Research & Development
US FDA Accepts Exelixis' Investigational New Drug Application for XB002 in Patients with Advanced Solid Tumors
5 April 2021 - - The US Food and Drug Administration has accepted US-based biotechnology company Exelixis, Inc's (NASDAQ: EXEL) Investigational New Drug Application to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of XB002 in patients with advanced solid tumors, the company said.

As a next-generation tissue factor-targeting antibody-drug conjugate, XB002 has the potential for an improved therapeutic index and may provide a favourable safety profile compared with earlier-generation tissue factor-targeting ADCs.

XB002 (formerly ICON-2) is an ADC composed of a human monoclonal antibody against tissue factor that is conjugated to a cytotoxic agent.

After binding to tissue factor on tumor cells, XB002 is internalized, and the cytotoxic agent is released, resulting in targeted tumor cell death.

XB002 is a rationally designed next-generation ADC that leverages proprietary linker-payload technology.

Preclinical data demonstrated that XB002 binds to tissue factor without affecting the coagulation cascade, in contrast with prior therapies in this class.

The data also demonstrated encouraging activity of XB002 in multiple solid tumor cancer models and improved tolerability compared with other tissue factor-targeting ADCs.

XB002 has shown significant tumor growth inhibition and, in some cases, complete regression.

The rational design and preclinical profile of this novel tissue factor-targeting ADC suggest that, if born out in clinical evaluation, XB002 could have an improved therapeutic index and favorable safety profile compared with earlier tissue factor-targeting ADCs.

Founded in 1994, Exelixis, Inc. (NASDAQ: EXEL) is an oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers.