Core Reminder: In August 2020, PackGene Biotech, Inc. (“PackGene”), a well-known provider of integrated CDMO solutions and AAV vector packaging for gene therapy, announced the completion of the B round of tens of millions yuan in financing.
In August 2020, PackGene Biotech, Inc. (“PackGene”), a well-known provider of integrated CDMO solutions and AAV vector packaging for gene therapy, announced the completion of the B round of tens of millions yuan in financing. Cathay Capital led this investment, and Oriza Seed co-invested. This round of financing is another strategic cooperation between PackGene and investment partners with deep accumulation and extensive deployment in the biopharmaceutical industry worldwide. This round of financing will be mainly used to advance the research and development of PackGene’s bio-vector technology, the construction of the production platform, and the management & operation of the corporate. In the meantime, to further consolidate its leading advantage in the gene therapy AAV sub-industry, to promote gene-based from concept to clinical, and to provide gene therapy worldwide with another strong empowerment to accelerate the process of its industrialization.
rAAV vector and its significance for gene therapy
Adeno-associated virus (AAV) is a single-stranded DNA virus. The current scientific consensus is that it does not cause any human diseases, and more than 80% of the population carries AAV. Recombinant adeno-associated virus (rAAV) is a genetically engineered vector. The part of its genome that encodes viral proteins is completely deleted and replaced by therapeutic genes or gene editing tools. rAAV can realize precise targeted therapy of different tissues and organs by selecting suitable serotype rAAV and vector design. rAAV vectors have advantages, including superior safety, long-term stable expression of therapeutic genes, can target most tissues and organs, and supports local and systemic injection, etc. and thus have become a safe and effective tool to treat thousands of human diseases that currently lack effective treatments. There are more than 250 clinical programs for gene therapy based on rAAV and have been rapidly increasing in recent years.
Cathay Capital and Oriza Seed invested in PackGene to help the take off of the gene therapy industry
According to relevant data, the European Union and the U.S. Food and Drug Administration (FDA) have successively approved 6 cell and gene therapy products, but China has not yet approved a safe and effective cell and gene therapy product for market use. The FDA predicts that by 2025, 10-20 cell and gene therapy products will be approved each year. At present, the total number of new drug research applications (IND) for cell and gene therapy registered with the FDA has exceeded 800. In contrast, up to now, the total number of new cell and gene therapy drug research applications accepted by the National Center for Drug Evaluation (CDE) in China was less than 50, far less than the FDA.
Based on the above challenges and opportunities, PackGene is positioned to provide safe and effective AAV vector packaging and overall solutions from DNA to IND for gene therapy. At the same time, it also supports the production and canning of clinical phase I and phase II samples for gene therapy. PackGene promotes the clinical application of cell and gene therapy technologies, so that gene therapy can benefit the general public. In recent years, PackGene has maintained rapid development in technology research and development. At present, it has a number of core intellectual property rights in the rapid, high-purity, high-titer, high-infectious rAAV production and virus packaging, and it has established long-term cooperative relationships with internationally renowned companies such as Biogen, AstraZeneca, CRISPR Therapeutics, LuyePharma, PTC Therapeutics, and institutions including Harvard Medical School, Singapore Science and Technology Agency, Tsinghua University, Peking University, Chinese Academy of Sciences, etc. Step by step, PackGene has built a gene therapy technology brand with global influence.
Dr. Huapeng Li from PackGene said: “We have always focused on the technological innovation of AAV in the past few years, and successfully developed the highly competitive viral vector technology and packaging technology. Based on the company’s continuous innovation and breakthroughs, we have received high recognition from customers over the world, and our company has gradually formed a gene therapy CDMO overall solution featuring AAV to meet customer requirements from DNA to IND declaration as well as clinical phase I and phase II. At present, PackGene has several gene therapy IND projects in implementation and has signed strategic partnerships with customers. By the end of 2020, our GMP-level large-scale AAV process development and production base, which is based on the leading design concept of “disposable technology” and meeting the requirements of gene therapy regulations, will be officially put into use, which can help the cooperative clients of PackGene to propel the clinical projects at a faster pace.”
