On April 20, 2011 ARIAD and Bellicum Pharmaceuticals reported that they have now broadened their previous agreement as a result of promising clinical data from Phase I/II trials of Bellicum’s ARGENT-regulated cancer vaccine and cell-therapy product candidates, both utilizing AP1903 to achieve chemical induction of dimerization (CID) (Press release Ariad, APR 20, 2011, View Source;p=irol-newsArticle&ID=1552552 [SID:1234500804]).
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Bellicum’s first product candidate, BPX-101 DeCIDe(TM) immunotherapy, is an autologous dendritic-cell cancer vaccine that includes an ARGENT-inducible regulatory construct. In the Phase 1/2 trial of patients with metastatic castrate-resistant prostate cancer at The University of Texas Health Science Center, Houston, patients received the Bellicum immunotherapy followed by AP1903 one day later. Data from the study showed that this small-molecule regulated immunotherapy was well tolerated and elicited both clinical and antigen-specific immune responses consistent with patient benefit in prostate cancer.
Bellicum’s second product candidate, CaspaCIDe(TM) DLI, is a donor lymphocyte infusion that contains the ARGENT-inducible safety switch. This is administered following a T-cell-depleted HSCT. In an investigator-sponsored Phase 1/2 trial also at Baylor College of Medicine, pediatric patients with acute lymphoblastic leukemia or acute myeloid leukemia undergoing HSCT received the CaspaCIDe cell therapy followed by administration of AP1903 upon diagnosis of graft-vs-host disease (GvHD). Interim data from the study showed that this small-molecule regulated cell therapy was well tolerated and rapidly reversed the deleterious systemic effects of GvHD.
ARIAD’s expanded exclusive agreement with Bellicum now covers products to treat the complications of cell transplantation, such as GvHD, in addition to certain cancer immunotherapies. ARIAD has an equity stake in Bellicum and is eligible to receive milestones on regulatory and clinical progress and royalties on future product sales. Bellicum is responsible for all manufacturing, regulatory and clinical activities and will hold the investigational new drug applications for these programs.