Immix Biopharma second interim clinical trial data readout for IMX-110

Immix Biopharma (IMMX) announced its 2nd IMX-110 interim update from the Company’s ongoing Phase 1b/2a IMMINENT-01 study of IMX-110 in combination with BeiGene’s (BGNE) anti-PD-1 antibody tislelizumab. As of the July 7, 2023 data cutoff date, out of 4 relapsed/refractory metastatic colorectal cancer patients treated with IMX-110 + tislelizumab: 3 out of 4 patients experienced tumor shrinkage at 2 months; 1 out of 4 patients experienced tumor control at 2 months; 1 out of 4 patients remain on IMX-110 + tislelizumab therapy as of July 7 2023; Median progression-free survival and overall survival not yet reached; Patients received a median of 8 earlier anti-cancer treatments that failed to halt cancer growth prior to receiving IMX-110 + tislelizumab and all 4 had proficient mismatch repair relapsed/refractory mCRC; IMMINENT-01 continues to enroll the next cohort of patients at a higher dose. Dosing of the second cohort of three relapsed/refractory cancer patients is complete, as of July 7, 2023, for the ongoing Phase 1b portion of the IMMINENT-01 Phase 1b/2a clinical trial investigating IMX-110 in combination with BeiGene anti-PD-1 antibody tislelizumab in relapsed/refractory solid tumors, including relapsed/refractory colorectal cancer. No dose limiting toxicities have been observed in the first 2 cohorts; the trial is now enrolling the next cohort of three patients at a higher dose of IMX-110 in combination with anti-PD-1 antibody tislelizumab. The efficacy evaluable population in IMMINENT-01 includes patients who have completed at least 1 follow-up RECIST assessment. Tumor growth is assessed every 2 months. To put this clinical trial update in perspective, multi-kinase inhibitor regorafenib combined with best supportive care in relapsed/refractory metastatic colorectal cancer patients with median 3 prior lines of therapy produced progression free survival of 2 months and a 1% response rate according to the FDA approval label. This study was not a head-to-head evaluation with IMX-110 and differences exist between trial designs, subject characteristics, and caution should be exercised when evaluating clinical data across studies.