ulenistamab (PBP1510) / Prestige BioPharma - LARVOL DELTA

First-in-human phase 1/2a study of PBP1510 (anti-PAUF mAb) in advanced/metastatic pancreatic adenocarcinoma: Safety results from early combination cohorts. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT05141149 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P1/2 data • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • ZG16B

Preliminary safety results from the first-in-human phase 1/2a study of PBP1510 (anti-PAUF mAb) in advanced/metastatic pancreatic adenocarcinoma (AACR 2025) - P1/2 | "Conclusion Interim safety data from dose-escalation of the first-in-class PBP1510 demonstrates acceptable tolerability up to 6 mg/kg in advanced/metastatic pancreatic adenocarcinoma patients who have failed previous lines of treatment. Clinical evaluation of PBP1510 in higher cohorts, including combination therapy with gemcitabine, is ongoing."

Clinical • Metastases • P1/2 data • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • ZG16B

Prestige Biopharma Completes Phase 1 Clinical Trial of 20 Patients for Pancreatic Cancer Antibody New Drug ’PBP1510’ [Google translation] (Medical Today) - "A pharmaceutical company specializing in antibody biopharmaceuticals, announced on the 12th that 20 patients completed the phase 1/2a clinical trial of the pancreatic cancer antibody new drug 'PBP1510'. With this, the phase 1 clinical trial is about to break through the 7th ridge with 20 patients administered....Following Spain, the number of patients administered PBP1510 in the US has exceeded 6, and 5 patients have completed registration in Singapore, making it progress rapidly....The company explained that as the number of patients who have completed the Phase 1 clinical trial exceeds 20, recruitment and administration of the remaining patients will proceed quickly."

Trial status • Oncology • Pancreatic Cancer

Prestige Biologics publishes study on pancreatic cancer target PAUF (Korea Biomedical Review) - "Prestige Biologics said Tuesday that it has published a research paper in the International Journal of Molecular Sciences, an SCIE journal, on the target protein PAUF (Pancreatic Adenocarcinoma Upregulated Factor) of its pancreatic cancer antibody therapeutic candidate PBP1510. The study suggests that PAUF may not just act on cancer cells but also regulate immune cells in the tumor microenvironment to promote pancreatic cancer progression....The researchers explained that by identifying how PAUF promotes the migration of monocytes and their differentiation into TAMs, PBP1510 shows promise as a therapeutic agent that can inhibit immunosuppressive mechanisms and activate anticancer immunity."

Clinical • Pancreatic Cancer

Prestige Biopharma announced its goal of reaching a market cap of 30 trillion won in 6 years. [Google translation] (HIT News) - "Prestige Biopharma has 15 biosimilar pipelines and is about to receive approval for Tuznue, a Herceptin (ingredient: trastuzumab) biosimilar...Currently, Tuznue's partners are Doctor Redis, Tabuk, Cipla, and Pharmapark...'We expect to receive a total of 14.5 billion won in milestones from these companies based on approval and sales launch.'...'The list of European partner candidates has been narrowed down to about three out of eight partners.'....'We plan to receive accelerated approval from the U.S. Food and Drug Administration (FDA) for PBP1510 in 2028. We are targeting sales of KRW 2.48 trillion by 2030.'"

Financing • Sales projection • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Prestige Biopharma "Expects to Sign European License Out Agreement" [Google translation] (Newspim) - "Prestige Biopharma dismissed concerns over the recent stock market plunge and announced on the 5th that it is in the process of negotiating a sales license out for the European region...Prestige Biopharma said that it currently has eight sales companies lined up for the sales license out in Europe and has begun the process of selecting a strong partner that can most quickly settle Tuznue into the market. The company explained that it is currently negotiating the contract terms because it is in an advantageous position to select a partner by taking advantage of Prestige Biologics’ unit price competitiveness with EU-GMP, given that CHMP has recommended approval...Prestige Biopharma will be revealed for the first time at the corporate briefing held at the Conrad Hotel in Yeouido on the 19th....In particular, the Tuznue sales strategy, CDMO business status, and the clinical progress of the world's first pancreatic cancer antibody new drug PBP1510 will be disclosed for the first time."

