Pharmaceutical industry officials are pinning high hopes on combination treatments using immunotherapies such as Genexine’s Hyleukin-7.
The Ministry of Food and Drug Safety approved last Thursday a clinical trial on a combo therapy using Hyleukin-7 in patients with metastatic and recurrent solid tumors.
The study will provide patients with a chemotherapeutic agent called Cyclophosphamide (CP), then administer Hyleukin-7.
The trial will take place at Seoul National University Hospital in two phases for two years -- phase-1b to assess safety and tolerance first, and phase-2a to evaluate the objective response rate and survival time.
Genexine said Hyleukin-7 as a monotherapy increased the number of cancer-fighting antibodies and tumor infiltrating lymphocytes (TILs) that kill cancer cells. A CP+Hyleukin-7 combo is believed to cause a significant rise in T cells, having a synergistic effect to destroy tumors, the company said.
The drug company is separately conducting a study on monotherapy of Hyleukin-7 in patients with solid tumors and brain cancer.
Genexine is also preparing phase-1b and phase-2a trials on combo treatment mixing Keytruda (pembrolizumab) with Hyleukin-7 in patients with breast cancer.
As Hyleukin-7 was recently selected as part of the Korea Drug Development Fund (KDDF)’s drug development project, the company plans to apply for Investigational New Drug (IND) within the year.
“We plan to submit IND application for Keytruda and Hyleukin-7 combo for breast cancer to the food and drug safety ministry within November. Then, we will recruit patients to conduct the study,” an official at Genexine said.
Some analysts estimated Hyleukin-7’s value to be around 1 trillion won ($896 million) based on anticipation for its role in combo treatments and clinical success probability.
Kang Ha-young, an analyst at KTB Investment & Securities, picked Genexine’s Hyleukin as the most anticipated drug to be given in combination with other immunotherapies and estimated the drug’s value at 916.2 billion won as of April 2018.
“Considering Hyleukiin-7’s safety, I estimated its drug development success probability at 15 percent,” Kang said. “As immunotherapies tend to have low response rates, other multinational drugmakers are actively engaging in trials to test combo treatments mixing different immunotherapies or chemical anticancer agents.”