Adaptimmune ($ADAP) has bagged two milestones from GlaxoSmithKline ($GSK). The checks landed in Adaptimmune's bank account after it tripled the size of a Phase I/II synovial sarcoma trial of its NY-ESO-1-targeting T-cell receptor (TCR) therapy on the strength of data from the initial cohort.
|Adaptimmune CEO James Noble|
Oxford, U.K.-based Adaptimmune is trialling its NY-ESO TCR therapeutic in patients with synovial sarcoma, a cancer with a poor prognosis that affects adolescents and young adults. Data from the first 10 people enrolled in the trial have encouraged Adaptimmune to step up the trial. Now, having previously enrolled people whose tumors expressed high levels of NY-ESO-1, the trial is opening up to patients with lower levels. This second cohort of 10 people with low levels of NY-ESO will receive the same treatment regimen as the initial clutch of patients treated with the therapy.
A third 10-person cohort, the members of which will have tumors that express high levels of NY-ESO, will receive a tweaked regimen. So far, participants in the Phase I/II trial have received one course of cyclophosphamide and fludarabine for lymphodepletion before being given the TCR therapy. In the third cohort, Adaptimmune will look at the removal of fludarabine from the lymphodepletion phase. The ultimate goal of all the cohorts is to determine whether Adaptimmune's autologous T cells are safe. As a secondary goal, Adaptimmune is looking at efficacy in terms of the rate and duration of responses.
Data generated to date have given Adaptimmune encouragement. "In the first cohort of this trial, we saw evidence of antitumor activity resulting from treatment with our NY-ESO TCR therapeutic in a solid tumor setting," Adaptimmune CMO Dr. Rafael Amado said in a statement. The first cohort included one patient who experienced a complete response after receiving the TCR therapy. In total, 6 patients responded. Given that the patients were either intolerant of or no longer responding to the standard first-line therapy, the data suggest the drug may help a hard-to-treat population.
Adaptimmune is testing the TCR therapy in synovial sarcoma in parallel to a study in patients with advanced multiple myeloma. Having entered into a $350 million pact with Adaptimmune in June 2014, GSK has the option to take responsibility for the NY-ESO-1 program once the full slate of clinical proof-of-concept data is available.
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