Biosceptre’s proposed Phase I clinical trial for BIL03s (anti-cancer monoclonal antibody therapy) was granted conditional approval by the Bellberry Ethics committee. Biosceptre is now seeking partners and external funding to progress BIL03s into the clinic.
Biosceptre has high confidence in the safety of BIL03s, in part as a result of pre-clinical toxicology studies and compassionate access patients treated in Australia under the TGA’s Special Access Scheme.
The planned clinical trial, approved on 5th of January, would recruit between 12 and 42 patients with a range of late stage cancers and seek in a Phase I clinical trial to confirm safety and tolerability of BIL03s and provide indications of efficacy in humans.
CEO Gavin Currie said “We are pleased that this clinical trial, building on significant preclinical data, has been conditionally approved, and believe that a successful clinical trial, our first for a systemic therapeutic product targeting nfP2X7, would provide further validation of our oncology therapy target. We are now seeking partners and external funding to progress BIL03s into clinic.
Biosceptre has published a clinical study demonstrating that its topical drug BIL010t provides a novel, safe and tolerable topical therapy for BCC in the British Journal of Dermatology (BJD).
Basal cell carcinoma (BCC) is the most common type of cancer, and its incidence is increasing. Biosceptre has discovered a variant of an important signalling protein P2X7, termed nfP2X7, that occurs in the cancer cell membrane and is present in BCC. In nfP2X7, a critical function involved in cell death is lost. Loss of this function is believed to play an important role in cancer. The nfP2X7 receptor is uniquely targeted by Biosceptre therapies without significant off-target safety issues. Biosceptre has developed three therapeutic candidates targeting nfP2X7. BIL010t, the subject of the BJD paper, is the most clinically advanced, and has the potential to provide a first in class therapy for BCC. Our article on BIL010t provides an overview of preclinical and clinical development activities to date for BIL010t.
The data presented in the paper demonstrates high patient compliance for BIL010t, with treatment being well-tolerated. Efficacy was also investigated with lesion size measured prior to and after 28 days treatment, with 65% of patients showing a reduction in lesion area and 20% no change in area. Histopathology of post-treatment excision of lesion sites showed 8 patients with stable disease, 9 with partial response and 3 with complete response. The conclusions from this study show that antibodies against nfP2X7 (BIL010t) have the potential to provide a novel, safe and well tolerated treatment for BCC.