Microsatellite Stable Colorectal Cancer Dosing Begins in Phase 2 Trial of Combo Therapy

Microsatellite Stable Colorectal Cancer Dosing Begins in Phase 2 Trial of Combo Therapy

Microsatellite stable colorectal cancer (MSS CRC) patients have begun receiving treatment in a Phase 2 clinical trial evaluating eFT508 in combination with Bavencio (avelumab), eFFECTOR Therapeutics announced.

In collaboration with Pfizer and Germany’s Merck KGaA, the trial (NCT03258398) aims to evaluate the efficacy, safety and tolerability of eFT508 alone and in combination with Bavencio.

The study includes initial assessment of the safety and tolerability of escalating doses of eFT508 plus Bavencio, after which patients will randomly be assigned to receive either the combo treatment or eFT508 alone.

Participants will get their assigned therapy in four-week treatment cycles; eFT508 will be taken orally twice daily and Bavencio will be administered intravenously every two weeks, in 10 mg/kg doses.

The immunotherapeutic eFT508 is a highly potent and selective oral inhibitor of MNK1 and MNK2 – terminal kinases in key oncologic signaling pathways. The new drug aims to block MNK1/2 in a way that promotes the immune system’s anti-tumor immune response.

The candidate is currently being evaluated in two Phase 1/2 clinical trials, one in patients with lymphoma (NCT02937675) and one in patients with solid tumors (NCT02605083).

Dr. Steve Worland, president and CEO of eFFECTOR, said in a press release that “eFT508 promotes anti-tumor immune response and we believe it has the potential to improve patient outcomes when used as a single agent or in combination with other immuno-oncology drugs, such as avelumab (Bavencio), an anti-PD-L1 checkpoint inhibitor.”

Referring to a poster presentation eFFECTOR brought to the American Society of Clinical Oncology annual meeting (ASCO 2017) this year, Worland added: “We’ve demonstrated that eFT508 is well-tolerated as a single agent in patients with refractory solid tumors in a Phase 1 study. The newly initiated trial represents the first of several Phase 2 trials we plan to conduct with eFT508.”

Bavencio is an anti-PD-L1 checkpoint inhibitor. By binding to PD-L1, the drug is thought to prevent tumor cells from hampering the activity of immune cells (like T-cells), thus exposing them to the body’s natural anti-tumor responses.

The U.S. Food and Drug Administration has granted Bavencio accelerated approval to treat patients with metastatic Merkel cell carcinoma, as well as previously treated patients with locally advanced and metastatic urothelial carcinoma.

The Phase 2 study will take place in six to ten U.S. sites. Interim data is expected in mid-2018, and researchers anticipate it will already include information from the first 20 patients in the study’s randomized portion.