A Phase 1b/2 Study of Standard Doses of Bortezomib and Pembrolizumab ± Reovirus (Pelareorep) Combination Therapy in Patients With Relapsed Multiple Myeloma (AMBUSH Study)

This phase I/II trial studies the safety of the combination of bortezomib, dexamethasone, and pembrolizumab with or without pelareorep in treating patients with multiple myeloma that has come back (relapsed) or does not response to treatment (refractory). Chemotherapy drugs, such as bortezomib and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. A virus modified in the laboratory, such as pelareorep, may be able to kill cancer cells without damaging normal cells. Giving the combination of bortezomib, dexamethasone, and pembrolizumab with pelareorep may work better in treating patient with multiple myeloma.

Start Date07 Oct 2022

Sponsor / Collaborator

University of Southern California

[+1]

NCT05519059 / CompletedPhase 1

A Multicenter, Single-Arm, Open-Label Phase I Clinical Study of Pelareorep With Paclitaxel in Advanced or Metastatic Breast Cancer

This ia a multicenter, Single-Arm, Open-Label Phase I Clinical Study Evaluating the Safety and Tolerability of Pelareorep Combined with Paclitaxel Injection and the Intracorporal Process of Pelareorep in Chinese Patients with Advanced or Metastatic Breast Cancer.

Start Date11 Oct 2021

Sponsor / Collaborator

Hangzhou Adlai Nortye Biopharma Co. Ltd.

CTR20201625 / CompletedPhase 1

评估Pelareorep联合紫杉醇注射液用于晚期或转移性乳腺癌中国患者的安全性、耐受性和Pelareorep体内过程的多中心、单臂、开放I期临床试验

[Translation] A multicenter, single-arm, open-label Phase I clinical trial to evaluate the safety, tolerability, and in vivo course of Pelareorep combined with paclitaxel injection in Chinese patients with advanced or metastatic breast cancer

主要目的：评价Pelareorep联合紫杉醇注射液用于晚期或转移性乳腺癌中国患者的安全性和耐受性，为后期临床试验制定给药方案提供依据。次要目的：1) 评价Pelareorep在晚期或转移性乳腺癌中国患者中病毒载量、病毒脱落、病毒复制和中和抗体产生情况。 2) 初步评价Pelareorep联合紫杉醇注射液治疗晚期或转移性乳腺癌中国患者的有效性。探索性目的：外周血中的生物标记物测定，包括基因表达分析、免疫细胞克隆性测定、基因组突变检测，以及它们与疗效之间的关系。

[Translation]

Primary objective: To evaluate the safety and tolerability of Pelareorep combined with paclitaxel injection in Chinese patients with advanced or metastatic breast cancer, and to provide a basis for the formulation of dosing regimens in later clinical trials. Secondary objectives: 1) To evaluate the viral load, viral shedding, viral replication, and neutralizing antibody production of Pelareorep in Chinese patients with advanced or metastatic breast cancer. 2) To preliminarily evaluate the efficacy of Pelareorep combined with paclitaxel injection in the treatment of Chinese patients with advanced or metastatic breast cancer. Exploratory objectives: Biomarker determination in peripheral blood, including gene expression analysis, immune cell clonality determination, genomic mutation detection, and their relationship with efficacy.

Start Date24 Sep 2021

Sponsor / Collaborator

SAFC Carlsbad, Inc.

[+2]

100 Clinical Results associated with Pelareorep(Oncolytics Biotech, Inc.)

100 Translational Medicine associated with Pelareorep(Oncolytics Biotech, Inc.)

100 Patents (Medical) associated with Pelareorep(Oncolytics Biotech, Inc.)

261

Literatures (Medical) associated with Pelareorep(Oncolytics Biotech, Inc.)

