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 Monday, June 3 at
8:00 a.m. ET
Moderna, Inc., (Nasdaq: MRNA) a clinical-stage biotechnology
company pioneering messenger RNA (mRNA) therapeutics and vaccines
to create a new generation of transformative medicines for
patients, today announced interim data from an ongoing Phase 1
clinical study in patients with both resected (adjuvant) and
unresected (advanced) solid tumors. The data showed that the
Company’s mRNA personalized cancer vaccine (PCV) 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 (SAEs) reported for the PCV when administered to patients as
a monotherapy or in combination with pembrolizumab.
Presented today at the 2019 American Society of Clinical
Oncology (ASCO) Annual Meeting, the study demonstrates the
immunogenicity of Moderna’s mRNA platform for developing PCVs. In
addition, clinical activity was observed in some patients receiving
mRNA-4157 in combination with pembrolizumab. These safety,
tolerability and immunogenicity data and the initial clinical
activity observed support Moderna’s randomized Phase 2 study
investigating pembrolizumab in combination with a 1 mg dose of
mRNA-4157, compared to pembrolizumab alone, for the treatment of
high-risk adjuvant melanoma.
“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 Tal Zaks, M.D., Ph.D., chief medical officer at Moderna. “This
study demonstrates the ability of Moderna’s mRNA personalized
cancer vaccine to elicit T-cells that are specific to the cancer
mutations. We also observed early signs of clinical activity of our
personalized cancer vaccine in combination with pembrolizumab,
including in two patients previously treated with checkpoint
inhibitors. We look forward to building on these learnings about
tolerability and immunogenicity by assessing activity in a
randomized Phase 2 study for the treatment of adjuvant
melanoma.”
“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
Sarah Cannon Research Institute, and a principal investigator of
the mRNA-4157 Phase 1 study. “We know that cancer mutations are
rarely shared between patients, so it’s encouraging to see
individualized, personalized cancer vaccines like mRNA-4157
eliciting immune responses. We’re pleased to be a part of a study
that aims to advance the science of immunotherapy through mRNA
vaccines, and deliver a novel approach that is customized for each
patient.”
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.
Presented by: Howard A. Burris, M.D., FACP, FASCO, Sarah Cannon
Research Institute(Poster Session, Saturday, June 1, 8:00
a.m. - 11:00 a.m. CT followed by a Poster Discussion at 1:15 p.m. -
2:45 p.m. CT)
The ASCO poster is now available on the "Events and
Presentations" section of our website.
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.
Results:
- 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.
Additionally, the National Cancer Institute (NCI) presented
early data today from its Phase 1 study of PCV mRNA-4650 as a
monotherapy for patients with advanced metastatic cancers. The NCI
program uses Moderna’s mRNA technology but uses a different
neoantigen selection process and study design than Moderna’s Phase
1 mRNA-4157 study.
Abstract 2643: A Phase 1/2 study to assess the immunogenicity
and tolerability of personalized mRNA vaccine mRNA-4650 encoding
defined neoantigens expressed by the autologous cancer.
Presented by: Gal Cafri, Ph.D., Postdoctoral Fellow, National
Cancer Institute Surgery Branch(Poster Session, Saturday, June
1, 8:00 a.m. - 11:00 a.m. CT)
Conference Call
Moderna will host a conference call and webcast on Monday,
June 3 at 8:00 a.m. ET to discuss these mRNA-4157 data.
Participants are invited to listen by dialing (866) 922-5184
(domestic) or (409) 937-8950 (international) and providing
conference ID 3016438 or join the live webcast by going to
the "Events and Presentations" area on the Investors page
of the Company's website, www.modernatx.com. An archived
webcast of the conference call can also be accessed through the
Company’s website and a replay of the call will be available there
for four weeks after the call.
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. Moderna is developing these potential mRNA treatments as
monotherapies and/or in combination with checkpoint inhibitors from
our strategic collaborators Merck and AstraZeneca. The company
currently has five I/O programs in development, including two
programs advancing into Phase 2 trials.
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 vaccine. Moderna develops and manufactures these
investigational PCVs at its personalized vaccines unit within its
Norwood, Mass. manufacturing facility.
About Moderna
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 AstraZeneca, Plc. and Merck,
Inc., as well as the Defense Advanced Research Projects
Agency (DARPA), an agency of the U.S. Department of
Defense, and the Biomedical Advanced Research and Development
Authority (BARDA), a division of the Office of the
Assistant Secretary for Preparedness and Response (ASPR)
within the U.S. Department of Health and Human
Services (HHS). Moderna has been ranked in the top
ten of Science’s list of top biopharma industry employers for the
past four years. To learn more, visit www.modernatx.com and
follow on Twitter at @moderna_tx.
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
with the U.S. Securities and Exchange Commission (SEC)
and in subsequent filings made by Moderna with
the SEC, which are available on the SEC's website
at www.sec.gov. Except as required by
law, Moderna disclaims any intention or responsibility
for updating or revising any forward-looking statements in this
press release in the event of new information, future developments
or otherwise. These forward-looking statements are based on
Moderna’s current expectations and speak only as of the date
hereof.
KEYTRUDA is a registered trademark of Merck Sharp &
Dohme Corp., a subsidiary of Merck & Co., Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20190601005011/en/
Moderna Contacts:Investors:Lavina TalukdarHead of
Investor
Relations617-209-5834lavina.talukdar@modernatx.comMedia:Krysta
PellegrinoKrysta@healthandcommerce.com650-255-6142
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