8-K
false 0001693415 0001693415 2020-08-25 2020-08-25

 

 

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): August 25, 2020

 

 

Translate Bio, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38550   61-1807780

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

29 Hartwell Avenue

Lexington, Massachusetts

  02421
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 945-7361

Not applicable

(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 (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

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 exchange

on which registered

Common Stock, $0.001 par value   TBIO   Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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 August 25, 2020, Sanofi Pasteur Inc. (“Sanofi”) will present information at the Third ISV COVID-19 Vaccines Virtual Congress hosted by the International Society of Vaccines (the “Virtual Congress”) regarding, among other things, its collaboration with Translate Bio, Inc. (the “Company”), to develop an mRNA vaccine for SARS-CoV-2 (severe acute respiratory syndrome 2), which causes the coronavirus disease referred to as COVID-19. A copy of the portion of Sanofi’s slide presentation to be presented at the Virtual Congress pertaining to the collaboration with the Company is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated by reference into this Item 7.01. The slides, to the extent applicable to the Company, describe preclinical data of the mRNA vaccine candidate at three dose levels in a non-human primate model, including binding antibody levels, neutralizing antibody titers and helper T-cell response. These data demonstrate that two immunizations of the mRNA vaccine induced high neutralizing titers that are comparable to the upper range of those observed in infected humans. Additionally, the mRNA vaccine induced Th1-biased T-cell responses.

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

Forward-Looking Statements

This Current Report on Form 8-K, including the document filed as Exhibit 99.1 hereto, contains forward-looking statements about the Company within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding the expected timing to begin clinical studies of a COVID-19 vaccine candidate under the collaboration between Sanofi and the Company, and expectations regarding manufacturing capacity and manufacturing approaches for such vaccine. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “hope,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including, but not limited to: risks and uncertainties related to the development of a COVID-19 vaccine; uncertainties related to general and industry-specific market conditions; the current and potential future impacts of the ongoing COVID-19 pandemic on the Company’s business, financial condition, operations and liquidity; the Company’s ability to advance the


development of its platform and programs under the timelines it projects, demonstrate the requisite safety and efficacy of its product candidates and replicate in clinical trials any positive findings from preclinical studies; the successful advancement of the collaboration agreement between the Company and Sanofi; uncertainties relating to the discovery and development of vaccine candidates based on mRNA, and specifically as it relates to COVID-19; uncertainties related to the ability to manufacture a COVID-19 vaccine; the content and timing of decisions made by the U.S. Food and Drug Administration, other regulatory authorities and institutional review boards at clinical trial sites, including decisions as it relates to ongoing and planned clinical trials; the Company’s ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the availability of significant cash required to fund operations; competitive factors; the impact of general economic, industrial or political conditions in the United States or internationally and other important risk factors discussed in the “Risk Factors” section in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020 filed with the Securities and Exchange Commission (the “SEC”) on August 6, 2020, and in any other subsequent filings made by the Company with the SEC. Any forward-looking statements about the Company contained in this Current Report on Form 8-K, including the document filed as Exhibit 99.1 hereto, speak only as of the date hereof, and the Company expressly disclaims any obligation to update such forward-looking statements, whether as a result of new information, future events or otherwise. The Company makes no representations about statements in Sanofi’s slides filed as Exhibit 99.1 that do not pertain to the Company.

 

Item 9.01

Financial Statements and Exhibits.

d) Exhibits

 

Exhibit

    No.    

  

Description

99.1    Excerpts from Sanofi Pasteur COVID-19 Vaccine Programs Slide Presentation, dated August 25, 2020.


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.

 

 

TRANSLATE BIO, INC.

Date: August 25, 2020

 

By:

 

/s/ Paul Burgess

   

Paul Burgess

   

Chief Operating Officer, Chief Legal Officer and Secretary

EX-99.1

Exhibit 99.1 Sanofi Pasteur COVID-19 Vaccine Programs John W. Shiver, Ph.D., Global R&D Head, Sanofi Pasteur ISV Aug 25, 2020 mRNA presentationExhibit 99.1 Sanofi Pasteur COVID-19 Vaccine Programs John W. Shiver, Ph.D., Global R&D Head, Sanofi Pasteur ISV Aug 25, 2020 mRNA presentation


