0001558370-20-013984.txt : 20201119 0001558370-20-013984.hdr.sgml : 20201119 20201119090923 ACCESSION NUMBER: 0001558370-20-013984 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20201119 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20201119 DATE AS OF CHANGE: 20201119 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Adaptimmune Therapeutics PLC CENTRAL INDEX KEY: 0001621227 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 STATE OF INCORPORATION: X0 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37368 FILM NUMBER: 201327259 BUSINESS ADDRESS: STREET 1: 60 JUBILEE AVENUE STREET 2: MILTON PARK CITY: ABINGDON, OXFORDSHIRE STATE: X0 ZIP: OX14 4RX BUSINESS PHONE: 44 1235 430000 MAIL ADDRESS: STREET 1: 60 JUBILEE AVENUE STREET 2: MILTON PARK CITY: ABINGDON, OXFORDSHIRE STATE: X0 ZIP: OX14 4RX FORMER COMPANY: FORMER CONFORMED NAME: Adaptimmune Ltd DATE OF NAME CHANGE: 20141001 8-K 1 adap-20201119x8k.htm 8-K
0001621227false00-000000000016212272020-11-192020-11-19

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): November 19, 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 November 19, 2020, Adaptimmune Therapeutics plc issued a press release announcing a presentation of durability of response data from patients with synovial sarcoma from its Phase 1 ADP-A2M4 trial at the virtual Connective Tissue Oncology Society annual meeting. The oral presentation was given by Dr. Brian Van Tine of the Washington University School of Medicine.

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 9.01    Financial Statements and Exhibits.

(d)  Exhibits.

Exhibit No.

    

Description of Exhibit

99.1

Press release dated November 19, 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: November 19, 2020

By:

/s/ Margaret Henry

Name:

Margaret Henry

Title:

Corporate Secretary

EX-99.1 2 adap-20201119xex99d1.htm EX-99.1

Exhibit 99.1

Graphic

Durable Responses with ADP-A2M4 in Synovial Sarcoma with Confirmed Responses in 44% of Patients and Disease Control Rate of 94% Presented at CTOS

- Data support confidence in SPEARHEAD-1 as a registrational trial -

- Projected to complete recruitment of all patients in Q1 2021 -

- Median duration of response was 28 weeks with ongoing responses beyond 72 weeks in two patients; median overall survival has not been reached –

PHILADELPHIA, Pa. and OXFORDSHIRE, UK., November 19, 2020 — Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, presented durability of response data from patients with synovial sarcoma from the Phase 1 ADP-A2M4 trial at the virtual Connective Tissue Oncology Society (CTOS) annual meeting. The oral presentation given by Dr. Brian Van Tine of the Washington University School of Medicine is available on-demand for congress attendees. Dr. Van Tine will also participate in a “live stream” session entitled - Immunotherapy in Sarcoma: Alveolar Soft Part Sarcoma, Clear Cell Sarcoma, Synovial Sarcoma (Proffered Papers Panel Discussion) scheduled for 9 AM EST today (November 19).

“The impact on patients treated with ADP-A2M4 is transformative, as they benefit from a durable response from a single treatment. This leads to the highest quality of life I have been able to provide patients with synovial sarcoma after treatment,” said Dr. Brian Van Tine, Associate Professor of Medicine, Division of Oncology, Section of Medical Oncology, Washington University School of Medicine.

“Data from this trial have enabled rapid execution of our pivotal trial, SPEARHEAD-1, and support our aim to commercialize ADP-A2M4 as the first engineered TCR T-cell product in the US in 2022,” said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. “However, this is only the beginning of the tremendous potential of our products targeting MAGE-A4. We will rapidly pursue additional indications, starting with the Phase 2 trial in gastroesophageal cancers with ADP-A2M4CD8 expected to initiate in the first half of 2021.”

Data presented at CTOS were updated durability of response and safety data from the 16 patients with synovial sarcoma who were treated in the Phase 1 ADP-A2M4 trial, presented earlier this year at ASCO. The data cut-off for this presentation was September 1, 2020 and results are summarized below:

Seven out of 16 patients (44%) had confirmed partial responses (PRs) per RECIST criteria, with disease control in 15 patients (94%)
There was a median duration of response of 28 weeks (range: 12-72+ weeks) with two PRs that were ongoing beyond 72 weeks at the time of data cut-off
Eleven out of 16 patients were alive at data cut-off and median overall survival had not been reached
Translational data indicate that induction of the IFNγ-related pathway by serum analyses is an emerging biomarker of response. MAGE-A4 expression and transduced cell dose correlate with tumor reduction
Most adverse events were consistent with those typically experienced by cancer patients undergoing lymphodepletion chemotherapy and cellular therapy including low blood counts and cytokine release syndrome

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 November 5, 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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Document and Entity Information
Nov. 19, 2020
Document and Entity Information [Abstract]  
Document Type 8-K
Document Period End Date Nov. 19, 2020
Entity File Number 1-37368
Entity Registrant Name ADAPTIMMUNE THERAPEUTICS PLC
Entity Incorporation, State or Country Code X0
Entity Tax Identification Number 00-0000000
Entity Address, Address Line One 60 Jubilee Avenue
Entity Address, Adress Line Two Milton Park
Entity Address, City or Town Abingdon, Oxfordshire
Entity Address, Postal Zip Code OX14 4RX
Entity Address, Country GB
City Area Code 44
Local Phone Number 1235 430000
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security American Depositary Shares, each representing 6 Ordinary Shares, par value £0.001 per share
Trading Symbol ADAP
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0001621227
Amendment Flag false
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