William Hearl, CEO of Immunomic Therapeutics / Courtesy of HLB

By Baek Byung-yeul

William Hearl, CEO of Immunomic Therapeutics, the U.S. subsidiary of the Korean biotech company, HLB, said that the company expects meaningful test results from its Phase 2 clinical trials of a drug for glioblastoma by August of this year at the latest.

Glioblastoma, known by the acronym, GBM, is a malignant brain tumor. Immunomic Therapeutics is undergoing Phase 2 clinical trials with its GBM drug candidate, ITI-1000, made by applying the UNITE platform, an immunotherapy platform technology, the development of which Hearl led.

"Patients in Phase I clinical studies showed remarkable survival benefits with a median survival rate of 40 months compared with 16 months using standard care controls. Phase II is ongoing and is nearing completion. It is looking to confirm the observations of overall survival benefits in a blind and placebo-controlled study of 120 subjects. We expect to learn the results of this study in 2022," Hearl said in a written interview with The Korea Times on May 23.

"The UNITE platform is intended to provide broad activation of the immune system activating both helper T-cells and cytotoxic T-cells. The process also generates Interferon-gamma cytokines and antibodies," Hearl, who recently visited Korea, said.

If the company gets the data it wants in the Phase II clinical trials, Immunomic Therapeutics will be able to announce its clinical trial results at this year's annual conference of the Society for Neruo-Oncology in the U.S. in November. The company will also try to win a breakthrough designation granted by the U.S. Food and Drug Administration (FDA).

According to the FDA, the breakthrough designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate a substantial improvement over available therapy in terms of clinically significant endpoints.

The CEO said he hopes the drug his company is developing will be of great help to patients suffering from GBM.

"Our vision for ITI-1000 is for this therapy to become the accepted standard of care for all GBM patients who are eligible to be treated by this process," he said. "For patients who have difficulty generating the cells necessary to be treated by the ITI-1000 protocol, we hope that the related product, ITI-1001, will be available to those individuals."

The U.S. company is also strengthening its cooperation with HLB.

"Over the last two years, HLB, under the vision of Chairman Jin Yang-gon, has added a number of strategic partnerships to the HLB pharma, life sciences and biotech group. It is an impressive group of companies that cover everything from drugs on the market to R&D companies to manufacturing and support businesses. I see many opportunities to collaborate in the future, so coming to Korea was the best way to meet with all of the people leading these companies," the CEO said.