NEWS | Innovation for Life

Prestige Biologics enters into MoU with Aurigene Pharmaceutical Services Limited to explore collaboration in the global biologics CDMO marketPrestige Biologics, a Contract Development and Manufacturing Organization (CDMO) specializing in biopharmaceuticals, announced the establishment of a strategic partnership with Aurigene Pharmaceutical Services Limited (APSL), a wholly owned step-down subsidiary company of Dr. Reddy’s Laboratories Limited, through the signing of a non-binding Memorandum of Understanding (MoU). The MoU, which is subject to a Definitive Agreement, will oversee collaborative efforts between Prestige Biologics and APSL to bring in a comprehensive set of services and capabilities towards meeting the CDMO needs of biologics-focused companies. “We are delighted to announce our strategic partnership with Aurigene Pharmaceutical Services Limited,” stated Duk Hoon Hyun, CEO of Prestige Biologics. “Prestige Biologics’ global prominence in the CDMO market, coupled with Aurigene’s pharmaceutical expertise in R&D services, will create an end-to-end service capability in the Biologics CRDMO segment through this collaboration, offering cell line development to large-scale manufacturing services for global Biologics customers.”Aurigene Pharmaceutical Services Limited is a Contract Research, Development and Manufacturing Organization (CRDMO) with end-to-end capabilities across drug discovery, development, and manufacturing of small and large molecules. Dr. Reddy’s Laboratories Limited, the parent company of APSL, is a global pharmaceutical company, founded in 1984, with four decades of expertise in pharmaceutical development, and a global commercial network. Prestige Biologics operates production facilities based in South Korea, with a manufacturing capacity of 154,000 litres, making Prestige Biologics one of the top 10 global CDMO companies working with animal cell culture.

CPhI Worldwide 2023 in EuropeEvent Dates: October 24th (Tuesday) - October 26th (Thursday), 2023Venue: Fira de Barcelona - Recinto Gran ViaCity/Country: Barcelona / SpainWebsite: www.europe.cphi.comSchedule:October 24th: 09:00* - 18:30October 25th: 09:00* - 18:30October 26th: 09:00* - 16:00   *The start time is the same for all days.RESERVATIONWe hope to meet with you to explore potential opportunities.Please let us know your desired date and time in the table below, and we will get in touch with you. Thank you.[ameliastepbooking service=1]INQUIRET. +8210 - 4401 - 9913   E. bd@prestigebio.com