15 Dec 2023·Clinical cancer research : an official journal of the American Association for Cancer Research

Comprehensive Single-Cell Immune Profiling Defines the Patient Multiple Myeloma Microenvironment Following Oncolytic Virus Therapy in a Phase Ib Trial

Article

Author: Kelly, Kevin R ; Wu, Kaijin ; Coffey, Matt ; Siddiqi, Imran ; Nuovo, Gerard J ; Mohrbacher, Ann F ; Carew, Jennifer S ; Dadrastoussi, Homa ; Merchant, Akil ; Tsao-Wei, Denice ; Colombo, Anthony ; Fields, Paul ; Nawrocki, Steffan T ; Fernandez Hernandez, Eduardo ; Kuhn, Peter ; Olea, Julian ; Villa Celi, Claudia ; Chen, Xuelian

Abstract:

Purpose::

Our preclinical studies showed that the oncolytic reovirus formulation pelareorep (PELA) has significant immunomodulatory anti-myeloma activity. We conducted an investigator-initiated clinical trial to evaluate PELA in combination with dexamethasone (Dex) and bortezomib (BZ) and define the tumor immune microenvironment (TiME) in patients with multiple myeloma treated with this regimen.

Patients and Methods::

Patients with relapsed/refractory multiple myeloma (n = 14) were enrolled in a phase Ib clinical trial (ClinicalTrials.gov: NCT02514382) of three escalating PELA doses administered on Days 1, 2, 8, 9, 15, and 16. Patients received 40 mg Dex and 1.5 mg/m2 BZ on Days 1, 8, and 15. Cycles were repeated every 28 days. Pre- and posttreatment bone marrow specimens (IHC, n = 9; imaging mass cytometry, n = 6) and peripheral blood samples were collected for analysis (flow cytometry, n = 5; T-cell receptor clonality, n = 7; cytokine assay, n = 7).

Results::

PELA/BZ/Dex was well-tolerated in all patients. Treatment-emergent toxicities were transient, and no dose-limiting toxicities occurred. Six (55%) of 11 response-evaluable patients showed decreased paraprotein. Treatment increased T and natural killer cell activation, inflammatory cytokine release, and programmed death-ligand 1 expression in bone marrow. Compared with nonresponders, responders had higher reovirus protein levels, increased cytotoxic T-cell infiltration posttreatment, cytotoxic T cells in significantly closer proximity to multiple myeloma cells, and larger populations of a novel immune-primed multiple myeloma phenotype (CD138+ IDO1+HLA-ABCHigh), indicating immunomodulation.

Conclusions::

PELA/BZ/Dex is well-tolerated and associated with anti–multiple myeloma activity in a subset of responding patients, characterized by immune reprogramming and TiME changes, warranting further investigation of PELA as an immunomodulator.

01 Nov 2023·Cancer immunology, immunotherapy : CII

Reovirus combined with a STING agonist enhances anti-tumor immunity in a mouse model of colorectal cancer.

Article

Author: Kubota, Eiji ; Tanaka, Mamoru ; Johnston, Randal N ; Aoyama, Mineyoshi ; Tanida, Satoshi ; Shimura, Takaya ; Kataoka, Hiromi ; Mori, Yoshinori ; Sugimura, Naomi

Reovirus, a naturally occurring oncolytic virus, initiates the lysis of tumor cells while simultaneously releasing tumor antigens or proapoptotic cytokines in the tumor microenvironment to augment anticancer immunity. However, reovirus has developed a strategy to evade antiviral immunity via its inhibitory effect on interferon production, which negatively affects the induction of antitumor immune responses. The mammalian adaptor protein Stimulator of Interferon Genes (STING) was identified as a key regulator that orchestrates immune responses by sensing cytosolic DNA derived from pathogens or tumors, resulting in the production of type I interferon. Recent studies reported the role of STING in innate immune responses to RNA viruses leading to the restriction of RNA virus replication. In the current study, we found that reovirus had a reciprocal reaction with a STING agonist regarding type I interferon responses in vitro; however, we found that the combination of reovirus and STING agonist enhanced anti-tumor immunity by enhancing cytotoxic T cell trafficking into tumors, leading to significant tumor regression and survival benefit in a syngeneic colorectal cancer model. Our data indicate the combination of reovirus and a STING agonist to enhance inflammation in the tumor microenvironment might be a strategy to improve oncolytic reovirus immunotherapy.

16 Oct 2023·Diseases (Basel, Switzerland)

Noncoding RNA Profile in Reovirus Treated KRAS-Mutated Colorectal Cancer Patients.

