0001104659-20-067350.txt : 20200529 0001104659-20-067350.hdr.sgml : 20200529 20200529074214 ACCESSION NUMBER: 0001104659-20-067350 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20200529 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20200529 DATE AS OF CHANGE: 20200529 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: 20924043 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 tm2021246d2_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): May 29, 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 May 29, 2020, Adaptimmune Therapeutics plc (the “Company” or “Adaptimmune”) issued a press release announcing a presentation of updated data from its ADP-A2M4 Phase 1 trial in an oral presentation by Dr. David Hong of the MD Anderson Cancer Center at the American Society for Clinical Oncology (ASCO) Annual Meeting held in virtual format. The data demonstrate durability and responses in synovial sarcoma, supporting SPEARHEAD-1 as a potential registrational trial. The ASCO presentation also describes a new response in a patient with lung cancer, and a response in a patient with head and neck cancer (reported in January 2020).

 

The Company also announced new responses in its SURPASS trial, confirming the potential for SPEAR T-cell therapies targeting MAGE-A4 to treat a broad range of cancers in addition to sarcoma. These data further support the rationale for two new Phase 2 trials – SPEARHEAD-2 in head and neck cancer, which will begin later this year, and a second trial in esophagogastric junction cancer planned for the first half of 2021.

 

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 May 29, 2020
104  Cover Page Interactive Data 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: May 29, 2020 By: /s/ Margaret Henry
    Name:  Margaret Henry
    Title:    Corporate Secretary

 

 

 EX-99.1 2 tm2021246d2_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

SPEAR T-cells Targeting MAGE-A4 Demonstrate New Responses in Esophagogastric Junction (EGJ),
Lung, and Head and Neck Cancers – Late Stage Development Initiated in EGJ Cancer

 

- New Phase 2 trial in EGJ cancer planned for 1H 2021, after first two patients treated responded to
next-generation ADP-A2M4CD8 therapy -

 

- Durability and efficacy data presented at ASCO support potential for SPEARHEAD-1 as a registrational
trial for sarcoma - commercial launch planned in the US in 2022 -

 

- Phase 2 trial combining ADP-A2M4 with pembrolizumab in head and neck cancer (SPEARHEAD-2) will
be the first time a SPEAR T-cell therapy is used in sequence with first line systemic therapy -

 

- The SURPASS trial (a Phase 1 trial with ADP-A2M4CD8) will focus on lung, EGJ, head and
neck, and bladder cancers -

 

- Confirmed complete response in a patient with liver cancer in the Phase 1 ADP-A2AFP trial (reported as
partial response in January) -

 

PHILADELPHIA, PA., and OXFORDSHIRE, U.K., May 29, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, presented updated data from its ADP-A2M4 Phase 1 trial at the American Society for Clinical Oncology (ASCO) Annual Meeting. The data demonstrate durability and responses in synovial sarcoma, supporting SPEARHEAD-1 as a potential registrational trial. The ASCO presentation also describes a new response in a patient with lung cancer, and a response in a patient with head and neck cancer (reported in January).

 

The Company also announced new responses in the SURPASS trial, confirming the potential for SPEAR T-cell therapies targeting MAGE-A4 to treat a broad range of cancers in addition to sarcoma. These data further support the rationale for two new Phase 2 trials – SPEARHEAD-2 in head and neck cancer, which will begin later this year, and a second trial in esophagogastric junction (EGJ) cancer planned for 1H 2021. A webcast of Dr. Elliot Norry, Adaptimmune’s Chief Medical Officer, and Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer, summarizing these and other clinical data is available here: https://bit.ly/3enqBBy.

 

“I am pleased to announce that we have identified a new indication to progress into late stage development. We plan to initiate a Phase 2 trial in esophagogastric junction cancer in the first half of 2021, with our next-generation ADP-A2M4CD8 SPEAR T-cells. In addition, the ASCO data demonstrate promising durability for ADP-A2M4 in sarcoma bolstering our ambition to have our first marketed therapy in 2022,“ said Adrian Rawcliffe, CEO. “I’m thrilled with the responses in a broad range of tumors with our programs targeting MAGE-A4 and AFP. I am confident that we will be able to identify more indications for late stage development as more patients are treated in our trials.”

 

During an oral presentation at ASCO, Dr. David Hong of the MD Anderson Cancer Center reported positive durability and efficacy data in synovial sarcoma from the ADP-A2M4 Phase 1 trial. Based on these data, the Company believes that SPEARHEAD-1 can support registration for ADP-A2M4. These positive data also supported removal of the futility analysis from SPEARHEAD-1, reducing the sample size from 60 to 45 patients.

 

 

 

 

Outside of sarcoma, Dr. Hong shared a new RECIST response in a patient with lung cancer, as well as the response in a patient with head and neck cancer reported earlier this year. Further, he reported evidence of anti-tumor activity in ovarian cancer, bladder cancer, and melanoma.

 

In the SURPASS trial, three patients have responded out of the first four treated with ADP-A2M4CD8. One patient with EGJ cancer treated in the first dose cohort had a confirmed partial response (PR) reported in January, which remains ongoing approximately six months post-infusion. As reported today, a second patient in the first dose cohort, also with EGJ cancer, has an unconfirmed PR. The third response in the trial is an unconfirmed PR in a patient with head and neck cancer. Data from this trial will be updated and presented in the second half of 2020 at a medical conference. Based on these data, the Company plans to initiate a Phase 2 trial in EGJ cancer in the first half of 2021.

