- 100% Tumor Shrinkage at 2-months in advanced metastatic colorectal cancer was demonstrated by IMX-110 + BeiGene / Novartis anti-PD-1 Antibody Tislelizumab combination in the first, lowest dose cohort (two out of two first evaluable patients) in its ongoing phase 1b/2a dose escalation clinical trial IMMINENT-01
- We believe results bolster scientific basis for IMX-110 in unlocking the immune system’s ability to fight cancer
Immix Biopharma Announces Early Positive IMX-110 Interim Clinical Trial Data Demonstrating 100% Tumor Shrinkage in Advanced Metastatic Colorectal Cancer at the Lowest Dose of IMX-110 + BeiGene / Novartis Anti-PD-1 Antibody Tislelizumab
Immix Biopharma, Inc. (Nasdaq:IMMX)
LOS ANGELES, May 03, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (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 April 14, 2023 data cutoff date.
“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. “These initial results potentially validate the scientific rationale for the promise of IMX-110 to unlock our immune system’s ability to fight cancer.”
Dosing 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. 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. Tumor shrinkage was observed in the first two out of two (2/2) evaluable patients (100%) at 2-months. 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. 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.
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.
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.
About IMMINENT-01
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 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 the pharmacokinetics and preliminary efficacy of IMX-110 + anti-PD-1 antibody tislelizumab.
As of the data cutoff of April 14 2023, the first cohort dosing at the lowest dose of IMX-110 + anti-PD-1 antibody tislelizumab has reached full enrollment.
Immix Biopharma is currently enrolling the next higher dose cohort of IMX-110 + anti-PD-1 antibody tislelizumab in advanced solid tumors.
About Colorectal Cancer
According to American Cancer Society, there were roughly 153,020 new cases of colorectal cancer in the United States in 2023. 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 advanced metastatic CRC is 15.6% according to NIH SEER.
About Immix Biopharma, Inc.
Immix Biopharma, Inc. (ImmixBioTM) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases. Our lead CAR-T cell therapy, NXC-201 for multiple myeloma and AL amyloidosis, has produced 92% and 100% response rates in each indication, respectively, as of February 9, 2023. Our lead TSTx is IMX-110, currently in Phase 1b/2a clinical trials as a monotherapy and in its IMMINENT-01 combination clinical trial with BeiGene/Novartis’ anti-PD-1 antibody, tisleilizumab, for which patient dosing began in February 2023. IMX-110 holds orphan drug designation (ODD) by the FDA for soft tissue sarcoma, and has received Rare Pediatric Disease Designation (RPDD) by the FDA the treatment of rhabdomyosarcoma, a life-threatening form of cancer in children. RPDD qualifies ImmixBio to receive fast track review and a priority review voucher (PRV) at the time of marketing approval of IMX-110. In combination with BeiGene / Novartis’s anti-PD-1 antibody tislelizumab in the ongoing IMMINENT-01 trial, IMX-110 produced 100% tumor shrinkage in relapsed/refractory colorectal cancer in the very first dose escalation cohort as of the April 14, 2023 data cutoff date. Learn more at www.immixbio.com.
Forward Looking Statements
This press release contains “forward-looking statements” Forward-looking statements reflect our current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward-looking statements. Such statements, include, but are not limited to, statements contained in this press release relating to our business strategy, our future operating results and liquidity and capital resources outlook. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, our ability to raise capital to fund continuing operations; our ability to protect our intellectual property rights; the impact of any infringement actions or other litigation brought against us; competition from other providers and products; our ability to develop and commercialize products and services; changes in government regulation; our ability to complete capital raising transactions; and other factors relating to our industry, our operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Immix Biopharma’s Annual Report on Form 10-K for the year ended December 31, 2022, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Immix Biopharma, Inc. specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
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Investor Contact
Suzanne Messere
Stern Investor Relations
Suzanne.Messere@sternir.com
Company Contact
irteam@immixbio.com
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