Phase 1 Study of Its mRNA Vaccine Against COVID-19 (mRNA-1273)

Phase 1 Study of Its mRNA Vaccine Against COVID-19 (mRNA-1273)

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Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Phase 1 Study of Its mRNA Vaccine Against COVID-19 (mRNA-1273)

Interim analysis of original cohorts of Phase 1 study evaluated two-dose vaccination schedule of mRNA-1273 across three dose levels (25, 100, 250 µg) in 45 healthy adults ages 18-55 years; results reaffirm and expand upon positive interim data announced on May 18th

Neutralizing antibody titers were observed in 100% of evaluated participants; at the 100 µg dose level selected for Phase 3, the geometric mean titers were above those seen in convalescent sera

Vaccination with mRNA-1273 elicited Th1-biased CD4 T cell responses

mRNA-1273 was generally safe and well-tolerated

Data support 30,000 participant Phase 3 study expected to begin on July 27

Conference call to be held on Wednesday, July 15 at 8:00 a.m. ET

CAMBRIDGE, Mass.–(BUSINESS WIRE)–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 the publication of an interim analysis of the open-label Phase 1 study of mRNA-1273, its vaccine(Vaccine Against COVID-19) candidate against COVID-19, in The New England Journal of Medicine. This interim analysis evaluated a two-dose vaccination schedule of mRNA-1273 given 28 days apart across three dose levels (25, 100, 250 µg) in 45 healthy adult participants ages 18-55 years, and reports results through Day 57. Results from participants in the initial dose cohorts who received both vaccinations and were evaluated at pre-specified timepoints reaffirm the positive interim data assessment announced on May 18th and show mRNA-1273 induced rapid and strong immune responses against SARS-CoV-2. The study was led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

from Businesswire

mRNA-1273 was generally safe and well-tolerated, with no serious adverse events reported through Day 57. Adverse events (AEs) were generally transient and mild to moderate in severity. The most notable adverse events were seen at the 250 µg dose level, with three of those 14 participants (21%) reporting one or more severe events. Solicited systemic adverse events were more common after the second vaccination and occurred in seven of 13 (54%) participants in the 25 µg group, all 15 participants in the 100 µg group and all 14 participants in the 250 µg group. The most commonly reported systemic adverse events following second vaccination at the 100 µg dose were fatigue (80%), chills (80%), headache (60%) and myalgia (53%), all of which were transient and mild or moderate in severity. The most common solicited local adverse event at the 100 µg dose was pain at the injection site (100%), which was also transient and mild or moderate in severity. Evaluation of clinical safety laboratory values grade 2 or higher and unsolicited adverse events revealed no patterns of concern.

Moderna announces publication of interim results from Phase 1 study of its mRNA vaccine against COVID-19 (mRNA-1273) in NEJM(Vaccine Against COVID-19)

Conference Call and Webcast Information

Moderna will host a live conference call and webcast at 8:30 a.m. ET on Monday, May 18, 2020. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 2186342. A webcast of the call will also be available under “Events and Presentations” in the Investors section of the Moderna website at investors.modernatx.com. The archived webcast will be available on Moderna’s website approximately two hours after the conference call.

About mRNA-1273

mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center(Vaccine Against COVID-19) (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing.

On May 6, the U.S. Food and Drug Administration (FDA) completed its review of the Company’s Investigational New Drug (IND) application for mRNA-1273 allowing it to proceed to a Phase 2 study, which is expected to begin shortly. On May 12, the FDA granted mRNA-1273 Fast Track designation. Moderna is finalizing the protocol for a Phase 3 study, expected to begin in July 2020. A summary of the company’s work to date on SARS-CoV-2 can be found here.

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 regarding the Company’s development of a potential vaccine against the novel coronavirus(Vaccine Against COVID-19), the parameters of Phase 1 and Phase 2 studies of mRNA-1273, the publication of study data for later cohorts in the Phase 1 study of mRNA-1273, the parameters and timing of the Phase 3 study of mRNA-1273, the potential filing of a biologics license application (BLA) for mRNA-1273, the Company’s potential manufacturing capabilities and projected vaccine dose production, and costs related to the mRNA-1273 program to be funded by the Company. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could”, “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: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 have not yet been established; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Quarterly Report on Form 10-Q 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 contained 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.

