The deal will allow CSC to initiate plans to begin a pivotal Phase III trial of Melapuldencel-T, an autologous melanoma initiating stem cell immune-based therapy intended to treat malignant melanoma.
The merger agreement provides for the issuance of an aggregate of up to approximately 5.33 million shares of NeoStem common stock, which hovered around $6 per share on Tuesday.
CSC shareholders will also be eligible for additional milestone and royalty payments of up to $90m. The closing of the merger is expected to occur in May.
Provenge pedigree
Neostem PCT - the company’s contract manufacturing arm, which previously made Denderon’s Provenge – “is a leader in cell therapy manufacturing and provides deep expertise and capabilities to its clients including NeoStem’s internal programs.
"For efficient and cost effective manufacturing at all stages of development, including late stage products, PCT’s focus on innovation and engineering will be incredibly valuable to advance Melapuldencel-T,” Neostem spokesman Eric Powers told BioPharma-reporter.com.
“PCT has in place the additional capabilities CSC will need to assure robust product manufacturing and logistics for a multi-center Phase III trial and a cost effective production for commercial sales if the CSC product is approved,” Powers said.
“Additionally, we can leverage the space and expertise in Irvine to do additional manufacturing and/or development work on behalf of our clients and internal programs alike,” he added.
Since 2005, CSC has developed ways to scale up high-purity human stem cells and their derivatives. CSC has been focused on the application of these cells in developing therapies such as Melapuldencel–T, which was approved to enter a Phase III clinical trial by the US FDA with a Special Protocol Assessment (SPA), as well as fast track and orphan drug designations for metastatic melanoma.
NeoStem CEO Robin Smith said the trial will cost about $25m.
“We continue to lead the industry in the development of novel proprietary cellular therapies, and adding CSC’s advanced immunotherapy technologies to our existing development pipeline and cGMP compliant cell therapy manufacturing facilities (PCT) brings us closer to our goal of delivering transformative cell based therapies,” Smith added.
This platform technology used to develop Melapuldencel-T may also be expanded into other indications, such as hepatocellular carcinoma and other immune responsive tumor types.
Hans Keirstead, CEO of CSC added, “We believe NeoStem’s and PCT’s deep expertise in scaled manufacturing, regulatory, and clinical development will advance our programs significantly.”