Article

Author: Saperstein, Rafael ; Maitra, Radhashree ; Goel, Sanjay

PURPOSE:

To investigate the alterations in the expression of noncoding, micro, and small RNA expression during treatment with oncolytic reovirus in KRAS-mutated colorectal cancer.

METHODS:

Oncolytic reovirus treatment was administered in phase 1 clinical trial (NCT01274624) for 5 days every 28 days, and blood samples were collected before the administration of the reovirus and 48 h, 8 days, and 15 days after its administration on day 1. Data from the blood samples were sorted using Transcriptome Analysis Software (TAC) 4.0, where a two-tailed t-test and a fold change filter were used to ascertain which sample signals had a statistically significant relative fold change of greater than 2 at multiple timepoints before or after oncolytic reovirus administration.

RESULTS:

The long noncoding RNA's RP11-332M2.1 (-6.1 x), LINC01506 (-16.18 x), and LINC00534 (-1.94 x) were downregulated at 48 h after reovirus administration [p < 0.05]. ncRNA's EPB41L4A-AS1 (-6.34 x, 48 h; 11.99 x, day 8), JAK2 (2.2 x, 48 h; -2.23 x, day 8), ANXA4 (20.47 x, day 8; -7.54 x, day 15), and PCDH9 (-2.09, day 8; 1.82 x, day 15) were affected by the reovirus treatment and reflected the progress of the treatment [p < 0.05]. The small RNA SNORA26 (-1.59 x, day 8) was downregulated 48 h after the reovirus administration [p < 0.05]. The microRNA MIR-4461 (6.18 x, day 8; -3.76 x, day 15) was also affected by the reovirus administration [p < 0.05].

CONCLUSION:

The administration of oncolytic reovirus to treat KRAS-mutated colorectal cancer is reflected in a noncoding RNA profile, and expression levels of the ncRNAs in that profile may thus be able to be used as a potential predictive marker for reovirus-treated colorectal cancer.

113

News (Medical) associated with Pelareorep(Oncolytics Biotech, Inc.)

27 Jun 2024

·www.prnewswire.com

American Cancer Society Projects Over 2 Million New Cases in 2024: Biotech Innovations Respond

