Kadmon Announces Trial-In-Progress Poster on KD033 at the 2021 American Association for Cancer Research Annual Meeting

Rhea-AI Summary

Kadmon Holdings, Inc. (NASDAQ:KDMN) has announced its presentation of a trial-in-progress poster on KD033-101 at the 2021 AACR Annual Meeting, scheduled for April 10-15, 2021. KD033 is being evaluated in a Phase 1 study targeting patients with metastatic or locally advanced solid tumors, with initial safety data expected in Q2 2021 and more comprehensive clinical results anticipated in Q4 2021. KD033 combines an anti-PD-L1 antibody with IL-15 to enhance immune response against tumors.

Positive

• KD033 is a novel immunotherapy that combines anti-PD-L1 with IL-15, potentially improving efficacy in treating solid tumors.
• Initial safety data from the KD033 trial is expected in Q2 2021, which could bolster investor confidence.
• Presentation of the trial at a major event like the AACR Annual Meeting may enhance visibility and credibility.

Negative

• Significant reliance on the success of KD033 could pose risks if clinical outcomes are unfavorable.
• Timeline uncertainties related to clinical trial results could affect investor sentiment.

NEW YORK, NY / ACCESSWIRE / March 25, 2021 / Kadmon Holdings, Inc. (NASDAQ:KDMN) today announced it will present a trial-in-progress poster on KD033-101, the Company's ongoing dose-escalation, dose-expansion trial of KD033 in patients with metastatic and locally advanced solid tumors, at the 2021 American Association for Cancer Research (AACR) Annual Meeting, taking place virtually April 10 - 15, 2021.

KD033 is currently being evaluated in an ongoing Phase 1 study in patients with metastatic or locally advanced solid tumors. Initial safety data from the trial are anticipated in Q2 2021. Additional clinical data from the trial are anticipated in Q4 2021.

Details of the AACR trial-in-progress poster are outlined below:

KD033-101 Poster Presentation

Title: A Phase 1 Multiple Ascending Dose Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 in Subjects With Metastatic or Locally Advanced Solid Tumors

Category: Session PO.CT08.01 - Phase I Clinical Trials in Progress

Date/Time: April 10, 2021, 8:30 AM - 11:59 p.m. ET

Abstract ID: CT227

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 was well tolerated in GLP toxicology studies at clinically relevant doses. KD033 process development and manufacturing was completed through a successful collaboration with Wuxi Biologics and exhibited desired manufacturability and stability criteria.

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) 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) our expected use for the proceeds from the offering of our convertible senior notes; (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) our ability to apply unused federal and state net operating loss carryforwards against future taxable income and/or (xv) 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. 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:
Ellen Cavaleri
Investor Relations
646.490.2989
ellen.cavaleri@kadmon.com

SOURCE: Kadmon Holdings, Inc.

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FAQ

What is the purpose of the KD033-101 clinical trial?

The KD033-101 trial is a Phase 1 study aimed at investigating the safety, pharmacokinetics, and preliminary efficacy of KD033 in patients with metastatic or locally advanced solid tumors.

When will Kadmon report initial safety data for KD033?

Initial safety data for KD033 from the clinical trial is expected to be reported in Q2 2021.

What is KD033's mechanism of action?

KD033 combines an anti-PD-L1 antibody with IL-15 to enhance immune response against tumors, potentially leading to durable therapeutic effects.

Where can I find more information about Kadmon's clinical trials?

Additional details about Kadmon's clinical trials, including KD033, can be found on their official website and in their SEC filings.

What dates will the AACR Annual Meeting take place?

The 2021 AACR Annual Meeting is scheduled to take place virtually from April 10 to April 15, 2021.