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Prestige Biopharma and Imagion Biosystems Sign an MOU, Developing Early Pancreatic Cancer Diagnosis PlatformAugust 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.”NEWS
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Prestige Biopharma completed the patient recruitment of 650 participants for the global Phase 3 clinical trial of Avastin biosiPrestige 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.
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Prestige Biopharma Joins CancerX as a MemberPrestige 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.NEWS
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Prestige Biopharma Receives FDA Fast Track Designation for PBP1510 in the Treatment of Pancreatic CancerPrestige 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.NEWS
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Prestige Biopharma Receives FDA Fast Track Designation for PBP1510 in the Treatment of Pancreatic CancerPrestige 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.NEWS
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Prestige Biopharma Requests FDA Fast Track Designation for Its First-in-Class Pancreatic Cancer Treatment PBP1510SINGAPORE, 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.”NEWS
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Final Analysis of Phase 3 Clinical Trial of Prestige Biopharma’s HD201 published in ‘BMC Cancer’The final analysis of phase 3 clinical trial of Prestige Biopharma’s Herceptin biosimilar has been published in ‘BMC Cancer’. Hence, the company is speeding up for the marketing authorization in US and Europe. Prestige Biopharma, a Singapore-based biopharmaceutical company, announced the publication of ‘Final analysis of the phase 3 randomized clinical trial comparing HD201 vs. referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting’ in ‘BMC (BioMed Central) Cancer’. HD201 (Tuznue) is the company’s Herceptin biosimilar. Based on the final analysis of phase 3 clinical trial, the company plans to expedite the preparation for BLA submission to US FDA (Food and Drug Administration).BMC cancer is a peer-reviewed open access medical journal that publishes original research on cancer and oncology. Following the previous analysis at a median follow-up of 31 months, this final analysis has compared long-term survival rates at a median follow-up of 37.7 months, confirming the comparable efficacy and safety of HD201 and trastuzumab. The publication of the final analysis was led by professor Xavier Pivot who took charge of the clinical trial of Roche’s Herceptin and Samsung Bioepis’ Herceptin biosimilar.The global phase 3 clinical trial of HD201 was carried out from February 2018 to January 2022 in 12 countries for a total of 502 HER2 positive cancer patients who randomly received treatment with either HD201 or referent trastuzumab. According to the final analysis, which was performed after all patients completed the study at a median follow-up of 37.7 months, HD201 has shown excellence in long-term efficacy and safety. The 3-year event-free survival (EFS) rates were 85.6% and 84.9% in the HD201 and referent trastuzumab groups, respectively, and the 3-year overall survival (OS) rates were 95.6% and 96.0%, confirming comparability of HD201 and the referent trastuzumab.Prestige Biopharma has previously supported the excellence of HD201 through several publications of studies and analysis. In July 2021, the company published a bridging study in ‘Pharmacology Research & Perspectives’ equivalent pharmacokinetic and safety profile to both US-Herceptin® and EU- Herceptin®. In March 2022, the company’s publication of phase 3 clinical trial analysis in ‘JAMA Oncology’ highlighted comparative efficacy and safety of HD201 and the referent trastuzumab in terms of the total pathological complete response rates.Lisa S. Park, CEO of Prestige Biopharma, commented: “This final analysis, based on the data that we have been accumulated over the past three years, has once again proved the excellence of HD201, being published in a reputable journal in the field of oncology. Confident with high comparability with the original drug, efficient production through our affiliate company Prestige Biologics, and past experience in applying for marketing authorization to EMA, we will focus on getting the marketing authorization for HD201 in various regions including US, Europe, Canada, and Korea as soon as possible.”The full article published in BMC Cancer can be found at: https://bmccancer.biomedcentral.com/articles/10.1186/s12885-023-10574-2Prestige Biopharma Chairman Lisa Soyeon Park in front of the laboratory in Singapore headquarters Screenshot of the online publication in BMC CancerNEWS
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Prestige Biopharma Obtains a Patent in Korea for Its Novel Antibody ‘PBP1710’ for Solid Cancer TreatmentSINGAPORE, January 10, 2023 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical company specializing in antibody drug development, announced that the company has obtained a patent in Korea for ‘Novel CTHRC1-specific antibodies and the use thereof’ (PBP1710) designed by its Innovative Discovery Centre (IDC) to treat solid cancer including pancreatic cancer.Solid tumors including pancreatic cancer, express abnormally high levels of CTHRC1 (collagen triple helix repeat containing 1), a protein that facilitates cancer cell migration and growth. PBP1710 specifically binds to CTHRC1 and exerts anti-metastasis and anti-tumor growth effects.According to IDC, PBP1710 has shown remarkable research results on a cellular level, reducing cancer cell migration and invasion by approximately 45% in solid cancer such as pancreatic cancer, ovarian cancer, breast cancer and colorectal cancer. In addition, animal testing has shown PBP1710’ effect to inhibit cancer cell proliferation is equivalent to that of current primary cancer treatment in the market.A source from Prestige Biopharma stated: “This patent registration is significant in that we are preoccupying the technological advantage on the anti-CTHRC1 antibodies that can be used as a wide range of solid cancer treatments. Considering that CTHRC1 is highly distributed in many different types of cancer, the successful development of PBP1710 as a next-generation antibody drug is expected to greatly contribute to the improvement of cancer patient treatment and survival, particularly in combination with other cancer treatments.”PBP1710 is currently under review for patent registration in 21 other countries and regions including the US, Europe, Japan, and China. Meanwhile, Prestige Biopharma’s first-in-class antibody pipeline for includes PBP1710 (Anti-CTHRC1) and PBP1510 (Anti-PAUF) for pancreatic cancer treatment which is currently in phase 1/2a clinical trial.NEWS
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Prestige Biopharma Obtains PBP1510 Patent in Indonesia, Marking the TenthSINGAPORE, November 10, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical company specializing in antibody drug development, announced that the company has obtained a patent in Indonesia for PBP1510 (INN-ulenistamab), the company’s first-in-class anti-PAUF monoclonal antibody.PBP1510 has thus far been patented in a total of ten countries including Indonesia, Korea, United States, Japan, Australia, Taiwan, Russia, South Africa, Singapore, and Malaysia. In addition, it is currently under review for patent registration in 14 countries such as Canada and New Zealand.Being a first-in-class anti-PAUF treatment, PBP1510 prevents the progression and metastasis of the cancer induced by PAUF (Pancreatic Adenocarcinoma Up-regulated Factor) and creating a more responsive environment for antitumor immunotherapy. Thus, it is expected to provide significant benefit to patients suffering from PAUF-positive pancreatic cancer.In 2020, PBP1510 was granted Orphan Drug Designation by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and Korea Ministry of Food and Drug Safety (MFDS). Currently, it is undergoing phase 1/2a clinical trial in Europe and U.S.To bring the new promising drug to patients as early as possible, Prestige Biopharma is planning to apply for FDA’s Fast Track program, a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.NEWS