Cue Biopharma, Inc. (NASDAQ:CUE) received the U.S. Food and Drug Administration (FDA) acceptance of the Investigational New Drug (IND) application for the evaluation of CUE-102 in the treatment of Wilms' Tumor 1 (WT1)-positive recurrent/metastatic cancers.
This IND acceptance enables the dose escalation of Phase 1 trial to start dosing at 1 mg/kg, supported by the safety and tolerability data from the CUE-101 (the first biologic from the CUE-100 series) trial.
Ken Pienta, M.D., acting chief medical officer, commented, "We believe CUE-102 provides a significant opportunity to address a high unmet medical need in a wide variety of WT1-positive malignancies including colorectal, pancreatic and lung, and potentially offers a tolerable and more effective treatment option to patients in need. We believe CUE-102 has the potential to change the treatment landscape for WT1-positive patients and are very pleased to now begin evaluating its potential benefit in the clinic."
The FDA clearance marks significant milestone for Cue Biopharma in its multi-target strategic collaboration with LG Chem Life Sciences, to develop multiple Immuno-STAT biologics focused in the field of oncology.
Cue Biopharma is currently trading down 12 percent at $3.70.
