-- KD025 was well tolerated, with responses
observed across all affected organs --
Kadmon Holdings, Inc. (NYSE: KDMN) today announced additional
positive findings from an ongoing Phase 2 clinical trial
demonstrating that KD025, its Rho-associated coiled-coil kinase 2
(ROCK2) inhibitor, was well tolerated and resulted in clinically
meaningful responses in patients with chronic graft-versus-host
disease (cGVHD). The results are being presented today in a poster
at the 59th American Society of Hematology (ASH) Annual Meeting in
Atlanta (Poster #3256).
New data from Cohort 2 of the trial (KD025 200 mg BID; n=16)
showed an Overall Response Rate (ORR) of 63%, as of a data cutoff
date of November 20, 2017. Updated data from Cohort 1 (KD025 200 mg
QD; n=17) showed an ORR of 65%. While data from Cohort 2 continue
to mature, responses were durable in Cohort 1, lasting five months
or longer in 70% of patients. Responses were also rapid: 71% of
patients across Cohorts 1 and 2 achieved response by the first
assessment (after 8 weeks of treatment). Responses were observed
across all affected organs, including Complete Responses (CRs) in
upper and lower gastrointestinal (GI) tract, mouth, skin, joints,
esophagus, eyes and liver. In addition, 64% of patients from
Cohorts 1 and 2 were able to reduce steroid dose, and four patients
completely discontinued steroids. Eighty-three percent (83%) of
patients were able to reduce dose of tacrolimus, another
immunosuppressive agent used to treat cGVHD. KD025 was well
tolerated, with no drug-related serious adverse events (SAEs) in
either cohort.
“Treatment with KD025 has demonstrated clinical activity across
multiple organs affected by cGVHD, including CRs in
difficult-to-treat fibrotic manifestations such as those in eyes
and joints,” said Madan Jagasia, MD, MS, MMHC, Professor of
Medicine; Chief, Section of Hematology-SCT, Medical Director,
Division of Hematology-Oncology, Vanderbilt University Medical
Center; Co-Leader, Translational Research and Interventional
Oncology; Vanderbilt-Ingram Cancer Center; and study investigator.
“In addition, KD025 has been well tolerated, with no drug-related
SAEs, and does not appear to increase risk of infection, a common
consequence of immunosuppressants frequently used to treat
cGVHD.”
“The overall response and durability of response observed are
particularly compelling in this complex patient population, the
majority of which had cGVHD involvement in four or more organs,”
said Harlan W. Waksal, M.D., President and CEO at Kadmon. “We will
continue to observe response rate, durability and safety in this
ongoing clinical trial as well as in future planned studies of
KD025 in cGVHD.”
The ASH poster is now available on the Investors section of
Kadmon.com, under “Presentations & Events.” Additional data and
analysis from the KD025-208 study will be provided on Monday,
December 11, 2017, after market close (4:00 p.m. ET), via slides
that will be available on the Investors section of Kadmon.com.
About KD025-208
KD025-208 is an ongoing Phase 2 clinical trial of KD025 for the
treatment of cGVHD. The trial is being conducted in adults with
steroid-dependent or steroid-refractory cGVHD and active disease.
The dose-finding trial includes 48 patients divided into three
cohorts at different dose levels (KD025 200 mg QD, 200 mg BID and
400 mg QD), enrolled sequentially following a safety assessment of
each cohort. An expansion cohort of approximately 40 patients will
be enrolled after the optimal dose has been determined. In October
2017, KD025 received orphan drug designation from the U.S. Food and
Drug Administration for cGVHD.
About cGVHD
cGVHD is a common and often fatal complication following
hematopoietic stem cell transplantation, a procedure that is often
used to treat patients with cancers such as myeloma or leukemia.
With cGVHD, transplanted immune cells (graft) attack the patient’s
cells (host), leading to inflammation and fibrosis in multiple
tissues, including skin, mouth, eye, joints, liver, lung, esophagus
and GI tract.
About Kadmon Holdings, Inc.
Kadmon Holdings, Inc. is a fully integrated biopharmaceutical
company developing innovative products for significant unmet
medical needs. We have a product pipeline focused on autoimmune and
fibrotic diseases.
Forward-Looking Statements
This press release contains forward-looking statements. Such
statements may be preceded by the words “may,” “will,” “should,”
“expects,” “plans,” “anticipates,” “could,” “intends,” “targets,”
“projects,” “contemplates,” “believes,” “estimates,” “predicts,”
“potential” or “continue” or the negative of these terms or other
similar expressions. Forward-looking statements involve known and
unknown risks, uncertainties and other important factors that may
cause our actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements. We believe that these factors include, but are not
limited to, (i) the initiation, timing, progress and results of our
preclinical studies and clinical trials, and our research and
development programs; (ii) our ability to advance product
candidates into, and successfully complete, clinical trials; (iii)
our reliance on the success of our product candidates; (iv) the
timing or likelihood of regulatory filings and approvals; (v) our
ability to expand our sales and marketing capabilities; (vi) the
commercialization of our product candidates, if approved; (vii) the
pricing and reimbursement of our product candidates, if approved;
(viii) the implementation of our business model, strategic plans
for our business, product candidates and technology; (ix) the scope
of protection we are able to establish and maintain for
intellectual property rights covering our product candidates and
technology; (x) our ability to operate our business without
infringing the intellectual property rights and proprietary
technology of third parties; (xi) costs associated with defending
intellectual property infringement, product liability and other
claims; (xii) regulatory developments in the United States, Europe
and other jurisdictions; (xiii) estimates of our expenses, future
revenues, capital requirements and our needs for additional
financing; (xiv) the potential benefits of strategic collaboration
agreements and our ability to enter into strategic arrangements;
(xv) our ability to maintain and establish collaborations or obtain
additional grant funding; (xvi) the rate and degree of market
acceptance of our product candidates; (xvii) developments relating
to our competitors and our industry, including competing therapies;
(xviii) our ability to effectively manage our anticipated growth;
(xix) our ability to attract and retain qualified employees and key
personnel; (xx) our ability to achieve cost savings and other
benefits from our efforts to streamline our operations and to not
harm our business with such efforts; (xxi) the use of proceeds from
our recent public offerings; and/or (xxii) the potential benefits
of any of our product candidates being granted orphan drug
designation. More detailed information about Kadmon and the risk
factors that may affect the realization of forward-looking
statements is set forth in the Company's filings with the U.S.
Securities and Exchange Commission (“SEC”), including the Company's
Quarterly Report on Form 10-Q filed pursuant to Section 13 of the
Securities Exchange Act of 1934, as amended, with the SEC on August
3, 2017. Investors and security holders are urged to read these
documents free of charge on the SEC's web site at www.sec.gov. The
Company assumes no obligation to publicly update or revise its
forward-looking statements as a result of new information, future
events or otherwise.
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version on businesswire.com: http://www.businesswire.com/news/home/20171210005091/en/
Kadmon Holdings, Inc.Ellen Tremaine, 646-490-2989Investor
Relationsellen.tremaine@kadmon.com
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