NCI-4650 / Moderna, Merck (MSD) - LARVOL DELTA

The paradigm shift in treatment from Covid-19 to oncology with mRNA vaccines. (PubMed, Cancer Treat Rev) - "The rapid development and large-scale production of mRNA platform has enabled for the development of both personalized vaccines (mRNA 4157, mRNA 4650 and RO7198457) and tetravalent vaccines (BNT111 and mRNA-5671). In other words, while developing a vaccine design, the underlying motivation should be a reasonable combination of delivery route and format. Exploring various administration routes and delivery route systems has boosted the development of mRNA vaccines."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases

Messenger RNA (mRNA)-Based, Personalized Cancer Vaccine Against Neoantigens Expressed by the Autologous Cancer (clinicaltrials.gov) - P1/2; N=5; Terminated; Sponsor: National Cancer Institute (NCI); Trial completion date: Jun 2019 ➔ Nov 2019; Completed ➔ Terminated; slow accrual

Clinical • Trial completion date • Trial termination

Messenger RNA (mRNA)-Based, Personalized Cancer Vaccine Against Neoantigens Expressed by the Autologous Cancer (clinicaltrials.gov) - P1/2; N=4; Completed; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Completed; N=64 ➔ 4; Trial completion date: May 2028 ➔ Jun 2019; Trial primary completion date: May 2026 ➔ Jun 2019

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date

Moderna reports first quarter 2019 financial results and provides business updates (Businesswire) - “Personalized cancer vaccines (PCVs) (mRNA-4157, NCI-4650): Two abstracts for Moderna PCV programs were accepted for presentation at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. Moderna will present new updates to clinical data from the Company’s Phase 1 study of mRNA-4157, a PCV being studied alone in patients with resected solid tumors and in combination with Merck’s pembrolizumab in patients with unresectable solid tumors. The National Cancer Institute (NCI) will also present data from its Phase 1 study of PCV NCI-4650, a monotherapy for patients with advanced metastatic cancers.”

P1 data