In late November, Celldex Therapeutics, Inc. (NASDAQ:CLDX) closed the acquisition deal of Kolltan Pharmaceuticals, Inc., bringing an innovative platform of antibodies targeting RTKs to its pipeline. Preclinical and clinical data indicate these candidates can help face tumor resistance mechanisms linked with current tyrosine kinase inhibitors and noted in people who didn’t respond to other cancer treatments.
Updating on progress recorded in METRIC enrollment, Celldex reported that enrollment in the Phase IIb randomized study of glembatumumab vedotin in subjects with metastatic triple negative breast cancers has accelerated steadily over the last many months across the U.S., Australia, Canada and the European Union.
Considering the existing rate of registration continues, Celldex projects enrollment will be closed by September 30, 2017. The company also added third arm to glembatumumab vedotin Phase II trial in metastatic melanoma. Registration has been started in a glembatumumab vedotin plus checkpoint inhibitor arm in people who failed previous checkpoint treatment.
Enrollment continues in the varlilumab and glembatumumab vedotin arm, with results from this portion of the trial anticipated this year. Positive report from the single-agent arm of trial in people who had initially progressed on checkpoint treatment were presented at the ESMO Congress in October 2016.
The Phase II trial of Opdivo and varlilumab continues to enroll subjects across numerous indications. Celldex projects that data from the Phase I trial of Opdivo and varlilumab will be presented this year. It intends to complete registration across all cohorts in the Phase II portion of the trial in Q1 2018 and will work with BMS to showcase data from the trial at a future medical meeting.
Provided the move of varlilumab into an extensive Phase II trial with BMS, comprising in renal cell carcinoma, and measures to identify segments for cost-containment, the company has decided not to progress the varlilumab/Sutent® and the varlilumab/Tecentriq® combination trials in renal cell carcinoma to Phase II.