Tizona Initiates Phase 1b Expansion Study of TTX-080 in Advanced Refractory or Resistant Malignancies

Tizona Therapeutics, Inc., a privately held, clinical-stage company developing first-in-class cancer immunotherapies, announced today that its lead investigational therapy, TTX-080, a novel antibody targeting HLA-G, has advanced to Phase 1b. This phase includes expansion tumor arms to evaluate the safety and efficacy of TTX-080 as monotherapy and combination regimens in patients with advanced malignancies.

The Phase 1b is a dose expansion study designed to assess TTX-080 as monotherapy and in combination with either pembrolizumab or cetuximab in patients with advanced refractory or resistant solid tumor malignancies, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and triple negative breast cancer. In addition to evaluating the anti-tumor activity of TTX-080, the study will continue to evaluate the safety, pharmacokinetics, and immunogenicity of TTX-080. Exploratory pharmacodynamic and biomarker analyses will also be conducted.

"The initiation of the Phase 1 dose expansion study is an important milestone for the TTX-080 clinical development program," said Christine O'Brien, Chief Executive Officer, Tizona. "As a novel checkpoint inhibitor, the TTX-080 program offers an opportunity to apply new understandings of immune regulation within the tumor microenvironment in solid tumor indications where patient outcomes remain a major unmet medical need."

The Phase 1b expansion study follows the Phase 1a study, an open label, multicenter, dose escalation clinical trial designed to assess the safety and tolerability of TTX-080 as monotherapy. The Phase 1a stage of the study, which has completed enrollment, determined a recommended Phase 2 dose of TTX-080 when administered as a single agent.

About TTX-080

TTX-080 is a potential first-in-class medicine that targets HLA-G, a novel and emerging immune checkpoint expressed across multiple tumor types. By blocking the interaction of HLA-G with its receptors, TTX-080 prevents the suppression of both innate and adaptive immune activity and has the potential to enhance anti-tumor responses. Tizona is currently enrolling patients in a Phase 1b clinical trial (NCT04485013) evaluating TTX-080 both as a monotherapy and in combination with other agents in patients with advanced cancers.

About Tizona Therapeutics, Inc.

Tizona is a privately held, clinical-stage immunotherapy company that develops first-in-class medicines to deliver transformational benefits for people with cancer. Tizona translates scientific breakthroughs into therapeutics that stimulate the immune system and counter immune suppression. Tizona's pipeline includes TTX-080, which targets HLA-G and is being evaluated in a Phase 1b clinical study in advanced cancers, and additional first-in-class preclinical and discovery stage programs targeting novel immuno-modulatory molecules.

In August 2020, Tizona entered into a transformative alliance with Gilead Sciences whereby Gilead purchased a 49.9 percent equity interest in Tizona and has the exclusive option to acquire the remainder of the company. This collaboration will fund Tizona's first-in-class programs, as well as other early pipeline programs.