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Updated Data from Ongoing MAGE-A10 and MAGE-A4 Studies Presented at the 2018 ESMO Congress

PHILADELPHIA and OXFORD, United Kingdom, Oct. 20, 2018 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (“Adaptimmune”) (Nasdaq: ADAP), a leader in T-cell therapy to treat cancer, presented initial data from the first two cohorts of its ongoing studies with its MAGE-A10 and MAGE-A4 SPEAR T-cells in two poster presentations earlier today at the European Society for Medical Oncology (ESMO) Congress in Munich, Germany.

/EIN News/ -- “We are encouraged by the safety data from these initial cohorts, which include heavily pretreated patients with advanced epithelial tumors. Our SPEAR T-cells have shown dose appropriate persistence and expansion, and early, but transient, evidence of antitumor activity in one ovarian cancer patient,” said Rafael Amado Adaptimmune’s President of R&D. “We have been dosing at higher doses in our MAGE‑A4 and MAGE-A10 studies with more intense preconditioning and we expect to see higher cell expansion. We look forward to reporting on these data in due course.”

Data update from ongoing MAGE-A10 studies
Data from the two ongoing MAGE-A10 studies (“triple tumor” and lung) are summarized below.

Overview of treated patients:

  • Cohort 1a of the non-small cell lung (NSCLC) study
    - 5 patients; target dose of 100 million cells; preconditioning: cyclophosphamide (Cy) alone at 1800 mg/m2/day for 2 days
  • Cohort 2 NSCLC study
     - 3 patients; target dose of 1 billion cells; preconditioning [fludarabine (Flu) 30 mg/m2/day and Cy 600 mg/m2/day] x 3 days
  • Cohort 1 “triple tumor” study in bladder, melanoma, and head & neck cancers
     - 3 patients (2 with head & neck cancer; 1 with melanoma); target dose of 100 million cells; preconditioning: [Flu 30 mg/m2/day and Cy 600 mg/m2/day] x 3 days
  • Cohort 2 of “triple tumor” study: no patients treated; the Safety Review Committee recommended dose escalation to Cohort 3 (based on safety in MAGE-A10 NSCLC patients)
  • These studies are both dosing in Cohort 3

Results:

  • In the 8 patients treated in Cohort 1 across both studies, the disease progressed
  • In the 3 patients treated in Cohort 2 (all treated patients were in the NSCLC study)
     - 1 patient died of pneumonia (unrelated to T-cell therapy)
     - 1 patient had stable disease (SD) at Week 4, but then progressed
     - 1 patient had SD at Weeks 4 and 8, but progressed at Week 12
  • MAGE-A10 SPEAR T-cells at the 100 million and 1 billion target cell doses showed no evidence of toxicity related to off-target binding or alloreactivity
  • The most common treatment-emergent adverse events (AEs), occurring in more than 20% of patients across both studies, were anemia, constipation, decreased appetite, lymphopenia, neutropenia, thrombocytopenia, diarrhea, hyponatremia, leukopenia, nausea, pyrexia, alopecia, vomiting, cytokine release syndrome (CRS), fatigue, peripheral edema, and sinus tachycardia/tachycardia
  • Of the 11 treated patients, 7 had serious AEs (SAEs); 3 of whom had related SAEs including 2 patients with CRS, and 1 with hemoptysis
  • Transduced cells were detectable in peripheral blood at levels consistent with dose
  • To date, experience with MAGE-A10 SPEAR T-cells did not show a consistent relationship between T‑cell infusion and elevation in serum IL-6, IL-8, or IFNγ and/or CRS

Data update from ongoing MAGE-A4 “basket” study
Data from the ongoing MAGE-A4 “basket” study in NSCLC, bladder, melanoma, synovial sarcoma, myxoid/round cell liposarcoma (MRCLS), head & neck, ovarian, gastric, and esophageal cancers were updated, and are summarized below.

Overview of treated patients:

  • Cohort 1: Three patients (all with ovarian cancer); target dose of 100 million cells; preconditioning: [Flu 30 mg/m2/day and Cy 600 mg/m2/day] x 3 days
  • Cohort 2: Three patients (all with ovarian cancer); target dose of 1 billion cells; preconditioning: [Flu 30 mg/m2/day and Cy 600 mg/m2/day] x 3 days
  • This study is dosing in Cohort 3

Results:

  • Of the 6 patients treated, best response was SD in 4 patients and progressive disease (PD) in 2 patients; 1 patient with SD had an overall 27% reduction of target lesions observed at Week 6, and at the time of the second scan, which took place after the ESMO poster cut-off date, was assessed as PD
  • MAGE-A4 SPEAR T-cells at the 100 million and 1 billion target cell doses showed no evidence of toxicity related to off-target binding or alloreactivity
  • The most common treatment-emergent AEs, occurring in >2 patients, were lymphopenia, neutropenia, decreased appetite, fatigue, nausea, anemia, dyspnea, leukopenia, febrile neutropenia, thrombocytopenia, pyrexia, abdominal pain, constipation, and vomiting
  • There were 4 patients with SAEs, 2 of whom had SAEs related to treatment including 1 patient with muscular weakness and 1 patient with SAEs of CRS and encephalopathy
  • A case study was provided in the poster for the patient who had SAEs of CRS and grade 2 encephalopathy
  • Transduced T-cells were detectable in the peripheral blood and expanded transiently, and greater persistence was related to higher T-cell dose

Overall conclusions:

  • The most frequent AEs and treatment-related AEs are consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or other cancer immunotherapies
  • Based on experience with NY-ESO TCR therapy, the benefit of treatment may become evident at higher cell doses
  • These preliminary data support continued investigation of MAGE-A4 and MAGE-A10 SPEAR T-cells in these study populations

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, MAGE-A10, and AFP across multiple 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 on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 2, 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.

Adaptimmune Contacts:
Media Relations:
Sébastien Desprez – VP, Communications and Investor Relations
T: +44 1235 430 583
M: +44 7718 453 176
Sebastien.Desprez@adaptimmune.com

Investor Relations:
Juli P. Miller, Ph.D. – Director, Investor Relations
T: +1 215 825 9310
M: +1 215 460 8920
Juli.Miller@adaptimmune.com

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