7/6/2023 0 Comments Shrinkit gs![]() IMMINENT-01 is a first-of-its-kind, ongoing phase 1b/2a clinical trial combining tissue specific therapeutic IMX-110 with BeiGene / Novartis’ anti-PD-1 antibody tislelizumab, in patients with advanced solid tumors. The colorectal cancer market is estimated to reach approximately $31.2 billion by 2025 from the estimated $26.3 billion in 2019 according to IndustryARC. The PD-1/PD-L1 antibody market size is approximately $49.5 billion in 2023 and expected to reach $123.3 billion by 2033 according to Future Market Insights. 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. ![]() To put this early interim clinical data in perspective, anti-PD-1 antibody pembrolizumab alone (marketed as KEYTRUDA® by Merck) produced tumor shrinkage in 3 of 19 patients (16%) with an evaluable postbaseline tumor assessment in a Phase 1b study of pembrolizumab in patients with advanced or metastatic colorectal cancer according to O’Neil, et al., 2017. Tumor shrinkage was observed in the first two out of two (2/2) evaluable patients (100%) at 2-months. No dose limiting toxicities have been observed in the first cohort, which means that the trial can now enroll the next cohort of three patients at a higher dose of IMX-110 in combination with anti-PD-1 antibody tislelizumab. “These initial results potentially validate the scientific rationale for the promise of IMX-110 to unlock our immune system’s ability to fight cancer.”ĭosing of the first cohort of three advanced metastatic colorectal cancer patients is complete, as of April 14, 2023, for the ongoing Phase 1b portion of the IMMINENT-01 Phase 1b/2a clinical trial investigating IMX-110 in combination with BeiGene / Novartis anti-PD-1 antibody tislelizumab in advanced solid tumors, including colorectal cancer. “We are excited to see 100% tumor shrinkage in the very first cohort at the lowest dose of IMX-110 in combination with anti-PD-1 antibody tislelizumab in our ongoing IMMINENT-01 dose escalation trial, especially in patients with advanced colorectal cancer, who have limited treatment options,” said Ilya Rachman, MD PhD, CEO of ImmixBio. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx) TM targeting oncology and immuno-dysregulated diseases, today announced positive early interim clinical trial data: 100% Tumor Shrinkage at 2-months in advanced metastatic colorectal cancer demonstrated by IMX-110 + BeiGene / Novartis anti-PD-1 antibody tislelizumab combination in the first cohort of patients (two out of two first evaluable patients) who received the lowest IMX-110 dose in its ongoing dose escalation 1b/2a clinical trial of IMX-110 + anti-PD-1 antibody tislelizumab (IMMINENT-01), as of the Apdata cutoff date. LOS ANGELES, (GLOBE NEWSWIRE) - Immix Biopharma, Inc.
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