NEWS | Innovation for Life

SINGAPORE, March 30, 2022 – Prestige Biopharma Limited and Vaxine Pty Ltd announced that the two organizations have entered into a memorandum of understanding (MOU) to collaborate on the supply of Vaxine’s COVID-19 Vaccine, Covax-19® (also known as Spikogen®) and on the co-development of COVID-19/influenza combo vaccine.Vaxine has developed a state-of-the-art recombinant protein vaccine against COVID-19 that is manufactured using insect cells and includes Vaxine’s proprietary Advax polysaccharide adjuvant. This vaccine showed efficacy against infection by the Delta variant in Phase 3 clinical trials and already is in use in the Middle East. In December 2021, the Australian Therapeutic Goods Administration (TGA) granted a provisional determination allowing an application to be lodged for a provisional approval for this COVID-19 vaccine. Regulatory submissions are similarly underway in many other countries in parallel.Industry experts remain concerned that the next pandemic might be even worse than Covid-19, creating an urgent need to develop strong and affordable pandemic vaccine platforms like the one Vaxine created for its Covid-19 and influenza pandemic vaccine production.Through this MOU, Prestige and Vaxine will be building a long-term vaccine partnership, initially focused on manufacturing and commercialization of Vaxine’s Covid-19 vaccine and then as Covid-19 enters an endemic phase development of a next generation Covid-19/influenza combo vaccine as well as other vaccine projects.The MOU will bring together Prestige’s global scale vaccine manufacturing capacity & research expertise with Vaxine’s innovative vaccine technologies including its vaccines against COVID-19, seasonal and pandemic influenza, hepatitis B, Japanese encephalitis, dengue, malaria, allergy and cancer.Lisa S. Park, CEO of Prestige Biopharma, commented: “We are very pleased to enter into an MOU with Vaxine, given their great strengths in creating novel vaccine technologies. Vaxine’s efforts are aligned with Prestige’s ultimate aim to provide innovative vaccines for the era of endemic COVID. With this partnership, Prestige will be able to accelerate the development of more effective and accessible vaccines and at the same time contribute to the growing global demand for vaccines in response to COVID-19 and potential future pandemics.”Dr Nikolai Petrovsky, CEO of Vaxine, commented: “We are delighted to enter into an MOU with Prestige Biopharma, given their exceptional capabilities in product development and large-scale drug manufacture. Through this partnership with Prestige we look forward to accelerating all the vaccines currently in our extensive development pipeline, starting with our Covax-19 vaccine and a Covid-19/influenza combo vaccine, but also including our pre-pandemic avian H7N9 influenza and Japanese encephalitis programs. Our Japanese encephalitis vaccine is particularly relevant right now with the first major endemic outbreak in Australia that has recently results in the patient deaths in multiple Australian states.”About Prestige Biopharma Limited:PRESTIGE BIOPHARMA LIMITED is a Singapore-based biopharmaceutical company with operations in USA and Korea, specializing in the discovery and development of biosimilars, novel antibodies and vaccines. Prestige strives to become a global innovator through the development of first-in-class antibody therapeutics including PBP1510 anti-PAUF mAb for pancreatic cancer (INN-Ulenistamab) that recently obtained orphan designation from FDA, EMA and MFDS. Prestige’s rich portfolio of biosimilars in various stages including HD201 trastuzumab in EU EMA’s MAA review, HD204 bevacizumab in global Phase 3, PBP1502 adalimumab in Phase 1 and others, is aimed to provide affordable quality medicines to those who need. Prestige has expanded its business into development and manufacturing of vaccines through its global scale vaccine center, starting with partnered commercial production of COVID-19 vaccines. For more information, please visit www.prestigebiopharma.com.About Vaxine Pty Ltd:VAXINE PTY LTD is an Australian biotechnology company specializing in the research and development of novel vaccines and drugs against pathogens that pose major public health or biodefense threats. The company was founded in 2002 by Professor Nikolai Petrovsky, a world leading vaccine expert based at Flinders University in Adelaide, South Australia. Vaxine has received extensive funding support from the US government for its pandemic vaccine development programs and has worked extensively with U.S army researchers to develop vaccines against a range of exotic pathogens including Ebola, dengue, Covid-19, malaria, MERS and Hantaan hemorrhagic fever. More recently, it has seen success with its allergy and cancer vaccine programs. At the center of Vaxine’s technological prowess lies Advax™, one of the first major breakthroughs in vaccine adjuvants in almost a hundred years. For more information, please visit www.vaxine.net.

SINGAPORE, May 23, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with operations in USA and South Korea, announced that its CEO Lisa S. Park and COO Michael J. Kim purchased KDR 138,206 shares of the company’s stock, worth KRW 2 billion, in total. The purchase has increased their holdings from 15.29% to 15.40% for CEO Park, and from 14.83% to 14.94% for COO Kim. The two largest shareholders are considering additional stock purchase in the future.After the European Medicines Agency (EMA)’s refusal of Marketing Authorization Application (MAA) for the company’s Herceptin® biosimilar HD201 was announced, its stock price plunged. While appealing the EMA’s decision and requesting for re-examination, the two executive directors of Prestige Biopharma bought up shares to reinforce trust and restore confidence of the shareholders. The company has confidence in long-term sustainable growth of its business.Dr. Lisa S. Park, CEO of Prestige Biopharma, commented, “We expect this in-house purchase would increase shareholder value and push up the share price. Prestige Biopharma will do its utmost to promote future value of the company.” She added, “Even though we are disappointed by the EMA’s decision, we are still confident with HD201 and its value, thus focus on preparing for the EMA’s re-examination for HD201 thoroughly.”

SINGAPORE, March 11, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with operations in USA and South Korea, announced positive efficacy and safety results of the Phase 3 study for HD201 (TROIKA), a biosimilar to Herceptin® (trastuzumab), published in JAMA Oncology on March 4, 2022.The publication highlights comparative efficacy and safety data for patients who received 1-year of treatment with HD201 or referent trastuzumab and completed a median follow-up of 31 months. The study met its primary endpoint (tpCR) and showed equivalent efficacy and comparable safety profile. The tpCR rates were 45% and 48.7% for HD201 and referent trastuzumab, respectively. The difference between the two groups was not significant at −3.8% (95% CI, −12.8% to 5.4%) and fell within the predefined equivalence margins. The results regarding secondary endpoints bpCR, overall response, and response based on mammography, ultrasonography, or clinical tumor evaluations supported the comparable efficacy between HD201 and referent trastuzumab. Similar safety, PK and immunogenicity results were reported for the two treatment arms.The final analysis for the 3-year Event-free survival (EFS) and Overall survival (OS) results is currently ongoing. The preliminary results of the current final analysis indicate highly comparable 3-year EFS and OS rates for HD201 and reference trastuzumab.Tuznue® has secured global distribution partnerships in major markets including Europe, the Middle East, South America, and Asia. It is currently under Marketing Authorization Application (MAA) review in EU EMA, Canada and South Korea.Prestige’s robust pipeline in clinical stage also includes an Avastin biosimilar HD204 (Vasforda®) in global Phase 3, and a Humira biosimilar PBP1502 in Phase 1 clinical trial in Europe.Lisa S. Park, CEO of Prestige Biopharma, commented: “We are pleased to demonstrate HD201’s excellence through the Phase 3 study results published in JAMA Oncology” and “the company will accelerate global launch of Tuznue that can enhance affordability of trastuzumab to the patients in need.”

SINGAPORE, March 8, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with operations in USA and South Korea, announced that the preclinical data of their First-in-Class pancreatic cancer treatment, PBP1510 (INN-Ulenistamab), has been shared in a poster presentation at the European Society for Medical Oncology (ESMO) Targeted Anticancer Therapies (TAT) Congress 2022 held virtually from March 7 to 8, 2022.ESMO is one of the leading professional organisations for medical oncology, together with American Association for Cancer Research (AACR) and American Society of Clinical Oncology (ASCO).Preclinical data of PBP1510 presented in the poster shows notable regression in tumour volume and weight in subcutaneous as well as orthotopic patient derived cancer xenograft (PDX) mouse models treated with PBP1510 compared to gemcitabine and IgG controls. In the orthotopic PDX model, tumour cells derived from pancreatic cancer patients are surgically implanted into the pancreas of mice. Such models are of high clinical relevance as they aid in establishing organ-specific tumour microenvironment with great accuracy.In repeated dose toxicity studies, no notable systemic or local toxicity was observed for up to 40 mg/kg of PBP1510. Absence of anti-drug antibodies was noted in all animals receiving PBP1510 indicating low immunogenic potential.Based on the efficacy and safety demonstrated in the preclinical study, PBP1510 is currently in Phase 1/2a clinical trial in France and Spain.The European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and Korean MFDS granted Orphan Drug Designation (ODD) to PBP1510 in 2020. ODD is granted to investigational drugs intended for the safe and effective treatment of rare diseases with an unmet medical need that affect very few individuals but cause great suffering. This designation provides companies with certain benefits and incentives including clinical protocol assistance, differentiated evaluation procedures for health technology assessments in certain countries, and if approved, marketing exclusivity in the EU and the U.S. for certain years.Prestige has strong pipeline portfolio comprising innovative antibody drugs and biosimilars including the frontrunning Herceptin biosimilar HD201 (Tuznue®) filed to EMA, Health Canada and MFDS, an Avastin biosimilar HD204 (Vasforda®) in global Phase 3, and a Humira biosimilar PBP1502 in Phase 1 clinical trial in Europe. The company’s second First-in-Class antibody PBP1710 targeting CTHRC1, a ubiquitous protein overexpressed in many types of cancer, is currently in preclinical stage.Lisa S. Park, CEO of Prestige Biopharma, commented: “We will identify an optimal dose of PBP1510 in combination with gemcitabine through Phase 1 study and continue on Phase 2a to investigate clinical efficacy,” and “Prestige will accelerate the development of PBP1510 that has demonstrated solid evidence and potential as the new cure for pancreatic cancer.”

