Caladrius Biosciences, Inc., recently presented novel data at the 2015 Annual Meeting of the Society for Immunotherapy of Cancer (SITC), which took place in Baltimore, Maryland, Nov. 4-8, 2015.
The clinical and analytic results were drawn from a concluded Phase 2 clinical trial and provide evidence that supports the technology currently being evaluated in an enrolling Phase 3 trial assessing the company’s lead investigational candidate, CLBS20, for the treatment of metastatic melanoma.
According to a company press release, data highlights included:
- A fresh subset analysis of the results from a randomized, open-label, Phase 2 clinical trial in 42 patients, which compared the effects of CLBS20 treatment in 18 patients versus a control group of 24 melanoma patients who received treatment with irradiated tumor cells alone. The results revealed that treatment with CLBS20 immunotherapy was associated with an improvement in survival rates, defined by non-measurable or measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and with the most advanced disease stage being either IV or recurring stage III.
- A sequence of clinical studies preformed by Caladrius to clarify the mechanism of action and support CLBS20’s efficacy. The results supported the tumor-initiating properties of the immunotherapy, as well as its antigenic potential on the self-renewing cancer-initiating cells that the company isolates during the manufacturing process. The results also revealed a statistically significant association between the immune response derived from CLBS20 and the overall survival of patients with melanoma. Moreover, researchers observed a decrease in multiple tumors as well as in inflammation markers at four weeks of follow-up in patients who responded to CLBS20 treatment.
The first poster presented at the conference, titled “Superiority of Dendritic Cell Vaccine vs Tumor Cell Vaccine: Survival by stratification subsets in MACVAC randomized phase II trial of patient-specific vaccines utilizing antigens from autologous melanoma tumor cell lines”, explained the analysis of the updated survival results. Due to the subset size, results did not reveal a statistically significant improvement in patient survival; however, there was a trend toward improved survival rates in all of the analyzed subsets.
The second poster presented, titled “Functional Properties of Patient-Derived Melanoma Cancer Stem Cells,” revealed results showing the tumor initiating nature of the purified cell lines used in the manufacturing process of CLBS20 as well as a pathway analysis using serum markers which clarified CLBS20’s mechanism of action and its immune response in those patients treated with the composite. The data analysis also revealed possible predictive markers of survival and markers that characterized low responders.
These data support the company’s expectations of CLBS20 efficacy, and indicate the potential to identify patients who will most likely benefit from the treatment.