Erratum: Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer

Dalgleish, Angus; Stebbing, Justin; Adamson, Douglas; Arif, S.A.M.; Bidoli, Paolo; Chang, D.T.; Cheeseman, Sue; Díaz‐Beveridge, Roberto; Fernández-Martos, Carlos; Glynne-Jones, R.; Granetto, Cristina; Massutí, Bartomeu; McAdam, Karen; McDermott, Ray; Martin, A.; Papamichael, D.; Pazo-Cid, Roberto; Viéitez, J.M.; Zaniboni, Alberto; Carroll, K. K.; Wagle, Shama; Gaya, A.; Mudan, Satvinder

doi:10.1038/bjc.2016.342

Cited by 17 publications

(13 citation statements)

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“…IMM-101 has been successfully used in stage 4 melanoma trials as a single agent (Stebbing et al, 2012). Furthermore, it has shown an ability to enhance responses to check point inhibitors (Dalgleish et al, 2018) as well as to increase the effectiveness of Gemcitabine in a randomized study in patients with advanced pancreatic cancer where a significant survival and quality of life benefit was seen on the IMM-101/Gemcitabine arm versus Gemcitabine alone (Dalgleish et al, 2016).…”

Section: Adjuvants Are Not Secondary Considerationsmentioning

confidence: 99%

Biovacc-19: A Candidate Vaccine for Covid-19 (SARS-CoV-2) Developed from Analysis of its General Method of Action for Infectivity

Sørensen¹,

Susrud²,

Dalgleish

2020

QRB Discovery

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This study presents the background, rationale and method of action of Biovacc-19, a candidate vaccine for corona virus disease 2019 (Covid-19), now in advanced preclinical development, which has already passed the first acute toxicity testing. Unlike conventionally developed vaccines, Biovacc-19’s method of operation is upon nonhuman-like (NHL) epitopes in 21.6% of the composition of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)’s spike protein, which displays distinct distributed charge including the presence of a charged furin-like cleavage site. The logic of the design of the vaccine is explained, which starts with empirical analysis of the aetiology of SARS-CoV-2. Mistaken assumptions about SARS-CoV-2’s aetiology risk creating ineffective or actively harmful vaccines, including the risk of antibody-dependent enhancement. Such problems in vaccine design are illustrated from past experience in the human immunodeficiency viruses domain. We propose that the dual effect general method of action of this chimeric virus’s spike, including receptor binding domain, includes membrane components other than the angiotensin-converting enzyme 2 receptor, which explains clinical evidence of its infectivity and pathogenicity. We show the nonreceptor dependent phagocytic general method of action to be specifically related to cumulative charge from insertions placed on the SARS-CoV-2 spike surface in positions to bind efficiently by salt bridge formations; and from blasting the spike we display the NHL epitopes from which Biovacc-19 has been down-selected.

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Section: Adjuvants Are Not Secondary Considerationsmentioning

confidence: 99%

Biovacc-19: A Candidate Vaccine for Covid-19 (SARS-CoV-2) Developed from Analysis of its General Method of Action for Infectivity

Sørensen¹,

Susrud²,

Dalgleish

2020

QRB Discovery

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“…Since IMM-101 is a heat killed preparation, treatment is not associated with the potential side-effects of delivering live or attenuated organisms (195). Moreover, one can speculate that IMM-101, by virtue of its potent type 1 inducing ability, will counter-regulate type 2 responses, helping to explain the encouraging clinical results to date in melanoma and pancreatic cancer (195,196). An open label, Phase 2 study of IMM-101 in combination with checkpoint inhibitor therapy Nivolumab is currently underway in patients with advanced melanoma in the United Kingdom (197).…”

