Imprime PGG / BTH1677, a soluble yeast beta-(1->3)/(1->6)-glucan

evidence_span

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experimental_model

Investigator-initiated multi-institutional single-arm phase Ib/II trial in previously treated patients

exposure

Imprime PGG at the 4 milligram per kilogram maximum tolerated dose with pembrolizumab

limitations

Single-arm with no randomised comparator, in patients who had already progressed on checkpoint blockade. Thirty patients were evaluable for efficacy.

nutrient_topic

Beta-glucan research collection; topical membership is not evidence of a direct clinical effect, and each preparation is recorded as its own entity with no family link joining any pair. · Beta-glucan

organism

Human

plain_language

Added to a checkpoint drug in patients who had already failed one, it did not help.

primary_references

[bg-p39670007] Phase Ib/II study of imprime PGG and pembrolizumab in patients with previously treated advanced non-small cell lung cancer (NSCLC): BTCRC LUN 15-017. (2024). https://pubmed.ncbi.nlm.nih.gov/39670007/ DOI: 10.21037/tlcr-24-346

tissue_or_cell_type

Advanced non-small cell lung cancer

Beta-glucan: a structural family rather than an agent, what decides whether a bound glucan actually signals, the complement route that a cereal and a yeast preparation share, and the unequal human evidence behind each (2026-09-22) · lines 333–344

AI-assisted literature curation; primary study URLs and scope retained in the document and extraction. Not publisher full text. · supports · Investigator-initiated multi-institutional single-arm phase Ib/II trial in previously treated patients · source_derived_draft · unverified_draft

### bg-no-benefit-with-pembrolizumab Confirmed objective response rate was 10% with one complete and two partial responses, median progression-free survival was 2.6 months and median overall survival was 11.1 months, prior immunotherapy negatively influenced overall survival with a hazard ratio of 2.95, and the combination of Imprime and pembrolizumab is tolerable but did not improve the outcome of advanced stage non-small cell lung cancer patients who previously progressed on anti-PD-1 or PD-L1 immunotherapies. Condition category: normal nutrient_topic: Beta-glucan research collection; topical membership is not evidence of a direct clinical effect, and each preparation is recorded as its own entity with no family link joining any pair. plain_language: Added to a checkpoint drug in patients who had already failed one, it did not help. organism: Human tissue_or_cell_type: Advanced non-small cell lung cancer experimental_model: Investigator-initiated multi-institutional single-arm phase Ib/II trial in previously treated patients limitations: Single-arm with no randomised comparator, in patients who had already progressed on checkpoint blockade. Thirty patients were evaluable for efficacy. exposure: Imprime PGG at the 4 milligram per kilogram maximum tolerated dose with pembrolizumab evidence_span: {"source_cache": "artifacts/glucan-research/39670007.abstract.txt", "locator": "Indexed abstract; zero-based, end-exclusive Unicode character offsets", "file_sha256": "2aad97fa3dcbfbdcedfc88a4fbcad902de0cbade16dcf3c94b26a9c6960ced38", "start_char": 0, "end_char": 2076, "text_sha256": "2aad97fa3dcbfbdcedfc88a4fbcad902de0cbade16dcf3c94b26a9c6960ced38"} [bg-p39670007] Phase Ib/II study of imprime PGG and pembrolizumab in patients with previously treated advanced non-small cell lung cancer (NSCLC): BTCRC LUN 15-017. (2024). https://pubmed.ncbi.nlm.nih.gov/39670007/ DOI: 10.21037/tlcr-24-346

evidence_span

{"source_cache": "artifacts/glucan-research/29486797.abstract.txt", "locator": "Indexed abstract; zero-based, end-exclusive Unicode character offsets", "file_sha256": "7e4ff586490d7fdbefa5e817f7ee8b59c72e666bfb473620331f2fb178f46789", "start_char": 0, "end_char": 2024, "text_sha256": "7e4ff586490d7fdbefa5e817f7ee8b59c72e666bfb473620331f2fb178f46789"}

experimental_model

Randomised controlled phase II trial with blinded central radiology review as the primary read

exposure

BTH1677 4 milligrams per kilogram weekly with bevacizumab, carboplatin and paclitaxel against the same backbone alone

limitations

Ninety-two patients randomised 61 to 31, with response read centrally. A higher rate of grade 3 or 4 adverse events occurred on the glucan arm.

