NEW YORK, NY / ACCESSWIRE / November 24, 2020 / Kadmon Holdings, Inc. (NASDAQ:KDMN) today announced that the Company will host a virtual key opinion leader event on Sunday, December 6, 2020 at 11:15 a.m. PT (2:15 p.m. ET) at the 62nd American Society of Hematology (ASH) Annual Meeting.
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), Corey Cutler, MD, MPH, FRCPC, Dana-Farber Cancer Institute, will contextualize the data across the Company's recent New Drug Application (NDA) filing and discuss how belumosudil may fit into the cGVHD treatment landscape, if approved.
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 Prior Lines of Therapy: The ROCKstar Study (KD025-213)
Presenter: Corey Cutler, MD, MPH, FRCPC, Dana-Farber Cancer Institute
Session: 722. Clinical Allogeneic Transplantation: Acute and Chronic GVHD, Immune
Date & Time: Sunday, December 6, 2020, 9:30 a.m. - 11:00 a.m. PT (12:30 p.m. - 2:00 p.m. ET)
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 Sunday, December 6, 2020 at 2:15 p.m. ET and will feature the presenting author of the ASH presentation, Corey Cutler, MD, MPH, FRCPC, Dana-Farber Cancer Institute. The live webcast event may be accessed through the following link:
Title: Kadmon Key Opinion Leader Event
Speaker: Corey Cutler, MD, MPH, FRCPC, Dana-Farber Cancer Institute
Date & Time: Sunday, December 6, 2020, 11:15 a.m. - 12:00 p.m. PT (2:15 p.m. - 3:00 p.m. ET)
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 An archived version of the webcast will be available in the News & Events section of the Investors page of Kadmon's website for 60 days following the event.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 U.S. Food and Drug Administration (FDA) for belumosudil for the treatment of patients with cGVHD and the NDA is being reviewed under the FDA's Real-Time Oncology Review (RTOR) pilot program. The FDA has granted Breakthrough Therapy Designation to belumosudil for the treatment of patients with cGVHD after failure of two or more lines of systemic therapy. The FDA has also granted Orphan Drug Designation to belumosudil for the treatment of cGVHD.
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 the United States are currently living with cGVHD.
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 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; (xvi) the rate and degree of market acceptance of our product candidates, if approved; (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 expected use of cash and cash equivalents and other sources of liquidity; (xxi) the potential benefits of any of our product candidates being granted orphan drug designation; (xxii) the future trading price of the shares of our common stock and impact of securities analysts' reports on these prices; (xxiii) our ability to apply unused federal and state net operating loss carryforwards against future taxable income and/or (xxiv) other risks and uncertainties. More detailed information about the Company 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 Kadmon's Annual Report on Form 10-K for the fiscal year ended December 31, 2019. 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.
Ellen Cavaleri, Investor Relations
SOURCE: Kadmon Holdings, Inc.
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