Haim Bio said that the Ministry of Food and Drug Safety has approved its investigational new drug (IND) application to conduct phase 1 clinical trials into NYH817100, a metabolism anticancer drug candidate.
With the approval, the company plans to conduct the trials of both mono- and combination-therapy of NYH817100 at Severance Hospital early as October in patients with advanced solid cancer who have failed standard treatment.
NYH817100 blocks the metabolism of cancer cells by using NYH817G and NYH100P, which inhibit substances that play a vital role in the cancer cell energy production pathway.
“The treatment is drawing attention as a possible fourth-generation anticancer agent,” the company said.
Haim Bio expects the anticancer drug to have no side effects and higher cure rates compared to conventional anticancer drugs.
“We have developed a drug that has high patient convenience that will be used for phase 1 clinical trial and established a clinical research team,” Haim Bio CEO Kim Hong-yeoul said. “Apart from the local trials, the company is working closely with Axcelead, a U.S. new drug development consulting firm, to receive a fast-track designation for phase 2 clinical trials.”