Nammi Therapeutics Inc (Nammi), a California-based clinical stage immuno-oncology company, announced on Friday the dosing of the first patient in the first in human Phase one trial (NCT06582017) for QXL138AM.

The Phase one study, a two-part, open-label multi-centre study, is expected to enrol around 100 subjects with advanced CD138-expressing cancers. Part A of the study is to assess the safety and tolerability of escalating doses of QXL138AM, with secondary endpoints evaluating pharmacokinetics and immunogenicity. Part B of the study includes dose expansion in three cohorts (two solid tumour indications with high CD138 prevalence and multiple myeloma) with primary endpoints focused on safety and tolerability and secondary endpoints evaluating anti-tumour activity. The company is to carry out the Phase one study at investigator sites across the United States.

While the two solid tumour indications for expansion have not yet been determined, QXL138AM has been granted Orphan Drug Designation in Pancreatic Cancer. Other factors, including prevalence of CD138 expression, preclinical efficacy, previous reports on clinical efficacy with approved Interferon alfa therapeutics, the extent of unmet need, and Nammi's clinical experience in Part A will also be used to determine the solid tumour indications for expansion.

Dr Dennis Kim, MD, chief medical officer for the study, said: "Interferon alpha 2 is a potent anti-cancer therapeutic, but its clinical benefit is limited by significant toxicity when administered systematically. QXL138AM utilises Nammi's masked immunocytokine technology, whereby the interferon alpha 2 is masked and fused to a tumour-targeting antibody. The antibody anchors QXL138AM on the surface of tumour cells where proteases can remove the mask thereby activating the Interferon alpha 2, facilitating a wider therapeutic window."