Genexine and its U.S. subsidiary NeoImmuneTech said Wednesday they have signed an agreement with Roche to start the research for a combination treatment using HyLeukin-7 and Tecentriq in three advanced high-risk skin cancer types.

HyLeukin-7 is a new drug pipeline that combined optimized interleukin-7 (IL-7) with hyFc, an original technology owned by Genexine, while Tecentriq is cancer immunotherapy developed by Roche that targets a protein called PD-L1 on tumors and immunocytes.

Their research areas include melanoma, Merkel cell carcinoma, and cutaneous squamous cell carcinoma.

Under the accord, NeoImmuneTech and Immune Oncology Network (ION) plans to conduct phase 1b/2a clinical trials jointly for the combination treatment of HyLeukin-7 and Tecentriq. ION is a network of investigators from the foremost cancer centers and universities in North America that conducts multicenter trials on high priority immunotherapy agents.

The purpose of the study is to evaluate the safety and anti-tumor activity of HyLeukin-7 in combination with Tecentriq in about 70 patients with anti-PD-(L)1 naive or refractory high-risk skin cancers. The company plans to start the multi-center open-label in the second half of this year in the U.S. and possibly additional countries.

Patients with advanced high-risk skin cancers have a poor prognosis and limited treatment options, as PD-L1 blockade fails to induce complete responses in most patients, especially those with low tumor infiltrating lymphocyte (TIL) counts. The trial aims to study HyLeukin-7’s effect on the efficacy of Tecentriq by enhanced antitumor T-cell immunity and increased TIL count.

“We are very excited to collaborate with Roche, a global leader in immuno-oncology, and with key opinion leaders from the ION, to advance the development of HyLeukin-7 and analyze its synergy with immune-checkpoint inhibitors,” NeoImmuneTech CEO Yang Se-hwan said. “We believe this combination regimen will deliver a strong dual effect over cancer by both increasing the numbers of T cells and eliminating cancer cells’ escape route.”

IOC also showed excitement in the planned trial.

“HyLeukin-7 has shown in multiple studies to substantially increase the total body complement of T cells with little toxicity,” said Martin A. Cheever, director of the IOC. “HyLeukin-7 is designed to be effective when used in concert with a variety of different immunotherapy regimens, including the combination with anti-PD-L1 that is being tested in this trial.”

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