Welcome to your regenerative medicine deal review for the month of May. The space was quiet this past month; however, NeoStem did strike up a licensing deal with China-based Cellular Biomedicine Group to provide international reach to its newly acquired targeted immunotherapy program. Read on to find out more.
New York-based NeoStem (NBS) announced a licensing agreement with Cellular Biomedicine Group (CBMG), a Chinese firm, to launch a Phase 2 study of an autologous (patient-specific) tumour cell-specific dendritic cell-based (TC-DC) immunotherapy for patients with late-stage liver cancer. NeoStem has four cell-based development programs, the most recent of which is a targeted immunotherapy platform the company took on after its recent acquisition of California Stem Cell. CBMG, which previously had a joint venture with California Stem Cell and exclusive rights to market the dendritic cell therapy in China, is also working with human adipose-derived and human umbilical cord-derived mesenchymal progenitor cells to target osteoarthritis and other indications broadly.
As part of the licensing deal CBMG will pay all costs related to the clinical study and marketing of the product in China, while NeoStem will be responsible for regulatory filings and manufacturing of the dendritic cell product. NeoStem can potentially earn $30 million in milestone payments depending on commercial success.
The TC-DC therapy requires extraction of a patient’s own tumour-initiating cells and subsequent culture and inactivation of these cells in vitro. These progenitor cells are then mixed with dendritic cells acquired from the patient’s blood and infused back into the patient to elicit an immune response targeted to the tumour-sustaining cancer cells in the liver. This approach is similar to that taken to prepare Dendreon’s Provenge (sipuleucel-T) for metastatic prostate cancer; however, the latter primes the dendritic cells against its target with a cancer-specific protein rather than the actual cell itself.
While immunotherapies like melapuldencel-T (recently acquired by NeoStem and in Phase 3 studies for metastatic melanoma) and the TC-DC therapy discussed here are intriguing, their path to adoption remains unclear. Provenge failed to meet sales expectations due to cost-effectiveness concerns with payers and cost-density issues with physicians, and NeoStem will be up against the same battles.
As NeoStem’s TC-DC technology requires isolation of a rare subset of cells from the tumour sample, it is conceivable it could be more costly than Provenge, which currently has a price tag of $93,000. Similar to Provenge, cost-density to physicians will also be a barrier to adoption. Patient-specific therapies generally require multiple administrations over a short time period, leaving doctors out of pocket for large sums of money while they wait for payers to reimburse. Of course, willingness-to-pay will be dictated by clinical outcomes. So, patient-specific immunotherapies that deliver high caliber results to patients should overcome these challenges.