Ten clinical trials are completed or ongoing. The corresponding protocols are termed P001 to P010. The first trial of IMP321 tested alone (monotherapy) has shown that 6 mg is the effective dose to increase over time the number of long-lived effector-memory CD8 T cells (i.e. immune cells responsible for tumor regression) in all patients. It also significantly increases the percentage of progression-free survival patients at the post-study visit. The chemo-immunotherapy trials are to provide therapeutic efficacy proof-of-concept in man in indications with very large potential markets. In the metastatic breast cancer trial, the addition of 12 s.c. injections IMP321 over 6 months doubled the tumor response rate compared to a cohort of patients receiving the standard chemotherapy only regimen. The vaccine adjuvant trials where a low-dose IMP321 is mixed with antigens before injection are designed to establish IMP321 as the gold standard T cell adjuvant for therapeutic vaccines.
Overall, more than 600 s.c. injections of IMP321 have been administered since 2005 and the product has a good local and systemic tolerability profile. The product is also non-immunogenic (i.e. anti-IMP321 antibodies were not detected).
P003: IMP321 in metastatic kidney cancer (21 patients, Paris) completed:
P005: IMP321 plus paxlitaxel in metastatic breast cancer (30 patients, Paris) completed:
P008: IMP321 plus gemcitabine in advanced pancreatic cancer (17 patients, Saint-Louis, USA) terminated:
P001: IMP321 alone or with influenza Ag (60 healthy volunteers, Paris) completed:
P002: IMP321 + HBsAg (48 healthy volunteers, Paris) completed:
P006: IMP321 + 8 melanoma peptides in disease-free melanoma (28 patients, Brussels) completed:
P007: IMP321 + a melanoma peptide in metastatic melanoma treated by lymphoablative chemotherapy and lympho-reconstitution (12 patients, Lausanne) completed.
P009: IMP321 + 6 melanoma peptides in metastatic melanoma (27 patients, Lausanne) recruiting:
P010: IMP321 + 5 survivin peptides in prostate carcinoma patients with biochemical failure (PROVAX study)(20 patients, Milan) recruiting): http://www.istitutotumori.mi.it/default.asp