“A Multicenter, Single-Arm, Open-Label Phase I Study of AN1004 (Pelareorep) Oncolytic Virus Plus Paclitaxel in Chinese Patients with Hormone Receptor-Positive and HER2-Negative Advanced / Metastatic Breast Cancer (REO 026-1)”

Li, Wei et al, Previously presented at the 2022 San Antonio Breast Cancer Symposium®; December 6-10, 2022

“Pelareorep primes the tumor for checkpoint inhibition therapy by activating the interferon-gamma signaling pathway and tumor inflammation signature in early breast cancer patients - results of the AWARE-1 trial”

Loghmani, Houra et al, Previously presented at the 2022 San Antonio Breast Cancer Symposium®; December 6-10, 2022

"Pelareorep combined with atezolizumab and chemotherapy demonstrates encouraging results as first-line treatment in advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) patients – Interim results from the GOBLET study"

Arnold, Dirk et al, Previously presented at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting; November 8-12, 2022

“The oncolytic virus pelareorep in combination with immune checkpoint inhibitor activates T-cell functioning in early breast cancer patients – immunophenotype results from AWARE-1 study”

González-Navarro, E.A et al, Previously presented at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting; November 8-12, 2022

“GOBLET: A phase 1/2 multiple indication signal finding and biomarker study in advanced gastrointestinal cancers treated with pelareorepand atezolizumab –safety and preliminary response results”

Collienne, Maike et al, Previously presented at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2022; June 29 – July 2, 2022

“The oncolytic virus pelareorep primes the tumor microenvironment for checkpoint blockade therapy in early breast cancer patients - Results from AWARE-1 study”

Gavilá, Joaquín et al, Previously presented at the European Society for Medical Oncology Breast Cancer 2022 Meeting; May 3-5, 2022

“Single Cell Analysis Shows That Reovirus Immune Priming Changes the Tumor Immune Micro Environment in Multiple Myeloma”

Olea, Julian et al, Previously presented at the American Association for Cancer Research Annual Meeting 2022; April 8-13, 2022

“Combination of reovirus (Pelareorep) and granulocyte-macrophage colony-stimulating factor (GM-CSF) alongside standard chemoradiotherapy and adjuvant chemotherapy (temozolomide) for patients with glioblastoma multiforme (GBM): Long term follow up results of the ReoGliophase Ibtrial”

Short, Susan, Previously presented at the American Association for Cancer Research Annual Meeting 2022; April 8-13, 2022

"GOBLET: A phase 1 / 2 multiple-indication biomarker, safety, and efficacy study in advanced or metastatic gastrointestinal cancers exploring treatment combinations with pelareorep and atezolizumab”

Arnold, Dirk et al, Previously presented at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium; January 20-22, 2022

“The Clinical Oncolytic Reovirus Formulation Reolysin Synergistically Augments the Anti-Leukemic Activity of Azacitidine”, Schwartz, Rayna et al, Previously presented at the 63^rd ASH® Annual Meeting and Exposition; December 11-14, 2021

“IRENE study: Phase 2 study of Retifanlimab and the oncolytic virus pelareorep in metastatic triple negative breast cancer” George, Mridula et al, Previously presented at the 2021 San Antonio Breast Cancer Symposium®; San Antonio, TX, USA; December 7-10, 2021

Singer R et al. Combination treatment with radiotherapy and oncolytic reovirus generates CD8+ T cell infiltration in primary and abscopal tumours in an organoid model of basal-like breast cancer. Previously presented at The International Conference on Immunotherapy Radiotherapy Combinations; 2021 Sep. 14-17.

Mahalingam D et al. Treatment with pembrolizumab in combination with the oncolytic virus pelareorep promotes anti-tumor immunity in patients with advanced pancreatic adenocarcinoma. Previously presented at the 2021 ASCO Annual Meeting; 2021 Jun 4-8.

