Kadmon to Present Initial Safety Data from Phase 1 Study of KD033 at the 2021 American Society of Clinical Oncology Annual Meeting
Kadmon Holdings announced initial safety data from its Phase 1 clinical trial for KD033, an anti-PD-L1/IL-15 fusion protein targeting metastatic or locally advanced solid tumors. The results indicate that KD033 was well tolerated in all lower-dose cohorts, allowing for dose escalation. No dose-limiting toxicities were reported among nine patients treated with doses up to 50 µg/kg. Additional data from the trial will be presented at the 2021 ASCO Annual Meeting on June 4, with more results expected in Q4 2021.
- KD033 demonstrated good tolerability with no dose-limiting toxicities reported.
- Ongoing dose escalation allows assessment of KD033's potential.
- Initial safety data support advancement into higher dose cohorts.
- None.
- Results Demonstrate KD033 was Well Tolerated in All Patients through Initial Dose Cohorts, Allowing for Continuation of Dose Escalation -
NEW YORK, NY / ACCESSWIRE / May 19, 2021 / Kadmon Holdings, Inc. (NASDAQ:KDMN) today announced initial safety data from the ongoing Phase 1 clinical trial of KD033, its anti-PD-L1/IL-15 fusion protein, in patients with metastatic or locally advanced solid tumors. The data will be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 4 - 8, 2021.
"We are pleased to share initial safety data demonstrating that KD033 has been well tolerated in lower-dose cohorts of patients with metastatic or locally advanced solid tumors," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "We are excited to advance into higher dose cohorts and assess the potential of KD033 to stimulate cancer-fighting cells via IL-15, a promising new immuno-oncology approach."
The KD033 data to be presented at ASCO includes initial safety results from the Phase 1 dose escalation portion of the KD033-101 clinical trial. Key highlights from the presentation include:
- Nine patients from the first three cohorts of the trial have been treated with KD033 doses up to 50 µg/kg as of April 21, 2021, with the longest exposure being 30 weeks
- KD033 has been well tolerated, with no dose-limiting toxicities reported
- Dose escalation continues
Additional clinical data from the KD033-101 trial will be available in Q4 2021.
KD033 is an antibody-cytokine fusion protein harnessing the immunostimulatory activity of IL-15. The IL-15 cytokine expands key tumor-fighting immune cells, including natural killer (NK), NKT and memory CD8 cells, to induce long-lasting responses. Importantly, IL-15 does not expand immunosuppressive Treg CD4 cells, allowing for a robust and durable anti-tumor response. With KD033, Kadmon has fused IL-15 to a PD-L1 antibody to direct IL-15 activity to the tumor microenvironment, promoting efficacy and inducing durable responses while potentially increasing tolerability.
The abstract is now available on the ASCO website at meetinglibrary.asco.org. A copy of the poster presentation will be available on June 4th on the Publications and Posters page of Kadmon's website. Details of the ASCO presentation are below:
Poster: Phase I dose escalation of KD033, a PDL1-IL15 bispecific molecule, in advanced solid tumors
Track: Developmental Therapeutics - Immunotherapy
Date & Time: Poster will be available beginning June 4th, 2021 at 9:00 a.m. E.T.
Abstract Number: 2568
About the KD033-101 Clinical Trial
KD033-101 is a Phase 1, open-label, dose-escalation and dose-expansion study investigating the safety and efficacy of KD033 in patients with metastatic or locally advanced solid tumors. The dose-escalation phase of the study will evaluate the pharmacokinetics and pharmacodynamics and identify the maximum tolerated dose (MTD) of KD033. The dose-expansion phase of the study will enroll patients who have progressed or are refractory to programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor therapy to assess safety, efficacy and determine the recommended Phase 2 dose (RP2D) of KD033.
About KD033
KD033 is a novel immunotherapy developed in-house and is fully owned by Kadmon. KD033 combines an anti-PD-L1 antibody with IL-15, a cytokine that expands key tumor-fighting cell types, including natural killer (NK), natural killer T (NKT) and memory T cells, to potentially induce durable responses and inhibit tumor growth. The anti-PD-L1 antibody directs IL-15 activity to the tumor microenvironment, limiting systemic exposure of IL-15 to potentially increase safety and tolerability.
KD033 is the most advanced candidate from Kadmon's IL-15 fusion protein platform. The Company is developing a portfolio of therapies combining IL-15 with select antibodies for the treatment of cancer.
About Kadmon
Kadmon is a clinical-stage biopharmaceutical company that discovers, develops and delivers transformative therapies for unmet medical needs. Kadmon's 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. Among those risks and uncertainties are risks related to market conditions, including market interest rates, and the trading price and volatility of Kadmon's common stock. 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; (v) the timing or likelihood of regulatory filings and approvals, especially in light of the COVID-19 pandemic; (vi) the commercialization, pricing and reimbursement of our product candidates, if approved; (vii) the implementation of our business model, strategic plans for our business, product candidates and technology; (viii) the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; (ix) our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; (x) costs associated with defending intellectual property infringement, product liability and other claims; (xi) regulatory developments in the United States, Europe, and other jurisdictions; (xii) estimates of our expenses, future revenues, capital requirements and our needs for additional financing; (xiii) the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; (xiv) our ability to maintain and establish collaborations; (xv) the rate and degree of market acceptance of our product candidates, if approved; (xvi) developments relating to our competitors and our industry, including competing therapies; (xvii) our ability to effectively manage our anticipated growth; (xviii) our ability to attract and retain qualified employees and key personnel; (xix) our expected use of cash and cash equivalents and other sources of liquidity; (xx) our expected use for the proceeds from the offering of our convertible senior notes; (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, 2020 and Quarterly Report on Form 10-Q for the fiscal year ended March 31, 2021. 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
ellen.cavaleri@kadmon.com
SOURCE: Kadmon Holdings, Inc.
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