Caladrius Biosciences Presents Additional Data Supporting Lead Product Candidate for Metastatic Melanoma at SITC 2015
Presentations reiterate improved survival rate of treated subjects in the Company’s Phase 2 trial and provide preliminary correlation between treatment and expectation of efficacy
BASKING RIDGE, N.J. (November 9, 2015) – Caladrius Biosciences, Inc. (NASDAQ: CLBS) (“Caladrius”), a company combining a leading cell therapy service provider with a therapeutics pipeline including a Phase 3 clinical program in immuno-oncology, announces today that the Company presented two posters including new clinical and analytical data at the Society for Immunotherapy of Cancer (SITC) 2015 Annual Meeting, which took place from November 4-8 in Baltimore, Maryland.
The data, drawn from ongoing analysis and follow-up from a completed Phase 2 study, further support the technology being explored in a currently enrolling Phase 3 clinical trial to investigate Caladrius’ lead product candidate, CLBS20, for the treatment of metastatic melanoma.
Data highlights included:
•A new subset analysis of patient results from a 42-patient, open-label, randomized Phase 2 trial that compared the treatment effects of CLBS20 (n=18) versus a control group of irradiated tumor cells alone (n=24). The analysis concluded that CLBS20 immunotherapy was associated with improved survival in each of the four different subsets defined by the stratification variables (namely measurable or non-measurable disease as defined by RECIST and most advanced stage of disease being stage IV or recurrent stage III – see below for associated table).
•A series of studies undertaken by the company to elucidate mechanism of action and support expectation of efficacy for CLBS20 in which the data supported the tumor-initiating properties and the antigenic potential of the self-renewing cancer-initiating cells that Caladrius isolates in its manufacturing process. The data also indicate a statistically significant relationship between immune response triggered by CLBS20 and overall survival of melanoma patients. The analysis showed decreases in multiple tumor and inflammation markers at four weeks after baseline in responding patients treated with CLBS20.
The first poster presentation, 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,” described analyses of updated survival data that previously had not been presented. Statistical significance could not be reached due to the size of the subsets; however, the analyses demonstrated a clear trend towards improved survival in all subsets.
The second poster presentation, titled “Functional Properties of Patient-Derived Melanoma Cancer Stem Cells,” presented data demonstrating the tumor initiating nature of the purified cell lines used in CLBS20 manufacturing and a pathway analysis using serum markers suggestive for the mechanism of action of CLBS20 and immune response of treated patients. The data analysis identified potential predictive markers of survival, and identified markers that typified low responders. In short, the data support Caladrius’ expectation of efficacy for CLBS20 and suggest the potential to identify the patients for whom the experimental treatment might be most effective.
The posters are available on the Caladrius website at www.caladrius.com/sitc2015posters.
Treatment Effect per Subsets Defined by Stratifications in Phase 2
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