First-In-Human Clinical Trial of Investigational Therapy for Multiple Advanced Solid Tumors Is Underway

Researchers plan to enroll 60 patients in the first-in-human phase 1 clinical trial to assess the safety and preliminary clinical activity of an anti-CD39 monoclonal antibody to treat advanced solid tumors.

Researchers have officially dosed the first patient in a phase 1 trial assessing ES002, an anti-CD39 monoclonal antibody under development for the treatment of advanced solid tumors.

The researchers intend to examine the safety, tolerability, pharmacokinetics (how the drug moves throughout the body), pharmacodynamics (how the drug works) and preliminary clinical activity of the treatment. Study completion is planned for December 2023.

“We are very pleased to see ES002 enter clinical trial testing in the United States,” said Steve Chin, chief medical officer of Elpiscience, in a news release.

The treatment has shown highly potent single-agent anti-tumor activity with notable reduction in tumor size and weight in prior in-vivo studies, but this trial is intended to be the first-in-human study of the drug.

This kind of monoclonal antibody is a type of immunotherapy that works by activating the immune system so that it helps to attack cancer cells. It functions by recognizing specific types of proteins on cells. ES002 is designed to promote anti-tumor immunity through blocking CD39 function, which is an enzyme that regulates production of a naturally occurring critical immune suppressor called adenosine.

Because it blocks CD39, ES002 also stabilizes pro-inflammatory extracellular ATP (a type of molecule) and restores anti-tumor immunity in the tumor microenvironment.

Elpiscience Biopharmaceuticals, Inc., the biopharmaceutical company developing the drug, received investigational new drug (IND) clearance from the Food and Drug Administration (FDA) in September 2021. This means that the FDA has given the go-ahead for a treatment to be assessed through clinical testing.

Researchers plan to treat 60 patients with advanced solid tumors. They have planned a dose escalation stage (part one) of 30 patients where they are supposed to be given the treatment via intravenous infusion once every 14 days, every 28 days as a treatment cycle for up to two years.

In a dose expansion stage (part two), three different groups of patients with pancreatic ductal adenocarcinoma, non-small cell lung cancer and colorectal adenocarcinoma are to be treated. The dosage for the second phase of the study will be determined by data from the first phase. During this second phase, patients are expected to receive the study drug at the same treatment cycle.

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