Manso L et al. A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (AWARE-1). In: AACR Virtual Annual Meeting 2021; 2021 Apr 10-15; Virtual. AACR; 2021. Abstract CT191

Roulstone V et al. Mechanisms of therapeutic synergy between pattern recognition response agonists and CDK4 inhibitors. In: AACR Virtual Annual Meeting 2021; 2021 Apr 10-15; Virtual. AACR; 2021. Abstract 1960

Kyula J et al. Talazoparib interacts with oncolytic reovirus to enhance death-inducing signaling complex (DISC)-mediated apoptosis and immune response. In: AACR Virtual Annual Meeting 2021; 2021 Apr 10-15; Virtual. AACR; 2021. Abstract 1932

“Combination Therapy with Oncolytic Viruses and CAR T Cells” Kottke et al, Previously presented at CAR-TCR Summit Europe 2021

“A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (REO-027, AWARE-1)”

Manso et al, Previously presented at the 2020 Virtual San Antonio Breast Cancer Symposium® - 43rd Annual Meeting;  San Antonio, TX, USA; December 9-11, 2020

“BRACELET-1 (PrE0113): A study to assess overall response rate by inducing an inflammatory phenotype in metastatic breast cancer with the oncolytic reovirus pelareorep in combination with anti-PD-L1 avelumab and paclitaxel”

Miller et al, Previously presented at the 2020 Virtual San Antonio Breast Cancer Symposium® - 43rd Annual Meeting;  San Antonio, TX, USA; December 9-11, 2020

“IRENE study: Phase 2 study of INCMGA00012 (retifanlimab) and the oncolytic virus pelareorep in metastatic triple negative breast cancer”

George et al, Previously presented at the 2020 Virtual San Antonio Breast Cancer Symposium® - 43rd Annual Meeting;  San Antonio, TX, USA; December 9-11, 2020

"Changes in T cell clonality in AWARE-1 study, a window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer"

Prat et al, SITC, 2020

“Oncolytic virus Pelareorep [P] plus Carfilzomib & Dexamethasone [Kd] phase 1 trial in Carfilzomib-refractory patients (NCI9603): responses with cytokine storm”, Sborov et al, ASCO, 2020

“A window-of-opportunity Study with atezolizumab and the oncolytic virus pelareorep in early Breast Cancer (REO-027, AWARE-1)”, Prat et al, ESMO Breast Cancer, 2020

“CEACAM6 is a candidate biomarker for pelareorep resistance in pancreatic adenocarcinoma (PDAC)”, Noonan Et al, ASCO GI, 2020

"Carfilzomib Impairs the Innate Antiviral Immune Response and promotes cytotoxic T-cell Expansion in Oncolytic Virus Treated Multiple Myeloma Patients", Pichiorri Et al, ASH, 2019

“A window-of-opportunity Study of pelareorep in Early Breast Cancer (AWARE-1)”, Prat Et al, SITC, 2019

"Exploratory analysis of T cell repertoire dynamics upon systemic treatment with the oncolytic virus pelareorep in combination with pembrolizumab and chemotherapy in patients with advanced pancreatic adenocarcinoma”, Wilkinson Et al, AACR, 2019

"Oncolytics Virus Replication Using Pelareorep and Carfilzomib in Relapsed Myeloma Patients Increases PD-L1 Expression with Clinical Responses", Hofmeister et al, ASH, 2018

"Reovirus infection of prostate cancer induces upregulation of the negative regulators PD-L1 and BTLA", Pandha et al, SITC, 2018

"Dose finding and safety study of Reovirus (Reo) with irinotecan/fluorouracil/leucovorin/bevacizumab (FOLFIRI/B) in patients with KRAS mutant metastatic colorectal cancer (mCRC): Final Results", Goel et al, ESMO, 2018

"Pelareorep to promote the expression of a IFN-gamma-related gene signature that predicts response to checkpoint blockade therapy", Grey Wilkinson et al, ASCO, 2018

