LOS ANGELES, CA, USA I November 8, 2024 I Nammi Therapeutics, Inc. (Nammi), a clinical stage immuno-oncology company with a diverse pipeline created with the Masked-Immunocytokine (MIC) and Nammisome platforms, announces dosing of the first patient in the first in human Phase 1 trial (NCT06582017).
The Phase 1 study is a two-part, open-label multi-center study that is expected to enroll approximately 100 patients with advanced CD138-expressing cancers. Part A of the study will evaluate the safety and tolerability of escalating doses of QXL138AM, with secondary endpoints assessing pharmacokinetics and immunogenicity. Part B of the study will involve dose expansion in three cohorts (two solid tumor indications with high CD138 prevalence and multiple myeloma) with primary endpoints focused on safety and tolerability and secondary endpoints assessing anti-tumor activity. The Company will conduct the Phase 1 study at investigator sites across the United States.
While the two solid tumor 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 tumor indications for expansion.
“Interferon alpha 2 is a potent anti-cancer therapeutic, but its clinical benefit is limited by significant toxicity when administered systematically. QXL138AM utilizes Nammi’s masked immunocytokine technology, whereby the interferon alpha 2 is masked and fused to a tumor-targeting antibody. The antibody anchors QXL138AM on the surface of tumor cells where proteases can remove the mask thereby activating the Interferon alpha 2, facilitating a wider therapeutic window,” said Dr. Dennis Kim, M.D., chief medical officer for the study.
“We’re very excited to have dosed the first patient with QXL138AM here at START,” stated Dr. Drew W. Rasco, Associate Director at The START Center for Cancer Research in San Antonio, TX. “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.”
About Nammi Therapeutics, Inc.
Nammi Therapeutics, Inc. is an immuno-oncology company based in Los Angeles that is developing platforms and products that selectively activate anti-tumor immunity within the tumor microenvironment while minimizing systemic activation. By reducing systemic activation of the immune system, Nammi expects to improve safety and enhance the ability to combine multiple immune modulators. In addition to the MIC platform, Nammi has also developed a nanoparticle platform to deliver Immune Modulating Prodrugs (IMPs) using their Nammisome technology. Multiple Nammisome clinical candidates have also been selected for development.
For further information, visit www.nammirx.com or email info@nammirx.com.
SOURCE: Nammi Therapeutics
Post Views: 1,501
LOS ANGELES, CA, USA I November 8, 2024 I Nammi Therapeutics, Inc. (Nammi), a clinical stage immuno-oncology company with a diverse pipeline created with the Masked-Immunocytokine (MIC) and Nammisome platforms, announces dosing of the first patient in the first in human Phase 1 trial (NCT06582017).
The Phase 1 study is a two-part, open-label multi-center study that is expected to enroll approximately 100 patients with advanced CD138-expressing cancers. Part A of the study will evaluate the safety and tolerability of escalating doses of QXL138AM, with secondary endpoints assessing pharmacokinetics and immunogenicity. Part B of the study will involve dose expansion in three cohorts (two solid tumor indications with high CD138 prevalence and multiple myeloma) with primary endpoints focused on safety and tolerability and secondary endpoints assessing anti-tumor activity. The Company will conduct the Phase 1 study at investigator sites across the United States.
While the two solid tumor 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 tumor indications for expansion.
“Interferon alpha 2 is a potent anti-cancer therapeutic, but its clinical benefit is limited by significant toxicity when administered systematically. QXL138AM utilizes Nammi’s masked immunocytokine technology, whereby the interferon alpha 2 is masked and fused to a tumor-targeting antibody. The antibody anchors QXL138AM on the surface of tumor cells where proteases can remove the mask thereby activating the Interferon alpha 2, facilitating a wider therapeutic window,” said Dr. Dennis Kim, M.D., chief medical officer for the study.
“We’re very excited to have dosed the first patient with QXL138AM here at START,” stated Dr. Drew W. Rasco, Associate Director at The START Center for Cancer Research in San Antonio, TX. “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.”
About Nammi Therapeutics, Inc.
Nammi Therapeutics, Inc. is an immuno-oncology company based in Los Angeles that is developing platforms and products that selectively activate anti-tumor immunity within the tumor microenvironment while minimizing systemic activation. By reducing systemic activation of the immune system, Nammi expects to improve safety and enhance the ability to combine multiple immune modulators. In addition to the MIC platform, Nammi has also developed a nanoparticle platform to deliver Immune Modulating Prodrugs (IMPs) using their Nammisome technology. Multiple Nammisome clinical candidates have also been selected for development.
For further information, visit www.nammirx.com or email info@nammirx.com.
SOURCE: Nammi Therapeutics
Post Views: 1,501