 

In January, the Company reported one confirmed PR in a patient with liver cancer from the ADP-A2AFP Phase 1 trial. Subsequently, this PR has been assessed as a confirmed complete response, which remained ongoing at the last assessment (Week 24). The next two patients with liver cancer (or hepatocellular carcinoma [HCC]) treated in Cohort 3 did not respond. A separate cohort for AFP expressing tumors other than HCC was initiated and the one patient treated to date has not responded. Detailed data will be presented in a poster and an oral presentation at the International Liver Congress (ILC) in August 2020 (rescheduled from April of this year).

 

RECIST Responses with SPEAR T-cell Monotherapy in Patients with Late Stage Cancers*

 

Indication  Responses/(n) a  SPEAR T-cell
Target		  SPEAR T-cell product
demonstrating responses		  New response
reported today
Synovial sarcoma  8 PR b / 16  MAGE-A4  ADP-A2M4  Yes
Head and neck  2 PR b / 4  MAGE-A4  ADP-A2M4/ ADP-A2M4CD8  Yes
EGJ  2 PR b / 3  MAGE-A4  ADP-A2M4CD8  Yes
Lung  1 PR / 2  MAGE-A4  ADP-A2M4  Yes
Melanoma  1 PR c / 2  MAGE-A4  ADP-A2M4  No
Liver (HCC)  1 CR d / 3  AFP  ADP-A2AFP  No

 

a: n=number of patients treated; b: includes one unconfirmed PR; c: patient treated in radiation sub-study of ADP-A2M4 Phase 1 trial; d: previously assessed as PR

CR=complete response; EGJ=esophagogastric junction; HCC=hepatocellular carcinoma; PR=partial response

* As of May 2020

 

ADP-A2M4 clinical update

 

·ASCO: Oral presentation by Dr. David Hong titled: “Phase 1 Dose Escalation and Expansion Trial to Assess Safety and Efficacy of ADP-A2M4 in Advanced Solid Tumors”

 

oSynovial sarcoma data

 

§50% response rate with inclusion of unconfirmed PR assessed after data cut-off (44% response rate without inclusion of unconfirmed PR)

 

§Median duration of response ~28 weeks, progression free survival ~20 weeks, median overall survival not reached

 

§3 out of the 7 responders have continued to benefit as of their one year assessments

 

§Disease control rate of 90% defined by best overall response (BOR) of PR or stable disease (SD) at time of data cut off (April 6, 2020)

 

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oOther cancer indications

 

§Confirmed responses in lung cancer (reported today) and head & neck cancer (as reported in January)

 

§Of note, there was a response in a patient with rectal mucosal melanoma from the radiation sub-study of this trial (still recruiting) reported in January, which remains ongoing at Week 24. This patient was not part of the ASCO dataset

 

oMost adverse events were consistent with those typically experienced by cancer patients undergoing lymphodepletion cytotoxic chemotherapy, and cellular therapy

 

oTrial closed for enrollment with the exception of ongoing recruitment in the low-radiation sub-study

 

·SPEARHEAD-1

 

oIntended to be a registrational trial

 

oBased on the strength of the ADP-A2M4 Phase 1 data, futility analysis removed reducing the sample size from 60 to 45 patients

 

oRecruiting patients in 20 centers in Canada, France, Spain, and the US

 

oScreened more than half the patients likely required to complete the trial

 

oCurrently, there are more than 30 patients identified who would be eligible based on HLA and MAGE-A4 expression

 

oAim to complete SPEARHEAD-1 recruitment by 1H 2021 and launch in the US in 2022

 

Other trials in the MAGE-A4 program

 

SURPASS

 

·Out of the first 4 patients treated (2 with EGJ cancer; 1 with ovarian cancer, 1 with head and neck cancer) 3 have been assessed as PRs (1 confirmed)

 

o2 patients with EGJ cancer (1 confirmed PR announced in January and a second unconfirmed PR announced today)

 

o1 patient with head and neck cancer with an unconfirmed PR

 

·Based on the responses in EGJ cancer, the Company plans to initiate a new Phase 2 trial in this indication

 

oPlanning to present the full trial design in 2H 2020 and to initiate the trial in 1H 2021

 

·Enrollment in the SURPASS trial will focus on indications for which there have been early signs of efficacy, including responses, with SPEAR T-cells targeting MAGE-A4. These indications include lung, EGJ, head & neck, and bladder cancers

 

·Cohorts 2 and 3 were merged and 3 patients will be treated in this new group with up to 5 billion SPEAR T-cells, before moving into the expansion phase (subject to safety)

 

·Data will be presented at an upcoming medical oncology congress in 2H 2020

 

SPEARHEAD-2

 

·The trial will enroll 10 patients with head and neck cancer combining ADP-A2M4 with pembrolizumab following initiation of first line pembrolizumab in the relapsed/metastatic setting

 

·This will be the first time that a SPEAR T-cell will be used in sequence with first line systemic therapy

 

·All patients will be apheresed and have their cells manufactured with the intent of having their SPEAR T-cells available by the time of their first assessment on pembrolizumab

 

·Patients who do not respond to pembrolizumab (published response rate ~20%) or who progress after an initial response will receive SPEAR T-cells and continue to receive pembrolizumab

 

·All clinical sites are in the process of being initiated

 

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ADP-A2AFP clinical trial

 

·There is one confirmed complete response, reported in January as a PR, in a patient with liver cancer – the first patient treated at target dose in Cohort 3

 

·The next two patients in this cohort did not respond

 

·Following requests from investigators, the Company opened a cohort for patients with non-hepatocellular carcinoma tumors that express AFP and the one patient treated in this cohort has also not responded

 

·Data will be presented at the International Liver Congress in August

 

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 May 14, 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.

 

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

 

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Entity Central Index Key 0001621227
Entity Tax Identification Number 00-0000000
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
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
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