On October 22, 2020, the Phase 3 COVE study of mRNA-1273 completed the enrolment of 30,000 participants in the U.S. The randomized, 1:1 placebo-controlled Phase 3 trial is studying mRNA-1273 at the 100 µg dose. The primary endpoint is the prevention of symptomatic COVID-19 disease. Key secondary endpoints include the prevention of severe COVID-19 disease and the prevention of infection by SARS-CoV-2 (the virus that causes COVID-19).

The Phase 3 COVE Study

• Evaluated Americans at the highest risk of severe COVID-19 disease.
• Included more than 7,000 Americans over the age of 65.
• Included more than 5,000 Americans who are under the age of 65, but have high-risk chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity, and cardiac disease.

These high-risk people represent 42% of the participants in the Phase 3 COVE trial.  

Moderna stated that it has also worked to develop a vaccine for everyone, including communities that have historically been under-represented in clinical research and are disproportionately impacted by COVID-19.

More than 11,000 participants from communities were of color, representing 37% of the study population, including over 6,000 participants who identify as Hispanic or LatinX, and more than 3,000 participants who identify as Black or African American.

That was not the only good news for Moderna. 

Moderna Inc at the SITC 2020 Meeting

At the Society for Immunotherapy of Cancer’s Annual Meeting (SITC 2020), Moderna shared news from the interim data from an ongoing Phase 1 study of its personalized cancer vaccine mRNA-4157 in combination with Keytruda® – the checkpoint inhibitor immunotherapy developed by Merck (MRK).  The dose expansion cohort included 10 patients with (HPV Negative) Head and Neck Squamous Cell Carcinoma (HNSCC) and 17 patients with Micro-Satellite Stable Colorectal Cancer.  

The data demonstrated that the combination was well tolerated at all doses and produced responses.

No responses were observed in the Micro-Satellite Stable Colorectal Cancer patients.

mRNA-4157 was well tolerated and adverse events were typically low grade and reversible.

In the dose-expansion cohort, the Overall Response Rate (ORR) in the (HPV negative) Head and Neck Squamous Cell Carcinoma group of patients is 50% (5/10).  Two patients achieved a complete response (CR) with no detectable disease, and three patients achieved partial response (PR). Median progression-free survival (mPFS) is 9.8 months, which compares favorably to the published ORR and mPFS of 14.6% and 2 months respectively, for Keytruda monotherapy. The Disease Control Rate (DCR) is 90% (9/10), and the median duration of response has not been reached.

The (HPV negative) Head and Neck Squamous Cell Carcinoma cohort continued to recruit and Moderna has decided to expand the size of the current cohort based on the interim data reported today.

From the President of Moderna 

Stephen Hoge, M.D., President of Moderna, said, “We are encouraged by these interim data from our personalized cancer vaccine program, which involves designing and manufacturing a unique vaccine for each patient based on their specific tumor. This study demonstrates the ability of Moderna’s mRNA personalized cancer vaccine to elicit clinical activity when given in combination with Keytruda (pembrolizumab). I would also like to welcome Dr. Aanur to Moderna and look forward to working closely with him to continue building our oncology therapeutic area.”

Dr. Praveen Aanur joins Moderna as VP of Therapeutic Area Head for Oncology Dept.

Dr. Praveen Aanur joins Moderna from Bristol-Myers Squibb (BMY) where he was responsible for multiple regulatory submissions across BMS’ immuno-oncology portfolio. In his seven years at BMS, Dr. Aanur had a wide range of roles increasing responsibility across Clinical Development and Translational Research. Dr. Aanur started his career as a physician and completed his Hematology-Oncology Fellowship at Oregon Health Sciences University, and a Fellowship in Bone Marrow Transplantation at Memorial Sloan Kettering in New York where he was also a clinical investigator in the Bone Marrow Transplant Unit. He holds an MBBS from Bangalore University, an MPH from the University of Alabama, and an MBA from Columbia University School of Business.

Moderna’s Immuno-Oncology Programs

Moderna’s oncology programs are currently focused on two main areas: cancer vaccines and intratumoral immuno-oncology (I/O) therapies. Moderna is developing potential mRNA products with its collaborators Merck and AstraZeneca (AZN). Currently, the company has five I/O programs in development, including two programs in Phase 2 trials.

Moderna’s Investigational Personalized Cancer Vaccine

These cancer vaccines use neoantigens identified from an individual’s tumor to program the body’s immune system to elicit a more effective anti-tumor response. Upon sequencing the tumor, Moderna’s proprietary algorithms predict the neoantigens (antigens encoded by tumor-specific mutated genes) most likely to trigger the immune system to attack particular cancer. Today, mRNA encoding up to 34 unique neoantigens can be delivered in a single vaccine. Moderna develops and manufactures these investigational personalized cancer vaccines at its personalized vaccines unit within its Massachusetts manufacturing facility. 

Prohost Observations

Moderna is building lucrative solid pipeline programs that will guarantee it a prosperous future. We believe that the firm’s COVID-19 vaccine might reach the market after the Pfizer/BioNTech COVID-19 vaccine is approved. We also believe that revenues’ growth would not be an outcome of its COVID-19 vaccine’s sales, but will instead materialize from the approval and sales of its mRNA pipeline products designed to treat infections, cancers as well as other chronic and life-threatening diseases.

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