Sanofi’s Two COVID-19 Vaccine Approaches 1 2 Baculovirus mRNA recombinant vaccine Platform + (2) vaccine approach (1) Protein mRNA approach mRNA Adjuvant Antigen Formulation (1) • Licensed recombinant platform • Innovative approach • Existing large scale capacity • Significant existing investment in mRNA capacity Advantage • BARDA collaboration to be applied towards vaccine • License/Collaboration Agreement with • Collaboration with for proven AS03 adjuvant • Phase I/II study start: Sept 2020 • Phase I/II study start: November 2020 Timelines • Earliest potential approval: Jun 2021 • Existing capacity for 100-600 million doses • Capacity for 90-360 million doses by 2021 Capacity • Capacity for >1 billion doses by 2021 BARDA: Biomedical Advanced Research & Development Authority; GSK: GlaxoSmithKline ® (1) Same as that for Flublok , manufactured with this platform and licensed in the U.S. 2 (2) In collaboration with Translate BioSanofi’s Two COVID-19 Vaccine Approaches 1 2 Baculovirus mRNA recombinant vaccine Platform + (2) vaccine approach (1) Protein mRNA approach mRNA Adjuvant Antigen Formulation (1) • Licensed recombinant platform • Innovative approach • Existing large scale capacity • Significant existing investment in mRNA capacity Advantage • BARDA collaboration to be applied towards vaccine • License/Collaboration Agreement with • Collaboration with for proven AS03 adjuvant • Phase I/II study start: Sept 2020 • Phase I/II study start: November 2020 Timelines • Earliest potential approval: Jun 2021 • Existing capacity for 100-600 million doses • Capacity for 90-360 million doses by 2021 Capacity • Capacity for >1 billion doses by 2021 BARDA: Biomedical Advanced Research & Development Authority; GSK: GlaxoSmithKline ® (1) Same as that for Flublok , manufactured with this platform and licensed in the U.S. 2 (2) In collaboration with Translate Bio


mRNA Vaccine Approach to address COVID-19 Pandemic messenger RiboNucleic Acid (mRNA) + Lipid NanoParticle (LNP) mRNA vaccine approach • Deliver mRNA packaged in LNP to the human cell. • The cell’s own machinery is used to translate the mRNA in vitro LNP into protein. Transcription mRNA-LNP mRNA Formulation • Large scale manufacturing capacity (up to 500 g mRNA batch size) • Rapid manufacturing timeline • Cell-free manufacturing process • No infectious elements • No risk of integration 3 3mRNA Vaccine Approach to address COVID-19 Pandemic messenger RiboNucleic Acid (mRNA) + Lipid NanoParticle (LNP) mRNA vaccine approach • Deliver mRNA packaged in LNP to the human cell. • The cell’s own machinery is used to translate the mRNA in vitro LNP into protein. Transcription mRNA-LNP mRNA Formulation • Large scale manufacturing capacity (up to 500 g mRNA batch size) • Rapid manufacturing timeline • Cell-free manufacturing process • No infectious elements • No risk of integration 3 3


SARS-CoV-2 mRNA Sequence Design Full-length pre-fusion stabilized SARS-CoV-2 Spike Protein Structure GSAS PP S1/S2S2’ SS RBD HR1 CD TM NTD SD1 SD2 FP CH HR2 CT QTNSPRRARSVAS SRLDKVEAE 982 SS – Signal Sequence 677 689 990 NTD – N-Terminal Domain RBD – Receptor Binding Domain SD1 – Subdomain 1 SD2 – Subdomain 2 S1/S2 – S1/S2 protease cleavage site S2’ – S2’ protease cleavage site FP – Fusion Peptide HR1 – Heptad Repeat 1 CH – Central Helix Wrapp, et.al. Science. 2020 CD – Connector Domain Mar 13;367(6483):1260-1263. doi: HR2 – Heptad Repeat 2 10.1126/science.abb2507. Epub 2020 Feb 19 TM – Transmembrane Domain CT – Cytoplasmic Tail 4 4SARS-CoV-2 mRNA Sequence Design Full-length pre-fusion stabilized SARS-CoV-2 Spike Protein Structure GSAS PP S1/S2S2’ SS RBD HR1 CD TM NTD SD1 SD2 FP CH HR2 CT QTNSPRRARSVAS SRLDKVEAE 982 SS – Signal Sequence 677 689 990 NTD – N-Terminal Domain RBD – Receptor Binding Domain SD1 – Subdomain 1 SD2 – Subdomain 2 S1/S2 – S1/S2 protease cleavage site S2’ – S2’ protease cleavage site FP – Fusion Peptide HR1 – Heptad Repeat 1 CH – Central Helix Wrapp, et.al. Science. 2020 CD – Connector Domain Mar 13;367(6483):1260-1263. doi: HR2 – Heptad Repeat 2 10.1126/science.abb2507. Epub 2020 Feb 19 TM – Transmembrane Domain CT – Cytoplasmic Tail 4 4


