GSK Exercises Option over SPEAR T-cell Therapy Program Targeting NY-ESO – Drug Discovery & Development

Posted: Published on September 8th, 2017

This post was added by Dr P. Richardson

Adaptimmune Therapeutics, a leader in T-cell therapy to treat cancer, announced thatGlaxoSmithKline plc(LSE:GSK) (NYSE:GSK) has exercised its option under a collaboration and license agreement signed in 2014 to exclusively license the right to research, develop, and commercialize Adaptimmunes NY-ESO SPEAR T-cell therapy program. Further details will be provided in a conference call scheduled for8:30 AM EDTthis morning; dial-in and webcast details are provided below.

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, commentedJames Noble, Chief Executive Officer at Adaptimmune. The commitment by one of the worlds 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 atASCO. 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.

Axel Hoos, SVP Oncology R&D, GSK said The aim of GSKs R&D is to develop medicines with transformational potential for patients. We have seen compelling data for the NY-ESO investigational cell therapy in synovial sarcoma and, following this option exercise, we will capitalize on our in-house Cell and Gene Therapy capabilities to support the development program for GSK3377794. We will continue to explore the potential for this novel cell therapy in multiple tumor types, and in combination with other cancer therapies.

Summary of Recent Data in Synovial SarcomaIn June of this year, data presented in an oral presentation atASCOfrom 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 NYESO. 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 120weeks (~28 months) among the 12treated 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.

Transition PlanAdaptimmune and GSK will work together over the coming months to ensure a smooth transition of the NY-ESO SPEAR T-cell development program to GSK. After the transition, GSK will assume sponsor responsibility for all NY-ESO-related activities including ongoing data publications regarding this program. Current plans for ongoing and planned clinical studies are summarized below by indication:

Sarcoma:

Non-small Cell Lung Cancer (NSCLC):

Ovarian:

Multiple Myeloma:

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GSK Exercises Option over SPEAR T-cell Therapy Program Targeting NY-ESO - Drug Discovery & Development

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