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 27, 2024 /PRNewswire/ -- USA News Group News Commentary – According to the American Cancer Society, 2024 will be the first year the USA expects to have more than 2 million new cancer cases. In order to respond to the rising rates of cancer, the National Cancer Institute is making calls for change in how cancer clinical research is performed "Because our patients can't wait." According to Spherical Insights, the Global Oncology Drugs Market is projected to grow by 11.5% CAGR through 2033 to US$564.5 billion, highlighting the need for more effective therapies and incentives for those who develop them. The biotech sector is actively addressing this need, with recent notable developments from several companies, including: O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), GSK plc (NYSE: GSK), Guardant Health, Inc. (NASDAQ: GH), Exelixis, Inc. (NASDAQ: EXEL), and Gilead Sciences, Inc. (NASDAQ: GILD). The article continued: According to the World Health Organization, the global cancer burden is growing amidst a mounting need for services. As well, an alarming trend is emerging, where cancer cases in younger people are rising sharply. Oncolytics Biotech® Announces Productive FDA Type C Meeting on its Metastatic Breast Cancer Program Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that the Company received productive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), supporting the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC). The FDA supports progression-free survival as the primary endpoint of the study, with overall survival as a key secondary endpoint. The Company's proposed study will enroll patients who have failed hormonal therapy and have received no more than one line of antibody-drug conjugate (ADC) therapy. "Aligning with the FDA on key design elements and objectives of our planned registrational trial for pelareorep marks a critical step towards bringing this innovative treatment to patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Our de-risked program builds on compelling data and key learnings from two randomized studies, BRACELET-1 and IND-213, which demonstrated clinically meaningful benefit in patients receiving pelareorep and paclitaxel compared to paclitaxel alone. Additionally, translational data from the AWARE-1 study highlights pelareorep's immune-mediated mechanism of action in breast cancer patients. We are now well-positioned to deliver on our mission of making pelareorep available to breast cancer patients in need of better treatment options." Wayne Pisano, Interim CEO and Chair of the Board of Oncolytics, commented, "We are appreciative of the thoughtful dialog with the FDA and are pleased to have reached an important regulatory milestone that provides a clear path forward for pelareorep's advancement towards registration in HR+/HER2- mBC. Looking ahead, initiating a registration-enabling trial has become a major corporate objective, and in parallel, we remain on track to report survival data from the BRACELET-1 study in HR+/HER2- mBC in the second half of the year. We believe these data will further bolster our compelling data package and underscores the therapeutic potential of pelareorep. We remain committed to improving the standard of care and addressing the high unmet medical needs of these patients." CONTINUED… Read this and more news for Oncolytics Biotech at: In other industry developments and happenings in the market this week include: GSK plc (NYSE: GSK), a global biopharma company, recently released positive results from an interim analysis of the DREAMM-8 phase III head-to-head trial evaluating belantamab mafodotin, in combination with pomalidomide plus dexamethasone (PomDex), versus a standard of care, bortezomib plus PomDex, as a second line and later treatment for relapsed or refractory multiple myeloma. As per the release, the drug combination reduced the risk of disease progression or death by nearly 50% versus standard of care. "With the robust results from the DREAMM-8 phase III head-to-head trial, we now have consistent data from two phase III trials supporting the potential for belantamab mafodotin combinations to redefine the treatment of multiple myeloma at or after first relapse," said Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, of GSK. "This is exciting news given the high unmet need for new and efficacious combinations once patients relapse or stop responding to initial treatments. We continue to share data and discuss our path forward with regulators." Guardant Health, Inc. (NASDAQ: GH), a leading precision oncology company, recently announced the launch of a new version of its Guardant360 TissueNext test that expanded the number of genes it identifies in a tumor tissue sample to 498. In addition to the panel expansion, Guardant has improved the test's operational workflow for a faster turnaround time. "The launch of the new Guardant360 TissueNext test is another step forward in our mission to conquer cancer with data," said Helmy Eltouky, Chairman and co-CEO of Guardant Health. "In addition to identifying guideline-recommended biomarkers, the upgraded test now provides more comprehensive gene coverage, so oncologists can make better informed decisions about the optimal treatment strategy for their patients with advanced cancer and help improve their outcomes." Exelixis, Inc. (NASDAQ: EXEL), a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care, recently settled two patent litigations with Cipla Ltd. and Cipla USA, Inc. (collectively Cipla) in response to Cipla's Abbreviated New Drug Application (ANDA) seeking approval to market generic versions of CABOMETYX® (cabozantinib) tablets prior to the expiration of the applicable patents. Prior to the settlement earlier this year, Exelixis also announced detailed results of its Phase 3 CONTACT-02 pivotal trial evaluating the above-mentioned cabozantinib in combination with atezolizumab in metastatic castration-resistant prostate cancer at this year's ASCO GU 2024 event. As per the results, the combination reduced the risk of disease progression or death by 35%. "Given there are limited options after progression on novel hormonal therapy, we recognize the need for a regimen that can delay disease progression, that has an acceptable tolerability profile and that is widely available to patients who may not have the means or desire to travel to specialized centers for other therapies," said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. "We look forward to discussing these important results with the U.S. Food and Drug Administration, and to learning more in the next analysis of overall survival, anticipated this year." Through its recently-acquired Kite subsidiary, Gilead Sciences, Inc. (NASDAQ: GILD) recently announced results from three new analyses for Yescarta (axicabtagene ciloleucel) in relapsed/refractory (R/R) large B-cell lymphoma (LBCL), including both new clinical research and real-world evidence highlighting manufacturing and product characteristics of Yescarta, and outpatient administration of both Yescarta and Tecartus® (brexucabtagene autoleucel) at the 2024 European Hematology Association (EHA) Annual Congress, June 13-16, Madrid. "We are committed to improving survival outcomes for people living with difficult-to-treat blood cancers," said Ibrahim Elhoussieny, Vice President, Medical Affairs, of Kite. "These new data support the potential benefit of utilizing Yescarta in earlier lines of treatment, both in terms of manufacturing success and product characteristics. Additional data support the safety and feasibility of administering CAR T-cell therapy in the outpatient setting. These data contribute to the body of evidence for efficient utilization and delivery of Yescarta and Tecartus and further support our ambition for patients." Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group

