8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): June 1, 2019

 

 

MODERNA, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38753   81-3467528
(State or other jurisdiction
of Incorporation)
  (Commission
File Number)
  (IRS Employer
Identification Number)
200 Technology Square
Cambridge, MA
  02139
(Address of registrant’s principal executive office)   (Zip code)

(617) 714-6500

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 203.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

symbol(s)

 

Name of each exchange

on which registered

Common stock, par value $0.0001 per share   MRNA   The NASDAQ Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

Emerging growth company  ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 


Item 7.01

Regulation FD Disclosure

On June 1, 2019, Moderna, Inc. (the “Company”) issued a press release announcing interim data from a Phase 1 study of mRNA-4157 personalized cancer vaccine (“PCV”). The data were presented on Saturday, June 1, 2019 at the 2019 American Society of Clinical Oncology (“ASCO”) Annual Meeting. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and a copy of slides presented at the ASCO Annual Meeting are furnished as Exhibit 99.2 to this Current Report on Form 8-K.

Additionally, at the ASCO Annual Meeting, the National Cancer Institute (“NCI”) presented early data from four patients in its Phase 1 study of PCV mRNA-4650 as a monotherapy for patients with advanced metastatic cancers. Early data found that mRNA-4650 was safe at all dose levels studied to date (0.13 and 0.39 mg) with no reported dose-limiting toxicities and no related grade 3/4 adverse events or serious adverse events. The NCI detected neoantigen-specific CD4 and CD8 T-cell responses against neoantigens included in the vaccine in the three patients evaluated to date. Immunogenicity analysis is ongoing for the fourth patient. The NCI program for mRNA-4650 uses the Company’s mRNA technology but uses a different neoantigen selection process and study design than the Company’s Phase 1 mRNA-4157 study.

The information in this Item 7.01 to this Current Report on Form 8-K, and in Exhibits 99.1 and 99.2 furnished herewith, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit
No.

  

Description

99.1    Press Release issued by the Company on June 1, 2019
99.2    Presentation at the ASCO Annual Meeting on June 1, 2019


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: June 3, 2019     MODERNA, INC.
    By:  

/s/ Lori Henderson

      Lori Henderson
      General Counsel and Corporate Secretary
EX-99.1

Exhibit 99.1

LOGO

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 Monday, June 3 at 8:00 a.m. ET

CAMBRIDGE, Mass.— June 1, 2019— 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.

Moderna Contacts:

Investors:

Lavina Talukdar

Head of Investor Relations

617-209-5834

lavina.talukdar@modernatx.com

Media:

Krysta Pellegrino

Krysta@healthandcommerce.com

650-255-6142

EX-99.2
A Phase 1, Open-Label, Multicenter Study 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
(Keynote-603)
Saturday 01 June 2019
Copyright © 2019 Moderna
Slide
1
Exhibit 99.2


Background
Copyright © 2019 Moderna
T-cell
targeting
of
mutation-derived
epitopes
(neoantigens)
has
been
demonstrated
to
drive
anti-tumor
responses
Immunizing
patients
against
such
neoantigens
in
combination
with
a
checkpoint
inhibitor
(CPI)
may
elicit
greater
anti-tumor
responses
than
CPI
alone
Mutations
are
rarely
shared
between
patients,
thus
requiring
a
personalized
approach
to
vaccine
design


mRNA-4157
is
a
personalized
neoantigen
cancer
vaccine
encoding
up
to
20
neoantigens:
(going
forward
all
patients
will
receive
a
vaccine
encoding
up
to
34
neoantigens)
Individually
designed
and
manufactured
for
each
patient
Encapsulated
in
a
proprietary
lipid
nanoparticle
and
delivered
intramuscularly
Selected
using
a
proprietary
algorithm
based
upon
each
patient’s
HLA
type
and
tumor
mutanome
from
whole
exome
DNA
and
RNA
sequencing
from
tumor
and
blood
samples
Personalized cancer vaccine process
Copyright © 2019 Moderna


Study design
Copyright © 2019 Moderna
0.04 mg
n=3
0.13 mg
n=6
1.0 mg
n=1
0.39 mg
n=3
0.04 mg
n=5
0.13 mg
n=5
1.0 mg
n=5
0.39 mg
n=8
Part A (Adjuvant patients):
Monotherapy mRNA-4157
Part B (Metastatic patients):
mRNA-4157 + pembrolizumab
Dose escalation cohorts
Histologies
in
part
A
and
B:
NSCLC
SCLC
Cutaneous
melanoma
HPV
negative
HNSCC
Bladder
urothelial
carcinoma
MSI
high
malignancies
TMB
high
malignancies
Objectives:
Safety
and
tolerability
of
mRNA-4157
monotherapy
and
in
combination
with
pembrolizumab
Biomarkers
including
antigen
T-cell
responses
Anti-tumor
activity


Study design
Copyright © 2019 Moderna
Screening
period
pembrolizumab
monotherapy
run-in* (Dosing
every 21 days
for 2 cycles)
mRNA-4157
+pembrolizumab
(Dosing every 21
days for up to 9
cycles)
pembrolizumab
monotherapy
(Dosing up to
35 cycles)
Safety
follow-up
(100 day
post
treatment)
*Part A patients are adjuvant patients receiving mRNA-4157 monotherapy.
Pembrolizumab run-in and pembrolizumab monotherapy period does not apply


