Exelixis Reports the US FDA’s Acceptance of IND for XB002 in Patients with Advanced Solid Tumors

April 6, 2021 Auto Bot Acceptance, Exelixis, FDA, NDA, patients, regulatory, reports 0

Shots:

  • The US FDA has accepted IND to assess the safety, tolerability, PK, and preliminary antitumor activity of XB002 in patients with advanced solid tumors. The P-I trial is expected to initiate in Q2’21
  • The preclinical data demonstrated that XB002 binds to tissue factors without affecting the coagulation cascade, in contrast with prior therapies in this class. The data also showed improved tolerability, tumor growth inhibition and complete regression
  • XB002 (ICON-2) is an ADC composed of a human mAb against tissue factor and have an improved therapeutic index and favorable safety profile compared with earlier-generation tissue factor-targeting ADCs

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