Kadmon Announces Acceptance of Late-Breaking Abstract of KD025 for cGVHD at the 2020 TCT Meetings
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Kadmon Announces Acceptance of Late-Breaking Abstract of KD025 for cGVHD at the 2020 TCT Meetings

Friday, January 10, 2020 4:15 PM
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NEW YORK, NY / ACCESSWIRE / January 10, 2020 / Kadmon Holdings, Inc. (NYSE:KDMN) today announced that expanded data from the interim analysis of ROCKstar (KD025-213), its ongoing pivotal trial of KD025 in chronic graft-versus-host disease (cGVHD), will be presented in a late-breaking oral presentation at the 2020 Transplantation & Cellular Therapy (TCT) Meetings to be held February 19-23, 2020 in Orlando, FL. The expanded dataset will include response rates across key subgroups and initial safety data for ROCKstar, which is evaluating KD025 in cGVHD in patients who had received at least two prior lines of systemic therapy.

In November 2019, Kadmon announced that KD025 met the primary endpoint at the planned interim analysis of ROCKstar, which was conducted as scheduled two months after completion of enrollment. At the interim analysis, KD025 showed clinically and statistically significant Overall Response Rates (ORRs) of 64% with KD025 200 mg once daily and 67% with KD025 200 mg twice daily.

At TCT 2020, Kadmon will also present long-term follow-up data from KD025-208, its ongoing Phase 2 study of KD025 in chronic graft-versus-host disease (cGVHD). These data were recently presented at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition in December 2019.

The abstracts are expected to be made available online via the TCT website in the coming weeks. Details of the presentations are as follows:

KD025-213 Oral Presentation

Title: Interim Analysis of KD025-213: A Phase 2, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects with Chronic Graft Versus Host Disease (cGVHD) after at Least 2 Prior Lines of Systemic Therapy (The ROCKstar Study; NCT03640481)
Presenter: Corey Cutler, MD, MPH, FRCPC, Dana-Farber Cancer Institute
Session Title: Late Breaking Abstracts
Session Date and Time: Sunday, February 23, 2020, 12:00 p.m. ET
Location: Marriott World Center, Orlando, FL
Abstract ID: LBA2

KD025-208 Poster Presentation

Title: KD025 for Patients with Chronic Graft-Versus-Host Disease (cGVHD) - Long-Term Follow-up of a Phase 2a Study (KD025-208)
Presenter: Daniel Weisdorf, MD, Clinical and Translational Science Institute, University of Minnesota
Session Title: Graft-Versus-Host and Graft-Versus-Tumor - Clinical: Prevention, Treatment and Biomarkers
Session Date and Time: Wednesday, February 19, 2020, 6:30 - 8:00 p.m. ET
Location: Marriott World Center, Orlando, FL
Abstract ID: #15205

About Kadmon

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) 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, Japan 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and subsequent Quarterly Reports on Form 10-Q. 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.

Contact Information

Ellen Cavaleri, Investor Relations
646.490.2989
[email protected]

SOURCE; Kadmon Holdings, Inc.

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