The pandemic launch of Spikevax, the company’s COVID-19 vaccine, was the company’s first commercial product.
But as the COVID-19 market moves past its peak and transitions into a seasonal model, Moderna has a total of 48 development programs on the go. It’s now looking to the late 2023 or early 2024 launch of its RSV vaccine: while it also has two other candidates in Phase 3 development (influenza and CMV vaccines).
Here are the seven priorities the company identifies for 2023.
Priority #1: ‘Execute the operational and sales plan for COVID booster for fall of 2023’
While the COVID-19 market is transitioning into a seasonal model, Moderna says the disease still represents a ‘substantial health burden’ (total hospitalizations from COVID-19 from October to February were still far above those for flu and RSV).
And Spikevax, for the moment, remains the company’s only commercial product and thus a key revenue driver. Remaining a key player in the COVID-19 market is therefore a top priority.
Moderna predicts the US fall COVID-19 market volume to be around 100 million doses (based on 2022 vaccination rates and including potential recommendation for 2-dose booster series for high-risk individuals).
“To ensure coverage of our vaccine, we are engaged in discussions with private customers as well as public entities such as the VA, CDC and the Department of Defense,” said Moderna’s Chief Commerical Officer, Arpa Garay, speaking in the company’s FY2022 earnings call last month.
“We are increasing awareness and educating consumers as well as healthcare providers about the benefits of booster vaccinations in alignment with public health agencies such as CDC and ACIP. We are reaching healthcare providers and consumers through innovative digital outreach programs. We have built the infrastructure needed to fulfil customer orders and shipments, and our commercial and medical organizations have been scaling to execute on this plan, and we are ready for the transition to a commercial market in the US.”
Globally, Moderna expects to see at least $5bn in COVID-19 vaccine sales revenue from currently contracted deliveries in 2023; although it expects to see additional sales add to that throughout the year.
Priority #2: ‘Build an unrivaled seasonal respiratory vaccine franchise’
Moderna plans to file for regulatory approval for its RSV vaccine candidate within the first half of this year. With the option of using a priority review voucher, it expects it could see a regulatory decision in late 2023 or early 2024.
Its influenza vaccine (mRNA-1010), meanwhile, is in Phase 3 trials. Although the latest data on the vaccine was mixed (Phase 3 interim data showed the candidate generated a strong immune response against Influenza A, but failed to demonstrate it was at least as effective as an existing vaccine against Influenza B), the company continues the champion the vaccine’s potential.
The vast majority of influenza cases are caused by Influenza A; while the company has already updated the vaccine in the hope it could improve immune responses against Influenza B.
“Our goal, over time, is to develop a superior influenza vaccine,” said Stephen Hoge, president, Moderna. “And so if we don’t see it with the first-generation product, I would note that we have four other flu programs in development, different stages of clinical trials, that are looking to do even better than perhaps flu mRNA-1010.”
The crown in Moderna’s seasonal respiratory vaccine portfolio could ultimately be a combo COVID, RSV and influenza vaccine (mRNA-1230): which is currently in Phase 1 trials.
Priority #3: ‘Execute a bold campaign of cancer vaccine studies’
Last month Moderna received FDA Breakthrough Therapy Designation from the FDA for mRNA-4157/V940, its personalized cancer vaccine.
A Phase 2b trial looking at mRNA-4157/V940, in combination with Merck’s PD-1 therapy Keytruda, met the study’s primary endpoint of recurrence-free survival as an add-on therapy in high-risk skin cancer patients.
Moderna and Merck now plan to discuss these results with regulatory authorities, initiate a Phase 3 study in melanoma this year and ‘rapidly expand’ to additional tumor types (including non-small cell lung cancer). It also pledges to explore ‘additional opportunities with strong biological rationale, within Keytruda-approved indications and beyond, in early-stage disease and metastatic settings’.
Priority #4: ‘Advance rare metabolic disease programs’
Moderna’s mRNA therapy (mRNA-3927) for Propionic Acidemia (PA), a rare and severe metabolic disorder, is in a Phase 1/2 clinical trial.
mRNA-3745, a candidate for Glycogen Storage Disease 1a (a rare, inherited metabolic disorder), is in a Phase 1/2 trial.
In Methylmalonic Acidemia, the first two groups of patients are fully enrolled in Moderna’s Landmark Study, a Phase 1/2 clinical trial to evaluate the safety and pharmacology of mRNA-3705.
Priority #5: ‘Drive rapid advancement and growth of our latent vaccine portfolio’
Moderna’s scientists are among those paying increasing attention to latent viruses: which – while often without symptoms in people initially infected – can be reactivated later in life or lead to lifelong problems. EBV infection, for example, typically is asymptomatic: but can also cause mononucleosis while studies have now suggested a link between EBV, MS and some types of cancer.
“At Moderna, we are committed to developing a portfolio of first-in-class vaccines against latent viruses for which there are still no approved vaccines, including EBV, CMV, and HIV,” says the company.
Moderna’s CMV vaccine (mRNA-1647) is in Phase 3 trials: while the company also has EBV, HIV and VZV vaccines in clinical studies. A pre-clinical program is underway for an HSV vaccine.
Priority #6: ‘Deliver the next-generation pipeline and platform… This is just the beginning’
Moderna has a total of 48 development programs on the go: four of these are in Phase 3 and nine are in Phase 2. It has also entered a series of collaborations and investments: such as a partnership with ElevateBio’s Life Edit Therapeutics on gene editing therapies; a research collaboration for mRNA-based conditionally activated therapeutics with CytomX; and the acquisition of OriCiro Genomics so far this year alone.
Moderna pledges to increase its R&D spending from $3.3bn in 2022 to $4.5bn in 2023.
Priority #7: ‘Build a culture of perpetual learning and strengthen our processes and digital system as we want to scale the company to another level’
As an mRNA success story, Moderna has certainly changed since it was founded in 2010. It now has 16 commercial subsidiaries across North America, Europe and Asia Pacific and around 3,900 employees.
So what will the company look like as it continues to grow and scale? Continuous learning and investments in digital and new tech will be an integral part of the company’s future, it says.
An example of this is the 2021 launch of its ‘AI Academy’ in partnership with Carnegie Mellon University. The AI Academy is intended to educate and empower employees at all levels to identify and integrate AI and machine learning solutions into every Moderna system and process.
“Moderna is advancing mRNA medicines at a breadth, speed, and scale that is uncommon in the biopharmaceutical industry, and we attribute this speed in part to the incorporation of digital technologies in our company,” said Stéphane Bancel as the academy announced its launch.
“As we look at the next 10-20 years, we believe that we have to learn as fast as we can to maximize the impact of mRNA technologies on patients and scale our company in very different ways than large companies have scaled in the last decades. We believe AI is a key enabler of our ability to build the best version of Moderna now and into the future.”
