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 CLB20 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
|Stratification by disease state||Treatment||No. of Patients||Median OS (months)||3-Year OS Rate (%)|
|Recurrent Stage III||CLBS20||3||> 60||67%|
|Recurrent Stage III||Control||6||30.3||17%|
About Caladrius Biosciences
Caladrius Biosciences, Inc. is among the first of a new breed of immunotherapy companies with proven expertise and unique experience in cell process optimization, development, and manufacturing. Caladrius combines a leading cell therapy service provider with a development pipeline including late-stage clinical programs based on a proprietary platform technology for immuno-oncology, as well as additional platform technologies for immunomodulation and ischemic repair. This integrated approach supports the industry in bringing significant life-improving medical treatments to market. For more information, visit www.caladrius.com
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company’s business strategy, the Company’s ability to develop and grow its business, the successful development of cellular therapies with respect to the Company’s research and development and clinical evaluation efforts in connection with the Company’s Immuno-oncology Program, Immune Modulation Program, Ischemic Repair Program and other cell therapies, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry, and the performance and planned expansion of the Company’s wholly-owned subsidiary and its center of excellence for cell therapy process development, engineering and manufacturing, PCT, as well as its efforts to expand its capabilities into the cell therapy tools market. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 2, 2015, and in the Company’s other periodic filings with the SEC. The Company’s further development is highly dependent on future medical and research developments and market acceptance, which is outside of its control.