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

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

Role of pelareorep in activating anti-tumor immunity in PDAC. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Oncology

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

Oncolytics Biotech to Present Promising Pelareorep Data in Pancreatic and Anal Cancers at ASCO GI Symposium (Canada Newswire) - "Oncolytics Biotech Inc...announced the presentation of two data sets through two abstracts showcasing pelareorep's potential in difficult-to-treat gastrointestinal cancers were accepted and will be presented at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco January 23-25, 2025."

P1/2 data • Anal Carcinoma • Pancreatic Ductal Adenocarcinoma

Oncolytics Biotech Reports Completion of Initial Safety Phase Enrollment for GOBLET Trial's New Pancreatic Cancer Cohort (PRNewswire) - "Oncolytics Biotech Inc...announced that the Data Safety Monitoring Board (DSMB) has recommended continued enrollment in Cohort 5 of the GOBLET study following their review of initial safety data. Enrollment in this cohort will resume pending final approval from the Paul Ehrlich Institute (PEI), Germany's medical regulatory body. Additional updates are expected in 2025, with safety data anticipated in the first half and initial efficacy results in the second half."

DSMB • P1/2 data • Pancreatic Ductal Adenocarcinoma

Oncolytics Biotech Reports Third Quarter 2024 Financial Results and Operational Highlights (Canada Newswire) - "Recent and Anticipated Milestones: H1 2025: Finalize master protocol for the adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line pancreatic ductal adenocarcinoma (PDAC) with the Global Coalition for Adaptive Research (GCAR) and submit it to the FDA; H1 2025: Safety run-in data from cohort 5 of the GOBLET study, investigating pelareorep and modified FOLFIRNOX (mFOLFIRINOX) with or without atezolizumab in newly diagnosed pancreatic cancer; H1 2025: updated efficacy data from cohort 4 of the GOBLET study, investigating pelareorep and atezolizumab in second-line or later anal cancer; Mid 2025: First patient enrolled in registration-enabling study evaluating pelareorep and paclitaxel in metastatic HR+/HER2- breast cancer; H2 2025: Initial efficacy results from cohort 5 of the GOBLET study, investigating pelareorep and mFOLFIRINOX with or without atezolizumab in newly diagnosed pancreatic cancer."

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

Planned HR+/HER2- metastatic breast cancer study could open the door to an accelerated approval (PRNewswire) - "The strong efficacy results from BRACELET-1 provide the foundation for a large Phase 2 study designed to support an accelerated approval. Early in 2025, we plan to submit to the FDA a pelareorep + paclitaxel combination therapy breast cancer trial. The study will enroll approximately 180 patients with HR+/HER2- advanced/metastatic breast cancer who have progressed on antibody-drug conjugates (ADCs) like Enhertu, who are not eligible for ADCs, or who cannot tolerate ADCs, which represents a patient population of approximately 55,000 patients in the US....Enrollment in the registration-enabling study is expected to commence in the first half of 2025."

IND • New P2 trial • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Oncolytics Biotech Announces…Upcoming Studies for…Pancreatic Cancer Treatments, Prepares for FDA Accelerated Approval Path (PRNewswire) - "Once the master protocol has been finalized with GCAR for the pelareorep combination therapy, we intend to approach the FDA before the end of the year. This study is designed to produce registrational data. Additionally, we continue to evaluate pelareorep combination therapy in patients with anal cancer, building on the promising initial efficacy data in this patient population. If the expanded results continue to show a favorable efficacy signal, we anticipate moving directly to a registration-enabling study."

IND • Anal Carcinoma • Pancreatic Cancer

Oncolytics Biotech Announces Key Progress... (PRNewswire) - "Anticipated upcoming milestones...H1 2025: Safety run-in data from cohort 5 of the GOBLET study, investigating pelareorep and mFOLFIRINOX with or without atezolizumab in newly diagnosed pancreatic cancer; H1 2025: updated efficacy data from cohort 4 of the GOBLET study, investigating pelareorep and atezolizumab in second-line or later anal cancer; H2 2025: Initial efficacy results from cohort 5 of the GOBLET study, investigating pelareorep and mFOLFIRINOX with or without atezolizumab in newly diagnosed pancreatic cancer."

P1/2 data • Anal Carcinoma • Pancreatic Cancer

Oncolytics Biotech Doses First Patient in Study of Pelareorep/FOLFIRINOX Combination Therapy in Pancreatic Cancer (Canada Newswire) - "Oncolytics Biotech Inc...announced the dosing of the first patient in the new GOBLET study cohort evaluating pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq) in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients. The co-primary endpoints of the cohort are objective response rate (ORR) and safety. It is supported by the US$5M Pancreatic Cancer Action Network (PanCAN) Therapeutic Accelerator Award, an innovative program established to accelerate the development of new treatments for pancreatic cancer patients."

Trial status • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Oncolytics Biotech Reports Favorable Results for BRACELET-1 Breast Cancer Study Reinforcing Path to Funding of a Registration-Enabling Study (Canada Newswire) - P2 | N=48 | BRACELET-1 (NCT04215146) | Sponsor: Oncolytics Biotech | "Results of the final BRACELET-1 analysis show that the median OS was not reached in the pelareorep + paclitaxel arm...In contrast, median OS for the paclitaxel monotherapy arm was 18.2 months...Had study follow-up continued beyond two years...the median OS for patients in the pelareorep + paclitaxel arm would be 32.1 months. In accordance with these results, the two-year survival rate for patients in the pelareorep + paclitaxel arm was 64% compared to 33% for paclitaxel monotherapy patients. Additionally, the final median progression-free survival (PFS) for BRACELET-1 was 12.1 months in the pelareorep + paclitaxel arm vs. 6.4 months in the paclitaxel monotherapy arm...Confirmed overall response rate (ORR) was 37.5% for pelareorep + paclitaxel and 13.3% for paclitaxel."

P2 data • Breast Cancer • Oncology • Solid Tumor

Oncolytics Biotech Reports Second Quarter 2024 Financial Results and Operational Highlights (PRNewswire) - "Recent and Anticipated Milestones: H2 2024: Overall survival results from the randomized BRACELET-1 trial in HR+/HER2- mBC; H2 2024: Finalize master protocol for the adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line PDAC with GCAR; H1 2025: GOBLET mFOLFIRINOX cohort safety run-in update."

Clinical protocol • P1/2 data • P2 data • Breast Cancer • Pancreatic Ductal Adenocarcinoma