Following the previously announced oral presentation of 12-month data from ROCKstar (KD025-213), the ongoing pivotal trial of belumosudil (KD025) for the treatment of chronic graft-versus-host disease (cGVHD),
The live webcast of the event will be accessible from the Investors page of Kadmon's website, investors.kadmon.com. Details of the ASH oral presentation and related key opinion leader event are as follows:
ROCKstar (KD025-213) Oral Presentation
Title: Belumosudil for Chronic Graft-Versus-Host Disease (cGVHD) after 2 or More
Session: 722. Clinical Allogeneic Transplantation: Acute and Chronic GVHD, Immune
Date & Time:
Abstract #: 353
The accepted abstract is now available online at www.hematology.org. The oral presentation will include updated data not available in the abstract.
Key Opinion Leader Event Details
The key opinion leader event will take place on
Title: Kadmon Key Opinion Leader Event
Date & Time:
Webcast Link: https://openexc.zoom.us/webinar/register/WN_NbmeCyjmQ1iQVOvy0FlGaA
Webinar ID: 980 1644 8979
Individuals may participate in an interactive Q&A session by submitting questions via the webcast platform. The live webcast may also be accessed through the Events & Presentations page in the Investors section of the Company's website at investors.kadmon.com. An archived version of the webcast will be available in the News & Events section of the Investors page of Kadmon's website for 60 days following the event.
ROCKstar (KD025-213) is an ongoing open-label trial of belumosudil in patients with cGVHD who have received at least two prior lines of systemic therapy. Patients were randomized to receive belumosudil 200 mg once daily or 200 mg twice daily, enrolling 66 patients per arm. The primary endpoint of the study is Overall Response Rate (ORR). The ORR endpoint was met at the interim analysis, conducted two months after completion of enrollment. At the study's primary analysis, conducted six months after completion of enrollment, belumosudil achieved ORRs of 73% and 74% in the respective arms. Belumosudil has been well tolerated and adverse events have been consistent with those expected in the patient population.
Belumosudil (KD025) is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response and pro-fibrotic processes. Kadmon has submitted a New Drug Application (NDA) to the
cGVHD is a common and often fatal complication following hematopoietic stem cell transplantation. In 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 gastrointestinal tract. Approximately 14,000 patients in
Kadmon is a clinical-stage biopharmaceutical company that discovers, develops and delivers transformative therapies for unmet medical needs. Our clinical pipeline includes treatments for immune and fibrotic diseases as well as immuno-oncology therapies.
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) the impact of the COVID-19 pandemic on our business, workforce, patients, collaborators and suppliers, including delays in anticipated timelines and milestones of our clinical trials and on various government agencies who we interact with and/or are governed by; (iv) our reliance on the success of our product candidates; (iv) the timing or likelihood of regulatory filings and approvals, including the acceptance of our NDA for belumosudil, especially in light of the COVID-19 pandemic; (v) our ability to expand our sales and marketing capabilities; (vi) our ability to expand our sales and marketing capabilities; (vii) the commercialization, 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