SINGAPORE, April 1, 2022 – Prestige Biopharma Limited a Singapore-based leading biopharmaceutical with operations in USA and South Korea, announced that the company has been recognized as the grand winner of the Bioprocessing Excellence in SEA (South-East Asia).The Awards Ceremony was held in conjunction with the 9th Biologics Manufacturing Asia and 6th Biologistics World Asia 2022 hybrid Conference, which was streamed live on 29 – 30 March 2022.Asia Pacific Bioprocessing Excellence Awards recognizes exceptional bioprocessing experts, organizations and technologies that facilitate biomanufacturing excellence at enhanced speed, reduced cost, and superior quality. The panel of expert judges include key opinion leaders with more than 20 years of experience from all the key players in Asia and globally.“We are very proud to receive this award and thank you for recognizing Prestige’s passion for driving innovation and change in bioprocessing,” said Dr. Deborah Moshinsky, Head of Global R&D of Prestige in her acceptance speech. “Prestige Group has undergone a significant expansion to our manufacturing capabilities. Our EU-GMP certified facility with global compliance recognition is currently expanding its capacity up to 234,000 liters through its 2nd Campus developments.”Prestige has developed biosimilars and first-in-class antibody drugs of high quality and strong cost competitiveness in expedited development programmes, with its proprietary bioprocessing technology.Prestige’s leading pipeline HD201 trastuzumab (Tuzune®) is currently under EU EMA’s MAA review and its manufacturing facility has received European Union Good Manufacturing Practices (GMP) certification last February.The company’s robust pipeline in clinical stage also includes an innovative therapy for pancreatic cancer, PBP1510 (INN: Ulenistamab) in Phase 1/2a clinical trial in Europe, an Avastin biosimilar HD204 (Vasforda®) in global Phase 3, and a Humira biosimilar PBP1502 in Phase 1 clinical trial in Europe.

SINGAPORE, February 21, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with operations in USA and South Korea, announced that the manufacturing facility for its Herceptin® biosimilar, Tuznue®, in Prestige Biologics Co., Ltd., has received European Union Good Manufacturing Practices (GMP) certification. EU-GMP certification is one of the highest standards of pharmaceutical production in the world, and it provides pharmaceuticals with the foundation to start selling their products into European markets.Tuznue, HD201, is a proposed biosimilar to Roche’s Herceptin and can be prescribed for the treatment of HER2 positive breast and metastatic gastric cancer. Tuznue’s equivalence to the originator has been demonstrated in 2 Phase 1 trials conducted in Europe and Australia and a global Phase 3 trial, which has been published in scientific journals and conferences. Tuznue has secured global distribution partnerships in major markets, and is currently under Marketing Authorization Application (MAA) review in EU EMA, Canada and South Korea.CEO Mr. Jay Yang, Prestige BiologicsPrestige Biopharma has strong pipeline portfolio comprising biosimilars and first-in-class antibody drugs. Following the frontrunning Tuznue, a biosimilar to Avastin®, HD204 (Vasforda®) is wrapping up the global Phase 3 clinical trial targeting filing to FDA and EMA this year. PBP1510 (Ulenistamab), first-in-class antibody drug for pancreatic cancer, and PBP1502, a biosimilar to Humira® are currently in Phase 1/2a and Phase 1 clinical trial in Europe, respectively.Lisa S. Park, CEO of Prestige Biopharma, commented: “EU GMP certification of our manufacturing arm in Korea demonstrated our global standard biomanufacturing facility and system that are applied to all of our products. By achieving one of the key requirements for product registration, we are one step closer to global launch of Tuznue that can enhance affordability of trastuzumab to the patients in need.”

