Vaccine Info

mRNA-4157 Cancer Vaccine

mRNA-4157 Cancer Vaccine Description

Moderna, Inc.'s mRNA personalized cancer vaccine (PCV) mRNA-4157 is a therapeutic cancer vaccine candidate that is a combination of validated defined neoantigens, predicted neoepitopes, and mutations in driver genes into a single mRNA concatemer (mRNA-4650).

On November 10, 2020, Moderna issued interim data from the Phase 1 dose-expansion cohort of mRNA-4157, in combination with pembrolizumab. The data showed that mRNA-4157 given in combination with Keytruda® is well tolerated at all dose levels and produced responses as measured by tumor shrinkage by RECIST 1.1 criteria in HPV(-) HNSCC patients. No responses were observed in the MSS-CRC group of patients.

In the dose-expansion cohort, the Overall Response Rate (ORR) in the HPV(-) HNSCC group of patients as measured by RECIST 1.1 is 50% (5/10) with two patients achieving a complete response with no detectable disease, and three patients achieving a partial response, all of which are ongoing.

The median progression free survival (mPFS) is 9.8 months, which compares favorably to the published ORR and the mPFS of 14.6% and 2.0 months respectively, for Keytruda monotherapy. Including four patients with stable disease, the Disease Control Rate (DCR) is 90% (9/10). The median duration of response has not been reached.

The HPV(-) HNSCC cohort continues to recruit and Moderna has decided to expand the size of the current cohort based on the interim data reported.

“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,” said Stephen Hoge, M.D., President of Moderna, in a press statement. “This study demonstrates the ability of Moderna’s mRNA personalized cancer vaccine to elicit clinical activity when given in combination with pembrolizumab."

Headquartered in Cambridge, Mass., to learn more, visit www.modernatx.com.

mRNA-4157 Cancer Vaccine Indication

The mRNA personalized cancer vaccine mRNA-4157 is indicated to vaccinate patients with metastatic common epithelial cancers. It is an mRNA-based individualized, therapeutic personalized cancer vaccine targeting 20 tumor-associated antigens that are specifically expressed by the patient's cancer cells, with potential immunostimulatory and antineoplastic activities.

mRNA-4157 Cancer Vaccine Dosage

Patients are vaccinated intramuscularly at 2-week intervals for (4) cycles, and dosing may be repeated for the second course of vaccination.

mRNA-4157 Cancer Vaccine News

November 11, 2020 - Moderna, Inc. shared interim data from the expansion cohort of its ongoing Phase 1 study of the Company’s mRNA personalized cancer vaccine (PCV) mRNA-4157 in combination with Merck’s Keytruda®1 at The Society for Immunotherapy of Cancer's Annual Meeting. The data shared today showed that mRNA-4157 given in combination with Keytruda® is well tolerated at all dose levels and produced responses as measured by tumor shrinkage by RECIST 1.1 criteria in HPV(-) HNSCC patients. No responses were observed in the MSS-CRC group of patients. Stephen Hoge, M.D., President of Moderna stated: “This study demonstrates the ability of Moderna’s mRNA personalized cancer vaccine to elicit clinical activity when given in combination with 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.”

November 9, 2020 - A clinical trial at the University of Arizona Health Sciences designed to study the safety and effectiveness of a personalized cancer vaccine in combination with the immunotherapy drug Pembrolizumab will expand its cohort after promising preliminary data were presented at the annual meeting of the Society for the Immunotherapy of Cancer.

June 1, 2019 - The data showed that the mRNA personalized cancer vaccine mRNA-4157, given alone or in combination with Merck’s pembrolizumab (KEYTRUDA®), was well-tolerated at all doses tested and elicited neoantigen-specific T-cell responses. There were no vaccine-related serious adverse events reported for the PCV when administered to patients as a monotherapy or in combination with pembrolizumab.

December 13, 2016 - Moderna announced '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).'

mRNA-4157 Cancer Vaccine Clinical Trials

Clinical Trial NCT03313778: Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone in Subjects With Resected Solid Tumors and in Combination With Pembrolizumab in Subjects With Unresectable Solid Tumors (KEYNOTE-603)

  • The purpose of this phase 1 study is to assess the safety, tolerability, and immunogenicity of mRNA-4157 alone in subjects with resected solid tumors, and in combination with pembrolizumab in subjects with unresectable solid tumors. 
  • Last Update Posted: March 30, 2020.

Clinical Trial NCT03897881: An Efficacy Phase 2 Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Patients With High-Risk Melanoma (KEYNOTE-942)

  • The purpose of this Phase 2 study is to assess whether postoperative adjuvant therapy with mRNA-4157 and pembrolizumab improves recurrence-free survival (RFS) compared to pembrolizumab alone in patients with complete resection of cutaneous melanoma and a high risk of recurrence.
  • Last Update Posted: February 6, 2020.