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Rock BioMedical, Inc. specializes in glycoengineering of biologics, leveraging precise modifications of glycan structures on key molecules to develop safer and more effective vaccines and monoclonal antibody drugs. Today, the company is pleased to announce a new addition to its senior management team. A seasoned expert in antibody drug development, Dr. Chen-Ni Chin, Vice President R&D of Rock BioTherapeutics, brings extensive professional experience from the global biopharmaceutical industry.

Dr. Chin has over 20 years of experience in the pharmaceutical and biotechnology sectors, having held senior research and development leadership roles at Merck, Johnson & Johnson, Mersana Therapeutics, and IGM Biosciences. She has been involved in the development of more than 20 antibody drugs and has led project teams in advancing numerous therapeutic antibodies from research concepts to clinical trials.

Her expertise, industry experience, and professional network will be an enormous enhancement to Rock BioMedical’s key development initiatives, particularly in glycoengineered biobetter antibodies. Dr. Chin’s involvement will greatly facilitate not only our research development efforts but also the pursuit of BD and licensing opportunities, driving the company’s innovation and growth in this field.

Rock BioMedical, Inc. specializes in glycoengineering of biologics, leveraging precise modifications of glycan structures on key molecules to develop safer and more effective vaccines and monoclonal antibody drugs. Today, the company proudly announces that its RBM001 low-sugar universal protein subunit vaccine against COVID-19 has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). This milestone marks a significant achievement in Rock BioMedical’s research and development journey within just three years of operation. The company is actively seeking international collaboration opportunities to accelerate the global expansion of its glycoengineering technology platform.

RBM001 is an innovative low-sugar universal protein subunit vaccine designed to induce broad protection against various COVID-19 variants through glycoengineering technology. Preclinical animal studies demonstrated that, compared with the conventional strain specific vaccine technologies, RBM001 exhibited superior safety and elicited enhanced and broadly protective immune response. The technology can be widely applied to vaccine development against not just COVID-19 but also other highly mutable viral infection such as influenza and HIV.

The Phase 1 clinical trial of RBM001 is scheduled to commence in Florida, USA, in the fourth quarter of 2024. It will be a randomized, placebo-controlled, double-blind, dose-ranging study aimed at evaluating the safety, tolerability, and immunogenicity of the low-sugar universal vaccine in healthy adult volunteers, with an estimated enrollment of 60 participants. The FDA’s approval of this IND application signifies a major step forward for Rock BioMedical’s low-sugar universal vaccine platform, transitioning from fundamental research to practical application. This approval demonstrates that the technology has attained a consistent and scalable manufacturing process suitable for new drug development, with sufficient product stability, as well as validated safety and immunogenicity data in preclinical efficacy and toxicology studies.

Rock BioMedical will continue to collaborate closely with CRO partners to ensure the smooth execution of the clinical trial, laying a solid foundation for the broader application of its platform technology in the future.

The sudden outbreak of the pandemic has accelerated vaccine research and clinical applications. Among them, mRNA (messenger RNA) technology is the probably the one that received the most attention globally and is now being applied to infectious diseases, rare diseases, respiratory illnesses, and cancer, offering new hope for disease prevention and treatment.

Universal Vaccines: Safe, Well-Tolerated, and Promising for Future Disease Prevention

Founded in 2021, Rock BioMedical, Inc. established its R&D laboratory in the National Biotechnology Research Park of Taiwan the following year and launched an overseas base in Boston, USA. The company focuses on the development of low-sugar universal vaccines. Notably, its low-sugar universal protein subunit vaccine against COVID-19 is expected to apply for clinical trials in the U.S. next spring. If successful, this advancement would establish Rock BioMedical as a global leader in universal vaccine development, enhancing national epidemic prevention capabilities while facilitating expansion into the global pharmaceutical market.

After acquiring key technology through exclusive licensing from the research team led by the former President of Academia Sinica, Dr. Chi-Huey Wong, Rock BioMedical has dedicated itself to glycoengineering of biologics for disease prevention and treatment, making it a pioneer in low-sugar universal vaccines. The company’s RD efforts are led by Dr. Jeng-Shin Lee, Senior Vice President of Rock BioMedical, who brings a combined expertise in medicine and virology. Prior to Rock BioMedical, Dr. Lee served as the Associate Director of Harvard Gene Therapy Initiative, Harvard Medical School and Chief Scientific Officer at AB Biosciences, Inc. in the US. Under his leadership, the RD team at Rock Bio has been making steady progress in the development of innovative vaccine and antibody drug products. Dr. Lee believes that mRNA vaccines offer distinct advantages and will be a driving force in future vaccine and drug development, aiding nations in combating COVID-19 and responding effectively to emerging infectious diseases.

Enhanced Immunity Against Emerging Viral Variants for Durable Protection

Proteins and carbohydrates are basic biomolecules in living organisms. Over 90% of human proteins are glycoproteins, and abnormalities in glycosylation processes are linked to inflammation, infections, and disease progression. Dr. Lee explained that glycoprotein biosynthesis in the cells is highly complex. Rock BioMedical is leveraging "low sugar universal vaccine" technology to develop COVID-19 vaccines by identifying glycosylation sites, analyzing glycan sequences, and "unmasking" antigens covered by glycan molecules. This approach enhances immune responses, allowing vaccines to induce stronger protective effects.

