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): July 18, 2019

 

ADAPTIMMUNE THERAPEUTICS PLC

(Exact name of registrant as specified in its charter)

 

England and Wales

 

1-37368

 

Not Applicable

(State or other jurisdiction of
incorporation)

 

(Commission File Number)

 

(IRS Employer Identification No.)

 

60 Jubilee Avenue, Milton Park

Abingdon, Oxfordshire OX14 4RX

United Kingdom

(Address of principal executive offices, including zip code)

 

(44) 1235 430000

(Registrant’s telephone number, including area code)

 

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:

 

 

o

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

 

o

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

 

o

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

 

o

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

 

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 o

 

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. o

 

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

 

Title of each class

 

Trading Symbol

 

Name of each exchange on which
registered

American Depositary Shares, each representing 6 Ordinary Shares, par value £0.001 per share

 

ADAP

 

The Nasdaq Global Select Market

 

 

 


 

Item 8.01                                            Other Events.

 

On July 18, 2019, Adaptimmune Therapeutics plc issued a press release announcing that it has initiated SURPASS, its first clinical trial with a next-generation SPEAR T-cell targeting MAGE-A4. The press release is furnished as Exhibit 99.1 to this report and is incorporated by reference herein.

 

Item 9.01                                            Financial Statements and Exhibits.

 

(d)  Exhibits.

 

Exhibit No.

 

Description of Exhibit

 

 

 

99.1

 

Press release dated July 18, 2019.

 

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SIGNATURES

 

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

 

 

ADAPTIMMUNE THERAPEUTICS PLC

 

 

 

 

Date: July 18, 2019

By:

/s/ Margaret Henry

 

 

Name: Margaret Henry

 

 

Title: Corporate Secretary

 

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Exhibit 99.1

 

 

Adaptimmune Starts the SURPASS Clinical Trial with its first Next-Generation SPEAR T-cells Targeting MAGE-A4 to Enhance Antitumor Responses

 

- These next-generation SPEAR T-cells may improve long term T-cell functions -

 

PHILADELPHIA and OXFORDSHIRE, United Kingdom, July 18, 2019 — Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, has initiated SURPASS, its first clinical trial with a next-generation SPEAR T-cell targeting MAGE-A4. This next-generation SPEAR T-cell, known as ADP-A2M4CD8, expresses the CD8α co-receptor alongside the engineered TCR that targets MAGE-A4. Preclinical data presented earlier this year at AACR indicate that co-expression of CD8α may broaden the immune response against solid tumors and increase antitumor activity by leveraging CD4+ cells into CD8+ killer or cytotoxic T-cells while retaining their CD4+ helper function.

 

“We are delighted to have started screening for the SURPASS study, not only because it is our first next-generation SPEAR T-cell to be evaluated as an improvement to affinity matured TCRs in a clinical trial, but also because it is the first of three studies we plan to start in the second half of this year to assess the safety and efficacy of our SPEAR T-cell platform,” said Rafael Amado, Adaptimmune’s President of Research & Development. “The preclinical data we presented at AACR indicate that adding CD8α may enhance the ability of CD4+ SPEAR T-cells to kill tumor cells and broaden antigen presentation.”

 

The SURPASS trial will enroll up to 30 patients across multiple solid tumor indications. Like Adaptimmune’s ongoing trials, the SURPASS trial will be a three-cohort dose escalation study. Unlike the other trials, the stagger between patients will be shorter and the starting dose in the first cohort will be 0.8 to 1.2 billion SPEAR T-cells, instead of 100 million SPEAR T-cells. Each dose cohort will enroll 3 patients and can be expanded to 6 patients if a dose limiting toxicity occurs. The dose ranges for the other two cohorts are:  1.2 to 3 billion and 3 to 6 billion SPEAR T-cells. After dose escalation is complete, there is an expansion phase with doses up to 10 billion cells.

 

About Adaptimmune

 

Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for cancer patients. The Company’s unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T -cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. For more information, please visit http://www.adaptimmune.com.

 

Forward-Looking Statements

 

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 6, 2019, and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.

 

Adaptimmune Contacts:

 

Media Relations:

Sébastien Desprez — VP, Communications and Investor Relations

T: +44 1235 430 583

M: +44 7718 453 176

 

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Sebastien.Desprez@adaptimmune.com

 

Investor Relations:

Juli P. Miller, Ph.D. — Senior Director, Investor Relations

T: +1 215 825 9310

M: +1 215 460 8920

Juli.Miller@adaptimmune.com

 

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