Prestige Biopharma IDC, a leading figure in antibody drug research, stood prominently as it participated in the '2023 Global Healthcare Week.'August 22, 2023 -  The event took place at BEXCO in Busan for three days starting from the 17th, featuring an opening ceremony with ribbon-cutting and participation in exhibition booths. During the event, Prestige Biopharma IDC, represented by CEO Seok Jae SEO, revealed its cutting-edge advancements in antibody drug research and development. The event, characterized as an integrated healthcare exhibition, was organized based on active support for the life care industry, one of Busan Metropolitan City's seven major strategic industries. The company also explained that it engaged in numerous meetings with industry stakeholders and domestic institutions to foster strategic partnerships.This event is the 6th edition held this year, with participation from 148 healthcare-related institutions. 29% increase compared to the previous year's participation of 115 institutions. With comprehensive support from Busan Metropolitan City, the event has grown significantly into a global bio event. Prestige Biopharma IDC, actively engaged in developing antibody pharmaceuticals, including for pancreatic cancer, shared that it utilized this event to discuss and formulate practical business strategies with various stakeholders in the healthcare industry, including medical experts.Especially noteworthy was the opening ceremony on the 17th, where Prestige Biopharma IDC's CEO, Seokjae SEO, joined key figures such as Economic Deputy Mayor Seongkwon Lee, Future Industries Director Gyeongdeok Lee, Director of Eunseong Medical Foundation, Namgyeongchan, President of the Korea Medical Devices Distribution Association, Buyeolkwang Branch, Gangbyeongsu of KOTRA Busan, Secretary General Kim Byeonggun of Busan Healthcare Industry Association, Director of the Innovative Health Convergence College at Dong-eui University, Gyeongtae Jeong, and Director of Industrial Promotion Support at Busan Economic Promotion Agency, Jihwan Oh, in cutting the opening ceremony ribbon. Subsequently, the company actively promoted various bio healthcare research activities, ranging from antibody drugs, biosimilars, vaccines to diagnostics, through its dedicated exhibition booth. Of particular significance was the opportunity to discuss the promotion of industrial growth at the Busan level and the establishment of a healthcare cluster.CEO Seokjae SEO of Prestige Biopharma IDC commented, "This event in Busan, where the significance of a healthy life has been highlighted even more after the post-COVID-19 era, was a meaningful occasion to promote various new drug research efforts that the company is undertaking for the sake of 'innovation for life.' Through this event, along with the cooperation of newly established relationships within the medical industry and comprehensive support from Busan Metropolitan City, we will solidify our position as a company that contributes to improving national health and promoting global healthcare in the post-pandemic era."Meanwhile, at Prestige Biopharma Group's Innovative Discovery Center (IDC), responsible for antibody drug development, core projects including the development of antibody drug PBP1510 for pancreatic cancer and a diagnostic kit for the same disease are being actively pursued. With Prestige Biopharma recently joining the 'Cancer Moonshot' project, a cancer conquest initiative led by U.S. President Joe Biden, related research is advancing vigorously.<picture : Seok Jae SEO, CEO of Prestige Biopharma IDC (fifth from the right), participating in the ribbon-cutting ceremony of the '2023 Global Healthcare Week,' held at BEXCO in Busan from the 18th to the 3rd for three days.><picture :  View of the Prestige Biopharma IDC booth participating in the '2023 Global Healthcare Week,' held at BEXCO in Busan from the 18th to the 3rd for three days.>

August 11, 2023     Prestige Biopharma and Imagion Biosystems Sign an MOU, Developing Early Pancreatic Cancer Diagnosis PlatformSINGAPORE, and San Diego, California –Prestige Biopharma, a biopharmaceutical company specializing in innovative antibody therapies, with a strong dedication to tackling pancreatic cancer, and Imagion Biosystems, the pioneer in molecular Magnetic Resonance Imaging (MRI) dedicated to changing the way we see cancer, have announced the establishment of a strategic partnership through signing a Memorandum of Understanding (MOU). Together, the companies will jointly pursue the development of the world’s first non-invasive early detection diagnosis and staging platform for pancreatic cancer. This potentially groundbreaking collaboration between the molecular MRI innovator listed on the Australian Stock Exchange (ASX: IBX), and a biopharmaceutical company listed on the Korean Stock Exchange marks a significant leap forward in the fight against one of the most lethal forms of cancer.Often referred to as the “silent killer,” healthcare systems globally lack a reliable method for early detection or diagnosis of pancreatic cancer, with approximately 80% of patients being diagnosed at stage 4 with terminal disease. Recognizing the need for an early detection solution, Prestige Biopharma aims to leverage its unique target protein PAUF as a biomarker, which is overexpressed in more than 80% of pancreatic cancer patients, along with Imagion Biosystems’ next-generation molecular MRI platform technology to explore possibilities for early pancreatic cancer diagnosis.Establishing earlier pancreatic cancer diagnosis paves the way for the subsequent focus on treatment strategies. Combining MagSense® molecular MRI and Prestige Biopharma’s PAUF-based antibody drug, PBP1510 aims to accelerate accurate diagnosis and therapeutic intervention.The MOU covers preclinical feasibility research that should be completed in a matter of months. Should the research produce favorable results, both companies may then agree to expand the collaboration to further advance the technologies. Both companies will bear their own costs during the period of the MOU with expenses during this phase well within the scope of normal preclinical feasibility R&D initiatives.“We are very pleased to form a strategic partnership with Imagion Biosystems,” stated Lisa Park, CEO of Prestige Biopharma. “Prestige Biopharma Group has made significant progress in building the pancreatic cancer therapeutics system, encompassing diagnosis, treatment, and even prevention. It is an honor for us to take a step closer to achieving our goal in pancreatic cancer diagnosis through the partnership with Imagion Biosystems.” “This is an important opportunity to deploy our MagSense® molecular MRI platform technology for improved detection and diagnosis of solid tumors and metastatic disease,” said Dr. Isaac J. Bright, CEO of Imagion Biosystems. “Prestige Biopharma is an innovative collaborator with whom we intend to accelerate access to, and improve management options for pancreatic cancer patients and their healthcare providers globally.”“We are very pleased to form a strategic partnership with Imagion Biosystems,” stated Lisa Park, CEO of Prestige Biopharma. “Prestige Biopharma Group has made significant progress in building the pancreatic cancer therapeutics system, encompassing diagnosis, treatment, and even prevention. It is an honor for us to take a step closer to achieving our goal in pancreatic cancer diagnosis through the partnership with Imagion Biosystems.”“This is an important opportunity to deploy our MagSense® molecular MRI platform technology for improved detection and diagnosis of solid tumors and metastatic disease,” said Dr. Isaac J. Bright, CEO of Imagion Biosystems. “Prestige Biopharma is an innovative collaborator with whom we intend to accelerate access to, and improve management options for pancreatic cancer patients and their healthcare providers globally.”

