NEWS | Innovation for Life

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 Cancer

SINGAPORE, 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.

SINGAPORE, 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.

SINGAPORE, November 02, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, announced that the request to the U.S. Food and Drug Administration (FDA) for a pre-submission meeting for Herceptin Biosimilar, HD201(Tuznue®) has been accepted and the meeting has been scheduled for 14th of December this year.The Biosimilar Biological Product Development (BPD) Type 4 Meeting is to discuss the format and content of a Biologics License Application (BLA) in advance of the final submission. The company will discuss the overall development program of HD201 with the FDA to identify potential filing and review issues.The company has been preparing for FDA BLA for HD201 since 2019 when the company had the Biosimilar Initial Advisory Meeting with the FDA. The FDA bridging study was completed in 2020 and the study result was published in the international journal of Pharmacology Research & Perspectives in July 2021. The study showed HD201’s equivalent pharmacokinetic and safety profile to both US-Herceptin® and EU- Herceptin®.Prestige Biopharma’s HD201 is a proposed biosimilar to Roche’s Herceptin® (trastuzumab) to be prescribed for the treatment of human epidermal growth factor 2 (HER2) positive breast and metastatic gastric cancer. Trastuzumab targets HER2, which is overexpressed in some types of cancer cells and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells.Currently, a New Drug Submission (NDS) for HD201 is under review by Health Canada and a Marketing Authorisation Application (MAA) by the Korea Ministry of Food and Drug Safety. In addition to filing a new MAA to the European Medicines Agency (EMA), the company also plans to apply for authorisation in other advanced biosimilars markets such as UK, Australia, and Switzerland.

SINGAPORE, [01 November 2022] / Prestige Biopharma Limited, a Singapore-based leading biopharmaceutical company, announced that the CEO of its subsidiary, Prestige Biopharma Korea, received 2022 Foreign Company Day award in South Korea.The ceremony was held on 1st of November 2022 at Intercontinental Hotel Seoul to award 44 companies’ representatives orders and merits of honor for their contribution to boosting Foreign Direct Investment (FDI) to South Korea.The CEO of Prestige Biopharma Korea, Tay Lai Wat, was awarded the commendation of the Ministry of Trade, Industry and Energy (MOTIE) minister for his commitment to FDI to South Korea.

SINGAPORE, October 14, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, has submitted a request to the U.S. Food and Drug Administration (FDA) for a pre-submission meeting to discuss the company’s planned Biologics License Application (BLA) for its Herceptin Biosimilar, HD201(Tuznue®).The Biosimilar Biological Product Development (BPD) Type 4 Meeting is to discuss the format and content of a BLA in advance of the final submission. The company will discuss the overall development program of HD201 with the FDA to identify potential filing and review issues.  The meeting is expected to take place around November, and the BLA submission by the end of the year.Prestige Biopharma’s HD201 is a proposed biosimilar to Roche’s Herceptin® (trastuzumab) to be prescribed for the treatment of human epidermal growth factor 2 (HER2) positive breast and metastatic gastric cancer. Trastuzumab targets HER2, which is overexpressed in some types of cancer cells and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells.Currently, a New Drug Submission (NDS) for HD201 is under review by Health Canada and a Marketing Authorisation Application (MAA) by the Korea Ministry of Food and Drug Safety. In addition to filing a new MAA to the European Medicines Agency (EMA), the company also plans to apply for authorisation in other advanced biosimilars markets such as UK, Australia, and Singapore.Lisa Park, CEO of Prestige Biopharma, commented: “This Type 4 Meeting will be the final gate of BLA for HD201. In addition to the Bridging Study on biosimilarity of HD201 to US-Herceptin® and the Biosimilar Initial Advisory Meeting with FDA in 2019, we have been through a series of meetings with the FDA on each step of the development to prepare the launch of HD201 in US to help more patients in need. We will take this final step to thoroughly review and finalise the application for FDA’s approval.”

SINGAPORE, October 6, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, announced that the company is attending the 2022 Biosimilar Medicines Conference which takes place in Brussels, Belgium, on October 6 and 7.The Biosimilar Medicines Conference by Medicines for Europe (MfE) aims to facilitate discussion on existing challenges and future opportunities for biosimilar medicine policy and pharmaceutical legislation. The MfE represents the pharmaceutical companies supplying the largest share of medicines across Europe. According to the association, its members currently supply over 67% of all medicines in Europe.This year’s conference is held in person after three years since COVID-19 pandemic. Speakers and panellists will explore how to turn the Pharmaceutical Strategy aim to ensure better access and affordability into concrete biosimilar medicine policy measures.At the conference, many former and current members of European Medicines Agency (EMA) will be speakers and address biosimilar medicine policies. Prestige Biopharma plans to actively engage in discussions on regulations and build network, while seeking opportunities for collaboration with major biopharmaceuticals in Europe.Dr. Susanne Schmidt, Director of Alliance & Portfolio Management in Prestige Biopharma, will participate in the conference. Dr. Schmidt had served as Senior Director of Global/International Business Development at Pfizer and has 25 years of experience in the biopharmaceutical industry, working for multiple leading pharmaceuticals.Dr. Schmidt commented: “The healthcare systems and policies in the European market vary from country to country. This conference, which brings together pharmaceutical experts from different countries in Europe, provides a good opportunity for in-depth study and understanding on the European market. We also plan to strengthen our presence in the European market by participating in more conferences held in individual European countries and introducing our pipeline portfolio and R&D results.”

