A First in Human, Phase 1/2a, Multicentre, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of PBP1510 in Patients With Advanced/Metastatic Pancreatic Cancer

The first in human clinical study is planned as an open-label, dose-escalation, and dose-expansion, multicentre, two-part, Phase 1/2a study of PBP1510 administered to patients with advanced/metastatic pancreatic cancer. The study will be conducted in two parts, Part 1 as a PBP1510 single agent dose-escalation, and PBP1510 dose-escalation in combination with gemcitabine, and Part 2 as PBP1510 dose-expansion at the RP2D in combination with gemcitabine.

Start Date05 Jun 2023

Sponsor / Collaborator

Prestige BioPharma Ltd.

100 Clinical Results associated with Ulenistamab

100 Translational Medicine associated with Ulenistamab

100 Patents (Medical) associated with Ulenistamab

Literatures (Medical) associated with Ulenistamab

INTERNATIONAL JOURNAL OF MOLECULAR MEDICINE

ZG16B: A key regulator of tumor progression and immune microenvironment modulation in cancer (Review)

Review

Author: Chen, Xing-Ming ; Zuo, Jin-Xiang ; Yang, Zi-Sheng ; Liang, Yu-Bo ; Wan, Ping ; Zhang, Xin-Yu ; Ke, Yang ; Zhang, Le-Yu

Zymogen granule protein 16B (ZG16B), also known as pancreatic adenocarcinoma upregulated factor, is a secretory lectin‑like glycoprotein that serves a crucial role in tumorigenesis and immune regulation. The present review summarizes the latest research progress on the molecular characteristics, biological functions, signaling pathway regulation and clinical importance of ZG16B. Structurally, ZG16B contains an N‑terminal hydrophobic signal peptide, a jacalin‑related lectin domain and a C‑terminal extension. Functionally, ZG16B promotes tumor cell proliferation, migration, invasion and angiogenesis, and increases vascular permeability by activating the Toll‑like receptor, C‑X‑C chemokine receptor type 4, β‑catenin and focal adhesion kinase signaling pathways. In the tumor microenvironment, ZG16B can modulate immune responses, enhance the immunosuppressive functions of myeloid‑derived suppressor cells and M2 macrophages, and also promote the maturation of dendritic cells. Clinically, ZG16B expression is upregulated in pancreatic cancer, ovarian cancer, colorectal cancer, gastric cancer and oral cancer, and its upregulation is associated with a worse prognosis in these malignancies. Several ZG16B‑specific therapeutic strategies, including monoclonal antibodies, RNA aptamers and trans‑splicing ribozymes, have shown preclinical efficacy against malignant tumors. Furthermore, a clinical trial is currently testing the efficacy and safety of PBP1510, a humanized ZG16B antibody, for the treatment of advanced pancreatic cancer. In conclusion, ZG16B may be considered a novel target for cancer diagnosis, prognosis and therapy.

News (Medical) associated with Ulenistamab

26 Nov 2025

·www.prnewswire.com

Prestige Biopharma and Biosidus Enter Exclusive License Agreement for Tuznue® Commercialization in Latin America

