Nammi Therapeutics has commenced a Phase I clinical trial of QXL138AM, a novel masked immunocytokine (MIC), in patients with advanced solid tumors and multiple myeloma. The first patient was dosed at The START Center for Cancer Research in San Antonio, Texas. This first-in-human study aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of QXL138AM.
The Phase I trial is structured in two parts and will be conducted at multiple sites across the US. The open-label, multi-center study anticipates enrolling approximately 100 subjects with advanced CD138-expressing cancers. Part A will focus on dose escalation to determine the safety and tolerability of QXL138AM, alongside pharmacokinetic and immunogenicity assessments. Part B will expand to dose cohorts with specific solid tumor indications and multiple myeloma to evaluate anti-tumor activity.
QXL138AM: Targeted Interferon Alpha Delivery
QXL138AM is designed to deliver a masked interferon alpha (IFNα) to the CD138 protein expressed on tumor cells. The therapy utilizes Nammi’s technology to mask interferon alpha 2, linking it to a tumor-targeting antibody. Activation occurs on the tumor surface via proteases, potentially offering a broader therapeutic window compared to systemic interferon alpha 2 administration, which is known for significant toxicity.
Trial Design and Endpoints
The primary objectives of the Phase I trial are to assess the safety and tolerability of QXL138AM. Secondary endpoints include evaluating anti-tumor activity in selected solid tumor indications and multiple myeloma. Specific solid tumor indications for Part B expansion will be determined based on CD138 expression prevalence, preclinical efficacy data, clinical efficacy of approved Interferon alfa therapeutics, unmet medical needs, and insights from Part A of the trial.
Expert Commentary
Dr. Drew Rasco, Associate Director at The START Center for Cancer Research, expressed enthusiasm for the trial, stating, "We’re very excited to have dosed the first patient with QXL138AM here at START. We believe that there is significant potential with Nammi’s immunocytokine technology in the treatment of multiple cancer types, and we look forward to working with the Nammi team to develop this new therapy over the coming years."
Orphan Drug Designation
QXL138AM has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for both pancreatic cancer (in 2022) and multiple myeloma, highlighting the unmet need and potential of this therapy in these indications.
