KDMN Kadmon Holdings

Kadmon Presents New Preclinical Data on its Immuno-Oncology Fusion Protein at SITC Annual Meeting

Kadmon Presents New Preclinical Data on its Immuno-Oncology Fusion Protein at SITC Annual Meeting

NEW YORK, Nov. 06, 2018 (GLOBE NEWSWIRE) -- Kadmon Holdings, Inc. (NYSE: KDMN) today announced it will present preclinical data on KD033, its anti-PD-L1/IL-15 fusion protein in development for oncology indications, at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, taking place November 7-11, 2018, in Washington, D.C.

KD033 is a novel immunotherapy designed to stimulate an immune response directed to the tumor microenvironment. Recombinant IL-15 alone, which stimulates cancer-fighting immune effector cells, is not well tolerated when administered systemically. Kadmon has developed a novel approach to overcome this challenge by fusing IL-15 to an anti-PD-L1 antibody to direct IL-15 activity specifically to the tumor microenvironment, promoting efficacy and inducing durable responses while potentially increasing tolerability.

New data demonstrated that a single dose of KD033 inhibited tumor growth across multiple in vivo syngeneic tumor models and achieved dose-dependent efficacy in a resistant melanoma syngeneic mouse model. KD033 induced a strong immune memory response with a single treatment, resulting in mice that remained tumor-free following several tumor re-challenges. Furthermore, KD033 in combination with anti-PD1 therapy demonstrated synergistic activity, providing rationale for administering KD033 in combination with other immune checkpoint inhibitors.

“Although immunotherapy has been game-changing for the treatment of cancer, many tumors learn to evade current therapies, limiting efficacy and durability of response. New approaches are needed to address relapsed or refractory patients as well as non-responders,” said Harlan W. Waksal, M.D., President and CEO at Kadmon. “By directing a potent cancer-fighting response to the tumor site, KD033 has potential to safely overcome resistance and induce long-lasting responses for patients. We look forward to continuing our research on KD033 and initiating our first-in-patient studies in the second half of 2019.”

About Kadmon Holdings, Inc.

Kadmon Holdings, Inc. is a fully integrated biopharmaceutical company developing innovative product candidates 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2017 and 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 the date hereof. Investors and security holders are urged to read these documents free of charge on the SEC’s website at 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

EN
06/11/2018

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