All Evaluable Patients to Date See Evidence of an Objective Response; Treatment Combination Associated with Statistically Significant Upregulation of PD-L1

Calgary, AB (Press Release) – Oncolytics Biotech^® Inc. ("Oncolytics") (TSX:ONC) (NASDAQ: ONCY) today announced that Dr. D.W. Sborov and colleagues made a poster presentation at the 15th Inter­na­tional Myeloma Workshop (IMW). The poster presentation, entitled "Combination Carfilzomib and the Viral On­co­lytic Agent REOLYSIN^® in Patients with Relapsed Multiple Myeloma: A Pilot Study Investigating Viral Pro­lifer­a­tion," discloses initial findings from a pilot study (NCI-9603) in patients with re­lapsed or refractory multiple myeloma treated using the com­bi­na­tion of car­filz­o­mib and REOLYSIN^®. The IMW runs from Sep­tem­ber 23rd to 26th in Rome, Italy.

Highlights of the data presented in­clude:

• 100% of patients (8 of 8) experienced an objective response as measured by changes in blood mono­clonal protein. Of these, 2 patients had a very good partial response (VGPR), 3 patients had a partial response (PR) and 3 patients had a minor response (MR);
• Only one patient has progressed to date and five of eight remain on study;
• The com­bi­na­tion of carfilzomib and REOLYSIN^® produced a sig­nif­i­cant (p=0.005) increase in caspase-3, a marker associated with apoptotic (programmed) cell death; and
• The treatment com­bi­na­tion was associated with an increased infiltration of CD8+ T-cells and the sig­nif­i­cant (p=0.005) upregulation of PD-L1, suggesting that the addition of a PD-1 or PD-L1 inhibitor may further optimize the treatment regimen.

"These findings dem­onstrate that the com­bi­na­tion of car­filz­o­mib and REOLYSIN^® shows promise in hemato­log­i­cal malig­nan­cies like multiple myeloma and provide compelling evi­dence that such drug com­bi­na­tions promote viral replication and cancer cell death," said Dr. Matt Coffey, Chief Operating Officer of Oncolytics. "Based on these results, we intend to move into ran­dom­ized studies in this indi­ca­tion."

The investigators noted that this is the first time a REOLYSIN^®-based com­bi­na­tion has been tested in re­lapsed multiple myeloma patients. A pre­vi­ous single-agent study conducted by the col­lab­o­rators in this patient pop­u­la­tion showed that REOLYSIN^® was well tolerated. The col­lab­o­rators and others were noted to have conducted pre­clin­i­cal in­vesti­ga­tions that dem­onstrated that the com­bi­na­tion of REOLYSIN^® and car­filz­o­mib synergistically in­­creased the killing of multiple myeloma cells. This provided the clin­i­cal rationale for this study. In this study, the com­bi­na­tion of car­filz­o­mib and REOLYSIN^® produced a sig­nif­i­cant (p=0.005) in­­crease in caspase-3, a marker asso­ci­ated with apoptotic cell death. The researchers also determined that the com­bi­na­tion of REOLYSIN^® and car­filz­o­mib in­­creases infiltration of CD8+ T-cells and sig­nif­i­cantly (p=0.005) upregulates PD-L1. The investigators concluded that these findings necessitate con­tinued in­ves­ti­ga­tion, and suggest that the addi­tion of a PD-1 or PD-L1 inhibitor may further optimize the REOLYSIN^® and car­filz­o­mib regi­men.

"To this point, multiple myeloma has not responded to checkpoint inhibitor ther­apy," said Dr. Brad Thompson, Pres­i­dent and CEO of Oncolytics. "The com­bi­na­tion of REOLYSIN^® and car­filz­o­mib upregulates PD-L1 and in­­creases infiltration of CD8+ T-cells, which may make the tumor sensitive to anti-PD-L1 ther­apy. The follow-on ran­dom­ized study we are cur­rently planning is ex­pec­ted to have a patient group treated with the com­bi­na­tion of REOLYSIN^®, a standard of care chemo­ther­apy, and a checkpoint inhibitor, as well as a patient group receiving REOLYSIN® and a standard of care chemo­ther­apy."

NCI-9603 is a U.S. National Cancer Institute sponsored single-arm, open-label study of in­tra­venously ad­min­is­tered REOLYSIN^® with dexa­meth­a­sone and car­filz­o­mib to patients with re­lapsed or refractory multiple myeloma. Patients receive treat­ment on days 1, 2, 8, 9, 15 and 16 of a 28-day cycle, to be repeated in the absence of disease pro­gres­sion or unacceptable toxicity. Approximately 12 patients will be enrolled in the study. The pri­mary out­comes in­clude measuring reovirus replication, safety, and tolerability. Secondary out­comes in­clude examining objective response, duration of response, clin­i­cal benefit, pro­gres­sion-free survival, and time to pro­gres­sion. Other out­comes will in­clude the mea­sure­ment of immunologic correlative markers.

A copy of the poster will be avail­able on the Oncolytics website at: http://www.oncolyticsbiotech.com/for-investors/presentations.

About Multiple Myeloma

Multiple Myeloma is a cancer of the plasma cells and the second most common hema­to­logical malig­nan­cy. The American Cancer Society esti­mates there will be 26,850 new cases diag­nosed in the United States and 11,240 deaths from the disease in 2015.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based bio­technology com­pany focused on the devel­op­ment of oncolytic viruses as poten­tial cancer thera­peutics. Oncolytics' clin­i­cal pro­gram in­cludes a variety of later-stage, ran­dom­ized human trials in various indi­ca­tions using REOLYSIN^®, its pro­pri­e­tary formulation of the human reovirus. For further in­­for­ma­tion about Oncolytics, please visit: www.oncolyticsbiotech.com.

This press release con­tains forward-looking state­ments, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking state­ments, in­­clud­ing the Company's ex­pec­ta­tions related to the pilot single-arm clin­i­cal trial in multiple myeloma, future trials in this indi­ca­tion, and the Company's belief as to the poten­tial of REOLYSIN^® as a cancer thera­peutic, 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 REOLYSIN^® as a cancer treat­ment, the tolerability of REOLYSIN^® outside a controlled test, the success and timely completion of clin­i­cal studies and trials, the Company's ability to suc­cess­fully com­mer­cial­ize REOLYSIN^®, un­cer­tain­ties related to the research, devel­op­ment and manu­fac­tur­ing of pharma­ceu­ticals, changes in tech­nology, general changes to the economic en­viron­ment and un­cer­tain­ties related to the regu­la­tory process. 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 should con­sider state­ments that in­clude the words "believes", "expects", "antic­i­pates", "intends", "estimates", "plans", "projects", "should", or other ex­pres­sions that are predictions of or indicate future events or trends, to be uncertain and forward-looking. 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 Inc.