Philadelphia, PA and Oxford, United Kingdom (Press Release) – Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in T-cell ther­apy to treat cancer, today announced that it has entered into a clin­i­cal trial col­lab­o­ration agree­ment with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada), for the assess­ment of Adaptimmune’s NY-ESO SPEAR® (Specific Peptide Enhanced Affinity Receptor) T-cell ther­apy in com­bi­na­tion with MSD’s anti-programmed death-1 (PD-1) inhibitor, KEYTRUDA® (pem­bro­lizu­mab), in patients with multiple myeloma. The study will eval­u­ate the safety, phar­ma­co­ki­netics, pharmacodynamics, and pre­lim­i­nary efficacy of the com­bi­na­tion, and is planned for initiation in 1H 2017.

Adaptimmune’s SPEAR T-cell can­di­dates are novel cancer immuno­therapies that have been engi­neered to target and destroy cancer cells. Its NY-ESO SPEAR T-cell ther­apy has pre­vi­ously been eval­u­ated in multiple myeloma in a single agent Phase I/II trial in which 20 out of 22 patients (91 per­cent) ex­peri­enced a response at day 100 post au­tol­o­gous stem cell trans­plant. KEYTRUDA is a humanized mono­clonal anti­body that works by in­creas­ing the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA blocks the inter­action between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lym­pho­cytes which may affect both tumor cells and healthy cells. Blocking this inter­action is reported to enable T-cell activation and potentiates antitumor activity.

“In initial single-agent studies of our NY-ESO SPEAR T-cell ther­apy in patients with ad­vanced myeloma in the context of stem cell trans­plan­ta­tion, we have seen encouraging evi­dence of antitumor effect, safe admin­istra­tion and prolonged persistence of transduced cells,” said Rafael Amado, Adaptimmune’s chief medical officer. “KEYTRUDA has shown pre­lim­i­nary evi­dence of activity in multiple myeloma, and there is pre­clin­i­cal evi­dence to sup­port the view that the com­bi­na­tion of NY-ESO SPEAR T-cell ther­apy and anti-PD1 ther­apy may lead to meaningful anti-tumor activity. We look forward to eval­u­ating our ther­apy alone and in com­bi­na­tion with KEYTRUDA in a ran­domized trial of patients with multiple myeloma who are refractory or have re­lapsed with standard ther­apy. ”

The agree­ment is between Adaptimmune and Merck & Co., Inc., Kenilworth, NJ, USA, through a sub­sid­i­ary. Under the agree­ment, the trial will be sponsored by Adaptimmune. The agree­ment also in­cludes provision for poten­tial expansion to in­clude Phase III registration studies in the same indi­ca­tion. Additional details were not disclosed.

About Multiple Myeloma

Multiple myeloma is a cancer formed by malignant plasma cells. Normal plasma cells are found in the bone marrow and are an important part of the immune system, which is made up of several types of cells that work together to fight in­fec­tions and other diseases. Multiple myeloma is char­ac­ter­ized by several features, in­clud­ing low blood counts, bone and cal­cium problems, in­fec­tions, kidney problems, mono­clonal gammop­athy, and others; and by the proliferation of these plasma cells within bone marrow. The American Cancer Society esti­mates that approx­i­mately 30,300 new cases will be diag­nosed in the United States in 2016. Average five-year survival rates are esti­mated to be approx­i­mately 45 per­cent with survival rates depending on factors such as age, stage of diag­nosis and suitability for auto-SCT, which is used as part of the treat­ment for eli­gible patients with multiple myeloma. Despite recent thera­peutic ad­vances, multiple myeloma remains an in­cur­able but treatable cancer. Patients are typically treated with repeat rounds of com­bi­na­tion ther­apy with the time in­ter­vals to relapse becoming shorter with each successive line of ther­apy. The majority of patients eventually have a relapse which cannot be further treated.

About Adaptimmune’s TCR Technology

Adaptimmune’s pro­pri­e­tary SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell re­cep­tor (TCR) tech­nology enables the com­pany to genetically optimize TCRs, equipping them to recog­nize cancer an­ti­gens that are presented in small quantities on the surface of a cancer cell, whether of intracellular or extracellular origin, thus initiating cell death. The com­pany’s dif­fer­en­ti­ated, pro­pri­e­tary tech­nology allows it to reliably generate parental TCRs to naturally presented targets, affinity optimize its TCRs to bind cancer proteins from solid and hema­to­logic cancers that are generally unavailable to naturally occurring TCRs, and to sig­nif­i­cantly reduce the risk of side effects resulting from off-target binding of healthy tissues.

About Adaptimmune

Adaptimmune is a clin­i­cal stage bio­pharma­ceu­tical com­pany focused on novel cancer immuno­therapy prod­ucts based on its SPEAR® (Specific Peptide Enhanced Affinity Receptor) T-cell plat­form. Established in 2008, the com­pany aims to utilize the body’s own machinery - the T-cell - to target and destroy cancer cells by using engi­neered, in­­creased affinity TCRs as a means of strengthening natural patient T-cell responses. Adaptimmune’s lead pro­gram is a SPEAR T-cell ther­apy targeting the NY-ESO cancer an­ti­gen. Its NY-ESO SPEAR T-cell ther­apy has dem­onstrated signs of efficacy and tolerability in Phase 1/2 trials in solid tumors and in hema­to­logic cancer types, in­­clud­ing synovial sarcoma and multiple myeloma. Adaptimmune has a strategic col­lab­o­ration and licensing agree­ment with GlaxoSmithKline for the devel­op­ment and commer­cial­iza­tion of the NY-ESO TCR pro­gram. In addi­tion, Adaptimmune has a number of pro­pri­e­tary pro­grams. These in­clude SPEAR T-cell ther­a­pies targeting the MAGE-A10 and AFP cancer an­ti­gens, which both have open INDs, and a further SPEAR T-cell ther­apy targeting the MAGE-A4 cancer an­ti­gen that is in pre-clinical phase with IND acceptance targeted for 2017. The com­pany has identified over 30 intracellular target peptides preferentially expressed in cancer cells and is cur­rently progressing 12 through unpartnered research pro­grams. Adaptimmune has over 250 employees and is located in Oxfordshire, U.K. and Philadelphia, USA. For more in­­for­ma­tion: 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 on Form 10-Q filed with the Securities and Exchange Com­mis­sion (SEC) on August 8, 2016, 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.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a sub­sid­i­ary of Merck & Co., Inc., Kenilworth, NJ, USA.

Source: Adaptimmune Therapeutics plc.