2022 R&D Day Highlights Moderna’s Broad Portfolio of mRNA Clinical Trial Programs
At Moderna’s sixth annual Research & Development Day, presentations from CEO Stéphane Bancel, President Stephen Hoge, M.D., and Moderna clinical team leaders discussed the organization’s advances across a portfolio of mRNA programs. The 2022 R&D Day sessions focused on Phase 3 trials and programs currently dosing in their target patient population.
Early sessions provided an overview of organic acidemias and shared preliminary data on two rare disease clinical trials: propionic acidemia (PA) and glycogen storage disease 1a (GSD1a), both of which are dosing in patients. This was followed by an update on the status of our personalized cancer vaccine trial (primary study analysis expected Q4). The second half of the agenda included discussion of three respiratory infectious disease vaccine programs, our cytomegalovirus (CMV) vaccine program, and the organization’s commercial launch preparation efforts.
More specifically, a Phase 1/2 propionic acidemia trial yielded favorable tolerability data along with encouraging early signs of clinical benefit. Encouraging safety data was also revealed in a Phase 1/2 trial evaluating a therapeutic candidate for glycogen storage disease 1a (GSD1a). The organization reported it is on track to report data from a Phase 2 Personalized Cancer Vaccine (PCV) study in 2022. Finally, Moderna will pursue an accelerated pathway for a potential 2023 approval of flu vaccine; a Phase 3 clinical trial of RSV vaccine is nearing full enrollment.
As Moderna’s pipeline advances, preparations are underway for numerous potential product launches. Current commercial priorities include planning for an endemic COVID-19 in 2023, expanding into respiratory markets with single-agent and combination vaccines for RSV, influenza, and COVID-19, preparing for a possible CMV vaccine launch, and entering the therapeutics market. Additionally, the organization continues to invest in building its global manufacturing capabilities.
“We continue to make significant progress in accelerating our pipeline. Our Phase 3 flu and RSV clinical trials are rapidly advancing toward completion. We are seeing early clinical benefits in two rare disease programs, and we expect to report on data from our personalized cancer vaccine trial later this year…As a reflection of the Company’s growth and progress, we are preparing for multiple product launches globally.”
- Stéphane Bancel, Moderna CEO
Forward-Looking Statement Disclaimer
This post contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: progress for the Company’s research and development efforts across its clinical pipeline, including the potential positive clinical benefit for the Company’s propionic acidemia therapeutic and therapy for GSD1a; the timing for personalized cancer vaccine data readouts; the status of clinical trials for seasonal flu and RSV; the timing for potential product launches; the potential to develop and market combination vaccines; and investments in manufacturing. The forward-looking statements in this post are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K and Quarterly Report for the quarter ended March 31, 2022 on Form 10-Q, in each case filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this post in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.