We are advancing our pipeline of Selective Translation Regulator Inhibitors (STRIs) with speed and scale.
Our STRIs are designed to overcome cancer’s complex, aggressive nature. They can augment efficacy of existing therapies and those in development, as well as target the oncoproteins, immune suppression factors and resistance mechanisms cancer frequently uses to evade therapeutic intervention.
Program (Target)
Discovery
Preclinical
Phase 1
Phase 2a
Phase 2b
Phase 3
Global Rights
Anticipated Milestones
Tomivosertib
(MNKi)
Discovery
Preclinical
Phase 1
Phase 2a
Phase 2b
Phase 3
1L NSCLC PD-L1 ≥50% - 1L in combo with pembro
1L NSCLC PD-L1 ≥50% - 1L in combo with pembro
Q1 2024: Topline data readout
Zotatifin
(eIF4Ai)
Discovery
Preclinical
Phase 1
Phase 2a
Phase 2b
Phase 3
Solid Tumors: ER + BC and KRAS NSCLC
Solid Tumors: ER + BC and KRAS NSCLC
Q4 2023: Mature PFS data in ZFA cohort
Data from resumed dose escalation
External Collaborations
eIF4Ei
Discovery
Preclinical
Phase 1
Phase 2a
Phase 2b
Phase 3
Solid Tumors
Solid Tumors
$507M deal value with option to co-promote and profit share
Tomivosertib
(MNKi)
Discovery
Preclinical
Phase 1
Phase 2a
Phase 2b
Phase 3
Investigator-initiated trial at Northwestern in r/r AML
Investigator-initiated trial at Northwestern in r/r AML
Zotatifin
(eIF4Ai)
Discovery
Preclinical
Phase 1
Phase 2a
Phase 2b
Phase 3
Investigator-initiated trial at Stanford in ER+ HER2- breast cancer in pre-operative setting
Investigator-initiated trial at Stanford in ER+ HER2- breast cancer in pre-operative setting
TOMIVOSERTIB
A POTENT AND HIGHLY SELECTIVE MNK INHIBITOR
Our lead product candidate, tomivosertib, is an oral small molecule inhibitor of MNK. We are developing tomivosertib in combination with inhibitors of checkpoint proteins such as PD-1 and PD-L1 for the treatment of patients with solid tumors. MNK are kinases that phosphorylate eIF4E. Through inhibition of MNK, tomivosertib downregulates production of multiple immune-suppressive proteins and reprograms T cells to delay exhaustion and dysfunction, increasing their ability to combat tumor cells. In preclinical and clinical studies showing target inhibition in patient tumor biopsies, tomivosertib can completely (>90%) block MNK signaling, and in preclinical models enhanced the ability of the immune system to attack tumors.
Based on tomivosertib’s mechanism in immune biology and the encouraging results in our Phase 2a clinical trial, we’ve initiated KICKSTART, a double-blind, randomized, placebo-controlled Phase 2b trial of tomivosertib combined with pembrolizumab in patients with metastatic NSCLC.
ZOTATIFIN
A POTENT AND HIGHLY SELECTIVE eIF4A mRNA HELICASE INHIBITOR
Our second product candidate, zotatifin, is a small molecule inhibitor of eIF4A. eIF4A is a helicase responsible for unwinding complex secondary structures in “onco” mRNAs and enables select tumor cells to overproduce proteins associated with cellular growth, including ER and KRAS. We have initiated multiple Phase 2a expansion cohorts with zotatifin both as a single agent and in combination with targeted agents in ER+ breast cancer and KRAS-mutant NSCLC.
eIF4E
A GLOBAL COLLABORATION WITH PFIZER
Our third program is focused on developing inhibitors of eIF4E. eIF4E is an oncogenic target involved in the translation of key disease driving proteins. These inhibitors are currently being developed by Pfizer under our research collaboration and license agreement. We have retained an option to co-promote and profit share in the United States.