Enrollment Ongoing In Phase I Trial Of Celldex Therapeutics, Inc. (NASDAQ:CLDX) CDX-014


Celldex Therapeutics, Inc. (NASDAQ:CLDX) recently reported that enrollment is ongoing in its Phase I trial of CDX-014. The trial in advanced renal cell carcinoma is designed to know the maximum tolerated dose and to suggest a dose level for further trial. The company anticipates the Phase I dose-escalation portion of the trial will complete registration by year-end 2017.

The highlights

Celldex considers that the cash/cash equivalents at the close of December 2016 together with the projected proceeds from future sales of their common stock under its Cantor agreement, are adequate to fulfill projected working capital needs and fund planned activities through 2018; however, this projection assumes they elect to compensate future Kolltan dependent milestones, if any, in equity rather than cash.

The Phase 1 trial of CDX-0158, formerly KTN0158, continues to register patients. This dose-escalation trial in subjects with advanced refractory GIST and other KIT-positive tumors is intended to know the maximum tolerated dose, suggest a dose for further trial and illustrate the safety profile of CDX-0158. Report from the trial is anticipated to be released by year-end 2017.

Celldex is currently exploring its plans for advancement of CDX-3379, formerly known as KTN3379, into Phase II trial. Moreover, the Phase II trial of Opdivo and varlilumab continues to register patients across multiple indications, which stands at 18 for colorectal cancer, 54 for ovarian cancer (n=54), 54 for neck and head squamous cell carcinoma, 25 for renal cell carcinoma and 20 in case of glioblastoma.

The Company expects that report from the Phase I trial of Opdivo and varlilumab will be showcased mid-year 2017. It intends to close registration across all cohorts in the Phase II portion of the trial in Q1 2018 and will coordinate with BMS to showcase data from the trial at an upcoming medical meeting.

Provided the movement of varlilumab into a Phase II trial with BMS and efforts to list parts for cost-containment, Celldex has determined not to advance the varlilumab/Sutent® and the varlilumab/Tecentriq® combination trials in renal cell carcinoma to Phase II.