americanpharmaceuticacreviewSeptember 08, 2017
Tag: GSK , SPEAR T-cell Therapy , NY-ESO
Adaptimmune Therapeutics announced GlaxoSmithKline has exercised its option under a collaboration and license agreement signed in 2014 to exclusively license the right to research, develop, and commercialize Adaptimmune’s NY-ESO SPEAR T-cell therapy program.
Adaptimmune will receive up to £48 million (~$61 million) from GSK over the course of the transition period. This includes development milestones of up to £18 million (~$23 million) and the option payment of £30 million (~$38 million), which also allows GSK to nominate two additional targets following completion of the transition. Successful continuation of development and subsequent commercialization of NY-ESO would trigger additional payments for development milestones, tiered sales milestones, and mid-single to low double-digit royalties on worldwide net sales.
"This is a very exciting day for Adaptimmune as GSK has exercised its option over our NY-ESO program, earlier than originally planned," said James Noble, Chief Executive Officer at Adaptimmune. "The commitment by one of the world’s leading pharmaceutical companies to the NY-ESO SPEAR T-cell program as a new treatment modality is a testament to the strength of our data in synovial sarcoma recently presented at ASCO. From a financial perspective, this option exercise extends our cash runway into 2020. We anticipate the transition of NY-ESO to GSK to be completed over the coming months, after which we will focus our clinical resources on delivery and execution from our wholly-owned assets MAGE-A4, MAGE-A10, and AFP."
In June of this year, data presented in an oral presentation at ASCO from the ongoing study of NY-ESO SPEAR T-cells in synovial sarcoma continued to indicate a favorable risk benefit profile in this aggressive and difficult-to-treat solid tumor. Initial anti-tumor activity was observed in all ongoing cohorts, including low expressors of NY ESO. NY-ESO SPEAR T-cells continued to be well-tolerated with all reported events of cytokine release syndrome resolved (the majority of events were Grade 1 or 2), and there were no reported events of seizure, cerebral edema, or encephalopathy. Survival data was promising with a median predicted overall survival of 120 weeks (~28 months) among the 12 treated patients in Cohort 1; or, 159 weeks (~37 months) for the ten patients in this cohort who received the target dose of one billion cells. In addition, 6 responses were observed in Cohort 1 patients.
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