NeoStem Subsidiary Signs Manufacturing Services Deal with Adaptimmune
NeoStem’s Progenitor Cell Therapy (PCT) subsidiary agreed to provide services to support Adaptimmune’s NY-ESO-1T cell therapy product being developed for multiple oncology indications. PCT’s services will include the transfer and qualification of Adaptimmune’s manufacturing process for the product candidate at PCT’s facility in Allendale, NJ. Subsequent manufacturing will also take place for clinical trials.
Adaptimmune develops products containing engineered T-cell receptors for the treatment of cancer and infectious diseases.
“With our sights set on future pivotal trials for our T-cell therapy products, we have invested significant effort towards establishing capabilities within Adaptimmune that support expansion of our clinical platform in terms of both scale and compliance with FDA requirements beyond Phase I/II. Our relationship with PCT is an important component,” said James Noble, CEO of Adaptimmune. Last month Adaptimmune reported preliminary results from an early phase clinical study using patients’ own T cells that have been genetically altered to attack multiple myeloma (MM) cells. The clinical study was designed as a single-arm open-label study where patients are given standard of care (autologous stem cell transplant) in conjunction with engineered T cells. The critical step in this new approach is that the infused T cells have been genetically engineered to carry receptors that help the T cells recognize and attack a tumor, while sparing healthy tissue, explained Noble.
Study objectives were to evaluate the safety, bioactivity, and antitumor effect of infusion of patients’ own T cells that have been genetically modified to express a high-affinity T cell receptor (TCR) specific for a type of tumor antigen (protein) known as a cancer testis antigen (CT antigen). The target CT antigens in the study are NY-ESO-1 and LAGE-1.
The initial six patient phase is complete and, based on the preliminary results, the study was extended to a target enrollment of 26 patients. To date, a total of 15 patients have been enrolled and have received the engineered T cells; of these, 13 have been assessed at day 100 and 11 patients have reached a minimum-of-six-month follow-up for assessment of tumor response to the treatment.