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Featured Company News - Adaptimmune Outlines Study Designs for Two T-Cell Clinical Trials - MAGE-A4 and NY-ESO SPEAR

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LONDON, UK / ACCESSWIRE / November 14, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Adaptimmune Therapeutics PLC (NASDAQ: ADAP), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=ADAP. The Company announced on November 10, 2017, that it would be presenting progress posters of two trials which will outline the study designs for ongoing clinical trials with MAGE-A4 and NY-ESO SPEAR T-cells. These progress posters would be presented at the 2017 The Society for Immunotherapy of Cancer (SITC) annual meeting scheduled from November 08, 2017, to November 12, 2017, at the Gaylord National Hotel & Convention Center in National Harbor, Maryland. For immediate access to our complimentary reports, including today's coverage, register for free now at:


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The progress posters of the two trials will summarize the study designs for Adaptimmune's ongoing MAGE‑A4 multi‑tumor study in urothelial (bladder), melanoma, head and neck, ovarian, non-small cell lung cancer (NSCLC), esophageal, and gastric cancers; and, the combination study with NY-ESO and NY‑ESO and KEYTRUDA® (pembrolizumab) in multiple myeloma.

Outline of Study Design for MAGE-A4 SPEAR T-cells

The MAGE-A4 SPEAR T-cells clinical trial is an open-label, non-randomized pilot study that evaluates the safety, tolerability, and antitumor activity of MAGE-A4 SPEAR T-cells in patients with HLA-A*02 and MAGE-A4 positive inoperable locally advanced or metastatic tumor(s). The dosage escalation study uses a modified 3+3 design wherein there will be three groups of patients. In Group 1 there will be 3 to 6 patients who will be treated using a dose of 100 million transduced SPEAR T-cells and will have a 21-day interval for safety review. The Group 2 will have 3 to 6 patients who will be treated using a dose of 1 billion transduced SPEAR T-cells, 7-day interval for safety review and the third Group 3 will also have 3 to 6 patients who will be treated using a dose of 1-5 billion transduced SPEAR T-cells, 7-day interval for safety review.

The patient candidates in the clinical trial must be over 18 years, have HLA-A*02 positive, have MAGE-A4 positive inoperable locally advanced or metastatic tumor(s) at ≥1+ intensity in ≥ 10% of tumor cells MAGE-A4 expression by immunohistochemistry (IHC), have ECOG status 0 or 1 and adequate organ function. They would follow the Lymphodepletion regimen wherein they will be given fludarabine (30 mg/m2/day) and cyclophosphamide (600 mg/m2/day) for 3 days.

The efficacy of the trial will be assessed by overall response rate, time to response, duration of response, progression-free survival, and overall survival at weeks 4, 8, and 12, month 6, and then every 3 months until confirmation of disease progression. The study is open and ongoing.

Outline of Study Design for NY ESO SPEAR T-cells with or without KEYTRUDA® in multiple myeloma

This trial is an open-label, randomized pilot study which will evaluate the safety, tolerability, and antitumor activity of NY-ESO SPEAR T-cells with or without KEYTRUDA® in patients with multiple myeloma. Patients who are eligible for this study would be randomly assigned either of the two treatment groups - NY-ESO SPEAR T-cells alone (Arm 1) or NY-ESO-1 SPEAR T-cells in combination with KEYTRUDA® (Arm 2). The clinical study will have total 20 patients and each group is expected to have 10 patients. Those eligible patients who do not receive the T‑cell infusion may be replaced.

The patient candidates in the clinical trial must be over 18 years, HLA-A*02:01, *02:05, or *02:06 positive, have histologically confirmed diagnosis of multiple myeloma with either primary refractory or relapsed/refractory disease expressing NY-ESO-1 and/or LAGE-1a, they should have received prior therapies including IMiD and a proteasome inhibitor as separate lines or a combined line of therapy; have ECOG status 0 or 1; and adequate organ function. The patients would be following the Lymphodepletion regimen fludarabine (30 mg/m2/day) and cyclophosphamide (600 mg/m2/day) for 3 days, followed by granulocyte-colony stimulating factor. For patients in Arm 2, KEYTRUDA® will be administered every 3 weeks, starting at week 3 following T-cell infusion until week 108. The target dosage is dose of 1 – 8 × 109 transduced SPEAR T-cells. The efficacy of the trial will be assessed by the International Myeloma Working Group (IMWG) Uniform Response Criteria. Overall response rate, time to response, duration of response, progression-free survival, and overall survival will be determined. The study is open and enrolling.

About Adaptimmune Therapeutics PLC

Adaptimmune is a clinical-stage biopharmaceutical Company and a leader in the TCR T-cell therapy space focused on developing novel cancer immunotherapy products. The Company has developed a proprietary T-cell receptor platform that enables us to identify cancer targets, find and genetically engineer T-cell receptors (TCRs), and produce TCR therapeutic candidates called SPEAR® (Specific Peptide Enhanced Affinity Receptor) T-cells that recognize these targets - 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. GlaxoSmithKline Plc (NYSE:GSK) exercised its option to exclusively license the right to research, develop, and commercialize Adaptimmune's NY-ESO SPEAR T-cell therapy program in September 2017. The process of transition is in progress. The Company is located in Philadelphia, US and Oxfordshire, UK.

Last Close Stock Review

At the closing bell, on Monday, November 13, 2017, Adaptimmune Therapeutics' stock slipped 3.70%, ending the trading session at $7.80. A total volume of 162.90 thousand shares have exchanged hands. The Company's stock price soared 50.58% in the last three months, 40.79% in the past six months, and 55.69% in the previous twelve months. Moreover, the stock skyrocketed 92.59% since the start of the year. The stock currently has a market cap of $4.37 billion.

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