Moderna Announces Presentation of Interim Data from Phase 1 Study of mRNA Personalized Cancer Vaccine at 2019 ASCO Annual Meeting
Data show the potential of using neoantigens identified from an individual’s tumor to elicit an immune response to cancer mutations
Tolerability and immunogenicity data support the randomized Phase 2 study of mRNA-4157 in combination with pembrolizumab
Conference call to be held on
Presented today at the 2019
“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
“For decades, the cancer community has been working on the concept of
developing medicines that can be personalized down to the individual
patient level,” said Howard A. “Skip” Burris III, M.D., president,
clinical operations & chief medical officer at
About the Data
Abstract 2523: A phase 1 multicenter study to assess the safety, tolerability and immunogenicity of mRNA-4157 alone in patients with resected solid tumors and in combination with pembrolizumab in patients with unresectable solid tumors.
In this dose-escalation study, 13 patients with resected solid tumors (melanoma, colon and lung cancers) received mRNA-4157 as adjuvant monotherapy after resection of their primary tumor. An additional 20 patients with metastatic, unresected solid tumors (melanoma, bladder, lung, colon, prostate, head and neck and endometrial cancers) received at least one dose of mRNA-4157 in combination with pembrolizumab.
- mRNA-4157 was well-tolerated at all dose levels studied with no dose-limiting toxicities or grade 3/4 adverse events (AEs) or SAEs reported when administered as a monotherapy or in combination with pembrolizumab. The most common grade 2 adverse events were fatigue, soreness at the injection site, colitis and myalgias.
- A cohort of patients at the top dose level (1 mg) are undergoing apheresis and deeper characterization of immunogenicity responses. Data from one such patient was available at the data cutoff and showed neoantigen-specific CD8 T-cell responses were detected to 10 out of 18 class I neoantigens after the 4th dose of the vaccine (compared to 0/18 at baseline).
- Clinical responses (one complete response + five partial responses) at doses ranging from 0.04-1.0 mg were observed in 6 out of 20 patients receiving at least one dose of mRNA-4157 in combination with pembrolizumab. The complete response occurred to pembrolizumab monotherapy before mRNA-4157 was administered. Of the five partial responses, two were seen in patients previously treated with a checkpoint inhibitor.
- Of the 13 patients who received adjuvant mRNA-4157 monotherapy, all patients have completed a full course of vaccination per the study protocol. Eleven patients remained disease free up to 75 weeks on study.
Presented by: Gal Cafri, Ph.D., Postdoctoral Fellow, National Cancer
Institute Surgery Branch
Moderna will host a conference call and webcast on
About Moderna’s Immuno-Oncology Programs
Moderna’s oncology programs are currently focused on two main areas:
cancer vaccines and intratumoral immuno-oncology (I/O) therapies.
An advantage of Moderna’s mRNA platform is that it allows for investigational medicines that combine in a single mRNA therapy several different approaches to activate the immune system to attack cancer, either with mRNA encoding for common tumor proteins found across cancer types or multiple mRNAs encoding for various immunomodulatory proteins.
Moderna’s investigational PCVs are designed to use neoantigens
identified from an individual’s tumor to program the body’s immune
system to elicit a more effective anti-tumor response. Upon sequencing
the tumor, Moderna’s proprietary algorithms predict the neoantigens
(antigens encoded by tumor-specific mutated genes) most likely to
trigger the immune system to attack a particular cancer. Today, mRNA
encoding up to 34 unique neoantigens can be delivered in a single
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic
alliances for development programs with
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended including, but not limited to, statements concerning: the
potential for Moderna’s investigational PCVs to use neoantigens
identified from an individual’s tumor to program the body’s immune
system to elicit a more effective antitumor response; and the planned
Phase 2 study investigating pembrolizumab in combination with mRNA-4157,
compared to pembrolizumab alone, in high-risk adjuvant melanoma. In some
cases, forward-looking statements can be identified by terminology such
as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,”
“anticipates,” “believes,” “estimates,” “predicts,” “potential,”
“continue,” or the negative of these terms or other comparable
terminology, although not all forward-looking statements contain these
words. The forward-looking statements in this press release are neither
promises nor guarantees, and you should not place undue reliance on
these forward-looking statements because they involve known and unknown
risks, uncertainties and other factors, many of which are beyond
Moderna’s control and which could cause actual results to differ
materially from those expressed or implied by these forward-looking
statements. These risks, uncertainties and other factors include, among
others: whether Phase 1 results for mRNA-4157 and mRNA-4650 will be
predictive of any future clinical studies; whether mRNA-4157 and
mRNA-4650 will be shown to be unsafe or intolerable during future
clinical studies; clinical development is lengthy and uncertain,
especially for a new class of medicines such as mRNA, and therefore our
clinical programs or development candidates may be delayed, terminated,
or may never advance; no mRNA drug has been approved in this new
potential class of medicines, and may never be approved; mRNA drug
development has substantial clinical development and regulatory risks
due to the novel and unprecedented nature of this new class of
medicines; and those risks and uncertainties described under the heading
“Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed
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