On May 19, 2021 Kadmon Holdings, Inc. (NASDAQ:KDMN) reported 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 (Press release, Kadmon, MAY 19, 2021, View Source [SID1234580371]). The data will be presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 4 – 8, 2021.

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"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 (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper) 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.