SINGAPORE, October 5, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, announced that a team of scientists at Prestige Biopharma Innovative Discovery Centre (IDC) published a study titled ‘PAUF Induces Migration of Human Pancreatic Cancer Cells Exclusively via the TLR4/MyD88/NF‐κB Signalling Pathway’ in the International Journal of Molecular Sciences.PAUF (pancreatic adenocarcinoma up‐regulated factor) is a novel secreted protein which is substantially expressed in pancreatic cancer cells. It is known to induce pancreatic cancer progression and metastasis. According to this study, PAUF binds directly to TLR4 (Toll‐like receptor 4), which is identified as a receptor for PAUF, on pancreatic cancer cell surfaces and promote cell migration exclusively through the TLR4/MyD88/NF‐κB pathway.In addition, the study demonstrated that the knockout of TLR4 led to a marked decrease in the expression of PD‐L1 (Programmed Death‐Ligand 1), an immune checkpoint contributing to cancer immune escape. Accordingly, the scientists are conducting a follow-up study to confirm if combining anti-PAUF treatment with TLR4 inhibitor can enhance treatment efficacy.The results of this study enhanced the understanding of the mechanism of PAUF‐induced tumour‐promoting effects. Furthermore, it suggests that TLR4 expression on cancer cells may be a critical biomarker for anti‐PAUF treatment, implying a potential clinical application in later phase clinical trials.Prestige Biopharma has been developing PBP1510 (INN: Ulenistamab), a first-in-class anti-PAUF monoclonal antibody for pancreatic cancer treatment. PBP1510 been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA), US Food and Drug Administration (FDA) and Korean MFDS. Currently, it is on Phase 1/2a clinical trial in France, Spain, and US.Sangseok Koh, President of Prestige Biopharma IDC commented: “Through this study, we found a potential therapeutic biomarker and target for the development of effective pancreatic cancer treatment. We will keep up our research to discover and develop methods to control TLR4 expression and further improve PBP1510’s treatment effect.”Meanwhile, Prestige Biopharma IDC is also undergoing research on technology for diagnosis of pancreatic cancer by detecting PAUF in the body. IDC aims to continue its efforts to enable early diagnosis of fatal diseases as well as effective treatment through innovative drugs.

SINGAPORE, September 28, 2022 – Prestige Biopharma announced on September 27 through a public disclosure that Octava Fund Limited, the company’s major institutional shareholder, has purchased 57,000 KDR of Prestige Biopharma stock. Tay Lai Wat, Executive Director of Prestige Biopharma, also purchased 5,000 KDR Group to help defend the stock price.The company explained that the additional investment from its major institutional shareholder confirmed their steady partnership and trust based on the fundamental and intrinsic value of the company as well as the potential growth of the business.Recently, Prestige Biopharma withdrew its Marketing Authorisation Application (MAA) for HD201 submitted to the European Medicines Agency (EMA). The company plans to file a new MAA for HD201 to the EMA with supplementation of data and analysis.Since EMA informed a negative opinion on the Marketing Authorisation Application for the company’s Herceptin Biosimilar in May, major shareholders have been concerned about the sharp drop in stock price and showing support and confidence by purchasing the company’s stock.In May, Chairman Lisa S. Park and Vice Chairman Michael J. Kim of Prestige Biopharma Group, the largest shareholders of the two companies, bought a total of KRW 7.5 billion worth of stock through Mason Partners, a joint investment company established by Chairman Park and Vice Chairman Kim. In July, Octava Fund had purchased KRW 1.3 billion of Prestige Biopharma stock and KRW 400 million of Prestige Biologics stock, amounting to a total of KRW 1.7 billion.Tay Lai Wat, Executive Director of Prestige Biopharma, commented: “The recent withdrawal of MAA submitted to the EMA is nothing more than a temporary delay in the company’s plan. The company has no issue with its fundamental value, business competence, and liquidity.”According to the company, a New Drug Submission (NDS) for HD201 is under review by Health Canada and a MAA by the Korea Ministry of Food and Drug Safety. At the same time, the company is on track with the phase 3 clinical trial of its Avastin biosimilar HD204, phase 1 clinical trial of its Humira biosimilar PBP1502 in Europe, and phase 1/2a clinical trial of its first-in-class antibody PBP1510 in Europe and US.