Patient demographics
Copyright © 2019 Moderna
Part
A:
13
Part B: 23
Age(y)
Range:
52-85
45-88
Median:
67
64
Sex
Male:
6
13
Female:
7
10
Race:
Caucasian
13
19
Black
-
1
Asian
-
1
Histologies
N =36
Part A
13
Melanoma
3
MSI
HIGH/MMR
Deficient
Colorectal Carcinoma
2
Non-small
Cell
Lung
Cancer
8
Part B
23
TMB High
Metastatic squamous cell cancer of the skin
1
Bladder
Urothelial
Carcinoma
5
HNSCC
2
Melanoma
1
MSI
HIGH/MMR
Deficient
Colorectal Carcinoma
2
Metastatic Castrate Resistant Prostate Carcinoma
1
Endometrial Carcinoma
1
Non-small
Cell
Lung
Cancer
8
Small
Cell
Lung
Cancer
2
Part B Prior Therapies
N=23 (%)
Number
of
patients
received
at
least
1
prior
therapy
22 (95.6)
Number of patient received
prior checkpoint inhibitors
Number
of
Prior Therapies
15 (65.2)
0
1
(
4.3)
1
3
(
13.0)
2
6
(26.1)
3
2
(8.7)
3+
11
(47.8)


Safety data
Copyright © 2019 Moderna
Related
AEs of at least grade 2 highest grade reported once per patient
Related Adverse Event*
Grade 2
Grade 3
Part A: mRNA-4157 monotherapy
4
0
LEFT ARM PAIN
1
-
COLITIS
1
-
FATIGUE
1
-
MYALGIAS
1
-
Part B: pembrolizumab monotherapy
3
4
DIARRHEA
-
1
AMYLASE INCREASE
-
1
LIPASE INCREASE
-
1
ELEVATED AST
1
-
ANEMIA
1
-
WORSENED DYSPNEA
1
-
ELEVATED GGT
-
1
Part B: mRNA-4157 & pembrolizumab
0
0
No mRNA-4157 related grade 3/4 AEs were reported


Part A: Adjuvant patients receiving mRNA-4157
monotherapy
Copyright © 2019 Moderna
13
adjuvant
patients
have
been
treated
with
mRNA-4157
13
patients
have
completed
full
course
of
vaccination
per
protocol
11
patients
remain
disease
free
up
to
72
weeks
on
study


Part B: Metastatic patients receiving mRNA-
4157/pembrolizumab combination
Copyright © 2019 Moderna
20
out
of
23
advanced/metastatic
patients
have
been
treated
with
mRNA-4157/pembrolizumab
combination
1
patient
with
MSI-High
CRC
had
a
CR
on
pembrolizumab
monotherapy
prior
to
vaccination
5
patients
had
a
PR
including
2
patients
who
have
progressed
with
prior
checkpoint
inhibitor
therapy
7
patients
had
stable
disease
and
10
patients
remain
on
study
treatment
with
ongoing
clinical
benefit
as
of
10-May-2019


Best overall response
Copyright © 2019 Moderna


Patient 40019 –
Small cell lung carcinoma
Copyright © 2019 Moderna


Patient 40031 –
Small cell lung carcinoma
Copyright © 2019 Moderna


Patient 40023 –
Bladder carcinoma
Baseline
Copyright © 2019 Moderna


Copyright © 2019 Moderna
Patient
was
dosed
with
1mg
of
vaccine
monotherapy
and
underwent
apheresis
at
baseline
and
7d
post
4th
dose.
Increases
in
ex
vivo
(unexpanded)
T-cell
responses
were
detected
against
all
neoantigen
pulsed
DC
pools
post
vaccination
(A).
Increases
in
in
vitro
stimulated
(IVS,
expanded)
T-cell
responses
were
detected
against
all
neoantigen
pulsed
DCs
pools
post
vaccination
(B).
All
positive
CD8
T-cell
responses
post
vaccination
were
to
neoantigens
with
high
predicted
binding
affinity
of
<
500
nm.
Patient 40033 neoantigen specific CD8 T cell response data
A
B


Robust CD8 T cell responses detected post-vaccine dose 4 to
55% of predicted class I neoantigens
Copyright © 2019 Moderna
CD8 T cell responses to individual
neoantigens were measured in in vitro
stimulated (IVS, expanded) T cells
Flow cytometry plots show increases in %
freq.
of
CD8
cells
producing
IFN 
7d
post
4
th
vaccine dose to multiple neoantigens
Greater than 3x (*in summary graph)
increases in neoantigen specific CD8 T-cells
were detected post vaccination against 10
out of 18 class I targeted neoantigens
included in patient 40033 vaccine


Conclusions
Copyright © 2019 Moderna
mRNA-4157
is
well
tolerated
at
all
dose
levels
studied
with
no
DLTs
reported
No
mRNA-4157
related
grade
3/4
AE
or
SAE
was
reported
Clinical
responses
have
been
seen
in
6
out
of
20
patients
treated
with
mRNA-4157/pembrolizumab
combination.
Of
these
6
patients
with
responses,
2
were
observed
in
patients
previously
treated
with
a
PD-(L)1
inhibitor.
Neoantigen
specific
CD8
T-cell
responses
were
detected
to
10
out
of
18
class
I
neoantigens
included
in
patient
40033
vaccine,
the
first
patient
dosed
at
1
mg
who
underwent
apheresis.
100%
of
positive
CD8
T-cell
responses
post
vaccination
were
to
neoantigens
with
a
high
predicted
binding
affinity
of
<
500
nm
Safety,
tolerability
and
immunogenicity
data
supports
the
advancement
of
mRNA-4157
to
phase
II
at
the
1
mg
dose


We’d like to thank all of the patients, their families, and care givers for
their participation in this trial.
Thank You!
Copyright © 2019 Moderna