nutrient_topic

Beta-glucan research collection; topical membership is not evidence of a direct clinical effect, and each preparation is recorded as its own entity with no family link joining any pair. · Beta-glucan

organism

Human

plain_language

A second trial pointed the same way on every measure and reached statistical significance on none of them.

primary_references

[bg-p29486797] A randomized, controlled trial evaluating the efficacy and safety of BTH1677 in combination with bevacizumab, carboplatin, and paclitaxel in first-line treatment of advanced non-small cell lung cancer. (2018). https://pubmed.ncbi.nlm.nih.gov/29486797/ DOI: 10.1186/s40425-018-0324-z

tissue_or_cell_type

Untreated advanced non-small cell lung cancer

Beta-glucan: a structural family rather than an agent, what decides whether a bound glucan actually signals, the complement route that a cereal and a yeast preparation share, and the unequal human evidence behind each (2026-09-22) · lines 320–331

AI-assisted literature curation; primary study URLs and scope retained in the document and extraction. Not publisher full text. · supports · Randomised controlled phase II trial with blinded central radiology review as the primary read · source_derived_draft · unverified_draft

### bg-second-trial-not-significant Objective response rate based on blinded central radiology review was higher in the BTH1677 arm versus control but the difference between groups was not statistically significant at 60.4% versus 43.5% with P = .2096, all other clinical endpoints also favoured the BTH1677 arm but none statistically differed between arms, and although a higher incidence of Grade 3 or 4 adverse events occurred in the BTH1677 versus control arm at 93.2% versus 66.7% no unexpected adverse events were observed while serious adverse events and discontinuations due to adverse events were lower. Condition category: normal nutrient_topic: Beta-glucan research collection; topical membership is not evidence of a direct clinical effect, and each preparation is recorded as its own entity with no family link joining any pair. plain_language: A second trial pointed the same way on every measure and reached statistical significance on none of them. organism: Human tissue_or_cell_type: Untreated advanced non-small cell lung cancer experimental_model: Randomised controlled phase II trial with blinded central radiology review as the primary read limitations: Ninety-two patients randomised 61 to 31, with response read centrally. A higher rate of grade 3 or 4 adverse events occurred on the glucan arm. exposure: BTH1677 4 milligrams per kilogram weekly with bevacizumab, carboplatin and paclitaxel against the same backbone alone evidence_span: {"source_cache": "artifacts/glucan-research/29486797.abstract.txt", "locator": "Indexed abstract; zero-based, end-exclusive Unicode character offsets", "file_sha256": "7e4ff586490d7fdbefa5e817f7ee8b59c72e666bfb473620331f2fb178f46789", "start_char": 0, "end_char": 2024, "text_sha256": "7e4ff586490d7fdbefa5e817f7ee8b59c72e666bfb473620331f2fb178f46789"} [bg-p29486797] A randomized, controlled trial evaluating the efficacy and safety of BTH1677 in combination with bevacizumab, carboplatin, and paclitaxel in first-line treatment of advanced non-small cell lung cancer. (2018). https://pubmed.ncbi.nlm.nih.gov/29486797/ DOI: 10.1186/s40425-018-0324-z

evidence_span

{"source_cache": "artifacts/glucan-research/28303530.abstract.txt", "locator": "Indexed abstract; zero-based, end-exclusive Unicode character offsets", "file_sha256": "1647608a80fde3f663b90783006859ae85ed15bc718a8d9031ba5acdb586eb7b", "start_char": 0, "end_char": 2002, "text_sha256": "1647608a80fde3f663b90783006859ae85ed15bc718a8d9031ba5acdb586eb7b"}

experimental_model

Randomised open-label multicentre phase II trial with both investigator and blinded central radiology review

exposure

BTH1677 4 milligrams per kilogram weekly with cetuximab, carboplatin and paclitaxel against the same backbone alone, randomised 2 to 1

limitations

Ninety patients, open-label, with the primary response endpoint read twice. The two reads disagree, which is the finding.

nutrient_topic

Beta-glucan research collection; topical membership is not evidence of a direct clinical effect, and each preparation is recorded as its own entity with no family link joining any pair. · Beta-glucan

organism

Human

plain_language

The doctors running the trial saw twice the response rate; the blinded reviewers saw a smaller difference that could have been chance.

primary_references

[bg-p28303530] A randomized, open-label, multicenter, phase II study evaluating the efficacy and safety of BTH1677 (1,3-1,6 beta glucan; Imprime PGG) in combination with cetuximab and chemotherapy in patients with advanced non-small cell lung cancer. (2017). https://pubmed.ncbi.nlm.nih.gov/28303530/ DOI: 10.1007/s10637-017-0450-3

tissue_or_cell_type

Advanced non-small cell lung cancer

Beta-glucan: a structural family rather than an agent, what decides whether a bound glucan actually signals, the complement route that a cereal and a yeast preparation share, and the unequal human evidence behind each (2026-09-22) · lines 307–318

AI-assisted literature curation; primary study URLs and scope retained in the document and extraction. Not publisher full text. · supports · Randomised open-label multicentre phase II trial with both investigator and blinded central radiology review · source_derived_draft · unverified_draft

### bg-the-two-reads-disagree Compared to control treatment the addition of BTH1677 numerically increased objective response rate by both investigator review at 47.8% versus 23.1% with p=0.0468 and central review at 36.6% versus 23.1% with p=0.2895, no other endpoints differed between arms, BTH1677 was well tolerated with adverse events expected of the backbone therapy predominating, and biomarker-positive patients displayed better objective response rate and overall survival than negative patients. Condition category: normal nutrient_topic: Beta-glucan research collection; topical membership is not evidence of a direct clinical effect, and each preparation is recorded as its own entity with no family link joining any pair. plain_language: The doctors running the trial saw twice the response rate; the blinded reviewers saw a smaller difference that could have been chance. organism: Human tissue_or_cell_type: Advanced non-small cell lung cancer experimental_model: Randomised open-label multicentre phase II trial with both investigator and blinded central radiology review limitations: Ninety patients, open-label, with the primary response endpoint read twice. The two reads disagree, which is the finding. exposure: BTH1677 4 milligrams per kilogram weekly with cetuximab, carboplatin and paclitaxel against the same backbone alone, randomised 2 to 1 evidence_span: {"source_cache": "artifacts/glucan-research/28303530.abstract.txt", "locator": "Indexed abstract; zero-based, end-exclusive Unicode character offsets", "file_sha256": "1647608a80fde3f663b90783006859ae85ed15bc718a8d9031ba5acdb586eb7b", "start_char": 0, "end_char": 2002, "text_sha256": "1647608a80fde3f663b90783006859ae85ed15bc718a8d9031ba5acdb586eb7b"} [bg-p28303530] A randomized, open-label, multicenter, phase II study evaluating the efficacy and safety of BTH1677 (1,3-1,6 beta glucan; Imprime PGG) in combination with cetuximab and chemotherapy in patients with advanced non-small cell lung cancer. (2017). https://pubmed.ncbi.nlm.nih.gov/28303530/ DOI: 10.1007/s10637-017-0450-3

availability_state

biomarker_context Imported condition classification; unverified.

evidence_span

{"source_cache": "artifacts/glucan-research/32132045.abstract.txt", "locator": "Indexed abstract; zero-based, end-exclusive Unicode character offsets", "file_sha256": "7dea757c889af10839a38a317d704760e7e15798bc15a5da3a1323ec4143cf42", "start_char": 0, "end_char": 1102, "text_sha256": "7dea757c889af10839a38a317d704760e7e15798bc15a5da3a1323ec4143cf42"}

experimental_model

Two single-patient reports of immunoglobulin infusion in patients with low anti-glucan antibody

exposure

BTH1677 with cetuximab or with pembrolizumab, plus intravenous immunoglobulin

limitations

Two patients. This is an anecdotal test of a mechanism, not evidence of treatment benefit, and no control condition exists for the tumour outcome.

nutrient_topic

Beta-glucan research collection; topical membership is not evidence of a direct clinical effect, and each preparation is recorded as its own entity with no family link joining any pair. · Beta-glucan

organism

Human

plain_language

Two patients who lacked the antibody were given antibody, and the drug started working.

primary_references

[bg-p32132045] Immunoglobulin Restores Immune Responses to BTH1677 in Patients With Low Levels of Antibodies to Beta-glucan. (2020). https://pubmed.ncbi.nlm.nih.gov/32132045/ DOI: 10.21873/anticanres.14090

tissue_or_cell_type

Peripheral blood and tumour

trigger_kind

biomarker_context Imported condition classification; unverified.

Beta-glucan: a structural family rather than an agent, what decides whether a bound glucan actually signals, the complement route that a cereal and a yeast preparation share, and the unequal human evidence behind each (2026-09-22) · lines 294–305

AI-assisted literature curation; primary study URLs and scope retained in the document and extraction. Not publisher full text. · supports · Two single-patient reports of immunoglobulin infusion in patients with low anti-glucan antibody · source_derived_draft · unverified_draft

### bg-adding-antibody-restores-it In two single-patient studies, one in a patient with metastatic colorectal cancer who received BTH1677 combined with the tumour targeting antibody cetuximab and a second in a patient with metastatic neuroendocrine tumour who received BTH1677 combined with the immune checkpoint inhibitor pembrolizumab, the patients had low serum titres of antibodies against beta-glucan and low innate immune effector functionality induced by BTH1677, and addition of intravenous immunoglobulins restored innate immune activity of BTH1677 and induced clinically meaningful anti-tumoural activity with long-term disease control. Condition category: biomarker_context nutrient_topic: Beta-glucan research collection; topical membership is not evidence of a direct clinical effect, and each preparation is recorded as its own entity with no family link joining any pair. plain_language: Two patients who lacked the antibody were given antibody, and the drug started working. organism: Human tissue_or_cell_type: Peripheral blood and tumour experimental_model: Two single-patient reports of immunoglobulin infusion in patients with low anti-glucan antibody limitations: Two patients. This is an anecdotal test of a mechanism, not evidence of treatment benefit, and no control condition exists for the tumour outcome. exposure: BTH1677 with cetuximab or with pembrolizumab, plus intravenous immunoglobulin evidence_span: {"source_cache": "artifacts/glucan-research/32132045.abstract.txt", "locator": "Indexed abstract; zero-based, end-exclusive Unicode character offsets", "file_sha256": "7dea757c889af10839a38a317d704760e7e15798bc15a5da3a1323ec4143cf42", "start_char": 0, "end_char": 1102, "text_sha256": "7dea757c889af10839a38a317d704760e7e15798bc15a5da3a1323ec4143cf42"} [bg-p32132045] Immunoglobulin Restores Immune Responses to BTH1677 in Patients With Low Levels of Antibodies to Beta-glucan. (2020). https://pubmed.ncbi.nlm.nih.gov/32132045/ DOI: 10.21873/anticanres.14090

availability_state

biomarker_context Imported condition classification; unverified.

evidence_span

{"source_cache": "artifacts/glucan-research/30988115.abstract.txt", "locator": "Indexed abstract; zero-based, end-exclusive Unicode character offsets", "file_sha256": "bd9bd1b314472b30b2e3513ecb5e048178de145217473fa87379e0977d21f90d", "start_char": 0, "end_char": 1787, "text_sha256": "bd9bd1b314472b30b2e3513ecb5e048178de145217473fa87379e0977d21f90d"}

experimental_model

Single and multiple intravenous infusions in healthy volunteers stratified by pre-treatment antibody level, with and without premedication

exposure

Imprime PGG 4 milligrams per kilogram intravenously, with antihistamine and corticosteroid premedication in some subjects

limitations

Healthy volunteers and pharmacodynamic endpoints only. Nothing here measures a tumour outcome, so the antibody strata are not validated treatment-selection thresholds.

nutrient_topic

Beta-glucan research collection; topical membership is not evidence of a direct clinical effect, and each preparation is recorded as its own entity with no family link joining any pair. · Beta-glucan

organism

Human

plain_language

Below a certain antibody level almost nothing happened; above it, the drug worked and also caused the infusion reactions.

primary_references

[bg-p30988115] Immune Pharmacodynamic Responses of the Novel Cancer Immunotherapeutic Imprime PGG in Healthy Volunteers. (2019). https://pubmed.ncbi.nlm.nih.gov/30988115/ DOI: 10.4049/jimmunol.1801533

tissue_or_cell_type

Peripheral blood

trigger_kind

biomarker_context Imported condition classification; unverified.

Beta-glucan: a structural family rather than an agent, what decides whether a bound glucan actually signals, the complement route that a cereal and a yeast preparation share, and the unequal human evidence behind each (2026-09-22) · lines 281–292

AI-assisted literature curation; primary study URLs and scope retained in the document and extraction. Not publisher full text. · supports · Single and multiple intravenous infusions in healthy volunteers stratified by pre-treatment antibody level, with and without premedication · source_derived_draft · unverified_draft

### bg-antibody-level-gates-the-response At the end of infusion free serum antibody levels decreased, circulating immune complex levels increased and complement activation was observed, at approximately 1 to 4 hours after end of infusion increased expression of cytokines and chemokines, a 1.5 to 4-fold increase in neutrophil and monocyte counts and a broad activation of innate immune genes were observed, low-antibody subjects with levels below 20 micrograms per millilitre typically showed minimal changes except when their levels rose above 20 micrograms per millilitre after repeated dosing, mild-to-moderate infusion-related reactions occurred in subjects with antibody at or above 20 micrograms per millilitre, and premedications alleviated some of the infusion-related reactions but also inhibited cytokine responses. Condition category: biomarker_context nutrient_topic: Beta-glucan research collection; topical membership is not evidence of a direct clinical effect, and each preparation is recorded as its own entity with no family link joining any pair. plain_language: Below a certain antibody level almost nothing happened; above it, the drug worked and also caused the infusion reactions. organism: Human tissue_or_cell_type: Peripheral blood experimental_model: Single and multiple intravenous infusions in healthy volunteers stratified by pre-treatment antibody level, with and without premedication limitations: Healthy volunteers and pharmacodynamic endpoints only. Nothing here measures a tumour outcome, so the antibody strata are not validated treatment-selection thresholds. exposure: Imprime PGG 4 milligrams per kilogram intravenously, with antihistamine and corticosteroid premedication in some subjects evidence_span: {"source_cache": "artifacts/glucan-research/30988115.abstract.txt", "locator": "Indexed abstract; zero-based, end-exclusive Unicode character offsets", "file_sha256": "bd9bd1b314472b30b2e3513ecb5e048178de145217473fa87379e0977d21f90d", "start_char": 0, "end_char": 1787, "text_sha256": "bd9bd1b314472b30b2e3513ecb5e048178de145217473fa87379e0977d21f90d"} [bg-p30988115] Immune Pharmacodynamic Responses of the Novel Cancer Immunotherapeutic Imprime PGG in Healthy Volunteers. (2019). https://pubmed.ncbi.nlm.nih.gov/30988115/ DOI: 10.4049/jimmunol.1801533

