London and Oxford, United Kingdom (Press Release) – GlaxoSmithKline plc and Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell ther­apy to treat cancer, today announced the transition of the devel­op­ment pro­gram for GSK3377794 (GSK ‘794), an NY-ESO SPEAR T-cell ther­apy, to GSK. As a result of the transition, GSK assumes full responsibility for future research, devel­op­ment, and poten­tial com­mer­cial­iza­tion of this pioneering ther­apy, and Adaptimmune will receive $27.5 million (£21.2 million) from GSK.

Dr. Hal Barron, Pres­i­dent R&D, GSK said, “The data we’ve seen for GSK ‘794 point to the poten­tially transformational nature of this T-cell ther­apy, as this is the first cell ther­apy to show clin­i­cal response in solid tumours. The concept of cells as medicines is an exciting component of our immuno-oncology portfolio and leverages our expertise in manu­fac­tur­ing T-cell ther­a­pies. This has been a prod­uctive col­lab­o­ration on GSK ‘794 and we look forward to con­tinued col­lab­o­ration with Adaptimmune.”

“This is a turning point for Adaptimmune. We are extremely proud of the part­ner­ship with GSK and the pioneering work we have led over the years with NY-ESO SPEAR T-cells, as the foundation of our targeted TCR ther­a­pies, showing responses in two solid tumors and treating more than 80 patients in six dif­fer­en­t indi­ca­tions,” said James Noble, Chief Executive Officer at Adaptimmune. “With the NY‑ESO pro­gram transitioned, Adaptimmune can focus its clin­i­cal, regu­la­tory and manu­fac­tur­ing resources on the devel­op­ment of our wholly owned ther­a­pies MAGE-A4, MAGE-A10, and AFP. We will con­tinue the pre­clin­i­cal work with GSK on its next target, PRAME.”

GSK ‘794 is an engi­neered T-cell ther­apy, for which a patient’s own cells have been genetically modified to express a T-cell re­cep­tor (TCR) recognizing with high affinity the tumor-specific an­ti­gen, NY-ESO. When the modified cells are re-infused into the patient, they recog­nize and kill tumor cells that express the NY-ESO an­ti­gen. NY-ESO is expressed at various levels across dif­fer­en­t tumors, and appears to be expressed at high levels in defined sub-types of soft tissue sarcomas, mel­anoma, multiple myeloma, bladder cancer, non-small cell lung cancer (NSCLC), ovarian cancer and gastro-intestinal cancers.

Effective im­medi­ately, GSK will assume responsibilities for all ongoing studies of NY-ESO SPEAR T‑cells, in­­clud­ing those in NSCLC, and the com­bi­na­tion study with KEYTRUDA® in multiple myeloma. Successful con­tin­u­a­tion of devel­op­ment and sub­se­quent com­mer­cial­iza­tion of GSK ‘794 will trigger addi­tional payments for devel­op­ment mile­stones, tiered sales mile­stones, and mid-single to low double-digit royalties on world­wide net sales.

About the Collaboration and License Agreement between Adaptimmune and GSK

Adaptimmune and GSK announced their strategic col­lab­o­ration and license agree­ment in June 2014 (https://bit.ly/2z1qMTn) for up to five pro­grams in­­clud­ing the first pro­gram, NY-ESO. The terms of the agree­ment were expanded in February 2016 (https://bit.ly/2IJ59qI) to accelerate devel­op­ment of NY-ESO SPEAR T-cell ther­apy to­ward registration trials in synovial sarcoma, to explore devel­op­ment in myxoid/round cell liposarcoma (MRCLS), and to enable com­bi­na­tion studies. In September 2017, GSK exercised its option to exclusively license the right to research, develop, and com­mer­cial­ize Adaptimmune’s NY-ESO SPEAR T-cell ther­apy pro­gram (https://bit.ly/2wMJKda).

Following the transition of the NY-ESO pro­gram, GSK has the right to nominate its third and fourth targets. GSK already nominated PRAME as its second target in January 2017 (https://bit.ly/2jCixVu). GSK is not able to nominate targets on which Adaptimmune is already work­ing, in­­clud­ing MAGE‑A10, MAGE-A4, and AFP SPEAR T-cells as well as its active pre­clin­i­cal pipe­line. Adaptimmune will take these three addi­tional targets when nominated, in­­clud­ing PRAME, through pre­clin­i­cal testing to an IND‑ready state, at which point GSK will be responsible for IND filing. Adaptimmune will not be responsible for any clin­i­cal work on these addi­tional pro­grams.

About GSK

GSK - a science-led global health­care com­pany with a special pur­pose: to help people do more, feel better, live longer. For further in­­for­ma­tion please visit www.gsk.com

Cautionary State­ment Regarding Forward-Looking State­ments

GSK cautions in­­vestors that any forward-looking state­ments or projections made by GSK, in­­clud­ing those made in this announcement, are subject to risks and un­cer­tain­ties that may cause actual results to differ materially from those pro­jected. Such factors in­clude, but are not limited to, those described under Item 3.D 'Principal risks and un­cer­tain­ties' in the com­pany's Annual Report on Form 20-F for 2017.

About Adaptimmune

Adaptimmune is a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the devel­op­ment of novel cancer immuno­therapy prod­ucts. The Company’s unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T‑cell plat­form enables the engi­neer­ing of T-cells to target and destroy cancer, in­­clud­ing solid tumors. Adaptimmune is cur­rently conducting clin­i­cal trials with SPEAR T-cells targeting MAGE‑A4, -A10, and AFP across several solid tumor indi­ca­tions. The Company is located in Philadelphia, USA and Oxfordshire, U.K. For more in­­for­ma­tion, please visit http://www.adaptimmune.com.

Forward-Looking Statements

This release con­tains “forward-looking state­ments” within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking state­ments involve certain risks and un­cer­tain­ties. Such risks and un­cer­tain­ties could cause our actual results to differ materially from those indicated by such forward-looking state­ments, and in­clude, without limitation: the success, cost and timing of our prod­uct devel­op­ment activities and clin­i­cal trials and our ability to suc­cess­fully ad­vance our TCR thera­peutic can­di­dates through the regu­la­tory and com­mer­cial­iza­tion processes. For a further description of the risks and un­cer­tain­ties that could cause our actual results to differ materially from those expressed in these forward-looking state­ments, as well as risks relating to our business in general, we refer you to our Quarterly Report filed on form 10-Q with the Securities and Exchange Com­mis­sion (SEC) on May 9, 2018 and our other SEC filings. The forward-looking state­ments con­tained in this press release speak only as of the date the state­ments were made and we do not under­take any obli­ga­tion to update such forward looking state­ments to reflect sub­se­quent events or cir­cum­stances.

Source: Adaptimmune.