Wednesday 10 February 2021

About Moderna

About Moderna
Moderna, Inc., is an American biotechnology company based in Cambridge, Massachusetts. It has a fully integrated manufacturing plant and clinical development site in Norwood, MA, which opened in 2018.1 It went public and was listed on NASDAQ in December 2018 and created the largest biotech initial public offering in history on NASDAQ.2 Moderna has been ranked in the top ten of Science’s list of top biopharmaceutical industry employers for the past five years.3

The company was founded in 2010 by three scientists, Derrick J. Rossi, Kenneth Chien and Robert Langer, at Harvard Medical School, and by Flagship Ventures.4 Since 2011, Moderna has been led by Stéphane Bancel as the company’s CEO. He is a French businessman with pharmaceutical sales and operations experience.

Since the start of the vaccine race in combating COVID-19, Moderna has been well known for its use of messenger RNA (mRNA) as a vaccine. However, when it was initially founded, it mainly focused on the use of modified mRNA technology to reprogram stem cells for therapeutic purposes,1 which is the research focus of the one of the co-founders, Professor Derrick Rossi.5 The company has changed their direction of interest very quickly since then. Nowadays, Moderna uses its mRNA platform to perform drug discovery and drug development, as well as vaccine development.

The products the company is developing
According to Moderna’s website, aside from the vaccine against the novel coronavirus SARS-CoV-2 (mRNA-1273), the company is also developing 10 other vaccine candidates against infections in three main areas.

1.Vaccines against respiratory infections
• Respiratory syncytial virus (RSV) vaccine for older adults (mRNA-1777 and mRNA-1172)
• RSV vaccine for young children (mRNA-1345)
• Human metapneumovirus and parainfluenza virus type 3 (hMPV/PIV3) vaccine (mRNA-1653)
• Novel coronavirus (SARS-CoV-2) vaccine (mRNA-1273)
• Influenza H7N9 (mRNA-1851)
• H10N8 (mRNA1440)
2. Vaccines against infections transmitted from mother to baby
• Cytomegalovirus (CMV) vaccine (mRNA-1647)
• Zika vaccine (mRNA-1893)
3. Vaccines against highly prevalent viral infections
• Epstein-Barr virus (EBV) vaccine (mRNA-1189)
• Chikungunya virus (mRNA-1944)

Of these, Moderna has 7 vaccine candidates, which are against H10N8,6 H7N9,6 RSV,7 Chikungunya virus,8 hMPV/PIV3,9 and Zika,10 currently in Phase 1 clinical studies. The company’s CMV vaccine is even currently in a Phase 2 dose-confirmation study.11

As mentioned earlier in this blog post, Moderna also performs drug development. It is now currently developing therapeutics mRNA for immuno-oncology (mRNA-2416 for advanced/ metastatic solid tumours or lymphoma, Phase 1;12 mRNA-2752 for relapsed/ refractory solid tumours malignancies or lymphoma, Phase 113), for rare diseases (mRNA-3704 for Methylmalonic Acidemia (MMA),Phase 1/214; mRNA-3927 for Propionic Acidemia (PA)15), and for cardiovascular diseases (mRNA AZD-8601, Phase 2)16, independently or with strategic collaborators.

Besides the public organizations mentioned in my previous blog post, Moderna has established a wide collaboration network with different biopharmaceutical companies (Merck, AstraZenecca, Alexion, et al.) and research institutions.



References
1. Key milestones and advancements in mRNA technology-Moderna. Moderna. https://www.modernatx.com/about-us/modernas-key-milestones-and-advancements
2. Moderna: 5 things to know about the largest biotech to IPO. MarketWatch, Dec. 7, 2018. https://www.marketwatch.com/story/moderna-ipo-5-things-to-know-about-what-could-be-the-largest-biotech-ipo-in-history-2018-12-05
3. Moderna named top employer by Science for sixth consecutive year. Business Wire, October 30, 2020. https://www.businesswire.com/news/home/20201030005447/en/
4. ModeRNA, stealth startup backed by Flagship, unveils new way to make stem cells. Erin Kutz. Xconomy, 4th Oct., 2010.
5. L. Warren, P.D. Manos, T. Ahfeldt, et al. Highly efficient reprogramming to pluripotency and directed differentiation of human cells with synthetic modified mRNA. Cell Stem Cell, Volume 7, Issue 5, p.618-630, November 05, 2010.
6. R.A. Feldman, R. Fuhr, I. Smolenov, et al. mRNA vaccines against H10N8 and H7N9 influenza viruses of pandemic potential are immunogenic and well tolerated in healthy adults in Phase 1 randomized clinical trials. Vaccine, Volume 37, Issue 25, 31 May 2019, Pages 3326-3334.
7. Moderna announces updates on Respiratory Syncytial virus (RSV) vaccine program. Moderna press release, October 8, 2020. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-updates-respiratory-syncytial-virus-rsv/
8. Moderna Announces Positive Phase 1 Results for the First Systemic Messenger RNA Therapeutic Encoding a Secreted Protein (mRNA-1944). Moderna press release, September 12, 2019. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-phase-1-results-first-systemic/
9. Safety and immunogenicity of mRNA-1653, a combined human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine, in healthy adults, and children 12-36 months of age with serologic evidence of prior exposure. ClinicalTrials.gov. ClinicalTrials.govhttps://clinicaltrials.gov/ct2/show/NCT04144348
10. Safety, tolerability, and immunogenicity of Zika Vaccine mRNA-1893 in healthy flavivirus seropositive and seronegative adults. Moderna press release, August 19, 2019. https://investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-fast-track-designation-zika-vaccine-mrna/
11. Moderna completes enrollment of Cytomegalovirus (CMV) Vaccine (mRNA-1647) Phase 2 study. Moderna press release, March 3, 2020. https://investors.modernatx.com/news-releases/news-release-details/moderna-completes-enrollment-cytomegalovirus-cmv-vaccine-mrna/
12. Dose escalation and efficacy study of mRNA 2416 for intratumoral injection alone and in combination with durvalumab for patients with advanced malignancies. ClinicalTrials.com. https://www.clinicaltrials.gov/ct2/show/NCT03323398?term=Moderna&recrs=ab&rank=2
13. Dose escalation study of mRNA-2752 for intratumoral injection to patients with advanced malignancies. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03739931?term=mRNA-2752-P101&rank=1
14. Open label study of mRNA-3704 in patients with isolated Methylmalonic Acidemia. ClinicalTrials.gov. https://www.clinicaltrials.gov/ct2/show/NCT03810690?cond=Methylmalonic+Acidemia
15. "The MaP Study": Mapping the Patient Journey in MMA and PA. ClinicalTrials.gov. https://www.clinicaltrials.gov/ct2/show/NCT03484767
16. Entering a new era in vascular and cardiac regeneration research. AstraZeneca. https://www.astrazeneca.com/what-science-can-do/topics/next-generation-therapeutics/entering-a-new-era-in-vascular-and-cardiac-regeneration-research.html

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