mRNA Vaccine Technology NON-LIVE SAFETY IMMUNOGENICITY MANUFACTURING • Induces potent • In vitro transcription • RNA does not • No live pathogens humoral and cell- • No cell culture integrate into the • Sequence specificity mediated immune host genome and • Scalable to large responses • Flexible product is degraded once capacity design • Self-adjuvanting the protein is • Well characterized made 5 *severe acute respiratory syndrome coronavirus 2, (SARS-CoV-2)mRNA Vaccine Technology NON-LIVE SAFETY IMMUNOGENICITY MANUFACTURING • Induces potent • In vitro transcription • RNA does not • No live pathogens humoral and cell- • No cell culture integrate into the • Sequence specificity mediated immune host genome and • Scalable to large responses • Flexible product is degraded once capacity design • Self-adjuvanting the protein is • Well characterized made 5 *severe acute respiratory syndrome coronavirus 2, (SARS-CoV-2)


Humoral Immunogenicity of CoV2 mRNA/LNP Vaccine in Cynomolgus Monkeys Induction of Robust Binding and Neutralizing Antibody Activities SARS-CoV2 ELISA vs pre-S dTM 4 Microneutralization 10 3 10 2 10 1 10 0 10 Timepoint (d) -4 14 21 28 35 42 -4 14 21 28 35 42 -4 14 21 28 35 42 -4 14 21 28 35 42 Day Day 0 14 21 28 35 42 0 14 21 28 35 42 0 14 21 28 35 42 Conv. 15mg 45mg 135mg Sera 15mg 45mg 135mg 15mg 45mg 135mg I.M. immunizations at Day 0, 21 6 MN Titer (IC50)Humoral Immunogenicity of CoV2 mRNA/LNP Vaccine in Cynomolgus Monkeys Induction of Robust Binding and Neutralizing Antibody Activities SARS-CoV2 ELISA vs pre-S dTM 4 Microneutralization 10 3 10 2 10 1 10 0 10 Timepoint (d) -4 14 21 28 35 42 -4 14 21 28 35 42 -4 14 21 28 35 42 -4 14 21 28 35 42 Day Day 0 14 21 28 35 42 0 14 21 28 35 42 0 14 21 28 35 42 Conv. 15mg 45mg 135mg Sera 15mg 45mg 135mg 15mg 45mg 135mg I.M. immunizations at Day 0, 21 6 MN Titer (IC50)


T Cell Immunogenicity of CoV2 mRNA/LNP Vaccine in Cynomolgus Monkeys Induction of TH1 Biased T cell Response at Day 42 IFNg (TH1) IL-13 (TH2) Peptide Pool: S1 IFNg (TH1) IL-13 (TH2) Peptide Pool: S2 7T Cell Immunogenicity of CoV2 mRNA/LNP Vaccine in Cynomolgus Monkeys Induction of TH1 Biased T cell Response at Day 42 IFNg (TH1) IL-13 (TH2) Peptide Pool: S1 IFNg (TH1) IL-13 (TH2) Peptide Pool: S2 7


Summary • SP is developing 2 COVID-19 vaccine approaches that will advance to clinical testing in Sept-Nov 2020; both candidates are manufacturable at scale needed to address the global pandemic. • Two immunizations of SP’s mRNA or adjuvanted recombinant vaccines into non- human primates induce high neutralizing titers that are comparable to the upper range of those observed in infected humans; pre-clinical efficacy results are forthcoming. • SP’s mRNA and adjuvanted recombinant vaccines induce in non-human primates TH1-biased and mixed TH1/TH2 T cell responses, respectively. • Multi-lateral partnerships (funders, government and academic institutions, private industry) are critical to advance these vaccine solutions at a pandemic pace. 8Summary • SP is developing 2 COVID-19 vaccine approaches that will advance to clinical testing in Sept-Nov 2020; both candidates are manufacturable at scale needed to address the global pandemic. • Two immunizations of SP’s mRNA or adjuvanted recombinant vaccines into non- human primates induce high neutralizing titers that are comparable to the upper range of those observed in infected humans; pre-clinical efficacy results are forthcoming. • SP’s mRNA and adjuvanted recombinant vaccines induce in non-human primates TH1-biased and mixed TH1/TH2 T cell responses, respectively. • Multi-lateral partnerships (funders, government and academic institutions, private industry) are critical to advance these vaccine solutions at a pandemic pace. 8