Reolysin (pelareorep) / Oncolytics, Andrus Reo, Adlai Nortye - LARVOL DELTA

Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: University of Southern California | Trial completion date: Oct 2026 ➔ Oct 2027 | Trial primary completion date: Oct 2025 ➔ Oct 2026

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Oncolytics Biotech Provides Updated Clinical Safety Data for Pelareorep, Including Across Multiple Gastrointestinal Tumors (PRNewswire) - "Updated clinical data now account for over 300 gastrointestinal cancer patients, including patients from the GOBLET study, demonstrating pelareorep's potential as a platform therapy...An updated analysis involving patients who received at least one intravenous dose of pelareorep demonstrates the existing favorable safety profile of pelareorep in combination with numerous treatment regimens across multiple tumor types...'With over 1,200 patients dosed and a consistent safety profile, pelareorep represents one of the most de-risked immunotherapies that is not already approved as a treatment option in gastrointestinal tumors'.'"

Retrospective data • Gastrointestinal Cancer

Oncolytics Biotech to Engage FDA for Potential Registration-Enabled Study in First-Line Pancreatic Cancer with Goal to Launch Trial Activities by Year-End (Oncolys BioPharma Press Release) - "Oncolytics Biotech...announced it has initiated regulatory discussions with the U.S. Food and Drug Administration (FDA) for a potential registration-enabled pivotal study in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). Assuming discussions with the FDA go as expected, the Company expects to commence study start-up activities before the end of 2025...The FDA interaction will focus on finalizing a clinical trial design that leverages pelareorep’s demonstrated synergy with chemotherapy with or without checkpoint inhibition, and overall survival as the primary endpoint. Among the potential options, Oncolytics will consider proposing an adaptive study in collaboration with a third party....Additional information on the study design, timelines, and next steps will be provided following regulatory feedback."

FDA event • New trial • Pancreatic Ductal Adenocarcinoma

Oncolytics Biotech Presents Aggregated Translational Data Providing Evidence of Pelareorep’s Effectiveness Across Multiple Tumor Types (PRNewswire) - "The translational research included the analysis of blood and tumor samples from patients in the GOBLET (pancreatic ductal adenocarcinoma (PDAC) and other gastrointestinal cancers) and AWARE-1 (breast cancer) studies. Analyses revealed consistent immune activation signatures, including: Upregulation of interferons, CXCL9/10/11, and PD-L1; Conversion of immunologically 'cold' tumors into 'hot' phenotypes; Expansion and mobilization of tumor-infiltrating lymphocyte (TIL) clones in the blood, which correlates with a reduction in tumor size; Modulation of the tumor microenvironment (TME) to enhance responsiveness to immune therapies....'We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep.'....additional translational data readouts are expected next year."

Biomarker • Retrospective data • Gastrointestinal Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Pancreatic Ductal Adenocarcinoma

Oncolytics Biotech to Host Key Opinion Leader Discussion Focusing on Pancreatic and Gastrointestinal Cancers (PRNewswire) - "Oncolytics Biotech...announced that it will host a key opinion leader (KOL) webinar to discuss pelareorep in metastatic pancreatic ductal adenocarcinoma (mPDAC) and other gastrointestinal cancers. The webinar will take place on Tuesday, July 22, 2025, at 1:00 p.m. ET....The webinar will feature KOLs Dirk Arnold, M.D., Ph.D. (Asklepios Tumorzentrum Hamburg), Alexander Eggermont, M.D., Ph.D. (University Medical Center Utrecht), Sanjay Goel, M.D., M.S., FASCO (Rutgers Cancer Institute of New Jersey), and Devalingam Mahalingam, M.D., Ph.D. (Northwestern University), who will join the Oncolytics management team to discuss pelareorep's existing pancreatic clinical data in addition to its potential as an immunotherapy in mPDAC and other gastrointestinal indications."

