Prestige Biopharma Positions PBP1710 as Its Next-Generation Growth Driver

Prestige Biopharma Positions PBP1710 as Its Next-Generation Growth Driver

Combination Therapy for Solid Tumors and Fibrotic Diseases Targeted, with Clinical Entry Planned for H2 2027

Prestige Biopharma is positioning its antibody drug candidate PBP1710 as a key next-generation growth driver. The strategy is aimed at securing a follow-on innovative drug pipeline after its biosimilar Tuznue and pancreatic cancer antibody drug candidate PBP1510.

PBP1710 is designed to target the fibrotic environment surrounding tumors and is intended for use in combination with existing anticancer therapies. Rather than being limited to a specific cancer type or a single therapeutic agent, the candidate has the potential to be explored across a variety of combination regimens. The company is also considering expanding its development into the treatment of fibrotic diseases. Clinical entry is targeted for the second half of 2027.

◇ Targeting CTHRC1 to Reduce Tumor Barriers and Expand Development Potential

PBP1710 is an antibody drug candidate targeting CTHRC1, a protein involved in the formation of the stromal matrix within tumor tissue. Its approach focuses on modifying the surrounding environment in which therapeutic agents act. By affecting the dense stromal structures within tumors, PBP1710 is intended to create more favorable conditions for existing therapies to exert their effects.

In solid tumors, the accumulation of extracellular matrix around the tumor can cause the tissue to become increasingly dense and rigid. Such changes may hinder the penetration of therapeutic agents into the tumor and reduce treatment response, and are considered one of the factors limiting the effectiveness of existing anticancer drugs.

PBP1710 is being developed as part of a combination strategy designed to alleviate this tumor microenvironment and help existing therapies work more effectively. The concept is to use PBP1710 alongside therapies that directly attack tumor cells in order to enhance overall treatment efficacy. At the preclinical stage, Prestige Biopharma has secured efficacy data supporting this proposed mechanism of action.

Prestige Biopharma views the fact that PBP1710 is not limited to a specific cancer type or a single therapeutic agent as one of its key strengths. The company believes the development scope can be broadened by identifying appropriate combination regimens with existing therapies for different solid tumors. Accordingly, PBP1710 is being developed as a follow-on pipeline asset with the potential to expand across multiple solid tumor indications rather than being confined to a single indication.

Fibrotic diseases are also being considered as separate indications. As PBP1710 is designed to influence signaling pathways associated with fibrosis, the company believes its development scope could be expanded beyond an oncology combination therapy to include treatments for fibrotic diseases. Its potential to address both solid tumors and fibrotic diseases is seen as a factor that enhances the overall scalability of the pipeline.

The development of PBP1710 also represents an effort to diversify Prestige Biopharma’s business portfolio. At present, the company’s pipeline-related revenue is generated solely from biosimilars, including Tuznue. Cumulative biosimilar-related revenue for the third quarter of fiscal year 2025 amounted to USD 3.43 million, or approximately KRW 4.9 billion, accounting for 46% of total revenue.

With pancreatic cancer antibody drug candidate PBP1510 already in clinical development, PBP1710 is expected to emerge as the company’s next growth driver. Because its development scope could potentially be expanded across multiple solid tumors and fibrotic diseases, it may offer a broader range of commercialization options, including co-development and licensing, compared with candidates limited to a single indication.

◇ Preclinical Toxicology Studies Underway Alongside Co-Development and Investment Initiatives

PBP1710 is being developed with the goal of entering clinical trials in the second half of 2027. The company has secured preclinical efficacy data, while toxicology studies are progressing according to the original development plan.

Prestige Biopharma has also established the infrastructure required for the production of antibodies for clinical use. The company has completed the establishment of its Research Cell Bank (RCB), Master Cell Bank (MCB), and Working Cell Bank (WCB).

The company is also exploring opportunities for collaboration with global pharmaceutical companies. In June, Prestige Biopharma presented research data on PBP1710 in cancer and fibrotic diseases at BIO USA in San Diego. Since then, it has held follow-up meetings with multiple global pharmaceutical companies, while additional discussions between research teams have also continued.

Securing sufficient development funding remains a key variable. Liquid assets, including cash and cash equivalents and short-term financial instruments, declined by KRW 103.5 billion from KRW 166.9 billion at the end of June, the beginning of fiscal year 2025, to KRW 63.4 billion at the end of March this year. The company recorded a cumulative consolidated operating loss of KRW 70.3 billion for the first three quarters. During the same period, cash flow from operating activities showed a net outflow of KRW 36.9 billion.

Prestige Biopharma plans to secure development funding through various measures, including attracting investment and pursuing co-development opportunities with global pharmaceutical companies. The company intends to manage its financing strategy by taking into account the overall development timeline and funding requirements at each stage.

A Prestige Biopharma official said, “Based on its differentiated mechanism of action and potential for indication expansion, we consider PBP1710 to be a highly promising pipeline asset. With our external communications channel recently consolidated through the Busan IDC, we will continue working to communicate development achievements and pipeline progress to the market more quickly.”

Source:  The Bell (https://www.thebell.co.kr/front/newsview.asp?click=F&key=202608061325097000108895)