"Potentiating effect of reovirus in anti-PD1 therapy in colorectal cancer", Sanjay Goel et al, AACR, 2018

"Pelareorep promotes the expression of a chemokine signature that predicts response to immunotherapy", Grey Wilkinson et al, AACR, 2018

"B and T lymphocyte attenuator (BTLA) and PD-L1 significantly upregulated in reovirus treated TRAMP-C2 tumours", Pandha et al, IOVC, 2018

"A study of pelareorep in combination with pembrolizumab and chemotherapy in patients (pts) with relapsed metastatic adenocarcinoma of the pancreas (MAP)”, Mahalingam et al, ASCO GI, 2018

"Pooled data analysis of the safety and tolerability of intravenous Pelareorep in combination with chemotherapy in 500 + cancer patients", Gutierrez et al, ESMO, 2017

"Mechanism of Pelareorep (Pel)-mediated cell death in a Phase I study in combination with irinotecan/ fluorouracil/ leucovorin/ bevacizumab (FOLFIRI/B) in patients with KRAS mutant metastatic colorectal cancer (mCRC)", Goel et al, ESMO, 2017

"A randomized (RCT) phase II study of oncolytic reovirus (pelareorep) plus standard weekly paclitaxel (P) as therapy for metastatic breast cancer (mBC)", Bernstein et al, AACR, 2017

"Oncolytic Virus Therapy in Pancreatic Cancer: Clinical Efficacy and Pharmacodynamic Analysis of REOLYSIN^® in Combination with Gemcitabine in Patients with Advanced Pancreatic Adenocarcinoma", Mahalingam et al, EMSO, 2015

"PDL-1 blockade and Sunitinib enhance the efficiency of oncolytic viral therapy", Mostafa et al, AACR, 2014

"Combination therapy with reovirus and PD-1 blockade effectively establishes tumor control via innate and adaptive immune responses", Rajani et al, 2014

"Combination therapy with reovirus and immunomodulatory drugs induces direct oncolytic and immune-mediated killing of multiple myeloma cells and overcomes stromal-mediated microenvironmental protection", Parrish et al, ASH, 2014

MOA – Immunity

“Elucidation of pelareorep pharmacodynamics in a phase I trial in patients with KRAS mutated colorectal cancer”, Goel et al, Molecular Cancer Therapeutics, 2020

“Pembrolizumab in combination with the oncolytic virus pelareorep and chemotherapy in patients with advanced pancreatic adenocarcinoma: a Phase 1b study” Mahalingam et al, Clinical Cancer Research, 2019

“Oncolytic viruses: how “lytic” must they be for therapeutic efficacy?” Davola & Mossman, OncoImmunology, 2019

“Oncolytic Viruses and Immune Checkpoint Inhibition: The Best of Both Worlds” Sivanandam et al, Molecular Therapy Oncolytics, 2019

"Prediction of response to pelareorep plus pembrolizumab in pancreatic ductal adenocarcinoma (PDAC)” Fountzilas et al, ASCO Abstract, 2019

"Oncolytic immunotherapy and bortezomib synergy improves survival of refractory multiple myeloma in a preclinical model” Thirukkumaram et al, Blood Advances, 2019

"Oncolytic viruses and checkpoint inhibitors: combination therapy in clinical trials” LaRocca and Warner, Clinical and Translational Medicine, 2018

“Oncolytic Reovirus and Immune Checkpoint Inhibition as a Novel Immunotherapeutic Strategy for Breast Cancer” Mostafa et al, Cancers, 2018

"Antibody-Neutralized Reovirus Is Effective in Oncolytic Virotherapy" Ilett et al, Cancer Immunology Research, 2018

"A Phase II Study of Pelareorep (REOLYSIN^®) in Combination with Gemcitabine for Patients with Advanced Pancreatic Adenocarcinoma" Mahalingam et al, Cancers, 2018

