Cue Biopharma presents data from Phase 1 trials of CUE-101

Cue Biopharma announced the presentation of new positive data from its ongoing fully enrolled Phase 1 trials evaluating its lead interleukin-2-based T cell engager, CUE-101, as a monotherapy and in combination with KEYTRUDA for patients with recurrent/metastatic HPV+ head and neck squamous cell carcinoma. New clinical data will also be reported from the company’s ongoing Phase 1 trial evaluating its second candidate, CUE-102, for the treatment of Wilms’ Tumor 1 positive recurrent/metastatic cancers. The data will be presented in two posters at the Society for Immunotherapy of Cancer’s 38th Anniversary Annual Meeting being held in San Diego, California and virtually November 1-5. Key data highlights from the fully enrolled CUE-101 combination expansion portion of the trial evaluating CUE-101 at the recommended Phase 2 dose of 4mg/kg plus pembrolizumab, as of data cutoff of September 27 with 17 evaluable patients, include: DCR of 65% and ORR of 47%, demonstrating evidence of clinical activity in comparison to the 19% ORR observed with pembrolizumab treatment alone in the KEYNOTE-040 trial 1,2- This includes one complete response and seven partial responses, in addition to three durable stable diseases of greater than or equal to 12 weeks. 56% ORR in patients with combined positive score 1-19, in comparison to the 14% with pembrolizumab monotherapy in the KEYNOTE-040 trial 1,2, with five of the eight responses in tumors with low PD-L1 expression. 21 of the 22 patients treated with CUE-101 and pembrolizumab remain alive at time of data cutoff, including eight patients living beyond 12 months. No unanticipated, significant safety concerns have emerged, and adverse events have been readily managed with appropriate medical care. Key data highlights from the CUE-101 expansion portion of the Phase 1b trial evaluating CUE-101 at the RP2D as monotherapy to date with 19 evaluable patients, include: mOS of 20.8 months in 2L+ patients treated with CUE-101 monotherapy, notably longer than the historical mOS of 7.5 and 8.4 months reported from third-party clinical trials with checkpoint inhibitors in 2L R/M HNSCC in CheckMate 1411 and KEYNOTE-040, respectively. DCR of 37% in late stage, refractory patients, including one confirmed PR of greater than 36 weeks duration and six DSD of greater than or equal to 12 weeks. Of note, one patient has maintained stable disease for over 22 months with no detectable evidence of HPV cell-free DNA in their blood after starting CUE-101 treatment and this patient recently demonstrated an unconfirmed partial response. Key data highlights from the CUE-102 Phase 1 clinical trial to date include: No DLTs reported to date in patients treated during the dose escalation phase at doses ranging between 1-8mg/kg of CUE-102 intravenously every 3 weeks; a MTD has not been reached. Two patients at the 2mg/kg dose, one with gastric cancer and one with ovarian cancer have demonstrated reduction in tumor burden.