Data Tables

Table 1: Binding Antibodies Geometric Mean Titers (GMTs) to S-2P
Geometric Mean Response (95% CI)
Convalescent Sera (N=38) = 142,140 (81,543 – 247,768)
N 25 μg N 100 μg N 250 μg
Day 1

15

116

15

131

15

178

(72 – 187)

(65 – 266)

(81 – 392)

Day 15*

15

32,261

15

86,291

15

163,449

(18,723 – 55,587)

(56,403 – 132,016)

(102,155 – 261,520)

Day 29

15

40,227

15

109,209

14

213,526

(29,094 – 55,621)

(79,050 – 150,874)

(128,832 – 353,896)

Day 36

13

391,018

15

781,399

14

1,261,975

(267,402 – 571,780)

(606,247 – 1,007,156)

(973,972 – 1,635,140)

Day 43

13

379,764

14

811,119

14

994,629

(281,597 – 512,152)

(656,336 – 1,002,404)

(806,189 – 1,227,115)

Day 57

13

299,751

14

782,719

13

1,192,154

(206,071 – 436,020)

(619,310 – 989,244)

(924,878 – 1,536,669)

* All participants seroconverted at Day 15
Table 2: Live Virus Neutralization Assay PRNT80 Geometric Mean Results
Geometric Mean Response (95% CI)
Convalescent Sera (N=3) = 158.3
N 25 µg N 100 µg

Day 1*

15

4

15

4

Day 43

13

339.7
(184.0 – 627.1)

14

654.3
(460.1 – 930.5)

* All Day 1 specimens exhibited less than 80% inhibitory activity at the lowest dilution tested, 1:8, and so were assigned a titer of 4
Table 3: Pseudovirus Neutralization Assay ID50 Geometric Mean Results
Geometric Mean Response (95% CI)
Convalescent Sera (N=38) = 109.2 (59.6 – 199.9)
N 25 µg N 100 µg N 250 µg
Day 1

15

10

15

10

15

10

Day 15*

15

14.5
(9.8 – 21.4)

15

23.7
(13.3 – 42.3)

15

26.1
(14.1 – 48.3)

Day 29

15

11.7
(9.7 – 14.1)

15

18.2
(12.1 – 27.4)

14

20.7
(13.3 – 32.3)

Day 36

13

105.8
(69.8 – 160.4)

15

256.3
(182.0 – 361.1)

14

373.5
(308.6 – 452.2)

Day 43

13

112.3
(71.2 – 177.1)

14

343.8
(261.2 – 452.7)

14

332.2
(266.3 – 414.5)

Day 57

13

80.7
(51.0 – 127.6)

14

231.8
(163.2 – 329.3)

14

270.2
(221.0 – 330.3)

* All participants seroconverted at Day 15
Samples that do not neutralize at the 50% level are expressed as <20 and plotted at half that dilution, i.e., 10

 

About KSRA

The Kavian Scientific Research Association (KSRA) is a non-profit research organization to provide research / educational services in December 2013. The members of the community had formed a virtual group on the Viber social network. The core of the Kavian Scientific Association was formed with these members as founders. These individuals, led by Professor Siavosh Kaviani, decided to launch a scientific / research association with an emphasis on education.

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Contacts

Moderna (Vaccine Against COVID-19)
Media:
Colleen Hussey
Senior Manager, Corporate Communications
203-470-5620
Colleen.Hussey@modernatx.com

Dan Budwick
1AB
973-271-6085
Dan@1abmedia.com

Investors:
Lavina Talukdar
Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.co

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Professor Siavosh Kaviani was born in 1961 in Tehran. He had a professorship. He holds a Ph.D. in Software Engineering from the QL University of Software Development Methodology and an honorary Ph.D. from the University of Chelsea.

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Nasim Gazerani was born in 1983 in Arak. She holds a Master's degree in Software Engineering from UM University of Malaysia.

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Somayeh Nosrati was born in 1982 in Tehran. She holds a Master's degree in artificial intelligence from Khatam University of Tehran.