“A randomized phase II study of weekly paclitaxel with or without pelareorep in patients with metastatic breast cancer: final analysis of Canadian Cancer Trials Group IND.213.” Bernstein, et al, Breast Cancer Research and Treatment, 2017

"Oncolytic reovirus as a combined antiviral and anti-tumour agent for the treatment of liver cancer" Samson, BMJ Hepatology, 2016

"Randomized Phase 2 Trial of the Oncolytic Virus Pelareorep (REOLYSIN^®) in Upfront Treatment of Metastatic Pancreatic Adenocarcinoma" Noonan, Molecular Therapy vol. 24 no. 6 jun. 2016 1151

"Combination Therapy With Reovirus and Anti-PD-1 Blockade Controls Tumor Growth Through Innate and Adaptive Immune Responses" Rajani et al, Molecular Therapy, 2016. 24(1): p. 166-74

"Controlled infection with a therapeutic virus defines the activation kinetics of human natural killer cells in vivo" El-Sherbiny et al, The Journal of Translational Immunology, 2015. 180(1): p. 98-107

"Cytotoxic and immune-mediated killing of human colorectal cancer by reovirus-loaded blood and liver mononuclear cells" Adair et al, International Journal of Cancer, 2013. 132(10): p. 2327-38

"Cell carriage, delivery, and selective replication of an oncolytic virus in tumor in patients" Adair et al, Science Translational Medicine, 2012. 4(138): p. 138ra77

"Oncolytic virus-initiated protective immunity against prostate cancer." Gujar et al, Molecular Therapy, 2011. 19(4): p. 797-804

"Pro-inflammatory cytokine/chemokine production by reovirus treated melanoma cells is PKR/NF-kappaB mediated and supports innate and adaptive anti-tumor immune priming" Steele et al, Molecular Cancer, 2011. 10: p. 20

"Reovirus virotherapy overrides tumor antigen presentation evasion and promotes protective antitumor immunity" Gujar et al, Molecular Cancer Therapeutics, 2010. 9(11): p. 2924-33

"Immune-mediated antitumor activity of reovirus is required for therapy and is independent of direct viral oncolysis and replication" Prestwich et al, Clinical Cancer Research, 2009. 15(13): p. 4374-81

"Reovirus Activates Human Dendritic Cells to Promote Innate Antitumor Immunity" Errington et al, The Journal of Immunology, 2008. 180(9): p. 6018-6026

"Characterization of the adaptive and innate immune response to intravenous oncolytic reovirus (Dearing type 3) during a phase I clinical trial" White et al, Gene Therapy, 2008. 15(12): p. 911-20

MOA – Lysis

"Oncolytic reovirus in combination with chemotherapy in metastatic or recurrent non-small cell lung cancer patients with KRAS-activated tumors" Villalona-Calero et al., Cancer, 2016. 122(6): p. 875-83

"The combination of intravenous REOLYSIN^® and gemcitabine induces reovirus replication and endoplasmic reticular stress in a patient with KRAS-activated pancreatic cancer" Mahalingam et al, BMC Cancer (2015) 15:513

"REOLYSIN^® is a novel reovirus-based agent that induces endoplasmic reticular stress-mediated apoptosis in pancreatic cancer" Carew et al, Cell Death & Disease, 2013. 4: p. e728

"Intravenous administration of REOLYSIN^®, a live replication competent RNA virus is safe in patients with advanced solid tumors" Gollamudi et al, Invest New Drugs, 2010. 28(5): p. 641-9

"Synergistic antitumor activity of oncolytic reovirus and chemotherapeutic agents in non-small cell lung cancer cells" Sei et al, Molecular Cancer, 2009. 8: p. 47

"Oncolytic viral therapy for human pancreatic cancer cells by reovirus" Etoh et al, Clinical Cancer Research, 2003. 9(3): p. 1218-23

"Reovirus oncolysis of human breast cancer" Norman et al, Human Gene Therapy, 2002. 13(5): p. 641-52