eFFECTOR Therapeutics has reported positive results from its Phase I/II clinical trial of eIF4A inhibitor zotatifin in solid tumour patients.
In these interim results, the company noted that the ongoing zotatifin trial showed treatment was generally well tolerated and resulted in multiple oncogenic drivers’ suppression.
Furthermore, it demonstrated initial clinical activity signals.
Treatment emergent adverse events (TEAEs) related to the therapy were mostly mild, readily managed and reversible in nature.
They included anemia, diarrhea, fatigue, vomiting and nausea.
A total of 25 patients received the recommended Phase II dose and no one exhibited zotatifin-related Grade 3, 4 or 5 TEAEs.
Early clinical activity signals were observed in two patients with breast cancer in Part II of the trial.
One patient with amplified Cyclin D1 and an ESR1 mutation progressed on previous treatment with fulvestrant and experienced a confirmed partial response when fulvestrant and zotatifin were combined.
In a patient with PIK3CA mutations, a second partial response was observed with the zotatifin, fulvestrant and abemaciclib combination.
eFFECTOR Therapeutics president and CEO Steve Worland said: “We saw encouraging results for down regulation of a number of oncogenic drivers, which not only provides clinical proof of mechanism, but also paves the way for how to combine zotatifin with other medicines.
“Notably, based on the evidence, we have advanced to Stage 2 of a Simon 2-stage trial design in the cohort of patients treated with zotatifin and fulvestrant after progressing on a CDK4/6 inhibitor and endocrine therapy and plan to open a new cohort in patients with ER+ breast with Cyclin D1 amplification.
“We look forward to generating more data in this cohort as the resulting dataset in a defined patient population could support a potential path to registration.”
The company expects to report topline data from its current expansion cohorts by this year end.
In July 2021, eFFECTOR dosed the first subject in the Phase Ib clinical trial of zotatifin to treat outpatients with mild to moderate Covid-19.