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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 28, 2020

 

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: 

 

¨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   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

 

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 28, 2020, Adaptimmune Therapeutics plc (the “Company”) issued a press release announcing a presentation of data from its Phase 1 trial with SPEAR T-cells targeting AFP at the International Liver Congress held in virtual format.

 

The press release is furnished as Exhibit 99.1 and is incorporated by reference herein.

 

The information in this Item 7.01, including Exhibit 99.1, shall not be deemed “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 it 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 filing.

 

Item 9.01Financial Statements and Exhibits.

 

(d) Exhibits.

 

  Exhibit No.   Description of Exhibit

 

99.1  Press release dated August 28, 2020
104  Cover Page Interactive Date File (embedded within the Inline XBRL document)

 

 

 

 

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: August 28, 2020 By: /s/ Margaret Henry
    Name: Margaret Henry
    Title: Corporate Secretary

 

 

 

 

Exhibit 99.1

 

 

Promising Data from Phase 1 Trial with ADP-A2AFP in Liver Cancer at the International Liver Congress
Confirm Safety Profile and Demonstrate Potential Benefit for Patients

 

PHILADELPHIA, Pa. and OXFORDSHIRE, UK., August 28, 2020 — Adaptimmune Therapeutics plc (“Adaptimmune”)(Nasdaq: ADAP), a leader in cell therapy to treat cancer, presented data from its Phase 1 trial with SPEAR T-cells targeting AFP at the virtual International Liver Congress (ILC). One patient out of four dosed with 5 billion or more cells had a complete response, which was reported previously. The data also demonstrate an acceptable safety profile in patients with hepatocellular carcinoma (HCC).

 

“A complete response in a patient with advanced liver cancer, and the anti-tumor activity we have reported in other patients with an acceptable safety profile, to date, further support the continued investigation of ADP-A2AFP,” said Elliot Norry, Adaptimmune’s Chief Medical Officer. “We remain encouraged by the potential of this therapy and we are fully committed to developing ADP-A2AFP for people with HCC. We have reported results for four patients at doses of 5 billion cells or more and we are looking forward to sharing more data as we continue to treat patients in the expansion phase of the trial. Further, we continue to review our translational findings and are evaluating ways to improve the therapy, if necessary.”

 

Dr. Bruno Sangro of Clinica Universidad de Navarra presented data from Cohort 3 and the expansion phase of the ADP-A2AFP Phase 1 trial during an oral presentation at ILC. Tim Meyer of University College London presented additional data from Cohorts 1 and 2 during a poster presentation. A video is available on Adaptimmune’s website (https://youtu.be/qAHamb3Yi8Y) of Elliot Norry, and Mark Dudley, SVP of Early Stage Development, discussing these data. The oral presentation and poster presentation are available online through the congress web site.

 

Topline data from ILC 1

 

·One patient had a complete response and also demonstrated a sustained reduction in serum AFP. This patient experienced disease progression, having developed new lesions at Week 32

·Overall, nine patients have been treated as of the data cutoff, of those

-Four patients have been treated with ~5 billion or more transduced cells (three in Cohort 3 and one in the expansion phase): 1 patient with the complete response, 1 with stable disease (SD), and 2 had progressive disease (PD)

-Five patients were previously treated in the first two dose cohorts with doses of 100 million and 1 billion transduced cells, respectively, and all patients had best responses of SD

·ADP-A2AFP SPEAR T-cells were associated with an acceptable safety profile with no evidence of significant T-cell related hepatotoxicity and no protocol-defined dose limiting toxicities

·Evidence of dose-dependent persistence of ADP-A2AFP SPEAR T-cells post-infusion

·Further translational evaluation is ongoing to understand indicators of response

 

1All data summarized are for patients with HCC with a data cut-off of July 6, 2020. Data from non-HCC patients to be presented at a future congress

 

 

 

 

Overview of Trial Design

 

·This is a Phase 1, open-label, dose escalation clinical trial designed to evaluate the safety and anti-tumor activity of ADP-A2AFP in patients with HCC or other AFP-expressing tumors who are not amenable to transplant, resection, or loco-regional therapy, and who failed or were intolerant to or refused standard-of-care treatment

·Dose escalation is complete, and this trial is enrolling in the expansion phase intended to treat up to 25 patients 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 people with cancer. 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.

 

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 SEC on August 6, 2020, 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.

 

Media Relations:

 

Sébastien Desprez — VP, Communications and Investor Relations 

T: +44 1235 430 583

M: +44 7718 453 176 

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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