Clinical • Licensing / partnership • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Prestige Biopharma enters phase 1 and 2a trials for ‘pancreatic cancer new drug candidate’ [Google translation] (HIT News) - "Prestige Biopharma...announced on the 18th that it has entered phase 1/2a clinical trials for its new pancreatic cancer antibody drug 'PBP1510', starting administration to two patients in the United States. It was also said that in the phase 1 clinical trial, 16 patients out of a total of 30 took the drug, crossing the 5th ridge....Phase 1 clinical trials, which will check the safety and tolerability of the drug through PBP1510 monotherapy and concurrent therapy with the existing anticancer drug gemcitabine, are scheduled to be completed within the year."

Trial status • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

PBP1510, a novel monoclonal antibody targeting pancreatic adenocarcinoma upregulated factor (PAUF): Phase 1/2a monotherapy and combination with gemcitabine in patients with advanced/metastatic pancreatic cancer. (ASCO 2024) - P1/2 | "PBP1510 was well tolerated by all patients at 1 mg/kg or 3 mg/kg in the first 2 monotherapy cohorts. The next monotherapy (PBP1510, 6 mg/kg) and combination (PBP1510, 1 mg/kg; gemcitabine 1000 mg/m2) cohorts are open for recruitment. Clinical trial information: NCT05141149."

Clinical • Metastases • Monotherapy • P1/2 data • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • ZG16B

Prestige Biopharma unveils pipeline lineup at Bio USA [Google translation] (HIT News) - "PBP1510 phase 1·2a, interim analysis announced this year...Prestige Biopharma Group announced on the 7th that it held a press conference at a separate booth prepared at the '2024 Bio International Convention...PBP1710, which is in the preclinical stage and is being introduced one after another in international academic journals and academic societies...CEO Koh explained that IDC441 is a new concept ADC that combines the function of suppressing tumor development by controlling the microenvironment around the tumor, unlike the existing ADC mechanism of action that is internalized from the cell surface....Koh also disclosed the clinical progress of PBP1510, a new pancreatic cancer antibody drug being developed by Prestige Biopharma. Currently, 14 patients have received the medication at the Spanish hospital, which opened first, and the US site is undergoing final preparations and is scheduled to begin administering the medication this month."

P1/2 data • Preclinical • Trial status • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Prestige Biopharma IDC consolidates 4 research organizations to 2 [Google translation] (HIT News) - "Prestige Biopharma...announced on the 16th that its subsidiary Prestige Biopharma IDC (CEO Sang-seok Ko, Innovative Discovery Center) has undergone organizational reorganization ahead of the completion of the new antibody drug research center....The company explains that the goals of the headquarters reorganization are to expand the indications for the pancreatic cancer treatment 'PBP1510 (development code name)', verify the efficacy of 'PBP1710 (development code name)', and develop new antibody treatments and transfer technology."

Clinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

PAUF-I: First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients With Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: Prestige Biopharma Limited

Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • ZG16B

A first-in-human phase 1/2a study of a novel anti-PAUF monoclonal antibody PBP1510 in patients with advanced/metastatic pancreatic cancer (AACR 2024) - P1/2 | "PBP1510 is administered as a 90-minute intravenous infusion in 28-day cycles and tumor assessments are performed every 8 weeks from the first dose.Phase 1 uses a 3 + 3 dose-escalation design to assess the safety, tolerability, pharmacokinetics (PK), and immunogenicity of ascending doses of PBP1510 as a single agent or in combination with gemcitabine (Table 1). The 1M cohort (1 mg/kg) was completed without any report of DLT. Dose escalation is in progress and DLT evaluation is ongoing for the 2nd and 3rd patients in the 2M cohort."

Clinical • Metastases • P1/2 data • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • ZG16B

Prestige Biopharma acquires Israeli patent for pancreatic cancer drug candidate [Google translation] (HIT News) - "Prestige Biopharma (CEO Park So-yeon) announced on the 23rd that it has acquired a patent in Israel for 'Antibody that specifically binds to PAUF protein and its use' for the new pancreatic cancer antibody drug 'PBP1510 (development code name)'...The company explains that this is the 13th patent following Korea, the United States, Russia, Ja.pan, and China. Based on this patent, the company plans to expand its exclusive rights to PBP1510, which is being developed as a new antibody drug for pancreatic cancer, and build a portfolio by development stage."

Patent • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

PAUF as a target for treatment of high PAUF-expressing ovarian cancer (ESMO 2023) - "Treatments (started from day 0): Human IgG (control), Anti-PAUF antibody (10 mg/kg, twice/week, ×4 weeks), Docetaxel (10 mg/kg, once, on day 0), or Anti-PAUF antibody + Docetaxel (via the same regimens of the two drugs) Conclusions Taken together, this study shows that the expression level of PAUF is an independent factor determining malignant behaviors of ovarian cancer and, for the first time, it suggests that PAUF may be a promising therapeutic target for high PAUF-expressing ovarian cancer. The anti-PAUF antibody used in this study, PBP1510, has gained orphan drug designation from the EMA, FDA, and MFDS (Korea), and entered phase I clinical trials."

