Posted on May 1st, 2014
by Robert Preti
Recently, NeoStem made the very exciting announcement that it has signed a definitive agreement to acquire California Stem Cell, Inc. (“CSC”) and with it, its innovative cancer immunotherapy Melapuldencel-T. This acquisition is significant to the company for a number of reasons, but, as the Chief Scientific Officer of NeoStem and the President of Progenitor Cell Therapy (“PCT”) I am personally excited to tell you how I see great synergy between this acquisition and our own manufacturing capabilities.
First, a bit about me, I have served on the Stem Cell Banking Committee and Cord Blood Subcommittee of the New York State Department of Health and on the New Jersey State Department of Health’s Blood Bank Advisory Committee, chairing the Hematopoietic Progenitor Cell Processing Subcommittee. In addition, I have served in a leadership capacity for many professional organizations, including treasurer and founding member of the International Society of Hematotherapy and Graft Engineering, now called ISCT (International Society for Cellular Therapy). I recently completed a five year term as a director for AABB, and am currently an Executive Committee member for the Alliance for Regenerative Medicine (ARM), where, among other activities, I co-chair the Standards and Technology Committee.
PCT, which I co-founded more than a decade ago, was originally built in response to a recognized need for high quality manufacturing and development services in an emerging industry. As the cell therapy field has grown, so too has PCT— the company has now served over 100 clients and performed more than 30,000 cell therapy procedures. Since PCT was acquired by NeoStem in 2011, we have found unique synergies and efficiencies in being a single company paving the way in this industry. As with the acquisition of PCT, NeoStem believes in seeking growth by way of strategic procurement and we have continued to remain opportunistic as the field matures and consolidation presents opportunities for those like us with the specialized knowledge base and expertise associated with this industry.
As part of our due diligence for this transaction, the NeoStem team, including representatives from our scientific, technical, manufacturing and quality teams, evaluated CSC’s entire manufacturing process as it has been developed over the years. We studied both the current and previous processes for generation of DC-TC (autologous dendritic cells pulsed with irradiated tumor cells) and have satisfied ourselves that improvements to the manufacturing process for the generation of the patient-specific cancer initiating cells used to load the dendritic cells and direct the immunotherapy towards the patients’ cells expressing that unique antigen profile both reduced the time to manufacture the cell line and significantly improved the success rate to generate the TC line for patients enrolled in the trial. CSC scientists and product development personnel recognized a few years ago the need to improve on the success rate of TC line generation, and we were pleased to conclude that they have overcome this limitation through enhancements in the tumor cell collection and handling, the transport media, and adaptations in the manufacturing process itself through the use of microsphere formation ahead of cell line expansion. Importantly, FDA has agreed that these changes have been implemented in a way that maintains comparability between the previous process and the current process.
Our diligence convinced me that CSC’s products and processes are a natural fit with NeoStem’s unique clinical, regulatory and manufacturing expertise. Here are just some of the reasons:
I am excited to welcome CSC’s management and staff into our growing company, and look forward to integrating and moving ahead with Melapuldencel–T and other cancer immunotherapy products.
Forward Looking Statements
This blog 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 blog, 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, Ischemic Repair Program, Immune Modulation 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. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside of its control. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see the factors described under the heading, “Item 1A. Risk Factors" in the Company's Annual Report on Form 10-K filed with the SEC on March 2, 2015 and those described in the Company's other periodic filings with the SEC. The Company undertakes no obligation to update or revise any forward-looking statements.
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