QBECO SSI / Qu Biologics - LARVOL DELTA

Qu Biologics’ Immunomodulator Improves Fatty Liver Disease (GlobeNewswire) - "Qu Biologics Inc...is pleased to report exciting data demonstrating that Qu Biologics’ QBECO SSI markedly improves fatty liver disease and its deleterious consequences in an animal model of preexisting obesity...In a series of studies at McMaster, Dr. Schertzer’s research group demonstrated that treatment with QBECO SSI resulted in a marked reduction in liver fat, inflammation, and fibrosis in fatty liver disease...Qu’s QBECO SSI is designed to work in a very different way by restoring innate immune function to directly clear not just fat infiltration but inflammation and fibrosis as well. Through this very novel mechanism, it is possible that Qu’s QBECO SSI may provide a more optimal way to clear inflammation and fibrosis to prevent the major sequalae of MAFLD and MASH in these challenging diseases."

Preclinical • Fibrosis • Inflammation • Metabolic Dysfunction-Associated Steatohepatitis

Qu Biologics’ Site Specific Immunomodulator Enables CAR T-cell Cancer Efficacy in Solid Tumor (GlobeNewswire) - "Qu Biologics...is pleased to report exciting survival data using a combination of Qu Biologics’ QBECO SSI and CAR T-cell therapy in laboratory models of aggressive cancer. The study was conducted in collaboration with the Yong Loo Lin School of Medicine, National University of Singapore (NUS Medicine). In this experimental study, scientists demonstrated that combining QBECO SSI with CAR T-cell therapy significantly improved survival rates compared to CAR T-cell therapy alone, achieving an impressive 80% survival rate after 31 days of treatment. In contrast, the survival rate for CAR T-cell therapy alone was notably low, falling to 0% after just 18 days of treatment. These study results are important because CAR T-cell therapy, while very effective in certain kinds of blood cancer, has not been effective in solid tumors, which represent more than 95% of all cancers."

Preclinical • Solid Tumor

Qu Biologics and Foundation Medicine Collaborate to Impact the Care of Patients with Late-Stage Colorectal Cancer (GlobeNewswire) - "Qu Biologics Inc...and Foundation Medicine, Inc. are pleased to announce a partnership aimed to impact the care of patients with late-stage colorectal cancer undergoing surgery...Qu Biologics is currently enrolling patients with late-stage colorectal cancer undergoing surgical resection of liver metastases in a randomized, placebo-controlled Phase II multicenter trial (PERIOP-06) to assess the effectiveness of QBECO SSI in reducing post-operative immune suppression and improving cancer outcomes. The engagement with Foundation Medicine will enable genomic profiling at both the genomic and transcriptomic levels of patients participating in the trial to predict response to Qu’s first-in-class immunotherapy and molecularly assess minimal residual disease longitudinally. This unique study will enable assessment of the relationships between the results of Foundation Medicine’s comprehensive genomic profiling, the change in patients’ immune..."

Enrollment status • Licensing / partnership • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Tracking the fate of bacteria-derived site-specific immunomodulators by positron emission tomography. (PubMed, Nucl Med Biol) - "Radiolabeling of SSIs allows for longitudinal in vivo imaging of biodistribution and trafficking. PET imaging revealed differential biodistribution of the SSIs based on the organotropism of the bacteria from which the SSI is derived. Trafficking from the site of injection to the targeted site is in part mediated via the lymphatics and involves macrophages and neutrophils."

Immunomodulating • Journal • Chronic Obstructive Pulmonary Disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Qu Biologics Receives Accelerating Clinical Trial (ACT) Funding for PERIOP-06 Clinical Trial (GlobeNewswire) - "Qu Biologics Inc...is pleased to announce that its Phase 2 clinical trial in late-stage colon cancer, PERIOP-06, was awarded CAD$400,000 in grant funding by the Accelerating Clinical Trial (ACT) Canadian Consortium....PERIOP-06 is a randomized, placebo-controlled, double-blind study to assess the effectiveness of QBECO SSI in relieving post-operative immune suppression and improving survival in patients undergoing surgery for late-stage colon cancer."

