Benzinga | Apr 19, 2021 07:09AM EDT

XBiotech To Test New Drug Candidate Combined With Approved Treatment In Pancreatic Cancer

* The FDA has signed off Phase 1/2 clinical study to evaluate XBiotech Inc's (NASDAQ: XBIT) XB2001 when added to the ONIVYDE/5-FU combination therapy for treating patients with pancreatic cancer.

* The Phase 1 portion of the study will examine increasing doses of XBiotech's new drug and assess the tolerability of the combination at escalating doses.

* Once a safe dose has been determined, the phase 2 portion will begin, enrolling 60 patients. The trial will be randomized to receive treatment with ONIVYDE/5-FU or ONIVYDE/5-FU combined with XB2001.

* Clinical endpoints in the study are safety, overall survival, objective response rate, progression-free survival, time to treatment failure, clinical benefit response, number of severe adverse advents, and biological measures of experimental drug activity.

* XB2001 specifically targets a process potentially involved in the growth and spread of malignant tumors. The drug also blocks inflammation associated with tissue injury, which may reduce toxicity associated with the chemotherapy and allow these drugs to be better tolerated and more effective.

* ONIVYDE (irinotecan liposome injection) is indicated, in combination with fluorouracil (5-FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.

* Price Action: XBIT shares are trading 7.1% higher at $18 in the premarket session on the last check Monday.