Patrys (ASX: PAB) has confirmed the safety and tolerability of its PAT-SM6 anti-tumour antibody for the treatment of melanoma in a Phase I trial.
The data provides uniform evidence of the treatment’s safety, with initial data supporting its ability to specifically target melanoma tumours.
Importantly, no significant safety issues were observed or reported for any patients treated with PAT-SM6 during infusion, immediately following dosing, or during the month-long follow up period.
Secondary endpoints were also met in the trial, with analysis of blood samples collected during the trial confirming that no patient generated a significant adverse immune response to PAT-SM6.
This is an important finding as adverse immune reactions to existing marketed antibodies are known to limit the effectiveness of these treatments.
Pre-dose and post-dose melanoma tumour samples from the final cohort were also examined.
Despite the low dose of PAT-SM6 relative to expected therapeutic dose levels, an increased level of cancer cell death was shown to be widespread in one of the patient’s post-treatment samples, compared to the same patient’s pre-treatment specimen.
Patrys is now planning to undertake a clinical trial of PAT-SM6 in patients with the blood cancer, multiple myeloma.
A Phase I/IIa open-label, multi dose escalation trial in relapsed and multi-resistant patients will be undertaken at the University of Würzburg Phase I/II unit in Germany.
The initiation of this trial follows on from preclinical studies that have shown that PAT-SM6 is able to specifically target bone marrow cells sourced from multiple myeloma patients, with either advanced or refractory disease, confirming the presence of the target on these cells.
In addition, treatment of primary multiple myeloma cells isolated from patients or cancer cells lines with PAT-SM6 caused significant cell death in all samples tested.
The study is expected to begin in April and take around 12 months to complete.