Early Clinical Data is in from Phase 1 Trials of Galectin-3 Inhibitor GR-MD-02 Immunotherapy

Early Clinical Data is in from Phase 1 Trials of Galectin-3 Inhibitor GR-MD-02 Immunotherapy

The Galectin-3 inhibitor, GR-MD-02, may be used to enhance the activity of immune checkpoint inhibitors in patients with solid tumors, according to preclinical and early clinical data from two Phase 1 trials.

The results were presented at the 9th GTCBio Immunotherapeutics & Immunomonitoring Conference, held Feb- 6-7 in San Diego.

“Preclinical results in mouse models of multiple types of cancers showed important anti-tumor and increased survival effects of combining GR-MD-02 with different types of immune modulators, providing a compelling case for progressing studies into human patients with cancer,” said William L. Redmond, PhD, in a press release. Redmond is an associate member, Laboratory of Cancer Immunotherapy, and director of the Immune Monitoring Laboratory, Earle A. Chiles Research Institute, Providence Cancer Center in  Portland, Ore.

“We are pleased that our translational medicine team is conducting two Phase 1 clinical trials which were initiated under the direction of principal investigator Brendan D. Curti, MD, director of the Providence Biotherapy Program at Providence Cancer Center,” Redmond said.

Galectin-3 often is produced by tumor cells to suppress the function of killer T-cells, to induce the formation of new blood vessels, and to promote the spread of cancer cells to distant organs (metastasis). Therefore, inhibiting Galectin-3 may be a promising approach in cancer treatment.

Galectin Therapeutics has been testing the Gelectin-3 inhibitor, GR-MD-02, in combination with immune checkpoint inhibitors. In an open-label, dose-escalation Phase 1 trial (NCT02575404), researchers are assessing GR-MD-02 in combination with Keytruda (pembrolizumab) in patients with advanced melanoma.

Among the first six patients enrolled in the lowest dose group, one achieved a complete response and another achieved a mixed response, without any safety concerns related to the drug. The study was expanded to include patients with oral/head and neck cancers (OHN) and non-small cell lung cancer (NSCLC).

In a second open-label Phase 1 trial (NCT02117362), the company is assessing the combination of GR-MD-02 with Yervoy (ipilimumab) in patients with advanced melanoma. The first seven patients enrolled in the study showed no safety signals related to the treatment, but because Keytruda was approved for metastatic melanoma, recruitment into this trial has slowed significantly.

“We are encouraged by these early safety results and look forward to further data on the safety and efficacy of GR-MD-02 used in combination with pembrolizumab in patients with metastatic melanoma, OHN, or NSCLC,” said Curti. “While we cannot conclude from the one partial response in the pembrolizumab study that the response was related to GR-MD-02, it provides us with a clinically relevant signal to follow as GR-MD-02 doses are escalated. We hope to report additional data in early 2018 when we anticipate a decision on progressing to Phase 2. This decision will be based on the response rate of the combination of pembrolizumab with GR-MD-02 as compared to historical response rates to pembrolizumab alone,” he said.

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