Gastrointestinal Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • ZG16B

PAUF-I: First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients With Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: Prestige Biopharma Limited | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Feb 2026

Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Prestige Biopharma joins Biden's 'Cancer Moonshot' to conquer pancreatic cancer (Korea Biomedical Review) - "Prestige BioPharma...said on Tuesday that it joined the Cancer Moonshot Project promoted by U.S. President Joe Biden....Accordingly, Prestige Biopharma will conduct various studies to revolutionize the treatment paradigm for pancreatic cancer, including diagnosis of pancreatic cancer using blood PAUF levels, treatment with anti-PAUF (PBP1510), and eventually anti-PAUF therapy for the prevention of pancreatic cancer. The membership will also enable Prestige Biopharma to build partnerships in the U.S."

Licensing / partnership • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

PAUF-I: First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients With Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: Prestige Biopharma Limited | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Sep 2023 ➔ Dec 2024

Enrollment open • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

FDA Grants Fast Track Designation to PBP1510 in Metastatic Pancreatic Adenocarcinoma (OncLive) - P1/2 | N= 80 | NCT05141149 | Sponsor: Prestige Biopharma Limited; "The FDA has granted a fast track designation to PBP1510 (ulenistamab) for the treatment of patients with unresectable or metastatic pancreatic adenocarcinoma that has relapsed following and/or is refractory to at least 1 prior line therapy....Key exclusion criteria include known brain metastases, major surgery within 4 weeks of the first dose of PBP1510, and treatment with any investigational anticancer drug within 4 weeks of enrollment."

P1/2 data • Regulatory

Prestige Biopharma Receives FDA Fast Track Designation for PBP1510 in the Treatment of Pancreatic Cancer (Businesswire) - "Prestige Biopharma has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for PBP1510 (International Non-proprietary name: Ulenistamab), in the treatment of unresectable or metastatic pancreatic adenocarcinoma (PDAC) that has relapsed following and/or is refractory to at least one line of prior therapy."

Fast track designation • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Prestige Biopharma's pancreatic cancer drug candidate put on FDA Fast Track (Korea Biomedical Review) - "Prestige Biopharma said on Thursday that its new pancreatic cancer antibody drug candidate, PBP1510, (ingredient: ulenistamab), was granted FDA Fast Track designation. PBP1510 specifically binds to PAUF and exerts anti-metastasis and immune modulation effects."

Fast track designation • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

PAUF-I: First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients With Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=80 | Not yet recruiting | Sponsor: Prestige Biopharma Limited | Trial primary completion date: Mar 2023 ➔ Sep 2023

Metastases • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

"#PrestigeBiopharma Obtains #PBP1510 #Patent in Indonesia, Marking the Tenth https://t.co/yzTBoPvwtm" (@1stOncology)

A clinical study assessing ZG16B/PAUF overexpression in high-grade ovarian serous adenocarcinoma (ESGE 2022) - P1/2 | "Recently, a new anti-PAUF/ZG16B antibody, PBP1510, was developed by PrestigeBiopharma (NCT05141149). This study provides arguments in support of a future clinical trial to evaluate this antibody in patients with ovarian cancer."

Clinical • Gastrointestinal Cancer • Hepatology • Immune Modulation • Inflammation • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • ZG16B

PAUF-I: First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients With Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=80 | Not yet recruiting | Sponsor: Prestige Biopharma Limited | Trial primary completion date: Oct 2022 ➔ Mar 2023

Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

US FDA Approves Prestige Biopharma’s IND for Phase 1/2a Trial of First-in-Class Pancreatic Cancer Treatment, PBP1510 (Businesswire) - "Prestige Biopharma Limited...announced that the U.S. Food and Drug Administration (FDA) has approved the Phase 1/2a clinical trial of its first-in-class anti-PAUF monoclonal antibody, PBP1510 (INN: Ulenistamab), for the treatment of pancreatic cancer....PBP1510 is also expected to be eligible for FDA’s accelerated approval program if certain conditions are met....The company believes that PBP1510 will be able to apply for the accelerated approval program with the validated surrogate endpoint from its Phase 2 study."

IND • Trial status • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor