Prestige Biopharma Debuts PBP1510 on the ESMO Stage
Prestige Biopharma CEO Lisa Park Interview at ESMO PBP1510 monotherapy and combination show strong safety Phase 2 trials planned for mid-to-late 2026 across multiple countries Aiming for conditional approval without full Phase 3 completion
Recognized as one of the world’s top three oncology conferences, the European Society for Medical Oncology (ESMO) annual meeting draws cancer specialists and pharmaceutical professionals from across the globe. Alongside oral presentations of key Phase III clinical trial results, companies engage in booth exhibitions, business meetings, and poster sessions.
HIT News spoke with representatives from Korean biotech firms participating in the event to discuss their goals for attending ESMO, key presentations, business outcomes, and future strategies as they expand their presence on the global stage.
Prestige Biopharma, a developer of antibody-based biopharmaceuticals, shared the scientific rationale and clinical value of its pancreatic cancer drug candidate PBP1510 (ingredient: ulnenistamab) with global oncology experts.
From October 17 to 20, the company presented safety data for PBP1510 at the European Society for Medical Oncology (ESMO) Congress held in Berlin, Germany. Prestige Biopharma also highlighted the clinical significance of inhibiting PAUF (Pancreatic Adenocarcinoma Upregulated Factor)—a novel biomarker and key oncogenic driver targeted by the drug.
PBP1510 is a targeted monoclonal antibody candidate designed to block tumor growth and metastasis by inhibiting PAUF, a major promoter of pancreatic cancer progression. At ESMO, the company disclosed initial safety results from the global Phase 1/2a “PAUF-I” trial, including both monotherapy and gemcitabine combination cohorts.
This marks the first time Prestige Biopharma has presented its research findings at ESMO, under the direct supervision of CEO Dr. Lisa Park (So-Yeon Park). The company also raised its global profile through a corporate booth and promotional displays targeting major pharmaceutical partners.
At the conference, HIT News spoke with CEO Park about the key findings from the PBP1510 presentation, the company’s development roadmap, and its long-term business goals on the global stage.
What was the purpose of Prestige Biopharma’s participation at ESMO?
“The Prestige Biopharma Group continues to pursue its mission of ‘Innovation for Life’. As part of this effort, we are committed to making advanced therapies more affordable by developing biosimilars that can lower drug costs for patients who might otherwise be unable to access treatment.
Our biosimilar Tuznue (trastuzumab; reference drug Herceptin) received approval from the European Medicines Agency (EMA) last year, and we have since signed multiple license and supply agreements with major pharmaceutical and biotech companies across Europe and beyond.
In addition, we are developing innovative treatments for cancers with high unmet medical needs, including our pancreatic cancer candidate PBP1510, which is currently in clinical development, and other pipeline assets such as PBP1710.
We attended ESMO to present our oncology pipeline and R&D progress to global medical experts, and to share the scientific significance of our PAUF-targeted antibody therapy strategy. Another key goal was to strengthen our international research network and explore opportunities for collaborative studies and partnerships in the future.”
You presented the new drug candidate PBP1510. What were the key highlights?
“PBP1510 is a monoclonal antibody drug candidate that targets PAUF (Pancreatic Adenocarcinoma Upregulated Factor), a major oncogenic driver in pancreatic cancer. PAUF promotes tumor growth and metastasis, and PBP1510 works by inhibiting this factor to block cancer progression.
At ESMO 2025’s ‘Meet the Investigator’ session, presentations were delivered by Prof. Xavier Pivot from the Strasbourg Cancer Center (France), Dr. Daniel A. King, Director of the Northwell Health Cancer Center (U.S.), and Dr. Yoon-Yong Park from Prestige Biopharma’s Immuno-Disease Center (IDC). They discussed the therapeutic rationale behind PAUF inhibition and its clinical potential.
We also presented interim findings from the Phase 1/2a “PAUF-I” study through an e-poster. The trial includes 32 patients with metastatic pancreatic cancer, divided into PBP1510 monotherapy and gemcitabine combination therapy groups.
Results showed no dose-limiting toxicity (DLT) and no Grade 4 or higher adverse events among treated patients. Participants maintained stable disease (SD) for more than four cycles, confirming that both 30 mg/kg monotherapy and 10 mg/kg combination therapy were well-tolerated, with no cumulative toxicity or unexpected side effects observed.