SINGAPORE, January 27, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical group with operations in USA and South Korea, announced that the company’s first-in-class anti-PAUF monoclonal antibody, PBP1510 has obtained a patent in Japan.Given that Japan is one of the biggest markets in the global biologics industry together with USA and Europe, PBP1510’s patent registration in Japan has significant impact in terms of its global reputation and marketability.PBP1510 has thus far been patented in the seven major countries in the world including USA, Japan, Australia, South Korea, Russia, Taiwan and South Africa, and currently around twenty countries such as Canada and New Zealand are reviewing PBP1510 for patent registration.The European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and Korean MFDS granted Orphan Drug Designation (ODD) to PBP1510 in 2020. French National Agency for the Safety of Medicines and Health Products has approved a Phase 1/2a clinical trial of PBP1510 in June last year. The Spanish regulatory authority is also reviewing the Phase 1/2a IND of PBP1510 and the company is preparing for a FDA submission as well.PBP1510, a first-in-class anti-PAUF treatment, acts by neutralizing PAUF to dismiss its cellular effects. Rapid progression of pancreatic cancer can be partly explained by PAUF and its important role in disease progression. Currently, no targeted molecular therapy against PAUF exists. PBP1510 effectively counteracts the effects induced by PAUF, thus creating a more responsive environment for antitumor immunotherapy and PBP1510 is expected to be a promising alternative to chemotherapy.Prestige Biopharma’s anti-PAUF antibody PBP1510 is envisioned to provide significant benefit in all patients affected by PAUF-positive pancreatic cancer.The company is planning to complete the clinical studies of PBP1510 by 2023 and its marketing authorisation application can be reviewed before Phase 3 clinical trial depending on the result of Phase 2 study. The New Drug Application (NDA) submission to FDA and EMA is planned in 2024.

SINGAPORE, January 12, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with operations in USA and South Korea, announced that the company’s Sputnik Light CMO project is going along as initially planned, amid Omicron spread.PBP signed a contract manufacturing agreement to produce Russia’s Sputnik Light COVID19 vaccine in November last year. The demands of Sputnik Light are expected to grow rapidly as both Sputink V (Ad26/Ad5 vector) and Sputink Light (Ad26 vector) use Sputink Light as a booster shot.According to the recent study of Russia’s Gamaleya National Research Center of Epidemiology and Microbiology, the expected efficacy of Sputnik V with Sputnik Light booster against Omicron infection could be more than 80%. Russia also mentioned that the study of reputed Harvard team demonstrated that boosting of Pfizer vaсcine with Ad26 vector produces optimal durable protection against Omicron.Currently, Sputnik V and Sputnik Light have been approved in more than 70 countries and in around 30 countries respectively, and PBP’s commercial production of both vaccines are planned to be commenced soon.PBP’s global-scale vaccine center in Korea with 104,000 liters of production capacity has been designed with multi-purpose production lines using Prestige Biologics (334970: KOSDAQ)’ proprietary technology, ALITA Smart BioFactoryTM, so the production facility can anytime be used for PBP’s other pipeline production such as antibody therapeutics.PBP’s CEO, Dr Lisa S. Park commented: “Currently, a considerable number of reputed studies are demonstrating the efficacy of Sputnik Light as a booster shot against Omicron infection and our production volume is also expected to increase due to its high demand” and “in 2022, PBP will prove our true potential and value to the market with visible performance and revenue from the existing pipeline and vaccine business.”

SINGAPORE, December 23, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with operations in USA and South Korea, announced that the company has joined COVID-19 Vaccines Global Access (COVAX) Marketplace launched by the Coalition for Epidemic Preparedness Innovations (CEPI).The scheme, called the COVAX Marketplace, is designed to address bottlenecks by facilitating access to supplies needed to produce COVID-19 vaccines. This secure platform enables global vaccine manufacturers and raw-material suppliers to share critical inputs to confidentially indicate their needs or available supplies to CEPI.PBP takes part in the COVAX Marketplace as a vaccine manufacturer and the company will be having more chances to discuss with global vaccine developers for its vaccine CMO business and securing a reliable supply chain network. The company ultimately aims to develop its own vaccine products in PBP’s global R&D center, Innovative Discovery Center (IDC) in Korea.PBP’s CEO, Dr Lisa S. Park commented: “With PBP’s global scale vaccine center with 104,000 liters of total production capacity in Korea and this COVAX partnership, the company will keep contributing to the growing global demands for COVID-19 vaccine production” and “the COVAX Marketplace will play a crucial role in combating the fast-spreading Coronavirus variants, now is the time for global pharmaceuticals to work together in solidarity to stop this pandemic.”