On July 17, 2023 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering CAR-T cell therapies and tissue specific therapeutics targeting oncology and immuno-dysregulated diseases, reported its 2nd positive IMX-110 interim update from the Company’s ongoing Phase 1b/2a IMMINENT-01 (NCT05840835) study of IMX-110 in combination with BeiGene’s anti-PD-1 antibody tislelizumab (Press release, Immix Biopharma, JUL 17, 2023, View Source [SID1234633262]). As of the July 7, 2023 data cutoff date, out of 4 relapsed/refractory metastatic colorectal cancer patients treated with IMX-110 + tislelizumab:

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3 out of 4 (75%) patients experienced tumor shrinkage at 2 months
1 out of 4 (25%) 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 (lines of therapy) prior to receiving IMX-110 + tislelizumab and all 4 had proficient mismatch repair (pMMR) relapsed/refractory mCRC
IMMINENT-01 continues to enroll the next cohort of patients at a higher dose
"We are encouraged that in these early cohorts of patients receiving just a fraction of what we believe will be the optimal dose, we continue to see signals of activity of IMX-110 in relapsed/refractory metastatic colorectal cancer patients that received a median of 8 lines of anti-cancer therapies that failed to halt cancer growth prior to receiving IMX-110 + tislelizumab," said Ilya Rachman, MD PhD, Chief Executive Officer of Immix Biopharma. "In the subsequent higher dose cohorts of IMMINENT-01, we are hopeful that clinical results will further improve. The optimal dose identified in IMMINENT-01 will be utilized in our upcoming Phase 2 IMMINENT-02 clinical trial."

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 (marketed as STIVARGA by Bayer) 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.

About IMMINENT-01
IMMINENT-01 (NCT05840835) is an ongoing phase 1b/2a clinical trial combining tissue specific therapeutic IMX-110 with BeiGene anti-PD-1 antibody tislelizumab, in patients with relapsed/refractory solid tumors. The novel approach combining TSTx IMX-110 with anti-PD-1 antibody tislelizumab is designed to expand the population of cancer patients experiencing extended remissions from immunotherapies by converting immunologically "cold" tumors "hot".

In Phase 1b of IMMINENT-01, cohorts of 3 patients will receive escalating doses of IMX-110 until the maximum tolerated dose is reached and the recommended phase 2 dose is determined.

Phase 2a will then begin, treating patients in certain solid tumor indications selected based on Phase 1b clinical data collected in a variety of tumor types. 30 patients are expected to be enrolled in IMMINENT-01.

The primary endpoints of IMMINENT-01 are to identify the maximum tolerated dose and recommended Phase 2 dose of IMX-110 + anti-PD-1 antibody tislelizumab, and to evaluate safety. The secondary endpoints of IMMINENT-01 are to evaluate preliminary efficacy and the pharmacokinetics and preliminary efficacy of IMX-110 + anti-PD-1 antibody tislelizumab.

As of the data cutoff of July 7, 2023, the 2nd cohort dosing at the lowest dose of IMX-110 + anti-PD-1 antibody tislelizumab has reached full enrollment.

Immix Biopharma is currently enrolling the 3rd, next higher dose cohort of IMX-110 + anti-PD-1 antibody tislelizumab in advanced solid tumors.

About Colorectal Cancer

According to NIH SEER, there were an estimated 1,388,422 people living with colorectal cancer in the United States as of 2020 and there were roughly 153,020 new cases of colorectal cancer in the United States in 2022. Globally, there are roughly 1,930,000 new cases of colorectal cancer each year, of which 519,500 are in Europe, 148,500 are in Japan, 20,500 are in Australia and New Zealand, and 555,000 are in China. The five-year survival rate in the United States for relapsed/refractory advanced metastatic CRC is 15.6% according to NIH SEER. 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.