Clinical data • Gastrointestinal Cancer • Pancreatic Ductal Adenocarcinoma

Oncolytics Biotech Highlights Transformative Pelareorep Survival Data in Multiple Tumors and Commitment to Registration-Enabling Studies (PRNewswire) - "Results from two completed first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) trials demonstrate a strong and consistent efficacy signal showing extremely rare 2-year overall survival rates of 21.9% vs. 9.2% based on pooled data from over 100 patients across two studies evaluating pelareorep combined with a chemotherapy backbone. In addition, a best-in-class 62% objective response rate (ORR) was observed in a single-arm study of pelareorep in combination with a chemotherapy backbone and a checkpoint inhibitor in 13 evaluable patients. These results collectively represent promising efficacy for a therapeutic regimen that includes an immunotherapy in this difficult-to-treat cancer...Data from more than 1,100 patients enrolled in multiple studies across several tumor types affirm that pelareorep has a favorable, well-understood safety profile."

Retrospective data • Pancreatic Ductal Adenocarcinoma

Oncolytics Biotech Highlights Transformative Pelareorep Survival Data in Multiple Tumors and Commitment to Registration-Enabling Studies (PRNewswire) - P2 | N=81 | NCT01656538 | N=48 | BRACELET-1 (NCT04215146) | Sponsor: Oncolytics Biotech | "Pelareorep's clinical activity in HR+/HER2- metastatic breast cancer – a large indication with continued significant unmet medical need and no currently approved immunotherapies – has been demonstrated in two randomized phase 2 studies, both of which showed a median overall survival (mOS) benefit of greater than 10 months compared to standard-of-care chemotherapy (IND.213 mOS: 21.0 vs. 10.8 months; BRACELET-1 mOS: not statistically reached; conservative estimate = 32.1 months vs. 18.2 months). In the randomized, controlled BRACELET-1 study, pelareorep combined with paclitaxel yielded a 12.1-month median progression-free survival (PFS) compared to 6.4 months in the paclitaxel alone control arm."

P2 data • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Role of pelareorep in activating anti-tumor immunity in PDAC. (ASCO 2025) - "We previously reported high tumor response rates in first-line metastatic PDAC patients treated with pela combined with gemcitabine, nab-paclitaxel and atezolizumab. These findings, while preliminary, demonstrate that pela induces not only anti-reovirus T cells but also activates innate and adaptive anti-tumor immunity in PDAC subjects treated with chemotherapy and atezolizumab. Tumor responses are associated with both the presence of TIL clones in the blood prior to treatment and the expansion of pre-existing TILs in the blood on treatment. These findings provide additional insights into the immunologic mechanisms by which pela-based therapy may provide clinical benefit in patients with metastatic PDAC."

IO biomarker • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CXCL10 • CXCL11 • CXCL9 • IFNG • PD-L1

Oncolytics Biotech to Present New Clinical Trial Data at ASCO Showing Pelareorep's Unique Immune Activation Capabilities (PRNewswire) - P1/2 | N=NA | GOBLET (2020-003996-16) | "Oncolytics Biotech...announced new data from the Phase I/II GOBLET clinical trial in a poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting....Highlights from the poster and abstract include: Pelareorep initiates the expansion of reovirus-specific T cells that are associated with favorable clinical responses at week 24; Pelareorep increases cytokines and chemokines associated with altering the TME to allow anti-viral and anti-tumor T cells to attack the tumor; The presence of TIL clones in the blood before treatment and the expansion of these clones in the blood post-treatment are associated with favorable clinical responses; Previously reported efficacy results from GOBLET Cohort 1, which is evaluating the therapeutic regimen of pelareorep, nab-paclitaxel, gemcitabine, and atezolizumab (Tecentriq) in first-line metastatic PDAC patients, showed a 62% overall response rate..."

P1/2 data • Pancreatic Ductal Adenocarcinoma

Oncolytics Biotech Reports First Quarter Financial Results and Highlights Clinical Momentum (PRNewswire) - "Anticipated Milestones: (i) Q2 2025: Pancreatic cancer translational data from Cohort 1 of the GOBLET study evaluating pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab; (ii) H1 2026: Initial efficacy results from Cohort 5 of the GOBLET study investigating pelareorep combined with modified FOLFIRINOX with or without atezolizumab in newly diagnosed metastatic pancreatic cancer."