Prestige Biopharma completed the patient recruitment of 650 participants for the global Phase 3 clinical trial of Avastin biosimilar, HD204Prestige BioPharma (CEO Lisa Soyeon Park) announced on the 25th of July 2023 that the company has completed the global Phase 3 clinical trial patient recruitment for the Avastin biosimilar (Bevacizumab biosimilar), HD204.According to the company, the clinical trial for HD204 with 650 enrolled patients is progressing smoothly, and they plan to apply for product approval as soon as valid data is secured by the end of this year. Additionally, Prestige BioPharma aims to expedite the commercialization process by rapidly completing the Phase 3 clinical trial for HD204, along with HD201 (Herceptin biosimilar), for which the European Medicines Agency (EMA) approval application is imminent.The global Phase 3 clinical trial for HD204, conducted by Prestige BioPharma, spans multinational clinical trial sites and it involves a total of 650 patients as a large-scale project. Despite some delays in patient recruitment in certain countries due to the COVID-19 pandemic situation over the past two years, the company announced that they have recently completed recruitment up to the 650th patient and are progressing with drug administration swiftly. Especially for a large-scale Phase 3 trial, it is expected that this completion of patient recruitment will accelerate the overall pace of the clinical trial.Furthermore, with the completion of patient recruitment for the global Phase 3 trial, Prestige BioPharma plans to pursue an aggressive product approval strategy to expedite the commercialization process. For the approval and sales of HD204 in Europe and the United States, the company has partnered with Intas Pharmaceuticals, which achieved 2 trillion won in sales last year and has a global sales network covering 85 countries, along with their subsidiary, Accord Healthcare, in the UK. Accord Healthcare is a global emerging player that has submitted more than 50 drug approval applications to the EMA since 2011 and is committed to immediately entering the fast-track commercialization process as soon as valid data for HD204 is secured.Prestige BioPharma's CEO, Lisa Soyeon Park, stated, "HD204 has already entered into licensing agreements for commercialization with Accord Healthcare and Pharmapark, and active discussions on sales-related partnerships with other global pharmaceutical companies are also underway." She further emphasized that as an antibody bio-pharmaceutical company with diverse pipelines of biosimilars and novel antibody drugs, they will accelerate commercialization through cooperative competition (co-opetition) with global pharmaceutical companies, focusing on advancing clinical progress and securing sales.

