Cue Biopharma Inc. (NASDAQ: CUE) stock declined by 2.61% at last close whereas the CUE stock price gains by 6.78% in the after-hours trading session. Cue Biopharma which is a clinical-stage pharmaceutical firm develops a new class of injectable biologics that specifically engage and regulate specific T cells directly within the body of individuals to revolutionize cancer, infectious disease, and autoimmune disease therapies.
Recent Past Development
Cue Biopharma has dosed the first patient in its Phase 1 monotherapy clinical trial of CUE-101 at the suggested Phase 2 dose of 4mg/kg in the Part B expansion phase.
Up to 20 patients are likely to be enrolled in the Phase 1b phase of the CUE-101 monotherapy clinical study in patients with HPV+ second line and beyond (2L+) head and neck squamous cell carcinoma (HNSCC). The evidence supporting the patient expansion has been positive thus far, with six patients in the dosage escalation Phase 1a phase of the CUE-101 monotherapy study having confirmed stable disease (SD) and one patient having confirmed the partial response of about 50% tumor reduction.
The Fc-fusion biologics of the CUE-100 family include peptide-MHC (pMHC) molecules as well as rationally designed IL-2 molecules. This one-of-a-kind biologic is expected to target, stimulate, and grow a large number of tumor-specific T cells directly in the patient.
Ken Pienta, acting chief medical officer of Cue Biopharma stated,
The CUE-101 monotherapy trial’s Part B patient expansion has begun, and they are extremely excited about it. They think that the results backing the selection of the cohort 6 dose of 4 mg/kg as a recommended Phase 2 dose provides them increasing confidence that CUE-101 might be a viable candidate for a registration-directed clinical trial as a single agent therapy for HPV+ 2L+ HNSCC.
CUE actively participated in a fireside discussion at the JMP Securities Life Sciences Conference, which took place on June 16-17, 2021.
Cue Biopharma gave an update at the fireside chat, detailing CUE-101’s ongoing Phase 1a/1b monotherapy dosage escalation clinical study as a second-line treatment for HPV+ recurrent/metastatic head and neck cancer patients.