P1/2 data • Pancreatic Cancer

A Phase II Randomized Study of Paclitaxel alone or combined with Pelareorep with or without Avelumab in Metastatic Hormone Receptor Positive Breast Cancer: the BRACELET-01/PrE0113 study. (PubMed, Clin Cancer Res) - "The addition of Pel to Pac was associated with increased toxicity, expanded peripheral T-cell clones, and numerically increased ORR and PFS compared to Pac; Pac/Pel/Ave further increased toxicity and blunted T cell responses without obvious increase in efficacy. Investigation of the Pac/Pel combination warrants consideration with careful attention to acute toxicity."

IO biomarker • Journal • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Oncolytics Biotech to Showcase New Pancreatic Cancer Data at ASCO Highlighting Pelareorep's Tumor-Fighting Mechanism of Action (PRNewswire) - "Oncolytics Biotech Inc....will present new data from Cohort 1 of the GOBLET study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago May 30-June 3, 2025 demonstrating pelareorep's anti-tumor activity in pancreatic ductal adenocarcinoma (PDAC) - the most common form of pancreatic cancer characterized by its poor prognosis and limited treatment options."

P1/2 data • Pancreatic Ductal Adenocarcinoma

Oncolytics Biotech Funds Pelareorep's Ongoing Clinical Development with a Share Purchase Agreement in Partnership with Alumni Capital (PRNewswire) - "Oncolytics Biotech...has entered into a share purchase agreement (SPA) with Alumni Capital LP (Alumni), an institutional investor. This partnership will provide Oncolytics with a flexible source of funding, enabling the Company to progress pelareorep toward key clinical milestones and minimize dilution to create and sustain shareholder value. The SPA allows Oncolytics to be judicious and plan for the timing and amount of any equity sales, which will be critical as pelareorep's development continues. Under the terms of the agreement, Oncolytics has the right to sell, and Alumni has the obligation to purchase up to US$20 million worth of common stock over a 15-month period at prices that are based on the market price at the time of each sale to Alumni."

Financing • Licensing / partnership • Solid Tumor

INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study (clinicaltrials.gov) - P2 | N=25 | Active, not recruiting | Sponsor: Mridula George, MD | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2024 ➔ Jun 2025 | Trial primary completion date: Jun 2024 ➔ Jun 2025

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

Oncolytics Biotech Reports Highlights and Financial Results for Q4 and Year-End 2024 (Canada Newswire) - "Anticipated Milestones: H1 2025: Finalize protocol for the adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line pancreatic ductal adenocarcinoma with the Global Coalition for Adaptive Research (GCAR) and submit it to the FDA; H2 2025: First patient enrolled in registration-enabling study evaluating pelareorep and paclitaxel in advanced or metastatic HR+/HER2- breast cancer; H2 2025: Initial efficacy results from Cohort 5 of the GOBLET study investigating pelareorep combined with modified FOLFIRINOX with or without atezolizumab in newly diagnosed metastatic pancreatic cancer."

Clinical protocol • Enrollment open • P1/2 data • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Pancreatic Ductal Adenocarcinoma

Oncolytics Biotech Strengthens Its Pipeline in 2025 with Key Pancreatic and Anal Cancer Advances in Addition to Metastatic Breast Cancer (PRNewswire) - "Pelareorep, in combination with modified FOLFIRINOX with and without atezolizumab, is now progressing toward full enrollment, with 30 patients set to participate in Stage 1 across the two treatment arms. Next Steps: Oncolytics will continue to collect safety data, and an initial efficacy readout is expected later this year."

P1/2 data • Trial status • Pancreatic Cancer

Oncolytics Biotech Receives FDA Fast Track Designation for the Treatment of Advanced/Metastatic Pancreatic Cancer (PRNewswire) - "Oncolytics Biotech® Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel, for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). This represents pelareorep's second FDA Fast Track designation."

Fast track • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Proteasome inhibition enhances oncolytic reovirus therapy in multiple myeloma independently of its direct cytotoxic effects. (PubMed, J Hematol Oncol) - P1 | "Although characterized as immunosuppressive drugs, PIs improved RV delivery to MM cells but also enhanced anti-MM efficacy through immune-mediated killing of myeloma cells, independently of their PI sensitivity. These results highlight a more generalizable use of PIs as therapeutic companions to support oncolytic-based therapies in cancers."

