Cancer therapy: Moderna, Merck begin late-stage study

Moderna and Merck & Co said on Monday they have started a late-stage trial of their experimental personalized mRNA cancer treatment in combination with blockbuster drug Keytruda for patients with a type of lung cancer.

The therapy, V940, belongs to a class of treatments called m-RNA-based individualized neoantigen therapy (INT) and is tailored for each patient to generate T-cells, a key part of the body’s immune response, based on the specific mutational signature of a tumor.

“As lung cancer is the leading cause of cancer death worldwide, there is a need for continued scientific advancements to help fight this disease at earlier stages when patients have the best chance for better outcomes,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “By combining KEYTRUDA with V940 (mRNA-4157), a promising new modality, we are researching innovative new approaches for earlier stage non-small cell lung cancer.”

“Addressing lung cancer reflects the constant struggle between medical innovation and biological complexity. Each patient’s cancer presents a labyrinth of genetic mutations, driving a novel approach of individualized medicines manufactured based on the distinct molecular tumor profile for each patient,” said Kyle Holen, M.D., Moderna’s Senior Vice President and Head of Development, Therapeutics and Oncology. “We believe an individualized neoantigen therapy can be this catalyst for innovation and drive us forward towards the next frontier of cancer care. I’m incredibly thankful for the patients, investigators, and clinical trial sites for helping us in this mission.”

As previously announced, in addition to INTerpath-002, the combination of V940 (mRNA-4157) plus KEYTRUDA is being investigated in INTerpath-001, formerly referred to as V940-001, a global, randomized, double-blind, placebo- and active-comparator-controlled Phase 3 trial evaluating approximately 1,089 patients with resected high-risk (Stage IIB-IV) melanoma. INTerpath-001 is actively screening in 14 countries (Australia, Belgium, Canada, Chile, France, Germany, Greece, Israel, Italy, Poland, Portugal, Spain, Turkey and the United Kingdom), representing 38 sites. The companies plan to continue expansion of the comprehensive clinical development program for V940 (mRNA-4157) to additional tumor types.

About V940 (mRNA-4157)

V940 (mRNA-4157) is a novel investigational messenger RNA (mRNA)-based individualized neoantigen therapy (INT) consisting of a synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the DNA sequence of the patient’s tumor. Upon administration into the body, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity.