Prestige Biopharma announces International Non-proprietary Name for PBP1510

Prestige Biopharma announces International Non-proprietary Name for PBP1510 Prestige Biopharma Receives WHO International Nonproprietary Name (INN) for PBP1510: “Ulenistamab” Prestige Biopharma, a global biopharmaceutical company specializing in antibody therapeutics (CEO: Soyeon Park), announced on the 31st that the World Health Organization (WHO) has assigned an International Nonproprietary Name (INN) to its investigational drug candidate PBP1510. The newly assigned name, “Ulenistamab,” has been officially listed in the WHO INN database and will serve as the internationally recognized generic name for PBP1510. The drug is a novel antibody therapeutic designed to neutralize PAUF (Pancreatic Adenocarcinoma Up-regulated Factor), a protein that is overexpressed in pancreatic cancer and acts as a key therapeutic target. The INN system is a global nomenclature program administered by the WHO to assign unique, universally recognized names to pharmaceutical substances. INNs are essential for the identification and prescription of medicines in many countries and are granted only after a rigorous evaluation process. Prestige Biopharma submitted its INN application to the WHO in May 2020. Following the submission, an expert INN panel composed of leading global specialists in medicine and pharmacology reviewed the drug’s composition, pharmacological properties, and therapeutic potential. After the formal review and public consultation period, the panel finalized the assignment of the name “Ulenistamab.” Accordingly, the active substance name of the PBP1510 anti-PAUF antibody will be internationally recognized as Ulenistamab. PBP1510 has previously received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Korean Ministry of Food and Drug Safety (MFDS) in 2020. The drug is currently undergoing Phase 1/2a clinical trials in France and Spain. Soyeon Park, CEO of Prestige Biopharma, stated, “Following its recognition through orphan drug designation, PBP1510 has now received international acknowledgment through the assignment of the INN ‘Ulenistamab.’ We expect this milestone to further accelerate its path toward commercialization. As we believe PBP1510 has the potential to significantly improve survival outcomes not only for pancreatic cancer patients but also for ovarian cancer patients, we will continue to dedicate our efforts to advancing clinical development and bringing this innovative therapy to patients as soon as possible.” Meanwhile, Prestige Biopharma recently published a new research paper investigating the potential of PBP1510 as a treatment for ovarian cancer. According to the study published in the SCI-indexed international journal Frontiers in Pharmacology, overexpression of PAUF may accelerate tumor progression and worsen prognosis not only in pancreatic cancer but also in ovarian cancer. The findings suggest that PBP1510 may also have therapeutic potential for ovarian cancer characterized by PAUF overexpression. Source: https://www.nbntv.co.kr/news/articleView.html?idxno=975429

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