Journal • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology

GOBLET platform study: Preliminary safety and tumor response results for the relapsed anal carcinoma cohort in patients treated with pelareorep and atezolizumab. (ASCO-GI 2025) - "Twelve patients are currently evaluable for tumor response in the SCCA cohort. Four out of 12 patients have achieved an objective response to therapy including 1 prolonged complete response (>15 months) and 3 partial responses resulting in an ORR of 33.3%. Final ORR, progression-free survival, and overall survival results are pending."

Clinical • IO biomarker • Anal Carcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

GOBLET study: Results of the safety run-in for first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients treated with pelareorep + modified FOLFIRINOX +/- atezolizumab. (ASCO-GI 2025) - "Pela combined with gemcitabine/nab-paclitaxel/atezolizumab showed promising tumor responses in mPDAC... The results of the GOBLET Cohort 5 safety run-in indicate that pela can be given safely in combination with mFOLFIRINOX +/- atezolizumab to newly diagnosed mPDAC patients. Safety and efficacy of these combination therapies will continue to be monitored (Eudra-CT: 2020-003996-16)."

Clinical • IO biomarker • Metastases • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CXCL10 • CXCL11 • CXCL9 • MSI

Pelareorep-based therapy demonstrates strong safety profile with new chemotherapy regimen in pancreatic cancer patients (Canada Newswire) - P1/2 | N=NA | "A promising efficacy signal in metastatic pancreatic ductal adenocarcinoma (PDAC) was previously observed for the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab....This cohort is being funded by a US$5 million grant from the Pancreatic Cancer Action Network (PanCAN). The three-patient safety run-in for each treatment arm has completed enrollment, and patients have completed the necessary evaluation period. The safety data have been reviewed by the Data Safety Monitoring Board (DSMB) and Paul Ehrlich Institute (PEI), Germany's medical regulatory body, and they have recommended patient enrollment continue without modification."

DSMB • P1/2 data • Pancreatic Ductal Adenocarcinoma

Pelareorep combination therapy shows continued meaningful improvement over checkpoint inhibitors alone in anal cancer patients (Canada Newswire) - P1/2 | N=NA | "The fourth cohort of the GOBLET study is evaluating pelareorep combined with the checkpoint inhibitor atezolizumab in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA)....Updated results from this cohort show that four of twelve evaluable patients achieved a partial response for an objective response rate of 33%. This includes one patient with a prolonged complete response that persisted for over 15 months. This is notable because historical response rates to checkpoint inhibitor monotherapy are low, generally 10-24%. There continue to be no safety concerns with the treatment regimen. At treatment cycle four, tumor-infiltrating lymphocyte (TIL) clonal expansion has been observed in the three responding patients for which data is available."

P1/2 data • Anal Carcinoma • Squamous Cell Carcinoma

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 - BRACELET-1 Study (clinicaltrials.gov) - P2 | N=48 | Active, not recruiting | Sponsor: Oncolytics Biotech | Trial completion date: Jul 2024 ➔ Jun 2025

Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • PGR

IRENE study: Phase 2 study of oncolytic virus pelareorep and PD-1 inhibitor retifanlimab in metastatic triple negative breast cancer (SABCS 2024) - P2 | "Five patients received prior treatment with checkpoint inhibitors - pembrolizumab or atezolizumab. One patient had a partial response. Tumor tissue, stool and blood samples collected during treatment will be assessed to understand the role of PD-L1 expression and gut microbiome, especially in the patient with response."

IO biomarker • Metastases • Oncolytic virus • P2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8

Regulatory Approval Clears Path for Oncolytics Biotech to Advance Promising Pancreatic Cancer Treatment, Following a Review of Safety Data (PRNewswire) - "Oncolytics Biotech Inc...announced that Germany's medical regulatory body, the Paul-Ehrlich-Institute (PEI), has approved the continuation of patient enrollment into Cohort 5 of the GOBLET study. This cohort is evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq) in newly diagnosed pancreatic ductal adenocarcinoma (PDAC) patients....Early safety data will be presented at the upcoming 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium later this month, with initial efficacy results expected in the second half of the year."

P1/2 data • Trial status • Pancreatic Ductal Adenocarcinoma