Dr. Lee emphasized that, in addition to glycoengineering as its core platform, the research team is exploring how mRNA-LNP technology can be further exploited for drug development in general. This new paradigm presents a faster and potentially more efficient approach to protein-based drug development. "We see a tremendous opportunity—mRNA vaccine technology has the potential to revolutionize global pharmaceutical R&D, paving the way for precision medicine through RNA-based therapies," he noted.

Rock Bio's "Low-sugar universal mRNA Vaccine Against Influenza" program seeks to create a vaccine targeting multiple influenza strains. By using glycoengineering to remove selective glycosites on the HA protein, the vaccine can induce an enhanced and broadly protective immune response. This method shows promise for broad applications in disease prevention and treatment.

Breakthrough Technologies for Pandemic Preparedness

The COVID-19 pandemic has had a tremendous impact on the world. Utilizing proprietary licensed technology and developmental experiences, Rock Bio is applying low-sugar universal vaccine technology beyond next-generation COVID-19 vaccines, leading to the "Low-sugar Universal mRNA Vaccine Against Influenza” program. This approach enabled Rock Bio to be recognized at the 2023 inaugural Moderna Taiwan mRNA Innovation Awards.

Dr. Lee indicated that future efforts would focus on developing safer and more effective vaccines for both seasonal and pandemic influenza to reduce the occurrence of severe diseases and death. "Winning the 'Moderna Taiwan mRNA Innovation Award' encourages us to further accelerate mRNA research and explore strategic partnerships with other research institutions. By integrating more R&D resources, we aim to unlock commercial applications and drive global innovation in mRNA-based therapies," he said.

Dr. Lee highlighted the importance of having more effective tools to combat pandemics for controlling infectious diseases. He expressed hope that these advancements will lessen the global impact of future pandemics, reducing their threats to public health and the economy.

News Source:https://health.udn.com/health/story/5999/7625907

Interview Video:https://www.youtube.com/watch?v=ETsONZjZlPE&t=35s

The International Union of Pure and Applied Chemistry (IUPAC), founded in 1919, is the world authority on chemical nomenclature, terminology (including the naming of new elements in the periodic table), standardized methods for measurement, atomic weights and many other critically-evaluated data in chemistry. Since 2019, the organization has compiled the latest achievements in chemistry and selected the top ten emerging technologies every year. This year, the technology of "low-sugar vaccinations" developed by a research team at Genomics Research Center, led by Chi-Huey Wong, Che Ma and Kuo-I Lin, was selected. It is for the first time that a Taiwanese research work is recognized by IUPAC.

圖片來源：IUPAC

The concept of low-sugar vaccination was conceived in 2009 and published by the team in the journal Proceedings of National Academy of Sciences of the USA, demonstrating that "the size of sugar molecules" is the key to virus infection and immune evasion. It was for the first time that "quantification of sugar molecules" on the virus surface glycoproteins has been conducted (research news: Removing the Sugar Coat of Influenza Hemagglutinin Proved Better Strategy In Vaccine Design).

Dr. Wong emphasized that “By designing the consensus sequence of hemagglutinin (HA) from different influenza viruses, and trimming the sugar molecules on the surface of the HA protein, particularly on the regions that are difficult to mutate making them fully exposed and recognized by the immune system, is the key to successfully develop molecular vaccines that are protective against a variety of influenza viruses." Based on this foundation, the team continued to explore the glycosylation of viruses and found that in addition to influenza viruses, the sugar trimming approach can also be applied to other human viruses, including, for example, SARS coronavirus, hepatitis C virus, dengue virus and HIV virus. As long as the sugar coat that shields the conserved epitope of a human virus can be removed, it is possible to develop a low-sugar vaccine with broad efficacy!

In 2022, as the COVID-19 pandemic wreaked havoc worldwide, the research team designed a low-sugar vaccine, called Mono-GlcNAc-Decorated S (SMG) protein vaccine, that was shown to elicit broadly protective immune responses against various variants of concerns. Exposing the conserved epitopes, including the sites that are originally sugar-coated and less susceptible to mutation, can trigger a broader immune response and provide better protection against infection from various variants. The virus challenge experiment in transgenic mice showed that the SMG vaccine was effective against the Alpha, Beta and Delta variants (research news: Mono-GlcNAc-decorated spike vaccine is highly effective against COVID-19 variants). This research was published in Science Translational Medicine and is the key publication selected as one of the top ten emerging technologies by IUPAC this year. Similarly, a low-sugar universal mRNA vaccine was successfully developed to protect against various emerging strains, including the recent Omicron variants (research news: mRNA vaccine of SARS-CoV-2 spike protein with deletion of multiple glycosites is broadly protective against variants of concern).

In 2023, an independent research team at Scripps Research also published the application of low-sugar vaccination to HIV vaccine development.

Dr. Ma commented, “The low-sugar vaccine technology has attracted the attention of the global community in the field of vaccine research. Trimming off the unnecessary glycan on viral glycoproteins is a simple and practical approach for designing better vaccines against various human viruses.”

News Source:https://www.genomics.sinica.edu.tw/en/news/awards-a-honors/741-low-sugar-vaccinations-selected-as-one-of-iupac-2023-top-ten-emerging-technologies-in-chemistry

IUPAC full article:https://iupac.org/iupac-2023-top-ten/

Related report:

De Gruyter：https://www.degruyter.com/document/doi/10.1515/ci-2023-0403/html