Cai Mingpo, Founder and Chairman of Cathay Capital, said: “Cathay Capital has always been concerned about the frontier developments and technological trends of gene therapy worldwide. We have witness PackGene passed the test of the international giants and achieved stable product delivery. Chinese customers also have a very high evaluation of PackGene’s services, especially the company’s founding team and management staff are very young, and the company’s culture has strong cohesion. We are full of confidence in the positive influence and development of PackGene in the future gene therapy industry. We look forward that PackGene can use its rich experience and technical strength to help gene therapy companies to promote more and more projects to the IND application and clinical stage. Especially after Sanofi became the investor of Cathay Capital and announced the joint strategic cooperation with us this year, Cathay Capital will work together with Sanofi and PackGene to promote the clinical progress in the field of gene therapy and create a new pattern in the field of gene therapy.”
Yang Aiying, partner of Oriza Seed, the investor of this round, said: “With the breakthrough of underlying technology and the expansion of clinical applications, the explosive development of gene therapy in recent years has shown its great clinical potential as a next-generation therapeutic drug. However, at this stage, the design and clinical production of gene therapy vectors have become a bottleneck in the development of the industry. Long cycles, strict quality control, insufficient production capacity, and high production costs have restricted the innovative biotech from rapidly advancing gene therapy products into clinical practice. PackGene has a profound accumulation in the construction and production process of AAV vectors, it has served a group of quality customers and achieved effective delivery. We are pleased to see the growth of PackGene in Guangzhou Development Zone, and we also look forward to its further progress in the future with high quality , low-cost viral vectors to help gene therapy companies to better develop gene therapy drugs that benefit ordinary patients.”
PackGene focuses on GMP-level AAV process and large-scale production
PackGene is a national high-tech enterprise featuring “High quality, Fast delivery, responsive services”, It is headquartered in Guangzhou Economic and Technological Development Zone, The U.S. branch is located in Worcester, Massachusetts. The company is positioned to provide gene therapy CDMO services with GMP-level AAV technology and large-scale production as the core. It also provides researchers with AAV packaging and vector cloning services, as well as gene therapy from the early stage of research, preclinical development and clinical trials, large-scale AAV overall solution. PackGene now has 600 square meters of GLP-level AAV production platform, 500 square meters of GMP pilot workshop (meet IND application AAV production requirements), and 4000 square meters of large-scale GMP base is under construction, and the annual output will reach 2×1018 VG. The base is expected to be put into use by the end of 2020.
PackGene’s CDMO service varieties cover multiple directions of gene therapy, such as gene editing, gene activation, RNAi, gene overexpression, non-coding RNA, etc., as well as in vivo or in vitro treatment strategies, providing technology services ranging from plasmid construction, bacterial banking, and cell banking, process development to large-scale AAV production technical services, process transfer, methodological transfer, IND application pharmaceutical research data writing, etc., to meet the needs of AAV-based gene therapy from IND application to clinical trial stage, from rare diseases to common diseases development.
PackGene’s innovative technology helps customers advance their projects
In recent years, PackGene has also established cooperation with internationally renowned companies such as Biogen, AstraZeneca, CRISPR Therapeutics, LuyePharma, PTC Therapeutics, Harvard Medical School, Singapore Bureau of Science and Technology, Tsinghua University, Peking University, Chinese Academy of Sciences, etc. Cooperation with many Chinese gene therapy companies have also been carried on. Dr. Huapeng Li, one of the company’s co-founders, has been engaged in AAV vector gene therapy research for many years at the Gene Therapy Center of the University of Massachusetts Medical School (the institution with the most AAV invention patents in the world). The co-founder team has more than ten years of rich experience in gene therapy viral vector design, pre-clinical upstream & downstream technology, biological medicine, clinical operation of gene therapy drugs, and project management, the core members have led the preclinical development, production and clinical trials of a variety of gene therapy drugs. PackGene has made rapid progress in technology research and development, and currently has a number of core intellectual property rights in rapid, high-purity, high-titer, high-infectious rAAV production and virus packaging. By July 2020, PackGene has submitted a total of nearly 20 patents, including 6 authorized invention patents and 10 authorized utility model patents.
