THERAPEUTIC AREAS OF FOCUS
At eFFECTOR, our team is relentlessly translating the best science to develop better medicines to treat cancer. An important part of developing and investigating new treatments is conducting clinical trials. We are currently recruiting patients to be part of our clinical trials to test potential new products.
Non-Small Cell Lung Cancer
Over the past several years, a class of drugs called checkpoint inhibitors (primarily anti-PD-(L)1 therapies), have emerged as an important new therapeutic area modality for the treatment of cancer. While checkpoint inhibitor treatment is very effective for some patients for a variety of cancers, these agents are generally not curative – including for people with non-small cell lung cancer (NSCLC). The majority of patients ultimately progress on their checkpoint inhibitor therapy.
There are approximately 70,000 U.S. patients with metastatic NSCLC who have some degree of PD-L1 expression. Patients with high PD-L1 expression (≥ 50%), who have historically responded the best to pembrolizumab and other checkpoint inhibitors, are eligible to enroll in KICKSTART, a double-blind, randomized, placebo-controlled Phase 2b trial of tomivosertib combined with pembrolizumab in patients with metastatic NSCLC. Patients enrolled in KICKSTART will receive tomivosertib or placebo plus pembrolizumab as their frontline treatment.
We are also investigating our second product candidate, zotatifin, in KRAS-mutant NSCLC as a single agent in non-G12C patients and in combination with a G12C KRAS inhibitor for patients who are G12C-positive. Activating KRAS mutations occur in approximately 25% of patients with NSCLC, an area in which there is a significant need to improve treatment outcome.
The National Cancer Institute estimates there are over 280,000 new cases of invasive breast cancer in the U.S. alone each year. In invasive estrogen receptor (ER)-positive breast cancers (representing approximately 60% of cases), patients are currently treated with endocrine therapy, which impacts estrogen’s effects in cancer cells, and CDK 4/6 inhibitors. However, because the majority of patients eventually progress, there is an immense need for new treatments.
Breast cancers often harbor overexpressed or mutated RTKS such as HER2 or FGFR, that can be treated with either approved or experimental agents that specifically target those proteins. In preclinical experiments, we have shown that zotatifin downregulates production of proteins within the ER and RTK pathways. We are advancing our product candidate zotatifin in several breast cancer subtypes, including ER+, Her2+ and FGFR+ metastatic breast cancer both as a single agent as well as in combination with targeted agents.
We are also evaluating tomivosertib in combination with taxane in patients with metastatic breast cancer. This trial, led by McGill University and fully funded through a grant from Stand Up To Cancer (SU2C) Canada, will further our understanding of the MNK pathway and chemotherapy-induced stress response.
At eFFECTOR, our passion is using the best science to develop better medicines to treat cancer. An important part of developing new treatments is conducting clinical trials. eFFECTOR is currently recruiting patients to be part of clinical trials to test potential new products.
Tomivosertib With Pembrolizumab In Subjects with NSCLC (Kickstart)
A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Intravenous eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial of Intravenous Zotatifin in Adults With Mild or Moderate Coronavirus Disease 2019 (COVID-19)
Expanded Access Policy
eFFECTOR Therapeutics is driven by science, and we are committed to developing safe and effective therapies for patients. Our goal is to provide our novel treatments to patients as quickly as possible, but in a way that stands up to scientific rigor and achieves the best clinical outcomes.
Our clinical programs are designed to answer important scientific questions about the potential risks and benefits of our product candidates, and to provide data to support regulatory approval. Patients are required to meet specific eligibility criteria to enter our clinical trials, and not every patient will meet eligibility criteria. When a patient does not meet the eligibility criteria for a clinical trial, or if a clinical trial is not available, and the patient has exhausted available treatment options, companies may consider providing access to its investigational medicines outside of a clinical trial through a process called Expanded Access.
eFFECTOR has determined that Expanded Access cannot currently be offered for any of its product candidates and the company does not currently provide its product candidates outside of enrollment in clinical trials.
If you have questions regarding this policy or any of our ongoing clinical trials, please contact: clinicaltrials@eFFECTOR.com