Lemonex Inc., a biotechnology company at the forefront of mRNA and siRNA therapeutics, recently submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety (MFDS) for their mRNA vaccine LEM-mR203 with their revolutionary nano-drug delivery platform, DegradaBALL®. This marks a major milestone for the company and brings them one step closer to making this revolutionary vaccine available to the public.
Lemonex is pioneering a new approach to vaccine development with its DegradaBALL® mRNA vaccine booster shot clinical trial for Covid-19. This innovative drug delivery platform technology is being tested for safety and reactogenicity in healthy adults, offering a potential new way to protect against the virus.
The emergence of mRNA vaccines has revolutionized the way pandemics are responded to, enabling quicker production. However, the current drug delivery technology applied to existing mRNA vaccines, known as LNP, has proven to have limitations such as safety concerns, the need for ultra-low-temperature cold chain, and intellectual property disputes. In order to overcome these issues, Lemonex has secured intellectual property rights for the next-generation drug delivery technology of DegradaBALL® – a groundbreaking innovation that is set to revolutionize the way we respond to pandemics.
Dr. Dal-Hee Min, CTO of Lemonex and Professor at Seoul National University, is excited to announce the development of LEM-mR203, a safer and more efficient mRNA vaccine candidate. This technology, known as DegradaBALL®, is designed to complement the limitations of LNP and has already been proven safe in human trials of a siRNA gene therapy product. By applying DegradaBALL to mRNA vaccines, the technology transfer and commercialization process is accelerated and the safety and proof-of-concept (PoC) of the mRNA-DegradaBALL® platform is secured. This breakthrough is an exciting step forward in the fight against COVID-19.
Dr. Cheolhee Won, CEO of Lemonex, announced the introduction of LEM-mR203 – a global first-in-class mRNA vaccine applied with the advanced DegradaBALL® drug delivery technology. This technology can ensure greater mRNA stability, as it can be pre-produced and stored in stock, avoiding any fragmentation or impurities that may arise during the complex encapsulation process. Lemonex is set to focus their development capabilities on the ‘Pandemic Vaccine Development within 100 Days’ project, in order to stay ahead of the curve in this rapidly changing field.
Lemonex is actively developing new drug candidates with the DegradaBALL® drug delivery platform. Most recently, Lemonex has completed administration and observation of the last subject in the phase 1 clinical trial for their siRNA gene therapy LEM-S401. Furthermore, Lemonex has successfully produced clinical samples for clinical entry of their dual-acting RNA immuno-oncology drug LEM-S403 after completing GLP-tox studies. To further its global reach, Lemonex has also signed an MOU with the International Vaccine Institute (IVI). With such monumental strides in the pharmaceutical industry, Lemonex is certainly on the rise.