ABIVERTINIB

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FUJOVEE™ (Abivertinib) (Cytokine Storm – STI 5656)

FUJOVEE (Abivertinib) is a small molecule third-generation tyrosine kinase inhibitor (TKI) that selectively targets both mutant forms of the epidermal growth factor receptor (EGFR) and Bruton’s tyrosine kinase (BTK)1

Inhibits the gatekeeper mutation of EGFR; T790M, as well as the common activating mutations (L858R, 19del).

Has minimal inhibitory activity against the wild type (WT) EGFR, contributing to its observed safety profile.  Good tolerability at oral doses up to 600 mg daily. 

Phase 2 NSCLC study completed with positive results published in Clinical Cancer Research.2

  • Among 209 response evaluable NSCLC patients who developed resistance to first line TKIs:
  • 93.3% (n/N: 195/209) subjects achieved tumor shrinkage at target lesions.
  • 57.4% (n/N: 120/209) subjects achieved the best overall responses (confirmed + unconfirmed PR).
  • 52.2% (n/N: 109/209) subjects achieved confirmed PR.
  • 24.9 months OS.

Complete clinical study report and prepare package to target discussing the regulatory path with FDA in 4Q22.

FDA granted IND clearance in Q2 2022 for the Phase 2 MAVERICK study to treat metastatic castrate resistant prostate cancer (mCRPC). 

Is also being tested as a potential treatment for cytokine storm associated with COVID-19 in ICU patients.

1) Epidermal Growth Factor Receptor (EGFR), Bruton Tyrosine Kinase (BTK)
2) Study Results:  https://clincancerres.aacrjournals.org/content/early/2021/11/04/1078-0432.CCR-21-2595