Kadmon Holdings, Inc. (NYSE: KDMN) today announced updated
positive results from an ongoing Phase 2 clinical trial (KD025-208)
evaluating KD025, its Rho-associated coiled-coil kinase 2 (ROCK2)
inhibitor, in patients with chronic graft-versus-host disease
(cGVHD). The results are being presented today in an oral
presentation at the BMT Tandem Meetings in Salt Lake City.
“KD025 continues to demonstrate a therapeutic benefit in cGVHD,
including in the most severe manifestations of the disease
characterized by end-organ fibrosis,” said Aleksandr Lazaryan,
M.D., MPH, Ph.D., Assistant Professor of Medicine, Division of
Hematology, Oncology and Transplantation, University of Minnesota
and study investigator. “KD025 was also well tolerated, and many
patients have been able to reduce or discontinue steroids and other
immunosuppressants, thereby helping to avoid their adverse effects
and improve patients’ quality of life.”
Updated data from Cohort 2 of the trial (KD025 200 mg BID; n=16)
showed an Overall Response Rate (ORR) of 69%, as of a data cutoff
date of January 3, 2018. Responses in Cohort 1 (KD025 200 mg QD;
n=17) remained the same, showing an ORR of 65%. Responses were
rapid, with approximately 70% of patients across Cohorts 1 and 2
achieving responses by the first assessment (after 8 weeks of
treatment). Responses were observed across all affected organs,
including in organs with fibrotic manifestations of the disease
such as lungs, eyes, skin and joints. In responders with 4 or more
organs involved, 6/13 (46%) showed responses in 4 or more organs.
In addition, 64% of patients were able to reduce steroid dose, and
four patients completely discontinued steroid use. Eighty-three
percent (83%) of patients were able to reduce the 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.
“These updated results in cGVHD and recent results in idiopathic
pulmonary fibrosis further demonstrate the activity and
tolerability of KD025 in inflammatory and fibrotic disease
settings,” said Harlan W. Waksal, M.D., President and CEO at
Kadmon. “We look forward to continuing our study of KD025 in cGVHD
and the potential opportunity to offer patients a new therapy for
this disease.”
Details of the presentation are as follows:
Date: Thursday, Feb. 22, 2018 Time: 4:45 – 6:15 p.m. MT Session:
Oral Abstracts - Session E: GVH / GVL Abstract Title: Initial
Results of KD025-208: A Phase 2a Open-Label Clinical Trial of KD025
for Steroid-Dependent Chronic Graft Versus Host Disease (cGVHD)
Location: Salt Palace Convention Center, Hall C
The BMT Tandem Meetings are the combined annual meetings of the
Center for International Blood & Marrow Transplant Research
(CIBMTR) and the American Society for Blood and Marrow
Transplantation (ASBMT).
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. We expect to enroll an expansion cohort of
approximately 40 patients 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 inflammatory
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,”
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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, if any, 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; and/or (xx) our ability to
achieve cost savings and benefits from our efforts to streamline
our operations and to not harm our business with such efforts. 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 November 9, 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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Kadmon Holdings, Inc.Ellen Tremaine, 646-490-2989Investor
Relationsellen.tremaine@kadmon.com
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