3175e6&confId=53637
For those unable to listen to the live conference call, a replay
will be available on the Investor’s section of the Company’s
website at www.krystalbio.com.
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.
VYJUVEKTM is the Company’s first commercial product, the
first-ever redosable gene therapy, and the only 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 Twitter.
Forward Looking Statements Any statements in
this press release about future expectations, plans and prospects
for Krystal Biotech, Inc., including statements about the potential
of the Company’s proprietary HSV-1 platform, the Company’s beliefs
about the clinical utility of KB707 and its potential therapeutic
capabilities, the Company expectations regarding the timing of a
Phase 1 study of the transcutaneous injection formulation of KB707,
the Company’s plans to file an amendment to the KB707 IND in the
second half of 2023 to evaluate inhaled KB707 in a clinical trial
in the first half of 2024, 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, the sufficiency of cash resources and need for
additional financing 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 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 release.
DisclosuresDr. Jason Luke is a consultant for
Krystal Biotech, Inc.
CONTACTInvestors and
Media:
Meg Dodge
Krystal Biotech
mdodge@krystalbio.com
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