Ascend Biopharmaceuticals reports favourable results from TG1042 Phase 2 study for CBCL treatment

Mar 21 2014

Ascend Biopharmaceuticals, a Melbourne-based immunotherapy company, has today announced the publication of a report utilising TG1042 (ASN-002) for the treatment of Cutaneous B-Cell Lymphoma (CBCL), in the journal PLOS ONE.

Ascend Biopharmaceuticals entered into an exclusive world-wide license agreement with Transgene in July of 2013 to develop TG1042 as an immunotherapeutic injection for multiple cancers including Cutaneous B-Cell Lymphoma, CBCL (a B-Cell lymphoma that involves the skin). Ascend plans to sponsor and commence clinical studies with TG1042 in Basal Cell Carcinoma later in 2014.

The report details an open label, multi-centre trial conducted by Transgene involving 13 CBCL patients injected directly with TG1042 into their cancers. The delivery of TG1042 into the lesions resulted in 54% of treated patients with a complete response (where all lesions disappeared) and 31% of the treated patients with a partial response (where at least half of all treated lesions disappeared), demonstrating that more than 80% of lesions responded to this therapy.

Primary CBCLs have an annual incidence rate of approximately 3.1 per 1,000,000 persons and comprises about 20–25% of all cutaneous lymphomas. Currently, treatment options for CBCL are confined to surgery or radiation therapy and there are no registered drugs for this indication.

“Primary cutaneous B-cell lymphomas are rare but a disfiguring disease with significant unmet medical needs. Intralesional TG1042 therapy is well tolerated and results in lasting tumor regressions” said Professor Reinhard Dummer, Principal Investigator on the study and an expert in Cutaneous Lymphoma at the University of Zurich. Both radiation therapy and surgery show a high initial response rate but up to 50% of patients relapse following the initial treatment.

“This study shows that in CBCL, TG1042 has a favourable risk/benefit ratio and has potential to be developed as an alternative to surgery or radiation therapy treatment to minimize risk of cancer recurrence.” Ascend CEO Clement Leong said.