Kevin Sharp, vice president of Samsung Biologics, met with reporters on the 18th (local time) at BioUSA held in Boston, where he said, "Based on our antibody-drug conjugate (ADC) capabilities, we will secure core technologies in the antibody-oligonucleotide conjugate (AOC) area and expand our contract development and manufacturing organization (CDMO) business portfolio."
This is the first time that Samsung Biologics has officially mentioned AOC as a business area. AOC is a technology developed from ADC, which Samsung Biologics entered this year. While ADC attaches drugs to antibodies to deliver them only to cancer cells, AOC attaches gene-modulating substances instead of drugs to antibodies.
◇Drone delivering gene therapies
Competitors of Samsung Biologics, Swiss Lonza and Chinese Wuxi Biologics, are also paying attention to the AOC market. Lonza has already established a dedicated production line for AOC, while Wuxi is providing integrated services from AOC therapeutic design and analysis to production.
Both ADC and AOC are antibody-based therapeutic technologies. ADC attaches toxic drugs to antibodies to selectively kill cancer cells, while AOC attaches gene-modulating substances to antibodies to regulate the genes of specific cells. If ADC acts as a guided missile targeting only cancer cells, AOC can be seen as a drone delivering gene therapies to the target locations accurately.
Gene therapies treat diseases by regulating the production of proteins from specific genes. DNA genetic information is transferred to messenger ribonucleic acid (mRNA) only for the necessary parts, creating various proteins that influence life phenomena. At this point, short RNA sticks to other mRNA, blocking protein synthesis. AOC delivers oligonucleotides synthesized from such RNA to cells with mutated genes.
Existing RNA therapies have the same mechanism of action, but they have limitations in distinguishing target cells. This means there is a concern about side effects, as it can regulate the genes of not only diseased cells but also normal cells. AOC does not have this problem because it has antibodies that bind only to the cells where gene regulation is needed, similar to how ADC targets only cancer cells.
◇Competition to dominate a 7 trillion won market by 2030
Currently, there are no commercially available AOC therapeutics. Nevertheless, seeing the potential, corporations are rushing to enter the AOC market.
Avidity Biosciences, a Nasdaq-listed company, is developing 'AOC1001' as an AOC therapeutic for type 1 myotonic dystrophy (DM1), which is currently in global phase 3 clinical trials and was designated as an innovative therapy by the U.S. Food and Drug Administration (FDA) last year.
Myotonic dystrophy is a genetic disease characterized by the gradual atrophy and weakening of muscles. DYNE-101, a new AOC candidate being developed by Dyne Therapeutics for DM1 treatment, was also designated as an innovative therapy by the FDA on the 17th.
As it is a rare disease treatment with no existing effective therapies, early approval is possible through expedited review processes. In this case, AOC therapeutics could receive formal FDA approval within 1 to 2 years at the earliest. Production is expected to be handled by CDMOs like Samsung Biologics, Lonza, and Wuxi.
According to a report released this month by global market research firm 360i Research, the AOC market size is expected to reach $3.15 billion (approximately 4.3 trillion won) in 2024, growing at an average annual rate of 8.89% to $5.26 billion (approximately 7.2 trillion won) by 2030. While there are no commercial products yet, significant capital has already been invested in discovering AOC candidates, clinical trials, and developing CDMO processes.