Also being presented are an extended follow-up and correlative data from Adaptimmune’s study of its T-cell therapy targeting NY-ESO in patients with multiple myeloma, and preclinical safety assessments of its next affinity enhanced T-cell therapy product directed at MAGE A-10, for which a clinical trial is expected to initiate later this year.
The data presented demonstrate the following:
- In the primary efficacy analysis, 50 percent of synovial sarcoma patients receiving Adaptimmune’s affinity enhanced T-cell therapy targeting NY-ESO responded, and 75 percent remain alive and on long term-follow up. Sixty (60) percent of patients receiving the target dose responded, and 90 percent remain alive and on long term-follow up;
- Adaptimmune’s affinity enhanced T-cell therapy targeting NY-ESO in multiple myeloma generated responses that were better than expected for autologous stem cell transplant (ASCT) alone, despite the patients having advanced stage disease with 60 percent of patients having tumor chromosomal abnormalities; and
- Adaptimmune’s platform technology enables the generation of multiple TCRs to a large number of cancer targets. Once affinity engineered, these TCRs are subjected to an extensive preclinical safety and efficacy package.
In the synovial sarcoma poster presentation, entitled: "Optimizing engineered TCR T-cell therapy for synovial sarcoma," Sandra P. D’Angelo, M.D., Assistant Attending, Sarcoma Medical Oncology / Immunotherapeutics Core at
- Adaptimmune’s affinity enhanced T-cell therapy targeting NY-ESO demonstrated robust clinical responses in synovial sarcoma, including a 50 percent (6/12) overall response rate (ORR) in patients receiving T-cells, and a 60 percent (6/10) response rate in a subset of patients who received the target dose of one to six billion total engineered T-cells. Two patients received below the target dose, and neither responded. This compares favorably to a historical partial response rate of approximately four percent observed with pazopanib, which is the only approved drug in this patient population.
- Seventy-five (75) percent (9/12) of all subjects who received any dose of NY-ESO-1 T cells - and 90 percent (9/10) of subjects who received the minimum intended cell dose - are alive and on long term follow-up. Forty-two (42) percent (5/12) of patients who received any dose have survival data beyond one year.
- NY-ESO-1 T-cells durably persist and maintain function without accumulation of exhaustion markers; persistence detected at up to 21 months in those receiving the minimum intended cell dose. Poor persistence was observed in subjects receiving less than 1 billion NY-ESO-1 T-cells, with no detectable cells beyond day 25.
- The encouraging anti-tumor activity considered in the context of a generally manageable safety profile is supportive of a favorable benefit:risk for NY-ESO-1 T-cells in this patient population. Most treatment related adverse events resolve within 30 days of treatment. The most common adverse events include: nausea, anemia, pyrexia, lymphopenia, and neutropenia. There were no treatment related deaths. Cytokine release syndrome was seen in 4 subjects; Grade 3 cytokine release syndrome was observed in 2/4 subjects, no grade 4 events were observed.
- The evidence of relapse seen in some patients provides rationale for testing of combination approaches or second generation T-cells designed to overcome the immune suppressive environment of selected tumors.
In the myeloma update entitled, “Deep phenotypic characterization of NY-ESO TCR engineered T cells and tumor in patients with advanced myeloma”,
Adaptimmune also presents preclinical data supporting its next first in human study in a poster entitled, “Preclinical safety testing of an Optimized Enhanced-Affinity MAGE-A10 -specific T cell receptor for adoptive T cell therapy”.
Adaptimmune’s affinity enhanced T-cell candidates are novel cancer immunotherapies that have been engineered to target and destroy cancer cells by strengthening a patient’s natural T-cell response. T-cells are a type of white blood cell that play a central role in a person’s immune response. Adaptimmune’s goal is to harness the power of the T-cell and, through its multiple therapeutic candidate, significantly impact cancer treatment and clinical outcomes of patients with solid and hematologic cancers
Adaptimmune is a clinical stage biopharmaceutical company focused on novel cancer immunotherapy products based on its T-cell receptor (TCR) 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 an affinity enhanced T-cell therapy targeting the NY-ESO cancer antigen. Its NY-ESO TCR affinity enhanced 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. As of
This press release contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “believe,” “may”, “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect” and other words of similar meaning. 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; our ability to submit an IND and successfully advance our technology platform to improve the safety and effectiveness of our existing TCR therapeutic candidates; the rate and degree of market acceptance of T-cell therapy generally and of our TCR therapeutic candidates; government regulation and approval, including, but not limited to, the expected regulatory approval timelines for TCR therapeutic candidates; and our ability to protect our proprietary technology and enforce our intellectual property rights; amongst others. 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 Annual Report on Form 20-F filed with the
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