SAN DIEGO, Dec. 20, 2019 /PRNewswire/ -- At a corporate symposium held in San Diego, Helixmith Co., Ltd. and Genopis, Inc. moved to launch a contract manufacturing business for plasmid DNA production.
Key executives and leadership members of Helixmith and Genopis attended the symposium to declare the launch of CDMO service in Q2 2020 using Genopis' proprietary technology and the existing 500 liter reactor. Moving ahead, the company will establish additional smaller scale reactors (60-300 L, 6-30 L) with feasibility runs and start small volume production service in the second half of the year.
Demand for plasmid DNA has risen steeply in recent years, driven by a boom in gene therapy development. pDNA is essential for the production of AAV (adeno-associated virus), lentivirus, and other viral vector platforms. Analyst estimates place the viral vector and plasmid DNA production market at around $290 million and expect the market to grow to $1.1 billion in 2023 with a CAGR of 25%.
While many contract manufacturing organizations have experience producing DNA for early-stage exploratory studies, few companies have the GMP capabilities to meet FDA requirements. Genopis has decades of hands-on experience producing GMP pDNA for both early stage and phase 3 clinical trials. Equipped with the right technologies and quality systems, Genopis' experience in and ability to efficiently execute GMP production for both clinical studies and future commercial purposes are key strengths.
As the demand for plasmid DNA surges beyond the production capacity of current CDMOs, some large companies are attempting M&As or scaling up existing facilities to expand production. Alongside discussions with potential partners regarding strategic alliances and the use of its existing production capabilities, Genopis began upgrading its facilities in September of this year with the expectation of entering the CDMO space.
This is also a timely decision for Genopis, as the company will complete production of VM202 plasmid DNA in February 2020, a flagship product under clinical study by its parent company, Helixmith Co., Ltd. Using Genopis' current 500 liter reactor capability, Helixmith will secure VM202 pDNA required for its current clinical trials and regulatory needs for the next two years. Genopis will use the 500 liter reactor for its CDMO service and the smaller scale production line once it is established in mid-2020.
Genopis has developed a short list of candidate clients and has been visited by large CMOs seeking strategic alliances and business opportunities. Keith Hall, COO, offers, "Genopis is a unique company, not only in the US, but globally when it comes to plasmid DNA production. Our team of experts actually began cultivating this field 30 years ago." He added, "We are aspiring to become the world's top-tier company in the field of plasmid DNA manufacturing based on our technology and decades of experience."
Sunyoung Kim, DPhil, who serves as chief executive of both Helixmith and Genopis, states, "Our decision to launch the CDMO business is happening at a time when gene therapy is emerging as mainstream in the bio-pharmaceutical industry. In fact, with Genopis, Helixmith has become the only full platform company in the field of plasmid DNA medicine, with capabilities covering R&D, clinical study, and GMP production all together. New drug development takes a long time by nature, but we expect CDMO manufacturing to generate meaningful revenues in the near future."
About VM202 (Engensis®)
VM202 (donaperminogene seltoplasmid) is a first-in-class, proprietary, non-viral, potentially regenerative plasmid DNA gene therapy. VM202 is a novel genomic cDNA hybrid human hepatocyte growth factor (HGF) gene with a novel and proprietary coding sequence (HGF-X7) expressing two isoforms - a configuration that closely mimics HGF productions in humans that is needed for optimal therapeutic benefits. Because there is no change in the coding region of the HGF gene, HGF proteins generated from VM202 are identical to wild-type human HGF proteins.
When introduced into the body, HGF protein is expressed from VM202 and induces the formation of new blood vessels, suppresses levels of select pain mediators, supports regeneration/repair of damaged peripheral nerves, and ameliorates atrophic condition of skeletal muscle.
About Genopis Inc.
Genopis, Inc., headquartered in San Diego, California, serves as a site for cGMP manufacturing operations, with current capabilities suited for microbial-based products and expandable for future mammalian-based products. Genopis specializes in plasmid DNA based technology and provides contract development and manufacturing organization (CDMO) services to help your company reach its clinical and commercial goals. The company is supported by staff members who have decades of experience ranging from clinical start-ups to commercial product companies. With this experience, our team provides the flexibility to transition rapidly in a fast-paced biotechnology environment and achieve our end goal, which is to provide medicine for our clients' patients.
About Helixmith Co., Ltd.
Helixmith Co., Ltd., is an R&D focused biopharmaceutical company based in Seoul, Korea, developing new and innovative biopharmaceuticals based on its proprietary technology and science to meet unmet medical needs. The company is currently focused on developing its proprietary plasmid DNA-based drug, VM202, for cardiovascular and neurological diseases including but not limited to PDPN, diabetic foot ulcer (DFU), amyotrophic lateral sclerosis (ALS), and ischemic heart disease (IHD). Trials involving VM202 are in various clinical stages in the U.S., Korea, and China.
COO, Genopis, Inc.
SOURCE Helixmith; Genopis