On March 25, 2021 Kadmon Holdings, Inc. (NASDAQ:KDMN) reported 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) (Free AACR Whitepaper) Annual Meeting, taking place virtually April 10 – 15, 2021 (Press release, Kadmon, MAR 25, 2021, View Source [SID1234577165]).
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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 (Free AACR Whitepaper) 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.