Prestige Biopharma announced today its participation with CancerX, a public-private partnership launched by The White House to accelerate the fight against cancer, as part of the renewed Cancer Moonshot Project. CancerX, a collaborative effort between Moffitt Cancer Center and Digital Medicine Society (DiMe), aims to unite diverse stakeholders and revolutionize cancer research, diagnosis, and treatment.Recognizing Prestige Biopharma’s strategic approach to pancreatic cancer treatment, CancerX has invited Prestige Biopharma to share its extensive experience in this field with leading global organizations participating in the Cancer Moonshot Project.Prestige Biopharma is committed to leveraging its participation in CancerX to actively lead various research initiatives, utilizing its unique target protein PAUF as a biomarker, in order to pioneer pancreatic cancer diagnosis, treatment, and even prevention.One of the primary goals that Prestige Biopharma is particularly enthusiastic about is the rapid commercialization of the world’s first diagnostic kit for early detection of pancreatic cancer. Joining the Cancer Moonshot Project will boost its acceleration of the diagnostic kit.Notable members of this project include global companies and research institutions such as Johnson & Johnson, Genentech, AstraZeneca, NCI, AWS, and Intel. The collaborative efforts of these renowned entities will serve as a powerful catalyst for emphasizing the importance of early pancreatic cancer diagnosis.About Prestige Biopharma:Prestige Biopharma is a Singapore-based pharmaceutical company, established in 2015. In 2021, the company was listed on the KOSPI market in Korea, showcasing its two novel antibody drugs and biosimilars of three blockbuster drugs. Notably, Prestige Biopharma is currently in the process of developing an antibody drug named PBP1510, which specifically targets and neutralizes PAUF, a protein found to be overexpressed in over 80% of pancreatic cancer patients. This protein is believed to play a crucial role in the progression and metastasis of pancreatic cancer. PBP1510 has been designated as an orphan drug by the FDA, EMA, and MFDS in 2021. It is currently undergoing Phase 1/2a clinical trials in the US and Europe and has recently been granted FDA Fast Track designation.

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.

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.

SINGAPORE, 28 February 2023Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, announced that the company requested Fast Track designation to US Food & Drug Administration (FDA) for its first-in-class anti-PAUF monoclonal antibody ‘PBP1510 (INN-ulenistamab)’ for pancreatic cancer treatment. FDA will review the request and decide within sixty days. In June 2022, the company was granted approval for phase 1/2a clinical trial of PBP1510 in the US by FDA. The company plans to further expedite the development through FDA’s approach. PBP1510 has been recognized as a promising new drug for pancreatic cancer treatment. The drug targets and neutralizes PAUF (Pancreatic Adenocarcinoma Up-regulated Factor), a protein that plays a critical role in tumor growth and rapid progression of pancreatic cancer. In 2020, PBP1510 was granted Orphan Drug designation by the US FDA, the European Medicines Agency (EMA), and Korea Ministry of Food and Drug Safety. In addition, the company has applied for patent for the first-in-class antibody in 24 countries, which has been successfully registered in 10 countries as of now including the US, Korea, and Singapore. Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. To receive Fast Track designation, it must be determined that a drug treats or prevents a serious condition with no current therapy or show some advantage over available therapy in a serious condition. Pancreatic cancer has the highest mortality rate among major cancers and is the third leading cause of cancer-related death in the US. The company aims to pave the express way for PBP1510 by seeking close consultation and support from FDA through Fast Track designation.  Upon receiving Fast Track designation, the company will have more frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval. In addition, it can have more frequent written communication from FDA on such matters as the design of the proposed clinical trials and use of biomarkers. These benefits lead to higher efficiency and stability in development. Moreover, the company is eligible for Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed which is the usual case. Dr. Lisa S. Park, CEO of Prestige Biopharma, commented: “We are making all round efforts to ensure the success of our first-in-class antibody PBP1510 through patent registration, clinical studies and development, and preparation for market authorization and commercialization. In addition to the Fast Track designation request, we also plan to request for FDA’s Breakthrough Therapy designation for PBP1510, as soon as we confirm preliminary clinical evidence on significant endpoint, to secure intensive guidance on efficient drug development program and organizational commitment involving senior managers.”