PackGene’s vision: to make gene therapy affordable
PackGene has always regards “making gene therapy affordable” as its company mission, and the challenge in the process of gene therapy R&D and industrialization: “rAAV serotype development, virus packaging and GMP mass production” as its business engine. PackGene is now accelerating the development, clinical research and commercialization of gene and cell therapy internationally with stable, efficient, economical products and technical services, and creating a global influential gene therapy star technology brand!
About Cathay Capital
Cathay Capital as the world’s leading investment fund focused on cross-border investment, Cathay Capital “founded by entrepreneurs, for entrepreneurs service”, since its inception in 2006, has regarded “to help ” spirit as the starting point, provided support for innovation, growth, and internationalization of small and medium-sized enterprises in China, Europe, North America, Africa and Southeast Asia, and is committed to becoming a financial investor with the most industrial resources and industry insights.
At of the end of 2019, the fund’s asset management scale reached 3.5 billion euros, with a total of 14 funds under management, which are divided into three series: small and medium-sized enterprises funds and mergers and acquisitions funds (PE) and innovation funds (VC). At present, it has invested in nearly 150 companies around the world, mainly focusing on companies with great innovation and development prospects in the fields of consumption, TMT, healthcare, automobile travel, energy, financial technology, high-end manufacturing, etc. It has tapped and invested in dozens of high-quality companies such as Sophia, ZBOM Home Furnishing, Health 100, Moncler, Poten Enviro, and Aihuishou, as well as star unicorn projects such as Momenta, Pinduoduo, Drivy, Glovo, and Chime, accompany them to grow into leading companies in various industries.
About Oriza Seed
Oriza Seed is a market-oriented professional early-stage equity investment platform, focusing on the investment opportunities of start-up and growth start-ups in the two major fields of TMT and Healthcare. The total scale of its six funds is approximately RMB 3.4 billion. There are both VC funds and angel funds targeting the six regions of Beijing, Shanghai, Guangzhou, Shenzhen, Suzhou and Hangzhou.
By of the end of 2019, Oriza Seed has invested and managed more than 100 innovative companies, including TZTEK Technology (688003), Jiangsu BR-Robot (688218), Zhongke Cambricon (688256), Top One Logistics company, and Pineapple Bun Light Novel , Ascentage Pharmaceuticals (06855), CStone Pharmaceuticals (02616), EpimAb Biotherapeutics, GeneQuantum Healthcare, WuXi JW Therapeutics, Biocytogen, Osmunda, Canhelp Genomics, ExcelMab, Redpine, DK Medtech, Huihe Healthcare, RootPath, Angitia, PackGene, etc.
About PackGene
PackGene focuses on recombinant adeno-associated virus (rAAV) and lentivirus production, virus packaging and vector cloning services, has established a GMP-level AAV process and large-scale production platform, and provides basic research, preclinical development and clinical trials of gene and cell therapy with economical, efficient, large-scale, compliant and controllable viral vector solutions. Through high-end quality, reliable and fast supply, and high-quality service, PackGene has established a long-term cooperative relationship with internationally renowned companies such as Biogen, AstraZeneca, CRISPR Therapeutics, LuyePharma, PTC Therapeutics, and Harvard Medical School, Singapore Science and Technology Agency, Tsinghua University. , Peking University, Chinese Academy of Sciences, etc. PackGene has always been with the mission of “making gene therapy affordable “, and is committed to building a global influential gene therapy star technology brand!