Moderna (NASDAQ:MRNA) experienced an 8.7% surge in its stock price on March 11 following the disclosure of details regarding the initiation of a phase II/III study on mRNA-4157/V940, its investigational individualized neoantigen therapy (INT), designed for patients with cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. This therapy, developed in partnership with Merck (NYSE:MRK), signifies a significant step forward in cancer treatment research.
The phase II/III study, named INTerpath-007, aims to evaluate the safety and efficacy of mRNA-4157 in combination with Merck’s renowned immuno-oncology drug Keytruda as neoadjuvant and adjuvant therapy for patients with resectable locally advanced CSCC. The study, slated to commence next month, will compare the treatment outcomes with the standard of care (SoC) alone, with the primary endpoint being event-free survival (EFS), while secondary endpoints include overall response rate (ORR), disease-free survival (DFS), and overall survival (OS).
This study marks the third clinical trial in the INTerpath program by Moderna/Merck, following the initiation of two pivotal late-stage studies evaluating the mRNA-4157/Keytruda combination in melanoma and non-small cell lung cancer (NSCLC) indications. The companies are poised to extend the application of mRNA-4157 to other oncology indications, underscoring their confidence in the INTerpath program.
Furthermore, the strategic collaboration between Merck and Moderna, initiated in 2016, aims to develop and market mRNA-based therapeutics for various cancer types. This partnership underscores the transformative potential of mRNA-based therapies, which offer individualized treatment tailored to the mutational signature of each patient’s tumor.
Moderna’s strategic pivot towards diversifying its pipeline beyond COVID-19 vaccines demonstrates its commitment to innovation and expansion. With plans to launch 15 new marketed products, including vaccines for respiratory syncytial virus (RSV), cytomegalovirus (CMV), and influenza over the next five years, Moderna aims to capitalize on its robust cash reserves generated during the pandemic years.
Moreover, Moderna anticipates potential FDA approval for its RSV vaccine mRNA-1345 in June, with commercial launch expected in the third quarter of 2024. This diversification strategy positions Moderna for sustained growth and resilience beyond the pandemic era, reflecting its stock performance and investor sentiment positively.
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