NEW YORK, NY / ACCESSWIRE / December 3, 2019 / Kadmon Holdings, Inc. (NYSE:KDMN) today announced that longer-term follow-up results from KD025-208, its ongoing Phase 2 study of KD025 in chronic graft-versus-host disease (cGVHD), will be presented in an oral session at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, FL.
The updated KD025-208 data showed continued improvement, with the Overall Response Rate (ORR) increasing to 65% across the modified intent to treat (mITT) population. KD025 continues to be well tolerated and approximately one-quarter of patients remain on KD025 for longer than a year and a half.
Earlier this month, Kadmon announced that the primary endpoint was met in the planned interim analysis of ROCKstar (KD025-213), the fully enrolled pivotal trial of KD025 in cGVHD patients who had received at least two prior lines of systemic therapy. The study showed clinically and statistically significant ORRs of 64% and 67% across the two dose groups. Additional data from the ROCKstar study are expected in Q1 2020.
In addition, results from an analysis supported by Kadmon that modeled U.S. cGVHD prevalence, prescribing patterns and healthcare costs will be presented in a poster session at ASH.
Details of the presentations are as follows:
KD025-208 Oral Presentation
Title: KD025 for Patients with Chronic Graft-Versus-Host Disease (cGVHD) - Long-Term Follow-up of a Phase 2a Study (KD025-208)
Presenter: Madan Jagasia, MBBS, MS, MMHC, Vanderbilt University Medical Center, Nashville, TN
Session Title: 722. Clinical Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstruction: Mechanisms of and Therapies for cGVHD
Session Date and Time: Monday, December 9, 2019, 4:30 - 6:30 p.m. ET
Location: Orlando Orange County Convention Center, W230, Level 2
Abstract #: 872
cGVHD Epidemiology Poster
Title: Epidemiology and Real-World Treatment of Chronic Graft-Versus-Host Disease Post Allogeneic Hematopoietic Cell Transplantation: A U.S. Claims Analysis
Presenters: Carlos R. Bachier, MD, Sarah Cannon Center for Blood Cancer, Sarah Cannon Blood Cancer Network, Nashville, TN, and Marcello Rotta, MD, Colorado Blood Cancer Institute, Sarah Cannon Blood Cancer Network, Denver, CO
Session Title: 901. Health Services Research - Non-Malignant Conditions: Poster I
Session Date and Time: Saturday, December 7, 2019, 5:30 - 7:30 p.m. ET
Location: Orlando Orange County Convention Center, Hall B, Level 2
Abstract #: 2109
Kadmon is a biopharmaceutical company developing innovative products for significant unmet medical needs. Our product pipeline is focused on inflammatory and fibrotic diseases as well as immuno-oncology.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, without limitation, statements regarding the anticipated use of proceeds of the Offering and the closing of the Offering. 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 also 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 the Offering and 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; (xxiv) the uncertainties related to market conditions and the completion of the Offering on the anticipated terms or at all; and/or (xxv) 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 Kadmon'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, 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. Kadmon 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.