SINGAPORE, Nov. 26, 2025 /PRNewswire/ -- Prestige Biopharma, a biopharmaceutical company specializing in antibody therapeutics, today announced an exclusive license and supply agreement with Biosidus, a biotechnology company headquartered in Buenos Aires, Argentina, with decades of experience in biosimilar development and commercialization, for the commercialization of Tuznue® (trastuzumab) across Latin American markets, including Argentina, Mexico, Bolivia, and Paraguay. Tuznue® is a biosimilar to Herceptin® (trastuzumab), approved for the treatment of breast cancer and metastatic gastric cancer. Prestige Biopharma received European Commission (EC) marketing authorization for Tuznue® in September 2024. This approval marks a major milestone for the company's biosimilar portfolio, signaling progress in expanding access to cost-effective treatments across key global markets. Under the agreement, Biosidus secures exclusive rights to market and distribute Tuznue® in Argentina, Mexico, Bolivia, and Paraguay, leveraging its extensive commercial network and deep expertise in biosimilar adoption. Prestige Biopharma will be responsible for the production and supply of the drug substance through its EU-GMP-certified, high-tech facility equipped with advanced single-use technology. Biosidus will manufacture the drug product at its facility in Buenos Aires, Argentina, from which it will supply the product to the local market, and export the product to the markets of Mexico, Paraguay and Bolivia. Lisa S. Park, CEO of Prestige BioPharma, commented: "We are pleased to announce our strategic partnership with Biosidus for Argentina and other key markets in Latin America. With its proven track record and deep regional expertise, Biosidus represents an ideal partner for the successful manufacturing and commercialization of our lead biosimilar. We are confident that this collaboration will further enhance the global value and reach of our biosimilar portfolio." Mariano Elizalde, CEO of Biosidus, said: "We are proud to partner with Prestige Biopharma to introduce Tuznue® in selected markets across Latin America. This agreement strengthens our Biosimilars portfolio and our commitment to expand access to biotechnological medicines in Latin America. Together with Prestige Biopharma, we are confident in offering patients and healthcare professionals a quality and affordable therapeutic option". About Tuznue® Tuznue® is a biosimilar of Herceptin® (trastuzumab), developed to offer a more cost-effective therapeutic alternative for patients. It maintains comparable efficacy and safety profiles to the original branded medication. Tuznue® is indicated for the treatment of patients with HER2-positive metastatic breast cancer (MBC), HER2-positive early breast cancer (EBC), and HER2-positive metastatic gastric cancer (MGC). About Prestige Biopharma Established in 2015 in Singapore, Prestige Biopharma is a biopharmaceutical company with a diversified portfolio. Among its many pipelines, a first-in-class antibody drug and key biosimilars referencing blockbuster drugs are ongoing clinical development. Notably, the first-in-class PAUF-based antibody drug, ulenistamab, has received Orphan Drug Designation from the U.S. FDA, the European EMA, and the Korean MFDS, along with Fast Track Designation from the U.S. FDA. A global Phase 1/2a clinical trial is currently underway in the United States, Europe, and Asia, with the aim of bringing this innovative therapy to the clinic. About Biosidus Biosidus is an Argentine company, a pioneer in biotechnology, which over the last 42 years has achieved a leadership position in Latin America and a growing share in other emerging markets in Asia, Africa and Eastern Europe, developing, producing and marketing biopharmaceuticals of the highest quality at affordable prices. 21% more press release views with Request a Demo

Orphan DrugLicense out/inDrug ApprovalFast Track

01 Aug 2024

·www.prnewswire.com

Prestige Biopharma's Herceptin Biosimilar Tuznue® Receives Positive CHMP Opinion from the EMA

Following approval by the European Commission, Prestige Biopharma's Herceptin biosimilar Tuznue® would become the first biosimilar from a Singaporean company to be authorized in the European Union. SINGAPORE, Aug. 1, 2024 /PRNewswire/ -- Prestige Biopharma, a pioneer in biopharmaceuticals, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for Tuznue®, a Herceptin (trastuzumab) biosimilar. This milestone positions Prestige Biopharma to become the first Singaporean firm to commercialize its biosimilar in the European Union. The CHMP's positive opinion is based on clinical evidence from Phase 1 and Phase 3 clinical studies that tested the biosimilarity of Tuznue® to Herceptin®. The Phase 1 clinical PK study in healthy volunteers demonstrated PK equivalence, as well as similarity in safety and immunogenicity. Finally, the global Phase 3 confirmatory efficacy and similarity study met its primary endpoint and demonstrated similarity in efficacy, PK, safety, and immunogenicity in HER2-positive patients with early breast cancer. This favourable decision is a crucial step toward final approval from the European Commission (EC). Once approved, Tuznue® will be commercialized across Europe. Prestige Biopharma has already established licensing agreements with major pharmaceutical partners for global marketing and sales. These agreements are set to generate immediate milestone payments and provide early revenue for the company. Negotiations are also underway to ensure a strong market entry for Tuznue® in Europe. "Receiving a positive CHMP opinion for Tuznue® marks a major milestone for Prestige Biopharma, significantly advancing our revenue generation strategy and accelerating future pipeline approvals," said Lisa Park, the CEO of Prestige Biopharma. "This recognition solidifies our position as a leading biosimilar developer. We are committed to leveraging this achievement to enhance our market presence and drive continued success." About TUZNUE® (HD201, Herceptin biosimilar) Tuznue® is a biosimilar of Herceptin® (trastuzumab), developed to offer a more cost-effective therapeutic alternative for patients. It maintains comparable efficacy and safety profiles to the original branded medication. Tuznue® is indicated for the treatment of patients with HER2-positive metastatic breast cancer (MBC), HER2-positive early breast cancer (EBC), and HER2-positive metastatic gastric cancer (MGC). About Prestige Biopharma: Established in 2015 in Singapore and listed in the Korea Exchange in 2021 (KOSPI: 950210), Prestige Biopharma Limited is a biopharmaceutical company with a diversified portfolio, including biosimilars (HD204 Avastin biosimilar in filing stage, PBP1502 Humira biosimilar in clinical stage) and new antibody drugs. Among its many pipelines, a first-in-class antibody drug and key biosimilars referencing blockbuster drugs are ongoing clinical development. Notably, the first-in-class, PAUF-based antibody drug, Ulenistamab, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) in Korea, as well as Fast Track Designation by the U.S. FDA. A global Phase 1/2a clinical trial is currently underway in the United States, Europe, and Asia, with the aim of bringing this innovative therapy to the clinic. Contacts Prestige Biopharma Group Donghee Im [email protected] Logo -