Financing • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

PERIOP-06: A Study of QBECO Versus Placebo in the Treatment of Colorectal Cancer That Has Spread to the Liver (clinicaltrials.gov) - P2 | N=115 | Recruiting | Sponsor: Sunnybrook Health Sciences Centre | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2023 ➔ Aug 2023

Enrollment open • Immunomodulating • Metastases • Trial initiation date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Solid Tumor

PERIOP-06: A Study of QBECO Versus Placebo in the Treatment of Colorectal Cancer That Has Spread to the Liver (clinicaltrials.gov) - P2 | N=115 | Not yet recruiting | Sponsor: Sunnybrook Health Sciences Centre

Immunomodulating • Metastases • New P2 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Immune Modulation • Inflammation • Oncology • Solid Tumor

Qu Biologics and Karolinska Institute Initiate Important New Collaboration to Validate Molecular Mechanisms of Qu Biologics’ First-in-Class Immunotherapy Platform (GlobeNewswire) - "Qu Biologics...announce a new collaboration with Associate Professor Jonas Fuxe and his research team at the Karolinska Institute (KI) in Stockholm, Sweden, to characterize the molecular targets of Qu's SSI therapy at the tissue level that lead to resolution of disease. This collaboration will include assessment of tissue biopsies from the gastrointestinal (GI) tract of patients with moderate-to-severe Crohn’s disease (CD) who experienced histological healing upon treatment with QBECO, Qu’s GI-targeting SSI."

Licensing / partnership • Crohn's disease • Immunology

Qu Biologics to Launch Phase 2B Clinical Trial to Assess Reduction of Postoperative Immune Suppression and Disease Progression in Patients with Late-Stage Colorectal Cancer (GlobeNewswire) - "Qu Biologics Inc...is pleased to announce it has received Health Canada clearance (No Objection Letter) and institutional-level ethics approval to proceed with a randomized placebo-controlled Phase II multicenter trial to assess the effectiveness of QBECO SSI in reducing postoperative immune suppression and improving cancer outcomes in patients with late-stage colorectal cancer undergoing surgical resection of liver metastases....Two additional Phase 2 randomized placebo-controlled studies, in late-stage colon cancer and immunosenescence, will begin enrolling in Q4 2022."

Enrollment status • New P2 trial • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Qu Biologics Closes USD$12M Equity Financing (Yahoo Finance) - "Qu Biologics Inc...is pleased to announce the closing of a USD$12M equity financing to enable expansion of Qu’s team, initiation of an additional three Phase 2 clinical studies, and the acceleration of Qu’s novel immunomodulation platform....'Given the broad application of our SSI platform, this funding brings Qu Biologics one step closer to providing critical, game-changing treatments for people living with cancer, infections, and chronic inflammatory diseases.'"

Financing • Inflammatory Bowel Disease

Qu Biologics’ Phase 2 RESTORE trial data presented at 2021 European Crohn’s and Colitis Congress (GlobeNewswire) - P2, N=20; RESTORE (NCT03472690); Sponsor: Qu Biologics Inc.; "Qu Biologics Inc...is pleased to announce that data from Qu’s RESTORE clinical trial was presented at the 16th Congress of the European Crohn’s and Colitis Organization (ECCO). Selected for oral presentation, the data was presented on Saturday, July 10th...demonstrated both symptom improvement/remission and endoscopic response. Clinical symptom and endoscopic response occurred in both patients who were naïve to previous immunosuppressive biologic therapies and in those who had previously failed these therapies."

P2 data • Crohn's disease • Inflammatory Bowel Disease

[VIRTUAL] RESTORE: Interim analysis of a Phase 2 study of QBECO SSI for the induction and maintenance of clinical and endoscopic remission in subjects with Moderate to Severe Crohn’s Disease (ECCO-IBD 2021) - "Both biologics naïve and experienced patients showed response to QBECO SSI treatment by Weeks 26 and 52, with higher response rates in biologics naïve patients. QBECO SSI was well tolerated."

Clinical • P2 data • Crohn's disease • Immunology • Inflammatory Bowel Disease

Results from Qu Biologics’ Crohn’s Disease RESTORE Trial Selected for Oral Presentation at ECCO 2021 (GlobeNewswire) - "Qu Biologics Inc...pleased to announce that the data from QBECO-CD-02, Qu’s Phase 2 study of QBECO SSI treatment for Crohn’s disease, was selected for an oral presentation at the 16th Congress of European Crohn’s and Colitis Organization (ECCO), a leading GI conference...RESTORE: Interim analysis of a Phase 2 study of QBECO SSI for the induction and maintenance of clinical and endoscopic remission in subjects with Moderate-to-Severe Crohn’s Disease – at 09:20-09:30 (CEST), Saturday, July 10."

