HLB Aims for Three Cancer Drug Approval and Groundbreaking Tumor-Agnostic Therapy by 2025

· With its liver cancer drug approval decision just a month away, HLB targets breakthroughs in oncology, including a pioneering FGFR2-targeted tumor-agnostic therapy.

 

HLB aims for three cancer drug approval and groundbreaking tumor-agnostic therapy by 2025. (IT Times)

SEOUL, South Korea, February 6, 2025 (IT Times) - With its liver cancer drug approval decision just a month away, HLB targets breakthroughs in oncology, including a pioneering FGFR2-targeted tumor-agnostic therapy.

With just a month left until the decision on the approval of its liver cancer drug, HLB has announced an ambitious two-year roadmap, targeting approvals for three cancer treatments and the development of a revolutionary tumor-agnostic therapy by 2025.

According to the roadmap revealed on February 6, HLB plans to secure approvals for its liver cancer drug by March, commercialize its adenoid cystic carcinoma treatment—already the first in the world to complete Phase II clinical trials—by mid-year, and file for approval of its cholangiocarcinoma (bile duct cancer) treatment by the end of 2025. This strategy is designed to achieve regulatory approval for three major treatments: liver cancer, adenoid cystic carcinoma, and cholangiocarcinoma.

# Blueprint for Future Drug Development
HLB also outlined its long-term drug development strategy, focusing on two key directions. First, the company plans to expand global clinical trials for cancer types with exceptional data obtained from its partner, Jiangsu Hengrui Pharmaceuticals. Second, HLB is targeting the development of a tumor-agnostic therapy, an innovative treatment that can be used for any cancer type, regardless of its origin.

The company has set its sights on developing lirafugratinib (pipeline name: RLY-4008), an oral targeted therapy acquired through a licensing agreement with a U.S. biotech firm. Lirafugratinib targets FGFR2-mutant cancers and is designed to serve as a tumor-agnostic therapy that can be prescribed to patients with FGFR2 mutations, regardless of the type of cancer they have.

# Tumor-Agnostic Therapy: A New Frontier in Oncology
Tumor-agnostic therapies represent a groundbreaking approach in oncology, treating cancers based on biomarkers rather than tumor location. The first tumor-agnostic therapy, Keytruda, was approved by the U.S. FDA in 2017, paving the way for this innovative class of treatments.

ClinicalTrials.gov shows that the Phase 1/2 clinical study for lirafugratinib, called ReFocus, is now sponsored by Elevar Therapeutics, a U.S. subsidiary of HLB. Elevar acquired the rights to the drug from Relay Therapeutics in 2022 and is pursuing a "two-track" strategy: submitting an NDA for cholangiocarcinoma in the U.S. this year while simultaneously expanding its clinical trials to develop lirafugratinib as a tumor-agnostic therapy.

Lirafugratinib targets FGFR2 (fibroblast growth factor receptor 2), a key receptor involved in cell growth and regeneration. It is designed to selectively inhibit FGFR2 mutations, making it a promising candidate for cancers such as cholangiocarcinoma, gastric cancer, endometrial cancer, breast cancer, and pancreatic cancer, where FGFR2 abnormalities are frequently observed.

Recruitment for cholangiocarcinoma patients in the clinical trials has been completed, and the drug has received breakthrough therapy designation from the FDA, increasing the likelihood of conditional approval following Phase III trials. Elevar aims to expand patient recruitment for other FGFR2-related cancers to demonstrate the drug’s efficacy as a tumor-agnostic therapy.

# Market Potential and Competitive Edge
FGFR2 abnormalities are estimated to account for 1.5% of all cancer cases. With the global oncology market expected to reach $194.7 billion by 2024, growing at a CAGR of 9.2%, HLB sees significant potential for lirafugratinib.

Currently, two second-line treatments for cholangiocarcinoma, Futibatinib and Pemigatinib, are available in the U.S. However, these drugs have low FGFR2 selectivity and are associated with severe side effects, such as hyperphosphatemia and diarrhea. In contrast, Lirafugratinib has demonstrated superior efficacy and significantly reduced side effects, meeting the criteria for a best-in-class FGFR2 inhibitor.

“Based on the results observed in recruited patients, we are confident in lirafugratinib’s potential as a tumor-agnostic therapy,” said Jung Se-ho, CEO of Elevar Therapeutics.  “This year, we aim to secure regulatory approval for Rivoceranib, our liver cancer treatment, while also advancing lirafugratinib’s NDA for cholangiocarcinoma. We believe 2025 will be a landmark year for both the company and patients.”

IT Times YoungHa Kim (yhkim@ittimes.com)

 

Read more: https://www.ittimes.com/news/articleView.html?idxno=63944

HLB Aims for Three Cancer Drug Approval and Groundbreaking Tumor-Agnostic Therapy by 2026 - IT타임스