We are advancing a number of programs that unleash the cancer-killing properties of immune cells to address the most difficult-to-treat cancers.
Our pipeline includes an array of investigational medicines for which we are generating data in preclinical and clinical studies. They are designed to precisely modulate novel molecular targets that are well-defined and measurable in tumor cells or in the tumor microenvironment. Our two most advanced development programs, CPI-444 and CPI-006, focus on the adenosine-cancer pathway.
Adenosine in the tumor microenvironment
CPI-444 precisely targets a critical receptor on immune cells to enhance their cancer-killing function
CPI-444, our lead program, is a small molecule drug that is administered orally. It is an antagonist of the adenosine A2A receptor, meaning it blocks adenosine A2A receptors on immune cells. By precisely targeting this critical receptor on immune cells, CPI-444 may unleash their cancer-killing properties. CPI-444 is designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor environment to the A2A receptor. It has demonstrated anti-tumor activity as monotherapy in several preclinical models and in human clinical trials. The preclinical results have been published in prestigious journals, and clinical data have been presented at several meetings, including the American Society of Clinical Oncology, the American Association for Cancer Research, and the Society for Immunotherapy of Cancer.
To date, well over 200 patients have been treated with CPI-444, which has demonstrated safety and anti-tumor activity in patients with refractory cancers.
We are currently evaluating CPI-444 in combination with the immunotherapy drug atezolizumab (an anti-PD-L1 antibody) in a Phase 1b/2 clinical trial in patients with renal cell carcinoma (RCC). CPI-444 is also being evaluated in a Phase 1b/2 trial in combination with atezolizumab in patients with non-small cell lung cancer (NSCLC) who have failed no more than two prior regimens.
The NSCLC study is being conducted by Genentech as part of its MORPHEUS platform, which was established to develop immunotherapy combination therapies more rapidly and efficiently.
For more information on CPI-444 and our clinical trials, please see our Annual Report available in the SEC Filings section of the website.
CPI-006 is a smart antibody that has multiple functions designed to “arm” and mobilize immune fighting cells to the tumor.
CPI-006 is a potent humanized monoclonal antibody directed against CD73. Unlike most antibodies, which are selected because they bind to a target, CPI-006 was designed to be a smart antibody and to perform specific functions: to enhance the activity and trafficking of immune cells, leading to improved cancer cell destruction. CPI-006 targets and blocks the CD73 enzyme, inhibiting adenosine production by tumor cells, as well as acting on other important immune processes.
We are developing CPI-006 to treat advanced cancers and are currently evaluating it in a multicenter Phase 1/1b dose-escalation study as a single agent (monotherapy), in combination with CPI-444, and in combination with the anti-PD1 pembrolizumab. The trial is designed to select the dose and evaluate the safety, pharmacokinetics, immune biomarkers and efficacy in patients with RCC, NSCLC and other solid tumors who have failed standard therapies.
For more information on CPI-006 and our clinical trials, please see our Annual Report available in the SEC Filings section of the website.
CPI-818 is a precisely targeted inhibitor of ITK, which is a critical regulator of T cell function.
CPI-818 is a small molecule drug given orally that has been shown to selectively inhibit ITK (interleukin-2-inducible T cell kinase). An enzyme, ITK is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell lymphomas and leukemias, as well as in normal immune function.
We developed CPI-818 to possess dual properties: to block malignant T cell growth and modulate immune responses. We believe inhibiting ITK may be of therapeutic benefit for patients with T-cell lymphomas, certain B cell lymphomas and those with solid tumors because of its potential immune-enhancing properties.
For more information on CPI-818 and our preclinical studies, please see our Annual Report available in the SEC Filings section of the website.