PBP1510 has been designated as an orphan drug by the U.S. FDA, European Medicines Agency (EMA), and Korean MFDS, and notably, it also received Fast Track designation from the FDA, underscoring its potential as a first-in-class therapy for pancreatic cancer.”
What is the clinical significance of these results?
“This study demonstrated that PBP1510, unlike traditional cytotoxic chemotherapies, can directly inhibit tumor growth and metastasis. This finding is highly meaningful, as it highlights PAUF inhibition as a new therapeutic avenue in pancreatic cancer treatment.
Moreover, the safety data were favorable, supporting the potential for long-term administration and combination therapy in future clinical phases.”
Beyond pancreatic cancer, in which other cancer types could PAUF inhibition be effective?
“Our research has shown that PAUF also plays a role in prostate and ovarian cancers. Based on these findings, we believe PBP1510 could potentially be applied to these cancer types in the future as well.”
What are the next research plans for PBP1510?
“While conducting the PBP1510 clinical trials, I often meet patients diagnosed at the terminal stage of pancreatic cancer, and I can’t help but think—if only their symptoms had been detected earlier, they might have had a better chance at timely treatment and improved survival.
To address this, we are developing a diagnostic kit for early detection of pancreatic cancer, which we plan to patent by the end 2025 or early 2026. This will allow us to implement an integrated program that combines both diagnosis and treatment.
Furthermore, we aim to broaden our scope to include prevention. By extending PBP1510’s potential use to preventive applications, we hope to establish a comprehensive program encompassing prevention, diagnosis, and treatment for pancreatic cancer.”
When do you expect PBP1510 to be commercialized?
“Based on the results of our ongoing Phase 1 trial, we plan to initiate Phase 2 studies in the U.S., Spain, Singapore, and Australia in the second half of 2026, using the optimized dosing and administration regimen. However, the clinical timeline may vary depending on circumstances and is not yet finalized.
If we obtain positive results from Phase 2, we believe it may be possible to seek regulatory approval even before completing Phase 3, both in Korea and internationally. Since approximately 50 patients will be enrolled at clinical sites in the U.S. and Spain, the study could be completed relatively quickly — allowing us to deliver the therapy to patients in need as soon as possible.”
ESMO brings together numerous key opinion leaders (KOIs) and major global pharmaceutical companies each year. Did you have meetings with them?
“Yes, we held meetings with several global pharmaceutical companies and research institutions during ESMO. While we are not yet able to disclose specific company names or discussion details, I can say that we explored a wide range of collaborative opportunities — including clinical partnerships, co-development projects, and technology transfer discussions.
There was particularly strong interest in the PAUF inhibition mechanism and its potential applications in hard-to-treat cancers such as pancreatic cancer, which led to several productive and meaningful discussions.”
Could you share Prestige Biopharma’s business and R&D vision moving forward?
“As a research-driven biopharmaceutical company, Prestige Biopharma is committed to building a sustainable global healthcare business model. On the business front, we are working to strengthen our global commercialization network through strategic partnerships and regulatory collaboration in key regions, establishing a foundation for faster market entry. Several new agreements are currently underway or under review.
The biosimilar market is now moving beyond its transitional phase, with increasing regulatory clarity and market predictability. In this evolving landscape, we believe the real differentiator will not simply be being a first mover, but achieving sustainable competitiveness through new formulation technologies that enhance dosing convenience and cost-efficiency, along with improved manufacturing productivity.
We are advancing initiatives to boost cell-line productivity, optimize manufacturing processes, and develop alternative raw materials, while actively pursuing joint development and technology partnerships with other biosimilar developers to accelerate product launches.
In the global market, subcutaneous (SC) formulations that enhance both patient convenience and treatment efficiency are gaining prominence. In line with this trend, our Immuno-Disease Center (IDC) recently filed a patent for a thermosensitive hydrogel formulation capable of delivering high-concentration protein drugs with sustained release in the body. This marks our entry into the next-generation drug delivery system (DDS) field and could serve as a future SC formulation platform technology.
Beyond our ongoing PBP1510 clinical program, we plan to expand our pipeline to new therapeutic targets and indications.
Ultimately, Prestige Biopharma aims to evolve into a global pharmaceutical leader, strengthening competitiveness across research, manufacturing, and commercialization to deliver better treatment options and innovative care for patients worldwide.”