Immix Biopharma, Inc. (NASDAQ:IMMX) is a clinical-stage biopharmaceutical company formed in January 2014, developing a novel class of Tissue-Specific Therapeutics (‘TSTx) in oncology and inflammation. The Company conducts various pre-clinical and clinical activities for developing its product candidates through a wholly-owned Australian subsidiary, Immix Biopharma Australia Pty Ltd., established in August 2016. The Company utilizes its proprietary System Multi-Action RegulaTors (‘SMARxT) Tissue-Specific Platform to produce drugs that can accumulate 3-5 times the rate of conventional medicines at intended therapeutic sites. Using the Company’s trademarked tumor micro-environment (‘TME) Normalization technology, the drug candidates attack all components of the TME while circulating in the bloodstream, and exiting through the tumor blood vessels.
(Image source: company website)
(Image source: company website)
The Company’s lead product candidate, IMX-110, is a TSTx with TME Normalization technology being developed initially for soft tissue sarcoma (‘STS). The tumor in STS is provided metabolic and structural support and immune suppression through Treg T-cells, by the TME that is activated by the recurrent inflammation caused by NF-κB, STAT3 and other key transcriptional factors, which are upregulated by multiple kinases produced by hypoxia (low oxygen concentration) and acidosis (an excessively acidic condition). IMX-110 is a negatively-charged TSTx delivered deep into the TME, disabling resistance pathways with a poly-kinase inhibitor, and inducing tumor cell death with an apoptosis inducer (which activates apoptosis, a non-inflammatory programmed cell death pathway). Conventional therapies are hampered by resistance caused by NF-κB and STAT3 activation.
(Image source: company website)
IMX-110 is currently undergoing Phase 1b/2a clinical trials for STS in the U.S. and Australia. As of September 2021, 14 patients who received between 3 and 13 lines of prior therapy have been treated with IMX-110. To date zero drug-related serious adverse events and zero dose interruptions due to toxicity were observed. Radiological progression-free-survival (‘PFS) of 6 months was observed in 50% of STS patients, with a 4-month median PFS (‘mPFS) across all STS patients. The trial includes patients with leiomyosarcoma, carcinosarcoma, poorly differentiated soft tissue sarcoma, cholangiocarcinoma, colorectal cancer, prostate cancer, pancreatic cancer, esophageal cancer, breast cancer, and nasopharyngeal cancer.
The Company entered into a Clinical Collaboration and Supply Agreement in August 2021 with BeiGene Ltd. for a combination Phase 1b clinical trial of IMX-110 and anti-PD-1 Tislelizumab (the subject of a collaboration and license agreement among BeiGene and Novartis) in solid tumors. IMX-110 demonstrated an immunomodulation effect in genetic mouse models of pancreatic cancer, and in combination with murine anti-PD-1, IMX-110 produced extended survival versus multi-drug combinations. The study seeks to demonstrate the potential for TSTx to be an integral component of combination therapies in a wide range of advanced solid tumors.
Using its SMARxT platform, the Company has produced additional drug candidates which share design and chemistry, manufacturing and controls (‘CMC) processes with IMX-110, which gives the advantage of similar tolerability profiles, as well as regulatory agency familiarity, and a consistent multi-target therapeutic approach.
IMX-111 is a TSTx built on TME Normalization technology with proprietary GLUT1 antibody biomarker targeting coupled with the Company's poly-kinase inhibitor / apoptosis inducer. GLUT1 is an essential cancer biomarker overexpressed on 92% of colorectal cancer cells and other tumor types, the degree of its overexpression correlating with more advanced stages of tumor progression. IMX-111 is the first cancer therapeutic to take advantage of GLUT1 overexpression in cancer.
IMX-120 is a TSTx built on the Company’s Immune Normalization Technology for inflammatory bowel disease (‘IBD) with proprietary GLUT1 antibody biomarker targeting coupled with polyphenol poly-kinase inhibitors. Overexpression and activation of GLUT1 on overactive immune cells has been shown to be widely present in patients with IBD. The inflammatory processes active in IBD are similar to those targeted by IMX-110. GLUT1 presents an ideal targeting moiety for the overactive immune cells, allowing for tissue-specific delivery of IMX-120.
The Company filed a form S-1 registration statement with the U.S. Securities and Exchange Commission (‘SEC) on 9/16/2021, to raise approximately $25 million from an initial public offering (‘IPO) of shares of its common stock, and has applied to list it on the Nasdaq Global Market under the trading symbol “IMMX.”
It is estimated that the Company’s cash and cash equivalents of approximately $0.11 million as of 6/30/2021, together with the approximate gross proceeds of $25 million from the IPO, will provide a cash runway to the Company through 3Q-2022.
The Company entered into a Master Service Agreement (‘MSA) in December 2014 with AxioMx, Inc., who develop and supply custom affinity reagents. AxioMx is granted a non-exclusive, royalty-free, worldwide, non-transferable license to certain intellectual property (‘IP) of the Company to perform services pursuant to the MSA. The Company is granted an exclusive product assignment option which grants it an exclusive, royalty-bearing right, with the right to sublicense, under the Deliverable (as defined in the MSA) to further research, develop, use, sell, offer for sale, import and export one or more assigned products pursuant to the MSA. The Company is liable to pay royalty of 3.5% of net sales for each deliverable used in licensed products for therapeutic purposes, or 1.5% of net sales for each deliverable used in licensed products for diagnostic or prognostic purposes.
The Company is a “Non-accelerated Filer,” and an “Emerging Growth Company” and “Smaller Reporting Company,” and has elected to take advantage of reduced disclosure, reporting and compliance requirements expected of public companies.
The Company has incurred net losses and negative cash flows since inception, and had an accumulated deficit of approximately $6.6 million as of 6/30/2021.
The Company will not generate revenue for several years, and it’s cash and cash equivalents balance, plus the proceeds from the IPO will not be sufficient to carry through the complete development stage, so the Company will need to raise funds again, which may dilute the share value.
The Company is dependent on third parties for manufacturing and marketing of its product candidates.
The Company faces competition from companies developing therapies for both oncology and inflammation, which include Kymera Therapeutics Inc., Morphic Holding Inc., and RAPT Therapeutics Inc., and companies developing therapies for IBD (including UC and CD), which include Arena Pharmaceuticals Inc., Landos Biopharma Inc., and Seres Therapeutics Inc. The Company is also competing with companies having approved therapies and developing therapies for soft tissue sarcoma including, but not limited to, BioAtla Inc., Epizyme Inc., Nanobiotix SA, C4 Therapeutics, Inc., Adaptimmune Therapeutics plc, Eisai, Novartis, and Janssen/Johnson & Johnson, and a company developing multi-kinase inhibitors, Mirati Therapeutics, Inc.
The Company has an interesting platform and technology with potential for monotherapy as well as combo therapies in orphan oncology and inflammatory indications. We await further details of the IPO.
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