Imprime PGG

also known as BTH1677 · imprime

Developed for: non-small cell lung carcinoma · colorectal cancer · breast cancer · colorectal carcinoma · cutaneous melanoma · head and neck squamous cell carcinoma · indolent B-cell non-Hodgkin lymphoma · malignant pancreatic neoplasm
+2 more
· melanoma · triple-negative breast carcinoma
Investigated by: HiberCell, Inc. · Merck Sharp & Dohme LLC · Dana-Farber Cancer Institute · Hoffmann-La Roche · Lawrence Feldman, MD · University of Illinois at Chicago

Trials 12

today NCT05159778 · Ph 2 NCT04995094 · Ph 2 NCT03555149 · Ph 1/2 NCT03246685 · Ph 2 NCT03003468 · Ph 1/2 NCT02981303 · Ph 2 NCT02086175 · Ph 2 NCT02132403 · Ph 1 NCT01309126 · Ph 3 NCT00874848 · Ph 2 NCT00874107 · Ph 2 NCT00545545 · Ph 1/2

20082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 11 trial
Phase 1	NCT02132403	Aug 2014 → Apr 2015	malignant pancreatic neoplasm	University of Illinois at Chicago	Terminated	No outcome recorded
Phase 1/23 trials
Phase 1/2	NCT03555149	Sep 2018 → Sep 2022	colorectal cancer	Hoffmann-La Roche	Terminated	No outcome recorded Stop: Enrollment
Phase 1/2	NCT03003468	Jul 2017 → Nov 2021	non-small cell lung carcinoma	Lawrence Feldman, MD	Completed	No outcome recorded
Phase 1/2	NCT00545545	Oct 2007 → Dec 2009	colorectal carcinoma	HiberCell, Inc.	Completed	No outcome recorded
Phase 27 trials · 2 missed
Phase 2	NCT05159778	Nov 2021 → Mar 2023	breast cancer	HiberCell, Inc.	Completed	No outcome recorded
Phase 2	NCT04995094	Aug 2021 → Feb 2023	cutaneous melanoma	HiberCell, Inc.	Withdrawn	No outcome recorded Stop: Enrollment
Phase 2	NCT03246685	Nov 2017 → Apr 2018	head and neck squamous cell carcinoma	HiberCell, Inc.	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT02981303	Feb 2017 → Dec 2020	melanoma, triple-negative breast carcinoma	HiberCell, Inc.	Completed	No outcome recorded
Phase 2	NCT02086175	Dec 2014 → Jul 2019	indolent B-cell non-Hodgkin lymphoma	Dana-Farber Cancer Institute	Completed	No outcome recorded
Phase 2	NCT00874848	Aug 2009 → Nov 2012	non-small cell lung carcinoma	HiberCell, Inc.	Completed	Missed primary
Phase 2	NCT00874107	Jun 2009 → Apr 2016	non-small cell lung carcinoma	HiberCell, Inc.	Completed	Missed primary
Phase 31 trial
Phase 3	NCT01309126	Apr 2011 → Feb 2017	colorectal cancer	HiberCell, Inc.	Terminated	No outcome recorded Stop: Enrollment
Comparator or background therapy3 trials
Phase 1	NCT00542464 Comparator	May → Sep 2006	—	HiberCell, Inc.	Completed	No outcome recorded
Phase 1	NCT00542217 Comparator	Dec 2005 → Apr 2006	—	HiberCell, Inc.	Completed	No outcome recorded
Phase 1/2	NCT00542529 Comparator	Nov → Dec 2006	—	HiberCell, Inc.	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 1

Date	Issuer	Release
2018-03-14	Merck Sharp & Dohme LLC	Results First-Line Lung Cancer Data and Other New Research from Merck’s Broad Oncology Program to be Presented at AACR Annual Meeting merck.com ↗ Imprime PGG, a soluble yeast β-glucan PAMP, in combination with Pembrolizumab induces infiltration and activation of both innate and adaptive immune cells within tumor sites in melanoma and triple-negative breast cancer (TNBC) patients.

All press releases naming this drug 1 release

Date	Issuer	Release
2018-03-14	Merck Sharp & Dohme LLC	First-Line Lung Cancer Data and Other New Research from Merck’s Broad Oncology Program to be Presented at AACR Annual Meeting merck.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 17 sources stand behind the page.

Field	Value	Cited text
Known as	Imprime PGG	“Imprime PGG 2 mg/kg IV on Days 1, 8, 15 for Cycles 1-4” NCT03003468 ↗ 14 NCT00874107 ↗ NCT01309126 ↗ NCT05159778 ↗ NCT02132403 ↗ NCT00874848 ↗ NCT00545545 ↗ NCT02981303 ↗ NCT02086175 ↗ NCT04995094 ↗ NCT00542464 ↗ Show 4 more sources
Known as	BTH1677	“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...” PMID 28303530 ↗ Mar 2017
Known as	imprime	“Imprime PGG (imprime), a pathogen-associated molecular pattern (PAMP), through pattern recognition receptors, successfully illicit a broad-based innate immune response in...” PMID 39670007 ↗ Nov 2024
Modality	Other / unclassified	“Imprime PGG, a glucan contained in yeast” NCT02132403 ↗
Route	Intravenous	“single intravenous dose of Imprime PGG when administered to healthy adult subjects” NCT00542217 ↗