Kadmon Holdings, Inc. (NYSE: KDMN) today announced updated
efficacy and safety results from an ongoing Phase 2 clinical trial
evaluating KD025 in patients with steroid-dependent or refractory
chronic graft-versus-host disease (cGVHD). Results from the study
will be presented in an oral session on Saturday, June 16th, 2018
at the 23rd Congress of the European Hematology Association (EHA)
in Stockholm, Sweden. The presentation is now available on the
Kadmon website.
The updated study results include four additional months of
patient follow-up, through May 2, 2018. The Overall Response Rate
(ORR) continues to be 65% (11/17) in Cohort 1 (KD025 200 mg QD;
n=17) and 69% (11/16) in Cohort 2 (KD025 200 mg BID; n=16).
Responses have been durable, with 47% (8/17) of patients in Cohort
1 having sustained a response for at least 20 weeks, up from 41%
(7/17) in the last reported analysis. Initial durability data from
Cohort 2 demonstrated that 38% (6/16) of patients have sustained a
response for at least 20 weeks, which is comparable to durability
data observed in Cohort 1 at the same median treatment duration.
Durability data continue to mature across Cohorts 1 and 2.
Sixty-six percent (66%; 22/33) of all patients were able to reduce
doses of corticosteroids and 15% (5/33) have completely
discontinued steroid use. In addition, 55% (18/33) of patients
across Cohorts 1 and 2 saw a clinically meaningful improvement in
cGVHD symptoms, as measured by at least a 7-point decrease in the
Lee Symptom Scale score. KD025 continued to be well tolerated, with
no treatment-related serious adverse events and no apparent
increased risk of infection.
“KD025 continues to achieve robust and durable responses across
multiple organs affected by cGVHD, while simultaneously allowing
the majority of patients to taper doses of steroids,” said Amandeep
Salhotra, M.D., Assistant Professor, Hematology and Hematopoietic
Cell Transplantation, City of Hope, Duarte, CA, and study
investigator. “In addition, the favorable tolerability profile of
KD025 has allowed patients to continue on treatment and maintain
responses, highlighting its potential for long-term use as a
backbone of cGVHD therapy.”
Kadmon plans to initiate an open-label, pivotal study of KD025
in cGVHD in Q3 2018, based on FDA guidance received in a Type C
meeting. The planned pivotal study (KD025-213) will enroll adults
who have received at least two prior lines of systemic therapy for
cGVHD. Patients will be randomized to receive KD025 200 mg QD or
200 mg BID (63 patients per cohort), and either dose may be
considered by the FDA for the registrational dose. The primary
endpoint is ORR, supported by a key secondary endpoint of Duration
of Response.
“These study results continue to show accumulation of clinical
benefit and underscore the significant potential of KD025 in cGVHD,
particularly in patients with multiple organs involved,” said
Harlan W. Waksal, M.D., President and CEO at Kadmon. “We have a
clear regulatory path forward for KD025 and we look forward to
initiating our pivotal study in the third quarter of this
year.”
About KD025-208
KD025-208 is an ongoing Phase 2 clinical trial of KD025,
Kadmon’s Rho-associated coiled-coil kinase 2 (ROCK2) inhibitor, 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. In October 2017, KD025 received orphan
drug designation from the U.S. Food and Drug Administration for
cGVHD.
About cGVHD
cGVHD is a potentially life-threatening condition following
hematopoietic stem cell transplantation. 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. Our product pipeline is 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,”
“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; (xxii) the potential benefits of any
of our product candidates being granted orphan drug designation;
(xxiii) the future trading price of the shares of our common stock
and impact of securities analysts’ reports on these prices; and/or
(xxiv) other risks and uncertainties. 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 (the “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 May 8, 2018. Investors and security
holders are urged to read these documents free of charge on the
SEC’s website 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180615005079/en/
Kadmon Holdings, Inc.Ellen Tremaine, Investor Relations,
646-490-2989ellen.tremaine@kadmon.com
Kadmon (NYSE:KDMN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Kadmon (NYSE:KDMN)
Historical Stock Chart
From Apr 2023 to Apr 2024