evidence_span

{"source_cache": "artifacts/glucan-research/27812183.abstract.txt", "locator": "Indexed abstract; zero-based, end-exclusive Unicode character offsets", "file_sha256": "949fc5939bec2e3fab259b6b6161fba8cdd7779c7efa0261a1e7dbf1cab111cf", "start_char": 0, "end_char": 1493, "text_sha256": "949fc5939bec2e3fab259b6b6161fba8cdd7779c7efa0261a1e7dbf1cab111cf"}

experimental_model

Whole blood from healthy human subjects with antibody-depleted and antibody-supplemented conditions

exposure

Imprime PGG in whole blood across a range of naturally occurring anti-beta-glucan antibody levels

limitations

Ex vivo whole blood rather than treated patients. The antibody dependence is demonstrated both by absence in low-antibody donors and by rescue with added antibody.

nutrient_topic

Beta-glucan research collection; topical membership is not evidence of a direct clinical effect, and each preparation is recorded as its own entity with no family link joining any pair. · Beta-glucan

organism

Human

plain_language

This soluble glucan does nothing on its own; it has to be caught by an antibody the person already had.

primary_references

[bg-p27812183] Imprime PGG-Mediated Anti-Cancer Immune Activation Requires Immune Complex Formation. (2016). https://pubmed.ncbi.nlm.nih.gov/27812183/ DOI: 10.1371/journal.pone.0165909

tissue_or_cell_type

Whole blood, neutrophil and monocyte

Beta-glucan: a structural family rather than an agent, what decides whether a bound glucan actually signals, the complement route that a cereal and a yeast preparation share, and the unequal human evidence behind each (2026-09-22) · lines 268–279

AI-assisted literature curation; primary study URLs and scope retained in the document and extraction. Not publisher full text. · supports · Whole blood from healthy human subjects with antibody-depleted and antibody-supplemented conditions · source_derived_draft · unverified_draft

### bg-imprime-needs-an-antibody-first Imprime-induced anti-cancer functionality is dependent on immune complex formation with naturally-occurring anti-beta glucan antibodies, the formation of Imprime-antibody complexes activates complement primarily via the classical complement pathway and is opsonised by iC3b, immune complex binding depends upon Complement Receptor 3 and Fc gamma Receptor IIa eliciting phenotypic activation of and enhanced chemokine production by neutrophils and monocytes enabling these effector cells to kill antibody-opsonized tumour cells, and importantly these innate immune cell changes were not evident in subjects with low antibody levels but could be rescued with exogenous antibody supplementation. Condition category: normal nutrient_topic: Beta-glucan research collection; topical membership is not evidence of a direct clinical effect, and each preparation is recorded as its own entity with no family link joining any pair. plain_language: This soluble glucan does nothing on its own; it has to be caught by an antibody the person already had. organism: Human tissue_or_cell_type: Whole blood, neutrophil and monocyte experimental_model: Whole blood from healthy human subjects with antibody-depleted and antibody-supplemented conditions limitations: Ex vivo whole blood rather than treated patients. The antibody dependence is demonstrated both by absence in low-antibody donors and by rescue with added antibody. exposure: Imprime PGG in whole blood across a range of naturally occurring anti-beta-glucan antibody levels evidence_span: {"source_cache": "artifacts/glucan-research/27812183.abstract.txt", "locator": "Indexed abstract; zero-based, end-exclusive Unicode character offsets", "file_sha256": "949fc5939bec2e3fab259b6b6161fba8cdd7779c7efa0261a1e7dbf1cab111cf", "start_char": 0, "end_char": 1493, "text_sha256": "949fc5939bec2e3fab259b6b6161fba8cdd7779c7efa0261a1e7dbf1cab111cf"} [bg-p27812183] Imprime PGG-Mediated Anti-Cancer Immune Activation Requires Immune Complex Formation. (2016). https://pubmed.ncbi.nlm.nih.gov/27812183/ DOI: 10.1371/journal.pone.0165909