Submitted by moderna-user-01 on Tue, 12/13/2016 - 19:34
IND/CTA Filed: 
Phase 1: 
Phase 2: 
Phase 1 Text: 
Started: Nov '17
Moderna/ Merck
Personalized Cancer Vaccines
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About Immuno-Oncology

Immuno-oncology is a therapeutic area that involves harnessing the body’s immune system to kill cancer cells in the same way the immune system responds to and eradicates a viral, microbial, fungal or parasitic infection. Also often referred to as immunotherapy, immuno-oncology is an increasingly expanding area of cancer drug development. This is particularly due to the successful introduction and use over the past several years of one type of immunotherapy known as checkpoint inhibitors.

T cells are a key part of the immune system; they identify and mount an attack on both infections and cancers. Checkpoint inhibitors enable T cells to better recognize cancer cells as foreign invaders that may otherwise go undetected and, therefore, evade attack. Unfortunately, not all patients respond to treatment with checkpoint inhibitors.

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Our mRNA-based, Personalized Cancer Vaccine (mRNA-4157)

We are developing an mRNA-based personalized cancer vaccine (PCV), mRNA-4157, with the potential to prime the immune system to recognize cancer cells and mount a strong, tailored response to each individual patient’s cancer. Utilizing our mRNA vaccine technology platform, we plan to first identify and then create a vaccine encoding for peptides containing unique mutations (i.e., neoantigens) present in each patient’s specific tumor. When injected in the body, the mRNA directs cells to produce and express these neoantigens. This, in turn, activates the immune system to better recognize and destroy the cancer cells. Our mRNA-based personalized cancer vaccine has the potential to improve clinical outcomes associated with checkpoint inhibitor therapies, including our partner Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab).

Moderna has developed a rapid cycle time, small-batch manufacturing technique that will uniquely allow us to supply vaccines tailored to individual patients within weeks.

mRNA-4157 has completed GLP toxicology studies.


Therapeutic Area:

GLP Toxicology: 

Modality:  Therapeutic Vaccines | Therapeutic Area:  Personalized Cancer Vaccine / Immuno-Oncology | Disease:  Various Cancers

Partnered Program with Merck