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ARIAD Announces Three Exclusive Out-License Agreements to Develop and Commercialize Its ARGENT(TM) Cell-Signaling Regulation Technology

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.

(Press release, Debiopharm, APR 14, 2011, View Source [SID:1234503768])

Oxford BioTherapeutics Licenses BioWa′s POTELLIGENT® Technology for the Research and of its Therapeutic Antibodies in Cancer

On April 6, 2011 BioWa and Oxford BioTherapeutics Ltd (OBT) reported that they have entered into a license agreement to provide OBT with access to BioWa’s patented POTELLIGENT Technology platform for the development of antibody-dependent cellular cytotoxicity (ADCC) enhanced antibodies (Press release Oxford BioTherapeutics, APR 6, 2011, View Source [SID:1234500498]). OBT intends to use POTELLIGENT Technology to develop, manufacture and commercialize selected ADCC programs from its pipeline of preclinical antibodies for oncology which it has built based upon novel targets identified using its OGAP proteomic database. In return for the license, OBT will pay to BioWa undisclosed license fees, development and commercialization milestones and royalties on sales of any products that it commercializes.

(Press release, Telik, APR 5, 2011, View Source [SID:1234504369])

Systemic Gene Therapy with Tumor Suppressor TUSC2/FUS1 Nanoparticles for Recurrent/Metastatic Lung Cancer

Thirty-one patients were treated at 6 dose levels ranging from 0.01 to 0.09 mg/kg and 7 had paired pre- and posttreatment biopsies (Poster AACR (Free AACR Whitepaper) 2011, Genprex, APR 2, 2011, View Source [SID:1234500633]). RT-PCR analysis detected high TUSC2 plasmid expression in 6 of 7 posttreatment tumor specimens but not in pretreatment specimens and negative controls. Immunohistochemical staining has been performed on one paired specimen, demonstrating low background TUSC2 protein staining in the pretreatment tissue compared with high intense TUSC2 protein staining in the posttreatment tissue. RT-PCR gene expression profiling analysis of apoptotic pathway genes in one paired specimen demonstrated significant upregulation and downregulation of genes involved in both the intrinsic and extrinsic apoptotic pathways. Among 4 patients treated without premedications, all 4 developed grade 2 or 3 fever. Among the 27 patients premedicated with dexamethasone and diphenhydramine, the highest fever was grade 2, which occurred in 2 subjects. The only dose-limiting toxicities were 2 episodes of transient grade 3 hypophosphatemia, resulting in an MTD of 0.06 mg/kg. Twentythree patients who received two or more doses were evaluable for response, with 5 achieving stable disease (2.6-10.8 months) and 18 progressing. One patient with stable disease had evidence of a durable metabolic response on positron emission tomography imaging. The pretreatment apoptotic index was predictive of disease stability. Median survival time was 9.1 months.