Candidate: Abivertinib (abivertinib maleate; STI-5656)

Type: Small molecule tyrosine kinase inhibitor (TKI) designed to selectively target both mutant forms of the epidermal growth factor receptor (EGFR) and Bruton’s tyrosine kinase (BTK). Abivertinib irreversibly binds to the BTK receptor, preventing phosphorylation of the receptor. As a result, it has shown potent immunomodulatory activities in vitro by inhibiting key pro-inflammatory cytokine production, including IL-1beta, IL-6 and TNF-alpha, according to Sorrento.

2021 Status: Sorrento said June 22 that it completed enrollment for its Phase II clinical trial of Abivertinib in hospitalized COVID-19 patients in Brazil (NCT04528667), following the recently completed enrollment of a 96-patient US Phase II clinical trial (NCT04440007). The 400-patient Brazil study is a randomized, double-blind, placebo-controlled study of Abivertinib’s safety and efficacy in patients hospitalized with COVID-19 with cytokine storm, and will look particularly at potential clinical benefits of the drug associated with its ability to reduce  inflammatory cytokine storm.

2020 Status: Sorrento said July 20 it received FDA clearance to launch a Phase II trial (NCT04440007) of STI-5656 in patients with COVID-19 who have moderate to severe pulmonary symptoms. The trial will be initially conducted in centers in the USA.

On May 21, Sorrento said it entered into a binding term sheet for an exclusive license to ACEA Therapeutics’ Abivertinib across all indications for all territories outside of China.  Sorrento and ACEA have since entered into an exclusive license agreement, whose value has not been disclosed.

Sorrento said it anticipates that the effects of STI-5656 will be incremental to the initial published findings by others for IL-6 inhibitors targeted for COVID-19 trials, and the drug’s clinical benefits will be more pronounced given its broader range of anti-cytokine activity, since Abivertinib targets multiple cytokines simultaneously.

Abivertinib has been studied in over 600 patients worldwide in various oncologic indications, including one registration trial in non-small cell lung cancer.

COVID-19: 300 Candidates and Counting

To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types:


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