Breakthrough in Cancer Gene Therapy: IMM60 Showcases Safety and Efficacy in Clinical Studies

Strategic Insights -

Cancer Weekly has reported on the groundbreaking research conducted by investigators at Imperial College London, which has yielded promising results for IMM60, a novel iNKT agonist formulated in a liposome. The study, IMPORT-201 (IMP-MEL), has demonstrated that IMM60 is well-tolerated as monotherapy and in combination with pembrolizumab in a heavily pretreated population. The research has shown that IMM60 initiates immune activation, with significant increases in dendritic and CD86+ B cells. Preliminary results indicate that IMM60 monotherapy has led to complete resolution of two lesions, a 69% decrease in size of one lesion, and stability in ten lesions.

Key Takeaways:

  • IMM60, a synthetically derived agonist of iNKT cells, has been shown to be well-tolerated in clinical studies, with no treatment-related SAEs or G3-5 AEs reported.
  • The study, IMPORT-201 (IMP-MEL), has demonstrated that IMM60 can initiate immune activation, with significant increases in dendritic and CD86+ B cells.
  • Preliminary results indicate that IMM60 monotherapy has led to complete resolution of two lesions, a 69% decrease in size of one lesion, and stability in ten lesions.
  • The combination of IMM60 with pembrolizumab is ongoing, and updated results from the Ph 1 portion of the study will be reported.
  • IMM60 has shown dose proportionality, with a terminal half-life of approximately 8 hours.
  • The study has enrolled eight patients with melanoma (n=4) or NSCLC (n=4) in the IMM60 monotherapy dose cohorts, and one patient with NSCLC has been enrolled in the IMM60 + pembrolizumab combination cohort.

Sources:

  • IMPORT-201 (IMP-MEL): A phase 1 first-in-human dose finding/randomized phase 2 study of a novel iNKT agonist IMM60 and pembrolizumab for advanced melanoma and metastatic non-small cell lung cancer (NSCLC). Journal of Clinical Oncology, 2023,41(16_suppl).
  • Cancer Weekly. June 20, 2023; p 34.

Statistics:

  • Eight patients with melanoma (n=4) or NSCLC (n=4) have been enrolled in the IMM60 monotherapy dose cohorts.
  • One patient with NSCLC has been enrolled in the IMM60 + pembrolizumab combination cohort.
  • The median number of prior therapies in the patients enrolled in the monotherapy cohort is 3.5 (range 2-7).
  • The most common related AE is G1-2 fatigue, reported in 2 patients.
  • IMM60 has shown dose proportionality, with a terminal half-life of approximately 8 hours.