AbbVie and Tizona Therapeutics Announce Strategic Collaboration to Develop First-in-Class Immunotherapy for Cancer Targeting CD39

- Initiation of clinical studies with TTX-030 is targeted in Q1 2019

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Jan 03, 2019, 08:30 ET

NORTH CHICAGO, Ill. and SOUTH SAN FRANCISCO, Calif., Jan. 3, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, and Tizona Therapeutics, Inc. ("Tizona"), a privately held immunotherapy company, announced today that they have entered into a global, strategic collaboration to develop and commercialize CD39-targeted therapeutics, including TTX-030, a first-in-class antibody for the treatment of cancer.

The ATP-adenosine axis has recently emerged as a key immune regulatory switch in the tumor microenvironment (TME) by controlling the inflammatory and suppressive activities of immune cells. CD39 is the enzyme responsible for the initial steps in the conversion of immune stimulatory extracellular ATP to immune suppressive adenosine in the TME. Inhibition of CD39 with TTX-030 represents a novel and differentiated approach to targeting this pathway.

"Immuno-oncology is one of AbbVie's key focus areas in our mission to discover and develop medicines that drive transformational improvements in cancer treatment," said Mo Trikha, Ph.D., Vice President, Head of Oncology Early Development, AbbVie. "Exploring the tumor microenvironment as a source of targets that can be modulated to inhibit cancer growth holds tremendous promise. The Tizona team has generated compelling preclinical data for their TTX-030 program, and we look forward to a productive collaboration focused on rapidly advancing this novel first-in-class antibody."

"Tumors employ various strategies to create a tolerogenic microenvironment, which reduces the immune system's ability to detect and fight cancer," said Courtney Beers, Ph.D., Vice President, Immunology, Tizona. "Preclinical research shows that inhibiting CD39 may hold the key to restoring and bolstering immune responses against tumors. In AbbVie, we have a partner who shares our passion for science and commitment to delivering breakthrough innovation to patients with cancer. We look forward to advancing this exciting program."

Under the terms of the agreement, Tizona has received an upfront payment of $105 million for the exclusive option to license the CD39 program including TTX-030. In addition, AbbVie has made an equity investment in Tizona. Tizona will lead clinical development through completion of Phase 1b studies, after which AbbVie has an exclusive option to lead global development and commercial activities. Tizona retains an option to co-develop and co-promote in the United States and is eligible for success-based development and commercial milestones and tiered royalties on net sales.

An investigational new drug application for TTX-030 has been accepted by the US Food and Drug Administration.

TTX-030, the Adenosine Axis, and the Tumor Microenvironment

TTX-030 is a monoclonal antibody that inhibits the activity of CD39, a cell surface enzyme upregulated on tumors, exhausted T cells, as well as many suppressive cell types as an immune evasion strategy. It catalyzes the conversion of ATP to AMP, the first step in the generation of adenosine. By blocking the action of CD39, TTX-030 prevents the formation of immune suppressive extracellular adenosine, which would otherwise inhibit effector cells in the tumor microenvironment (TME). In addition to preventing the formation of suppressive adenosine, TTX-030 prevents the degradation of ATP, preserving its ability to stimulate dendritic and myeloid-derived cells responsible for innate immunity and immune cell priming necessary for adaptive immunity.

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2017 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

SOURCE AbbVie