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mRNA the key term at JP Morgan Healthcare Conference
BioNTech, Moderna stress mRNA application for wider diseases, Hanmi promotes Pyeongtaek plant for DNA, mRNA vaccine contract manufacturingBy Lim Jeong-yeo
Published : Jan. 12, 2021 - 17:44
At the event, which kicked off virtually for the first time in 2021 on Monday, multiple pharmaceutical firms including the recently newsworthy BioNTech and Moderna presented their yearly business blueprints. South Korea’s Hanmi Pharmaceutical also took part, proposing its newest bio plant in Pyeongtaek, Gyeonggi Province, as a possible contract manufacturing facility for mRNA vaccines.
BioNTech, the German company who developed its COVID-19 vaccine with Pfizer, announced at the JP Morgan 2021 event that it will be expanding the use of mRNA technology in new disease areas.
CEO Ugur Sahin, Chief Commercial Officer Sean Marett and Chief Strategy Officer Ryan Richardson each took turns drawing light to mRNA’s potential on the premise that COVID-19 is likely to stick around.
Infectious diseases like coronavirus are difficult to prepare vaccines for because they arrive unexpectedly and disappear quickly, before returning with new viral characteristics. There were only seven infectious disease vaccines approved by the US Food and Drug Administration from 2017 to 2020.
According to BioNTech, this is why mRNA vaccine technology should be valued, as it has shown compelling efficacy and safety for all tested age groups, can create reengineered vaccines in six weeks should there sprout up new viral variants and recipients can be revaccinated if immune responses wane.
While 2020 saw the acceleration of mRNA research and development, the immediate future will link mRNA with other infectious disease vaccines, vaccines against cancer, CAR-T cell amplifying vaccines and systemic mRNA encoded into immunotherapies for optimal drug delivery, BioNTech officials said.
For the COVID-19 mRNA vaccine, BioNTech has the capacity with its current partners to produce 1 billion doses in 2021. The company aspires to increase that number to 2 billion by end-2021 by expanding current sites and adding more suppliers and contract manufacturers.
BioNTech has six manufacturing sites, including three Pfizer sites, and its BioNTech alliance in Puurs, Belgium and Marburg and Mainz in Germany. It also has external contract manufacturing sites that are expanding lipid nanoparticles and fill-and-finish capacities.
According to BioNTech, it shares profits 50-50 with Pfizer and 35 to 40 percent with China’s Fosun Pharma.
Moderna, another company with an mRNA vaccine against COVID-19, echoed much of what BioNTech said.
CEO Stephane Bancel, Chief Financial Officer David Meline, Chief Medical Officer Tal Zaks and President Stephen Hoge stepped up as presenters.
According to Moderna, DNA is the storage, mRNA the software and the protein an application.
Using the mRNA technology, Moderna was able to create a 94 percent efficacious vaccine against the ongoing pandemic and have that approved for emergency use by global medical authorities in just 11 months of having acquired the sequence of the virus. Moderna only has some 1,000 people on its team.
This was possible, Moderna explained, because mRNA is an information molecule.
mRNA has a higher probability of technical success, and can accelerate research and development timelines, which in turn creates financial efficiency that outstips recombinant technology, Moderna officials said.
In 10 years and with $3 billion of investment, Moderna projects to be able to apply the mRNA technology for cell therapies, cancer vaccinations and immuno-oncology and regenerative therapeutics.
The 2020 pandemic has changed how the world thinks about infectious disease vaccines and added power to the belief that vaccines promise the best return on each health care dollar invested, Moderna said.
The company will continue to expand its mRNA vaccines portfolio, taking into account that the market has huge unmet medical needs.
There were more than 80 new viruses discovered in the last 40 years, but only 4 percent have a vaccine commercially available in the US. Worldwide vaccine revenue was $35 billion in 2019.
As for the COVID-19 vaccine, Moderna will have 600 million to 1 billion doses in production capacity in 2021.
From Korea, Hanmi Pharmaceutical’s CEO Kwon Se-chang in a presentation pitched the company’s Pyeongtaek Bio Plant as being able to contribute to the global endgame against COVID-19.
Hanmi’s Pyeongtaek Bio Plant has the capability to mass-produce DNA and mRNA vaccines, as well as diagnostics kits and treatments. The plant is equipped with facilities for pharmaceuticals that use fermented E. coli tablets. The same facility can be used for plasmid DNA vaccines and mRNA vaccines for COVID-19, Kwon said.
The plant also has a good manufacturing practice-abiding facility for enzymes needed in mRNA synthesis.
Kwon also introduced that Hanmi Pharm’s affiliated Hanmi Fine Chemical has the ability to produce various base materials for vaccines, ranging from nucleotides to active pharmaceutical ingredients, intermediates, peptides and lipids. Lipids are used for mRNA vaccines.
Hanmi is continuing its efforts for the development of 28 innovative novel treatment pipelines, as well as looking forward to the probable commercialization approval of Rolontis and Oraxol from the FDA this year.
Rolontis, outlicensed from Hanmi to US’ Spectrum Pharmaceuticals, is an investigational drug for neutropenia, an abnormally low concentration of a type of white blood cell called neutrophils that leads to a compromised immune response.
Oraxol, outlicensed to US’ Athenex, is a proposed novel treatment for metastatic breast cancer.
The 39th annual JP Morgan Healthcare Conference is to run until Thursday via an exclusive online link given to participating parties. In this year’s event, more than 400 companies, both public and private, are to deliver presentations to more than 8,000 participants, according to JP Morgan.
Korean companies making official presentations include Samsung Biologics to the main audience and Hanmi Pharmaceutical, Hugel, HK inno.N, LG Chem and Genexine to smaller audiences.
By Lim Jeong-yeo (email@example.com)
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