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 14, 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 1.01                                            Entry into a Material Definitive Agreement.

 

On May 14, 2019, Adaptimmune Therapeutics plc (the “Company” or “Adaptimmune”) entered into a collaboration and license agreement (the “Collaboration Agreement”) with Alpine Immune Sciences, Inc. (“Alpine”), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, to develop next-generation SPEAR T-cell products which incorporate Alpine’s secreted and transmembrane immunomodulatory protein (termed SIP™ and TIP™) technology.  The Company believes that this collaboration will further enhance its efforts to design and develop next-generation SPEAR T-cell therapies. Under the terms of the Collaboration Agreement, Adaptimmune will provide an upfront payment of $2 million to Alpine and research funding for ongoing programs.  In addition, Alpine is eligible for downstream development and commercialization milestones of up to $288 million, if all pre-specified milestones for each program are achieved.  Alpine is also eligible to receive low-single digit royalties on worldwide net sales of the applicable products.

 

The foregoing summary of the material terms of the Collaboration Agreement does not purport to be complete and is qualified in its entirety by the full text of the Collaboration Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2019.

 

Item 8.01                                            Other Events.

 

On May 15, 2019 the Company issued a press release announcing its entry into the Collaboration Agreement.  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 May 15, 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: May 15, 2019

By:

/s/ Margaret Henry

 

 

Name:

Margaret Henry

 

 

Title:

Corporate Secretary

 

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Exhibit 99.1

 

GRAPHIC

 

Adaptimmune and Alpine Immune Sciences Announce Collaboration and License Agreement to Develop Next-Generation SPEAR T-Cell Products

 

- Adaptimmune to license Alpine’s Secreted and Transmembrane Immunomodulatory Protein technology for use with SPEAR T-cells to enhance antitumor responses -

 

May 15, 2019, Adaptimmune Therapeutics plc, Philadelphia, PA, and Oxfordshire, UK (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, and Alpine Immune Sciences, Inc., Seattle, WA , (NASDAQ:ALPN), a leading immunotherapy company focused on developing treatments for autoimmune diseases and cancer, today announced a collaboration and license agreement to develop next-generation SPEAR T-cell products which incorporate Alpine’s secreted and transmembrane immunomodulatory protein (termed SIP™ and TIP™) technology. This collaboration will further enhance Adaptimmune’s efforts to design and develop next-generation SPEAR T-cell therapies.

 

SPEAR T-cell therapies have demonstrated clinical promise for the treatment of solid tumors. Based on knowledge emerging from translational research of resistance mechanisms, we will start our first next-gen clinical study with ADP-A2M4CD8 in the second half of 2019,” said Rafael Amado, Adaptimmune’s President of R&D. “We are very excited to begin this collaboration with Alpine which complements our research on next-generation SPEAR T-cells. We believe that Alpine’s platform technology could engage further rapid and flexible immunomodulatory mechanisms, which would enable the development of future next-generation SPEAR T-cells with enhanced antitumor potential.”

 

“Our directed evolution platform has successfully generated many unique, multi-functional protein domains designed to favorably modulate the tumor microenvironment via validated immune targets,” said Stanford Peng, MD PhD, Alpine’s President and Head of Research & Development. “We look forward to working with Adaptimmune to develop next-generation SPEAR T-cell therapies to achieve improved clinical outcomes.”

 

Alpine and Adaptimmune will collaborate on a specified number of programs to develop SIP and TIP candidates with tailored affinities and modulatory activities that may enhance the anti-tumor responses seen with Adaptimmune’s SPEAR T-cells.

 

For each program, Adaptimmune has an option to take a worldwide exclusive license for development and commercialization of SPEAR T-cell products incorporating the developed SIP or TIP candidate for the treatment of cancer.

 

Under the terms of the collaboration agreement, Adaptimmune will provide an upfront payment and research funding for ongoing programs.  In addition, Alpine may be eligible for downstream development and commercialization milestones up to $288M, if all pre-specified milestones for each program are achieved.

 

Alpine will receive low-single digit royalties on worldwide net sales of the applicable products.

 

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.

 

About Alpine Immune Sciences, Inc.

 

Alpine Immune Sciences, Inc. is committed to leading a new wave of functional immune therapeutics. Alpine is employing directed evolution to create potentially powerful multifunctional immunotherapies to

 

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improve patients’ lives. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a dual ICOS/CD28 antagonist, engineered to reduce pathogenic immune responses. The second, ALPN-202 for cancer, is a dual PD-L1/CTLA-4 antagonist and PD-L1-dependent CD28 costimulator intended to combine checkpoint inhibition with T cell costimulation — an approach currently absent from approved checkpoint therapies. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

 

Forward-Looking Statements Adaptimmune

 

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.

 

Forward-Looking Statements Alpine

 

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies, the potential future development plans of our and our collaborators’ product candidates and our and our collaborators’ ability to successfully develop and achieve milestones in development programs. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “intend,” and other similar expressions among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our or our collaborators’ product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; our discovery-stage and pre-clinical programs may not advance into the clinic or result in approved products; any of our or our collaborators’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

 

“Transmembrane Immunomodulatory Protein”, “TIP”, “Secreted Immunomodulatory Protein”, “SIP” “Variant Ig Domain”, “vIgD”, and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

 

Adaptimmune Contacts:

 

Media Relations:

Sébastien Desprez — VP, Communications and Investor Relations

T: +44 1235 430 583

 

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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

 

Alpine Contacts:

 

Investor Relations:

Pure Communications

Courtney Dugan, 212-257-6723

cdugan@purecommunications.com

 

Media Relations:

Pure Communications

Jennifer Paganelli, 347-658-8290

jpaganelli@purecommunications.com

 

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