HLB Targets Three New Anticancer Drugs by Next Year

HLB, with about a month left until the approval of its liver cancer new drug, has finalized its roadmap for the next two years.

HLB announced on the 6th that if it receives approval for its liver cancer new drug from the U.S. Food and Drug Administration (FDA) in March this year, it plans to secure prescription drugs for three cancer types?liver cancer, seminoma, and cholangiocarcinoma?by the end of this year.

The new drug development will be pursued in two directions. For cancer types where the partner company, Hansoh Pharmaceutical, has completed clinical trials and shown outstanding data, global clinical trials will be expanded first. The strategy is to develop a tumor-agnostic anticancer drug aiming to become the second Keytruda.

Recently, through the oral targeted anticancer drug ‘Lirapugratinib,’ for which rights and technology were licensed from a U.S. biotech company, HLB has set a plan to develop a ‘tumor-agnostic therapy’ that can be prescribed to all patients regardless of cancer type for FGFR2-mutated cancers.

Tumor-agnostic therapy is a new area of anticancer drugs that can be prescribed based on specific biomarkers regardless of the tumor’s site of origin. In 2017, the global blockbuster ‘Keytruda’ was the first tumor-agnostic therapy to receive FDA approval.

According to the U.S. clinical trial information site ‘ClinicalTrials,’ the sponsor for the phase 1/2 clinical trial of ‘Lirapugratinib’ recently changed to ‘Eleva Therapeutics.’ Eleva, which licensed the compound last year from the Nasdaq-listed company Relay Therapeutics, is proceeding with the new drug application (NDA) process with the U.S. FDA this year for FGFR2-mutated cholangiocarcinoma treatment. It is pursuing a ‘two-track’ strategy by also expanding clinical trials as a tumor-agnostic therapy.

Lirapugratinib is a targeted anticancer drug that targets FGFR2 (fibroblast growth factor receptor-2), a receptor involved in cell growth and regeneration. The original developer, Relay Therapeutics, predicted the potential of Lirapugratinib as a tumor-agnostic therapy when it started phase 1/2 clinical trials in 2020. Recruitment has been ongoing not only for cholangiocarcinoma patients but also for various solid tumor patients such as gastric cancer, endometrial cancer, breast cancer, and pancreatic cancer, where FGFR2 abnormalities are frequently observed.

Among seven patient groups, recruitment for the cholangiocarcinoma patient group has been completed. For cholangiocarcinoma, it has already been designated as a breakthrough therapy by the FDA, making conditional approval with phase 3 trials after approval highly likely. Eleva plans to steadily increase patient numbers for other solid tumors besides cholangiocarcinoma to prove efficacy as a tumor-agnostic therapy.

Eleva CEO Jeong Se-ho said, "Considering the prognosis of patients recruited so far, we believe Lirapugratinib has high potential as a tumor-agnostic therapy, so we decided to proceed with additional patient recruitment." He added, "This year, along with the approval and market preparation of liver cancer new drug Rivoserab, we also plan to proceed with the NDA for cholangiocarcinoma treatment."

In the U.S., second-line treatments approved for cholangiocarcinoma include Futibatinib and Pemigatinib. However, they have the disadvantage of low selectivity for FGFR2, causing severe side effects such as hyperphosphatemia and diarrhea. Lirapugratinib has demonstrated efficacy through clinical trials and has reduced concerns about side effects compared to existing drugs.