0001410578-19-001463.txt : 20190930 0001410578-19-001463.hdr.sgml : 20190930 20190930085930 ACCESSION NUMBER: 0001410578-19-001463 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20190930 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20190930 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: 191124499 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 tv529984_8k.htm FORM 8-K
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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): September 30, 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: 

 

¨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 7.01Regulation FD Disclosure.

 

On September 30, 2019, Adaptimmune Therapeutics plc (the “Company”) issued a press release announcing the presentation of updated data from patients with synovial sarcoma who were treated in the Company’s ongoing Phase 1 trial with SPEAR T-cells targeting MAGE-A4 (ADP-A2M4). The data were presented on September 30, 2019 in an oral presentation at the European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain. The press release is furnished as Exhibit 99.1 and is incorporated by reference herein.

 

The information contained in Item 7.01 of this Form 8-K, including Exhibit 99.1 furnished herewith, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by the Company by specific reference in such a filing.

 

Item 9.01Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.  Description of Exhibit
    
99.1  Press release dated September 30, 2019.
104  Cover Page formatted in Inline XBRL

 

 

 

 

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: September 30, 2019 By: /s/ Margaret Henry
    Name:  Margaret Henry
    Title:    Corporate Secretary

 

 

 

 

 EX-99.1 2 tv529984_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

 

Clear Benefit for Patients with Synovial Sarcoma Demonstrated in Updated Data from Ongoing

Phase 1 Trial with ADP-A2M4 Presented at ESMO

 

- Clinical responses in 7 out of 12 patients with synovial sarcoma,
and clinical benefit in 11 out 12 patients -

 

PHILADELPHIA and OXFORDSHIRE, United Kingdom, Sep. 30, 2019 -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, presented updated data from patients with synovial sarcoma who were treated in the ongoing Phase 1 trial with SPEAR T-cells targeting MAGE-A4 (ADP-A2M4). The oral presentation by Brian Van Tine, MD, PhD of Washington University in St. Louis, occurred earlier today at the European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain.

 

“These data demonstrate a clear benefit of SPEAR T-cells for this population of patients with synovial sarcoma. These results are truly meaningful in this rare and deadly disease because patients with advanced synovial sarcoma have very few treatment options,” said Elliot Norry, Adaptimmune’s interim Chief Medical Officer. “These data and the recent FDA orphan drug designation for ADP-A2M4 in sarcoma are important positive steps to expedite further development. We recently started SPEARHEAD-1, our Phase 2 trial in synovial sarcoma and myxoid/round cell liposarcoma (MRCLS), with the aim to commercialize ADP-A2M4 in 2022.”

 

Overview of data presented at ESMO

This is a Phase 1 dose escalation, multi-tumor trial to assess the safety, tolerability, and antitumor activity of ADP-A2M4 in HLA-A2+ patients. As of Sep. 03, 2019, data from 12 patients with synovial sarcoma treated in the expansion phase of this trial demonstrated a best overall response rate of 58% (including both confirmed and unconfirmed partial responses [PRs]). There was a disease control rate of 92%, defined as objective overall response (including confirmed and unconfirmed PRs) and stable disease.

 

Most adverse events were consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or other cancer immunotherapies. Fatal aplastic anemia was reported in 1 patient with synovial sarcoma in this trial. This event was previously described and reported to the US Food and Drug Administration.

 

The median age of these patients was 54 years and they had received a median of 2 prior lines of systemic therapy. The median dose received was 9.7 billion SPEAR T-cells (range 3.4 to 10 billion transduced cells).

 

Data from patients with synovial sarcoma treated in the expansion phase of this trial were previously reported in May of this year. At that time 8 patients had been assessed, with 6 showing a decrease in tumor size, of which 3 patients had confirmed partial responses and 1 patient had an unconfirmed partial response.

 

Detailed summary of response data presented at ESMO for ADP-A2M4 in patients with synovial sarcoma

Twelve patients received treatment in the expansion phase of this trial and had post-baseline scans to assess efficacy by time of data cutoff (Sep. 03, 2019).

·Of the 12 patients with post-baseline scans to assess efficacy:
o11/12 showed clinical benefit with best overall responses of PR (confirmed or unconfirmed; n=7) or stable disease (SD; n=4); this represents a disease control rate of 92%
o7/12 had clinical responses representing a best overall response rate of 58% with
§5 confirmed PRs (cPR) by RECIST criteria; 3 of which remain ongoing at the time of data cutoff; 2 of which developed progressive disease (PD)
§2 unconfirmed PRs (ucPR) that remain ongoing at the time of data cutoff
·Higher peak SPEAR T-cell expansion was associated with decreases in target lesions from baseline

 

1

 

 

About Adaptimmune’s ADP-A2M4 program in sarcoma

Adaptimmune’s ADP-A2M4 SPEAR T-cell therapy is directed to a member of the MAGE family of cancer testis antigens (MAGE-A4) expressed in a number of solid tumor cell types. The MAGE- A4 antigen is among the most commonly expressed cancer testis antigens. Adaptimmune is evaluating ADP-A2M4 in synovial sarcoma and MRCLS in a number of trials including the recently initiated Phase 2 trial SPEARHEAD-1 in sarcoma, as well as the ongoing Phase 1 trial, which includes a radiation sub-study to enhance T-cell trafficking and antitumor activity. Both the radiation sub-study and Phase 1 trial include sarcoma as well as multiple other solid tumor indications. Adaptimmune is also evaluating a next-generation SPEAR T-cell (ADP-A2M4CD8) targeting MAGE-A4 in sarcoma as well as other solid tumor indications in the SURPASS trial.

 

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.

 

Adaptimmune 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 Aug. 1, 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

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

 

2

 

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Sep. 30, 2019
Cover [Abstract]  
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Document Period End Date Sep. 30, 2019
Entity File Number 1-37368
Entity Registrant Name ADAPTIMMUNE THERAPEUTICS PLC
Entity Central Index Key 0001621227
Entity Incorporation, State or Country Code X0
Entity Address, Address Line One 60 Jubilee Avenue
Entity Address, Address Line Two Milton Park
Entity Address, City or Town Abingdon, Oxfordshire
Entity Address, Country GB
Entity Address, Postal Zip Code OX14 4RX
City Area Code 44
Local Phone Number 1235 430000
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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

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