Moderna Provides Update on mRNA Vaccine Pipeline

Moderna announced today its updates to its vaccine portfolio across various infectious diseases and cancer as well. The company plans to use its mRNA platform for a variety of respiratory and latent viruses and cancer.

Here are some updates the company provided for their portfolio:

COVID-19 vaccines

The company had vaccine sales of approximately $18.4 billion, and it reiterated that in 2023 they expected a minimum of approximately $5.0 billion in COVID-19 vaccines sales from confirmed advance purchase agreements and 2022 contract deferrals. In addition, they mentioned they had potential additional contracts in the United States, Europe, Japan, and other countries.

Respiratory syncytial virus (RSV) vaccine
The company’s phase 3 RSV efficacy study for its mRNA-1345 RSV vaccine has enrolled 36,604 participants in adults who are 60 years of age and above. The primary endpoints are safety and vaccine efficacy, and they reported that they have accrued the number of cases required to complete their first interim efficacy analysis.

Seasonal influenza vaccine
Moderna’s southern hemisphere immunogenicity study in adults (18+) is fully enrolled (6000 participants) for its investigational influenza vaccine, mRNA-1010. They expect a readout of data in this quarter.

In addition, they have a northern hemisphere efficacy study in adults who are 50 years of age and older. This is fully enrolled with 22,510 participants, and the data readout could occur this winter depending upon cases accrued in the study and vaccine efficacy.

"With our infectious disease franchise continuing to accelerate with exciting near-term catalysts for RSV phase 3 data and Flu phase 3 data, and recent breakthroughs in the development of individualized cancer treatments, as well as our rapid advancement in rare diseases and promising cardiology programs, the Moderna platform is delivering across several modalities,” Stéphane Bancel, Chief Executive Officer of Moderna, said in a statement.

Personalized cancer vaccine
Moderna and Merck said their vaccine, mRNA-4157/V940, in combination with Keytruda, demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death compared to Keytruda monotherapy in stage 3/4 melanoma patients with high risk of recurrence following complete resection.

Cytomegalovirus (CMV) vaccine

Moderna said its phase 3 CMVictory trial for its mRNA-1647 vaccine is approximately 40% enrolled, and they are looking for candidates in Japan.

R&D, Strategic Collaborations
The company has planned a number of reinvestments including increases in investments in R&D, manufacturing infrastructure, and company buildout, and plans to pursue external investment opportunities (licenses and/or M&A). R&D investments in 2023 are estimated at $4.5 billion, up from approximately $3.3 billion for 2022.

“Our board has approved a significant increase to our R&D investments, with a budget for 2023 of around $4.5 billion. 2023 is going to be a very exciting year for Moderna, and most importantly, for patients," Bancel said.

In addition, Moderna has entered into an agreement to acquire OriCiro Genomics, a Japanese company with a novel development approach for cell-free synthesis and amplification of plasmid DNA, a key building block of mRNA manufacturing and have formed strategic research collaboration with CytomX Therapeutics for development of mRNA-based conditionally activated therapeutics for oncology and non-oncology condition and maintains ongoing strategic collaborations include a partnership with Carisma Therapeutics to discover, develop and commercialize in vivo engineered chimeric antigen receptor monocyte (CAR-M) therapeutics for the treatment of cancer. Additionally, Moderna is partnering with Metagenomi to accelerate the development of in vivo gene editing therapeutics.

To learn more about the pipeline, read an interview with Sunny Himansu, MBBS, DSM, associate director, ID Bacteriology, Infectious Diseases, Moderna, who offers some insights into the mRNA platform, the role of mRNA therapies, and where they are with some of their investigational vaccines.