- Results Demonstrate KD033 was Well Tolerated in All Patients through Initial Dose Cohorts, Allowing for Continuation of Dose Escalation -
"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
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
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
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.
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.
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
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