Biological activity of most relevant β-glucans investigated in clinical studies
| Clinical trial (ref.) | Features | Patients | β-glucans/other drugs | Results |
|---|---|---|---|---|
| Halstenson CE, et al., [96] | Phase 1a/b.Single center, randomized, double-bind, placebo-controlled, dose escalation study | Healthy volunteer subjects | Imprime PGG | Acceptable safety profile, well tolerated |
| NCT03246685 [97] | Phase 2.Multicenter, open-label study | Advanced Squamous Cell Carcinoma of H&N (SCCHN) patients | Imprime PGG & Pembrolizumab | Terminated for enrollment failure |
| Uhlik M, et al., [98] | Phase 2.Multicenter, open-label study | 44 ABA positive mTNBC patients | Imprime PGG & Pembrolizumab | mTNBC:- Objective response rate (ORR) was 15.9%, with 1 complete response (CR) and 6 partial responses (PR)- 17/44 shown stable diseases (SD) for more than 1 year (best response) and 4/44 for more than 2 years- Overall survival (OS) rate at 1 year was ~ 63%; median OS is 18.1 months by Kaplaian-Meyer estimation (95% CI, 12 months-not reached) |
| Chan A, et al., [99] | Phase 2.Multicenter, open-label study | 40 ABA positive metastatic melanoma patients | Imprime PGG & Pembrolizumab | Melanoma patients:- disease control rate (DCR) was 45% (with 1 CR and 8 SD)- median OS was 8.8 months (with 12 month OS rate equal to 45%) |
| Modak S, et al., [100] | Phase 1. | 24 chemo-resistant NB patients | Oral β-glucan & 3F8 | - Acceptable safety profile, well tolerated- The maximum dose tolerated of β-glucan was not reached- A clinical response was observed in 63% of patients |
| Kushner BH, et al., [101] | Phase 1. | 15 high-risk NB patients in remission | β-glucan & bivalent gangliosides vaccine | Acceptable safety profile, well tolerated |
| NCT03003468 [102] | Phase 1b/2. | mNSCLC patients | Imprime PGG & Pembrolizumab | On going |
| NCT03555149 [103] | Phase 1b/2.Open-label, multicenter, randomized Umbrella study | mCRC patients (cohort 3) | Imprime PGG & Atezolizumab (cohort 3) | On going |
mCRC: metastatic CRC; mNSCLC: metastatic NSCLC; mTNBC: metastatic triple-negative breast cancer; NB: neuroblastoma