Gilead Invests $1.5 Billion to Acquire First-in-Class Early-Stage Immuno-Oncology Asset from Tizona Therapeutics

On July 21, Gilead Sciences announced a $300 million equity investment in Tizona Therapeutics, acquiring a 49.9% stake in the company. Gilead also holds an exclusive option to acquire the remaining 50.1% equity interest, with future exercise fees and potential milestone payments totaling $1.25 billion. Gilead may decide whether to exercise this option to acquire the remaining stake in Tizona upon or prior to the release of Phase Ib clinical data for the antibody drug candidate TTX-080. Additionally, Gilead will provide financial support to Tizona to advance the development of its existing pipeline of novel drug candidates.

TTX-080 is a monoclonal antibody drug discovered by Tizona Therapeutics that targets human leukocyte antigen-G (HLA-G). HLA-G is a non-classical major histocompatibility complex class I (MHC I) molecule, which has been recognized in recent years as an emerging immune checkpoint protein. It inhibits the effector functions of infiltrating immune cell subsets through interactions with specific receptors and is upregulated in various tumor cells. Due to the distinct expression profile of HLA-G compared to PD-L1, HLA-G inhibitors hold potential for treating tumor patients who are unresponsive to anti-PD-(L)1 therapy, or they may enhance the depth of clinical response in tumors sensitive to anti-PD-(L)1 therapy.

The US Investigational New Drug (IND) application for TTX-080 has been cleared by the FDA, with Phase I clinical trials scheduled to officially commence in the third quarter of this year. Tizona Therapeutics plans to evaluate the potential of TTX-080 as a monotherapy or in combination with other agents for the treatment of advanced cancer. Another core asset of Tizona is TTX-030, a first-in-class anti-CD39 monoclonal antibody. However, this program is being co-developed by Tizona and AbbVie and is not subject to the constraints of Tizona’s recent transaction with Gilead Sciences. Prior to the closing of the transaction with Gilead, Tizona will spin off the TTX-030 assets into an independent entity.

Daniel O’Day, Chairman of the Board and Chief Executive Officer of Gilead Sciences, stated: “Tizona is dedicated to developing differentiated, first-in-class cancer immunotherapies that can benefit patients who do not respond to current immune checkpoint inhibitors. In the first half of this year, Gilead has been committed to building a diverse immuno-oncology (I-O) pipeline, and the transaction with Tizona represents a significant milestone in this strategic initiative. We currently have numerous opportunities to develop novel immunotherapies that can improve the landscape of cancer treatment.”

On May 27, Gilead Sciences also entered into a ten-year strategic collaboration with Acrus Biosciences, valued at up to $2 billion, to jointly develop and commercialize existing and potential future projects in Acrus’s product pipeline. Gilead paid Acrus an upfront fee of $175 million and made a $200 million equity investment. Additionally, Gilead will pay Acrus a total of $1.225 billion in option fees and milestone payments over the course of the partnership. During the collaboration period, Gilead will also provide $400 million in research and development funding to Acrus. Acrus’s pipeline includes a series of immuno-oncology (I-O) assets targeting popular checkpoints such as PD-1, CD73, and TIGIT.

On June 23, Gilead Sciences reached an agreement with Pionyr Immunotherapeutics, adopting a collaboration model identical to its recent equity acquisition of Tizona Therapeutics. Gilead acquired a 49.9% stake in Pionyr for $275 million and secured an exclusive option to acquire the remaining equity, exercisable through a payment of $315 million plus up to $1.15 billion in milestone payments. Additionally, Gilead will provide financial support for the development of Pionyr’s clinical programs. Pionyr primarily focuses on developing drugs that modulate the tumor microenvironment, thereby enhancing the therapeutic efficacy of tumor immunotherapies.

Since officially assuming the role of CEO of Gilead Sciences on March 1, 2019, Daniel O’Day has implemented sweeping reforms to the company’s organizational structure and business portfolio. In 2019, Gilead’s key narrative centered on senior leadership changes, while in 2020, the company actively pursued external transactions and collaborations, with a particular focus on strategically building its innovative oncology business.

Original Title:Gilead Targets $1.5 Billion First-in-Class Early-Stage Oncology Immunotherapy Asset to Deepen I-O Pipeline