Clinical ResultOrphan DrugLicense out/inPhase 3Fast Track

21 Mar 2023

·www.biospace.com

Prestige Biopharma Receives FDA Fast Track Designation for PBP1510 in the Treatment of Pancreatic Cancer

SINGAPORE--(BUSINESS WIRE)-- 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. PBP1510 targets Pancreatic Adenocarcinoma Upregulated Factor (PAUF), a tumour-specific protein, found to be overexpressed in majority of pancreatic cancer cases. PAUF overexpression promotes key cellular functions, including proliferation, migration, invasion, and growth of pancreatic cancer cells, and contributes to the development of acquired resistance to chemotherapeutic agents. PBP1510 is designed to target these key biological mechanisms that results in limited effectiveness of current treatment options and rapid progression of pancreatic cancer. By effectively inhibiting the tumorigenic effects of PAUF overexpression in preclinical models, PBP1510 represents a promising therapeutic strategy for addressing the unmet medical needs of pancreatic cancer patients. A global Phase 1/2a clinical trial is currently underway in the United States, Europe, and Asia, with the aim of bringing this innovative therapy to the clinic. The first-in-human Phase 1/2a study is an open-label, multicentre, two-part study in patients with advanced/metastatic pancreatic cancer. Phase 1 is a dose-escalation phase, wherein PBP1510 will be administered, either as monotherapy or in combination with gemcitabine, in two separate dose-escalation cohorts. From Phase 1 part of the study a recommended Phase 2a dose (RP2D) will be determined based on the analysis of pharmacokinetics, safety, and efficacy data. Phase 2 is a dose-expansion phase, wherein PBP1510 at the RP2D in combination with gemcitabine will be administered to evaluate efficacy and safety of PBP1510. Overall, the Phase 1/2a study aims to collect important safety data on the use of PBP1510 as a monotherapy or in combination with gemcitabine and explore the efficacy of a combined PBP1510 and gemcitabine regimen. The study will substantiate the preclinical findings of PBP1510’s synergistic antitumour activity in combination therapy with gemcitabine without increased toxicity, as anticipated from their distinct mechanisms of action. With Fast Track designation from the FDA, PBP1510 represents a promising advancement in the treatment of pancreatic cancer. Prestige Biopharma intends to take full advantage of the benefits offered by the designation to provide faster access for patients in need. View source version on businesswire.com: Contacts info@prestigebio.com Source: Prestige Biopharma Limited View this news release online at:

Fast TrackPhase 1Phase 2

100 Deals associated with Ulenistamab

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Pancreatic Cancer	Phase 2	Spain	Prestige BioPharma Ltd.	16 Feb 2022
Pancreatic adenocarcinoma metastatic	Phase 2	Spain	Prestige BioPharma Ltd.	16 Feb 2022
Ovarian Cancer	Preclinical	Singapore	Prestige BioPharma Ltd.	18 Apr 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO2025	Phase 1/2	Pancreatic Cancer	27	Ulenistamab monotherapy	nipudjiori(ubdndhmkwe) = gorbpepdaw nrvtfkyqud (xbpsfycxzs ) View more	Positive	17 Oct 2025
				Ulenistamab + gemcitabine	gakceqcwas(oogichxdbz) = atbjnsshmb qoayzlsrsd (bkrkyuxacn ) View more

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