P2 data • Crohn's disease • Inflammatory Bowel Disease

QBECO-CD-02: QBECO SSI for Clinical and Endoscopic Remission in Moderate to Severe Crohn's Disease (clinicaltrials.gov) - P2; N=20; Terminated; Sponsor: Qu Biologics Inc.; Active, not recruiting ➔ Terminated; Corporate Decision to terminate study after Lead-In portion of the study completed.

Clinical • Trial termination • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

Positive Signals for Endoscopic and Histologic Response in Patients with Crohn’s Disease Treated with Qu Biologics’ QBECO (GlobeNewswire) - P2, N=20; RESTORE (NCT03472690); Sponsor: Qu Biologics Inc.; "Qu Biologics Inc...pleased to report positive signs of clinical, endoscopic and histologic response in subjects participating in Stage 1 of their Phase 2 RESTORE trial...'We are very encouraged to see QBECO demonstrate an objective biologic effect in the gastrointestinal tract of patients with Crohn’s disease'...Results from Stage 1 of the RESTORE Trial are anticipated to be available in February 2021. This data will inform the design of Stage 2 of the study, which is planned to be a larger international randomized placebo-controlled trial (n=150) for the treatment of patients with moderate-to-severe Crohn’s disease."

P2 data • Crohn's disease • Inflammatory Bowel Disease

Qu Biologics Completes $8M Financing (GlobeNewswire) - "Qu Biologics Inc...is pleased to announce an oversubscribed $8 million financing. With the proceeds, Qu Biologics will complete stage 1 of the RESTORE Phase 2 clinical trial for patients with moderate to severe Crohn’s disease and its Phase 2 Study to assess activation of anti-cancer immune response in colon cancer...'We are pleased to have oversubscribed our bridge round based on the promising interim data from our RESTORE trial and we are looking forward to the important full data from our two studies, which will both complete in the first half of 2021,' said Hal Gunn, MD, CEO of Qu."

Financing • P2 data • Colon Cancer • Crohn's disease • Inflammatory Bowel Disease • Oncology

Novel Escherichia coli-Derived Therapeutic Immunotherapies Reduce Innate Immune Responses to Protect MUC-2 Deficient Mice from Spontaneous Colitis (ICMI 2017) - "These data demonstrate QBECO treatment ameliorates spontaneous colitis in aged Muc2-/- mice. Together, these findings may have broader implications for our understanding of IBD pathology and aid in the development of novel immunotherapeutics focused on reconstituting normal immune function in the context of IBD."

Preclinical • Immunology • Inflammation • Inflammatory Bowel Disease

QBECO SSI for Clinical and Endoscopic Remission in Moderate to Severe Crohn's Disease (clinicaltrials.gov) - P2; N=20; Active, not recruiting; Sponsor: Qu Biologics Inc.; Recruiting ➔ Active, not recruiting; N=170 ➔ 20; Trial completion date: Sep 2019 ➔ Dec 2020; Trial primary completion date: Jan 2019 ➔ Dec 2020

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date

Qu Biologics Completes Enrollment in First Stage of Phase 2 Clinical Trial in Moderate to Severe Crohn’s Disease (GlobeNewswire, Qu Biologics, Inc.) - "Qu Biologics Inc...is pleased to announce the completion of enrollment for the first stage of the RESTORE clinical trial, 'A Phase 2...Study of QBECO SSI for the Induction and Maintenance of Clinical and Endoscopic Remission in Subjects with Moderate to Severe Crohn’s Disease'. In this open-label first stage of a 170-patient study, 20 patients with moderate to severe Crohn’s disease will be treated for up to 52 weeks with the novel investigational agent, QBECO SSI, which is designed to restore, rather than suppress, immune function."

Enrollment closed

Immune Stimulation Using a Gut Microbe-Based Immunotherapy Reduces Disease Pathology and Improves Barrier Function in Ulcerative Colitis. (PubMed, Front Immunol) - "The most rapid and noticeable change observed in QBECO treated UC patients was a marked reduction in rectal bleeding. Collectively, this work demonstrates for the first time that strategically activating immune function rather than suppressing it, not only does not worsen colitis induced-damage, but may lead to an objective reduction in UC disease pathology."

Journal

Novel Microbial-Based Immunotherapy Approach for Crohn's Disease. (PubMed, Front Med (Lausanne)) - P1/2; "...Aims: To assess safety, efficacy, and tolerability of a novel microbial-derived immunotherapy, QBECO, that aims to restore rather than suppress immune function in CD...Larger trials are now needed to confirm clinical improvement and the unique biological findings. Clinical Trial Number: NCT01809275 (https://clinicaltrials.gov/ct2/show/NCT01809275)."

Biomarker • IO Biomarker • Journal