Calgary, AB and San Diego, CA (Press Release) – Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), cur­rently devel­op­ing pelareorep, an in­tra­venously delivered immuno-oncolytic virus, today announced that the first patient was treated in a phase 1 dose escalation study combining pelareorep and car­filz­o­mib with Bristol-Myers Squibb’s checkpoint inhibitor Opdivo® (nivolumab) to treat re­lapsed multiple myeloma patients. This study is based on findings from the NCI 9603 multiple myeloma study that com­bined pelareorep with car­filz­o­mib that resulted in objective responses, elimination of multiple myeloma cells and most importantly, an inflamed pheno­type with PD-L1 overexpression.

“Having worked with pelareorep in multiple myeloma and under­stand­ing its ability to act as a poten­tiator of checkpoint blockade, I’m very excited to work with the Oncolytics team on this study,” said Dr. Craig Hofmeister, Associate Professor, Department of Hematology and Medical Oncology Emory University School of Medicine. “Pelareorep has proven its ability to create an inflamed pheno­type and its poten­tial for upregulation of PD-1 on tumor-infiltrating lym­pho­cytes. My hope is this study leads not only to an effective com­bi­na­tion dosing schedule but provides quantitative data describing the ex­pres­sion of PD-1, along with correlative studies that reveal the roles of both immune-mediated and direct cytotoxic myeloma cell killing.”

This open-label, phase 1 study, conducted by Dr. Hofmeister at Emory University, will enroll up to 62 patients to examine the side effects and best dosing schedule of pelareorep when given in com­bi­na­tion with dexa­meth­a­sone, car­filz­o­mib, and nivolumab in treating par­tic­i­pants with re­lapsed multiple myeloma. The pri­mary objectives of the study are to determine the maximum tolerated dose of pelareorep in com­bi­na­tion with car­filz­o­mib and nivolumab. Secondary out­come measures in­clude time to pro­gres­sion, pro­gres­sion-free survival and over­all survival, as well as the char­ac­ter­i­za­tion of an inflamed pheno­type and con­firmation of bio­marker responses indicative of tumor inflammation.

“We now have our second checkpoint inhibitor com­bi­na­tion study enrolling, and I’m excited for the poten­tial of the immune and bio­marker data to come from it,” said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. “These studies, along with our soon to be ini­ti­ated studies combining pelareorep with Merck’s Keytruda, also in multiple myeloma, and Roche’s Tecentriq in neoadjuvant breast cancer, will provide further evi­dence that pelareorep has the poten­tial to expand the use of checkpoint inhibitors by priming tumors cells. The con­firmation of our predictive bio­markers en­hances the likelihood of success in registrational studies, thereby reducing both clin­i­cal and commercial risk making pelareorep more attractive to poten­tial partners.”

For more in­for­ma­tion about the study, in­­clud­ing a com­pre­hen­sive list of inclusion and exclusion criteria, please visit: www.clinicaltrials.gov (identifier: NCT03605719).

About Pelareorep

Pelareorep is a non-pathogenic, pro­pri­e­tary isolate of the unmodified reovirus: a first-in-class intra­venously delivered immuno-oncolytic virus for the treat­ment of solid tumors and hema­to­logical malig­nan­cies. The com­pound induces selective tumor lysis and promotes an inflamed tumor pheno­type through innate and adaptive immune responses to treat a variety of cancers and has been dem­onstrated to be able to escape neutralizing anti­bodies found in patients.

About Oncolytics Biotech Inc.

Oncolytics is a bio­technology com­pany devel­op­ing pelareorep, an in­tra­venously delivered immuno-oncolytic virus. The com­pound induces selective tumor lysis and promotes an inflamed tumor pheno­type – turning "cold" tumors "hot" – through innate and adaptive immune responses to treat a variety of cancers. Oncolytics' clin­i­cal devel­op­ment pro­gram emphasizes three pillars: chemo­ther­apy com­bi­na­tions to trigger selective tumor lysis and immuno-therapy and immune modulator (IMiD) com­bi­na­tions to produce innate and adaptive immune responses. Oncolytics is cur­rently conducting and planning addi­tional studies in com­bi­na­tion with checkpoint inhibitors and targeted and IMiD ther­a­pies in solid and hema­to­logical malig­nan­cies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further in­for­ma­tion, please visit: www.oncolyticsbiotech.com.

This press release con­tains forward-looking state­ments, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking in­for­ma­tion under appli­­cable Canadian securities laws (such forward-looking state­ments and forward-looking in­for­ma­tion are col­lectively referred to herein as “forward-looking state­ments”). Forward-looking state­ments, in­­clud­ing the Company's belief as to the poten­tial and mode of action of REOLYSIN, also known as pelareorep, as a cancer thera­peutic; and other state­ments related to antic­i­pated devel­op­ments in the Company's business and tech­nolo­gies involve known and unknown risks and un­cer­tain­ties, which could cause the Company's actual results to differ materially from those in the forward-looking state­ments. Such risks and un­cer­tain­ties in­clude, among others, the avail­a­bil­ity of funds and resources to pursue research and devel­op­ment projects, the efficacy of pelareorep as a cancer treat­ment, the success and timely completion of clin­i­cal studies and trials, the Company's ability to suc­cess­fully com­mer­cial­ize pelareorep, un­cer­tain­ties related to the research and devel­op­ment of pharma­ceu­ticals, un­cer­tain­ties related to the regu­la­tory process and general changes to the economic en­viron­ment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities com­missions for addi­tional in­for­ma­tion on risks and un­cer­tain­ties relating to the forward-looking state­ments. Investors are cautioned against placing undue reliance on forward-looking state­ments. The Company does not under­take to update these forward-looking state­ments, except as required by appli­­cable laws.

Source: Oncolytics Biotech.