[MA, USA and Beijing, China – August] The COVID-19 pandemic has been an inescapable, lethal, and overwhelming aspect of daily human life, threatening health and safety on a global scale. Biocytogen is excited to announce a breakthrough in scientific research and development (R&D) of therapeutic treatment strategy against the novel SARS CoV-2 viral spike protein (S protein) in the hope of effectively treating this deadly disease.
Biocytogen is uniquely positioned to leverage the unique capabilities of its flagship RenMab™ transgenic mouse in combination with its Antibody Drug Development Platform in an integrated approach towards a dramatically accelerated timeline for the production of an effective COVID-19 treatment. In the early stages of the outbreak when vaccines were discussed in the community, Biocytogen took concrete action to enact this powerful technology to advance the R&D of COVID-19 neutralizing antibodies. In development since only February 2020 and currently in the CMC stage, the Coronavirus Project (YH007) at Biocytogen has already shown great promise with excellent pre-clinical findings. YH007 is now in the process of being geared up for upcoming clinical stage applications and clinical trials, which are soon to be conducted by Eucure Biopharma.
After screening over 200 antibodies that demonstrated strong binding activity towards SARS CoV-2 S protein as part of YH007, Chief Scientific Officer and Director of Antibody Discovery at Biocytogen, Dr. Yi Yang has announced two promising antibodies, Ab1 and Ab5, both of which were derived from the RenMab™ Mouse Platform. He describes these new monoclonal antibodies which, “have completely different epitopes and can neutralize wild-type and the multiple currently known drug-resistant mutant strains” of SARS CoV-2. Furthermore, “compared with single use, the combination of Ab1 and Ab5 (cocktail therapy) has more significant effects in preclinical animal in vivo efficacy studies.” To this end, Biocytogen is currently developing a proprietary therapeutic coronavirus “cocktail therapy,” comprised of fully-human antibodies targeting the S protein, which should enhance the prophylactic and therapeutic potential in the case of the constantly evolving and mutating coronavirus. Biocytogen is a scientific service-providing, pre-clinical antibody discovery, and drug development team that has worked with over 70% of the world’s Top 20 pharmaceutical companies and stands at the crux of therapeutic antibody R&D.
Scientists are looking to therapeutic monoclonal antibodies as potential treatments in many disease areas, and Biocytogen has gradually transitioned from being a pure technology service company to a full biotechnology company focused on new drug development to serve these disease areas. While the RenMab™ Mouse and Drug Development Platform are Biocytogen’s flagship systems, it seeks to constantly incorporate cutting-edge technologies in gene editing, antibody generation and in vivo pharmacology into its toolkit. This includes proprietary single-cell screening innovations from Berkeley Lights.
Dr. Shen Yuelei, CEO and founder of Biocytogen and CEO of Eucure Biopharma, affirms the company’s commitment to research of coronavirus and help toward the COVID-19 pandemic: “Combining Eucure expertise in clinical trial design and execution with its own therapeutic antibody drug discovery platform, Biocytogen will do its best to accelerate the R&D of antibody drugs. We will make every effort to increase product and service availability and continue to collaborate with and empower pharmaceutical companies to make their own contributions to the fight against the pandemic.”
About RenMab™ Mouse
Created through advanced chromosome engineering and 5 years of R&D effort, the RenMab™ Mouse from Biocytogen produces fully-human antibodies that are of strong specificity, high affinity, and rich diversity. The antibody gene replacement of RenMab™ Mouse is noteworthy, being significantly better than that of existing models, as it has a complete human antibody gene replacements for mouse heavy and κ chain variable antibody gene regions, while still retaining crucial mouse genes to support immune cell development and produce functional, clinically relevant antibodies. Development of the immune system in the RenMab™ Mouse has demonstrated no significant abnormality when compared to wild-type mice, with immune cell profiles, B-cell development, and human immune repertoire all indistinguishable from normal. Given its robust immune response and rich antibody gene diversity, RenMab™ Mouse currently carries the highest potential in the development of antibody drugs.
Biocytogen’s powerful Extreme Genome Editing (EGE™) technology and quality-controlled preparation protocols exemplify the expertised capabilities of this biotechnology company, dedicated to innovation of new medicines. With an exceptionally large scale of production, Biocytogen’s optimized animal breeding and transport supply allow for highly efficient in vivo drug efficacy evaluations, punctuated by our specialized autoimmune and immuno-oncology disease models.
Beginning with targeted immunization of the flagship product RenMab™ Mouse for hit generation, Biocytogen offers its meticulously designed, multi-step, signature Drug Development Platform used in subsequent screening for the most ideal and clinically-translatable fully-human antibody candidates. Together, RenMab™ Mouse and the Drug Development Platform make Biocytogen a ‘one-stop shop’ for research and development of novel antibody drugs. Science experts support experimentally-validated, rapid fully-human antibody generation from RenMab™ Mouse, followed by performing careful pre-clinical screening and pharmacological efficacy evaluations, all the way up to an Investigative New Drug (IND) application.
At present, Biocytogen has completed over twenty pre-clinical research and development antibody projects with its partners, some of which have successfully completed clinical applications in China and abroad. Soon to come are the RenLite™ and RenNano™ Mouse models, which are engineered to produce light chain or heavy chain only fully-human antibodies, respectively, further marking Biocytogen as a global leader in novel antibody drug development and disease model-based efficacy studies.
About Eucure Biopharma
Eucure Biopharma is an innovative biotechnology company rooted in China with a global vision. With a core team with rich experience in new drug development, Eucure focuses on the development of innovative antibody drugs with independent intellectual property rights. Relying on its strong clinical development team, Eucure is now developing innovative drugs that meet the clinical needs for patients in China and across the world. Eucure Biopharma is currently specialized in the field of immunotherapy, building a strong preclinical and clinical pipeline for over ten targets. In addition to the two Eucure products that have already obtained clinical approvals in the United States, one product has obtained Chinese clinical approval and three products have entered Phase I clinical trials in Australia. Leveraging cooperative development and strong clinical assets, Eucure is able to effectively advance multiple products in therapeutic antibody drug development.