Section: Mycobacterium Obuense (Imm-101)mentioning

confidence: 99%

“…IMM-101 is a preparation of heat killed, whole cell, M. obuense National Collection of Type Cultures (NCTC) 13365, one of over 100 named species within the genus Mycobacterium , and an “old friend.” M. obuense is a rapidly dividing mycobacterium that normally grows as an environmental saprophyte ( 194 ). Since IMM-101 is a heat killed preparation, treatment is not associated with the potential side-effects of delivering live or attenuated organisms ( 195 ). Moreover, one can speculate that IMM-101, by virtue of its potent type 1 inducing ability, will counter-regulate type 2 responses, helping to explain the encouraging clinical results to date in melanoma and pancreatic cancer ( 195 , 196 ).…”

Section: Trained Immunity Utility For Vaccinesmentioning

confidence: 99%

Mitigating Coronavirus Induced Dysfunctional Immunity for At-Risk Populations in COVID-19: Trained Immunity, BCG and “New Old Friends”

et al. 2020

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The novel, highly contagious coronavirus SARS-CoV-2 spreads rapidly throughout the world, leading to a deadly pandemic of a predominantly respiratory illness called COVID-19. Safe and effective anti-SARS-CoV-2 vaccines are urgently needed. However, emerging immunological observations show hallmarks of significant immunopathological characteristics and dysfunctional immune responses in patients with COVID-19. Combined with existing knowledge about immune responses to other closely related and highly pathogenic coronaviruses, this could forebode significant challenges for vaccine development, including the risk of vaccine failure. Animal data from earlier coronavirus vaccine efforts indicate that elderly people, most at risk from severe COVID-19 disease, could be especially at risk from immunopathologic responses to novel coronavirus vaccines. Bacterial "new old friends" such as Bacille Calmette-Guérin (BCG) or Mycobacterium obuense have the ability to elevate basal systemic levels of type 1 cytokines and immune cells, correlating with increased protection against diverse and unrelated infectious agents, called "trained immunity." Here we describe dysfunctional immune responses induced by coronaviruses, representing potentially difficult to overcome obstacles to safe, effective vaccine development for COVID-19, and outline how trained immunity could help protect high risk populations through immunomodulation with BCG and other "new old friends."

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“…Mycobacteria play an irreplaceable role in modulating immune responses by enhancing the crosstalk between innate and adaptive immunity. A phase II, randomized, open-label study of heat-killed mycobacterium obuense IMM-101 plus gemcitabine was well tolerated but not significantly improved in midian OS among APC patients (6.7 vs 5.6 months, P = 0.074) [ 87 , 88 ]. However, OS was significantly improved for 2.6 months in the pre-defined metastatic subgroup in the IMM-101 plus gemcitabine group.…”

Section: Introductionmentioning

confidence: 99%

Novel agents for pancreatic ductal adenocarcinoma: emerging therapeutics and future directions

Zhang

Yang

et al. 2018

J Hematol Oncol

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A poor prognosis of pancreatic ductal adenocarcinoma (PDAC) associated with chemoresistance has not changed for the past three decades. A multidisciplinary diagnosis followed by surgery and chemo(radiation)therapy is the main treatment approach. However, gemcitabine- and 5-fluorouracil-based therapies did not present satisfying outcomes. Novel regimens targeting pancreatic cancer cells, the tumor microenvironment, and immunosuppression are emerging. Biomarkers concerning the treatment outcome and patient selection are being discovered in preclinical or clinical studies. Combination therapies of classic chemotherapeutic drugs and novel agents or novel therapeutic combinations might bring hope to the dismal prognosis for PDAC patients.

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Erratum: Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer

Cited by 17 publications

References 0 publications

Biovacc-19: A Candidate Vaccine for Covid-19 (SARS-CoV-2) Developed from Analysis of its General Method of Action for Infectivity

Biovacc-19: A Candidate Vaccine for Covid-19 (SARS-CoV-2) Developed from Analysis of its General Method of Action for Infectivity

Mitigating Coronavirus Induced Dysfunctional Immunity for At-Risk Populations in COVID-19: Trained Immunity, BCG and “New Old Friends”

Novel agents for pancreatic ductal adenocarcinoma: emerging therapeutics and future directions

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