7 Hills Pharma Inc. has announced the safe dosing of the first patient in its Phase 1b/2a clinical trial evaluating alintegimod, a novel integrin activator, in patients with solid tumors resistant to immune checkpoint inhibitors. This multicenter study (NCT06362369) aims to assess the safety and efficacy of alintegimod in augmenting T cell activation and trafficking to overcome resistance to existing immunotherapies.
The Phase 1b/2a trial is supported by significant funding, including a $13.4 million award from the Cancer Prevention and Research Institute of Texas (CPRIT) and a $2.0 million award from the National Cancer Institute (NCI).
Alintegimod: A Novel Approach to Enhance Cancer Immunotherapy
Alintegimod represents a first-in-class, orally delivered small molecule designed to selectively activate the integrins LFA-1 and VLA-4. These integrins play a crucial role in the cancer immunity cycle, particularly in immune cell trafficking, antigen presentation, and T cell activation. By targeting these rate-limiting steps, alintegimod aims to enhance the body's natural immune response against cancer cells.
Lionel D. Lewis, Chief Medical Officer of 7 Hills Pharma, expressed gratitude for reaching this milestone, stating, "Treating a courageous first cancer patient is a significant step forward in our mission to deliver safer, more effective, and more accessible immunotherapy options for many patients with hard-to-treat cancers."
Preclinical and Clinical Evidence
Preclinical studies have demonstrated that alintegimod can improve the effectiveness of a broad range of immune checkpoint inhibitors. Furthermore, a Phase I clinical trial previously conducted by 7 Hills Pharma showed that alintegimod exhibits oral bioavailability and a favorable safety profile at exposures exceeding therapeutic levels.
The ongoing Phase 1b/2a trial will further evaluate the safety, tolerability, and preliminary efficacy of alintegimod in combination with immune checkpoint inhibitors in patients with advanced solid tumors who have progressed on or are resistant to prior immunotherapy. The trial's outcomes could provide valuable insights into the potential of integrin activation as a strategy to overcome resistance to cancer immunotherapy.
