Biological activity of most relevant β-glucans investigated in clinical studies

Clinical trial (ref.)FeaturesPatientsβ-glucans/other drugsResults
Halstenson CE, et al., [96]Phase 1a/b.
Single center, randomized, double-bind, placebo-controlled, dose escalation study
Healthy volunteer subjectsImprime PGGAcceptable safety profile, well tolerated
NCT03246685 [97]Phase 2.
Multicenter, open-label study
Advanced Squamous Cell Carcinoma of H&N (SCCHN) patientsImprime PGG & PembrolizumabTerminated for enrollment failure
Uhlik M, et al., [98]Phase 2.
Multicenter, open-label study
44 ABA positive mTNBC patientsImprime PGG & PembrolizumabmTNBC:
- 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 patientsImprime PGG & PembrolizumabMelanoma 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 patientsOral 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 remissionβ-glucan & bivalent gangliosides vaccineAcceptable safety profile, well tolerated
NCT03003468 [102]Phase 1b/2.mNSCLC patientsImprime PGG & PembrolizumabOn 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