Nammi Therapeutics Begins Phase 1 Study Dosing First Patient with QXL138AM for Solid Tumors and Multiple Myeloma

Nammi Therapeutics, Inc., a Los Angeles-based clinical stage immuno-oncology company, has announced the dosing of the first patient in a Phase 1 trial involving their new treatment, QXL138AM. The trial, registered under NCT06582017, marks the first in human testing of this innovative therapy designed using the Masked-Immunocytokine (MIC) and Nammisome platforms.

The Phase 1 study is structured in two parts and aims to enroll about 100 patients diagnosed with advanced cancers that express CD138. The initial segment of the study, Part A, will primarily assess the safety and tolerability of progressively increasing doses of QXL138AM. Additionally, this phase will evaluate pharmacokinetics and immunogenicity as secondary endpoints. In Part B, the study will expand to include three distinct patient cohorts, focusing on two solid tumor types with high CD138 prevalence and multiple myeloma. The primary endpoints in this segment will also involve safety and tolerability, with secondary endpoints dedicated to measuring the anti-tumor activity of the treatment. This extensive study will take place at various investigator sites across the United States.

While the specific solid tumor indications for Part B's expansion are yet to be finalized, QXL138AM has already received Orphan Drug Designation for Pancreatic Cancer. The choice of solid tumors for the study will be guided by factors such as the prevalence of CD138 expression, preclinical efficacy data, prior clinical outcomes with approved Interferon alfa therapies, the degree of unmet medical needs, and the clinical insights gained during Part A of the study.

Dr. Dennis Kim, the chief medical officer overseeing the study, explained the mechanism of QXL138AM. According to Dr. Kim, Interferon alpha 2 is a powerful anti-cancer agent but is often hampered by significant systemic toxicity. Nammi’s technology cleverly masks the Interferon alpha 2 and fuses it to a tumor-targeting antibody, which specifically anchors the treatment to the surface of tumor cells. Here, tumor-associated proteases can remove the mask, thereby activating the Interferon alpha 2 right at the tumor site, and allowing a broader therapeutic window with fewer side effects.

Dr. Drew W. Rasco, Associate Director at The START Center for Cancer Research in San Antonio, Texas, expressed enthusiasm about the commencement of the trial. He highlighted the promising potential of Nammi's immunocytokine technology in treating various cancer types and affirmed his commitment to collaborating with Nammi to advance this therapy.

Nammi Therapeutics, Inc. focuses on developing platforms and products that selectively activate anti-tumor immune responses within the tumor microenvironment while minimizing systemic immune activation. This approach is intended to not only improve safety but also enhance the potential for combining multiple immune modulators. Besides the MIC platform, Nammi has created the Nammisome technology, a nanoparticle platform to deliver Immune Modulating Prodrugs (IMPs). Several Nammisome-based clinical candidates are currently in development.