Phase 3Clinical ResultImmunotherapy

27 Jun 2024

·www.prnewswire.com

Oncolytics Biotech® Announces Productive FDA Type C Meeting on its Metastatic Breast Cancer Program

Clear path forward on key elements of the planned potential registration-enabling trial in HR+/HER2- metastatic breast cancer On track to report overall survival results from the randomized HR+/HER2- metastatic breast cancer BRACELET-1 trial in H2 2024 SAN DIEGO and CALGARY, AB, June 27, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapeutics for oncology, today announced that the Company received productive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), supporting the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC). The FDA supports progression-free survival as the primary endpoint of the study, with overall survival as a key secondary endpoint. The Company's proposed study will enroll patients who have failed hormonal therapy and have received no more than one line of antibody-drug conjugate (ADC) therapy. "Aligning with the FDA on key design elements and objectives of our planned registrational trial for pelareorep marks a critical step towards bringing this innovative treatment to patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Our de-risked program builds on compelling data and key learnings from two randomized studies, BRACELET-1 and IND-213, which demonstrated clinically meaningful benefit in patients receiving pelareorep and paclitaxel compared to paclitaxel alone. Additionally, translational data from the AWARE-1 study highlights pelareorep's immune-mediated mechanism of action in breast cancer patients. We are now well-positioned to deliver on our mission of making pelareorep available to breast cancer patients in need of better treatment options." Wayne Pisano, Interim CEO and Chair of the Board of Oncolytics, commented, "We are appreciative of the thoughtful dialog with the FDA and are pleased to have reached an important regulatory milestone that provides a clear path forward for pelareorep's advancement towards registration in HR+/HER2- mBC. Looking ahead, initiating a registration-enabling trial has become a major corporate objective, and in parallel, we remain on track to report survival data from the BRACELET-1 study in HR+/HER2- mBC in the second half of the year. We believe these data will further bolster our compelling data package and underscores the therapeutic potential of pelareorep. We remain committed to improving the standard of care and addressing the high unmet medical needs of these patients." About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot." This allows the anti-tumor immune cells, induced by pelareorep, to attack the cancer. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: or follow the company on social media on LinkedIn and on X @oncolytics. 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 contained in this press release include Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our belief that we are now well-positioned to deliver on our mission of making pelareorep available to breast cancer patients in need of better treatment options; our belief that the outcome of the meeting with the FDA is an important regulatory milestone that provides a clear path forward for pelareorep's advancement towards registration in HR+/HER2- mBC; our corporate objective of initiating a registration-enabling trial; our belief that we remain on track to report survival data from the BRACELET-1 study in HR+/HER2- mBC in the second half of the year; our belief in the therapeutic potential of pelareorep; our commitment to improving the standard of care and addressing the high unmet medical needs of these patients; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' 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, Oncolytics' 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. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' 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 any obligation to update these forward-looking statements, except as required by applicable laws. Logo: Company Contact Jon Patton Director of IR & Communication [email protected] Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 [email protected] SOURCE Oncolytics Biotech® Inc.

Clinical ResultImmunotherapyFast TrackPhase 2

24 Jun 2024

·www.biospace.com

Oncolytics Biotech® Announces President and Chief Executive Officer Dr. Matt Coffey to Take Medical Leave of Absence

Wayne Pisano, Chair of Oncolytics' Board of Directors, to serve as interim CEO Overall Survival data from BRACELET-1 breast cancer study continues to be expected in H2 2024 Pelareorep combination therapy advancing towards registration-enabling study in pancreatic cancer SAN DIEGO and CALGARY, AB, June 24, 2024 /PRNewswire/ --Oncolytics Biotech, Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapeutics for oncology, today announced that Matt Coffey, PhD, President and Chief Executive Officer of Oncolytics will take a medical leave of absence, effective immediately. Wayne Pisano, Chair of Oncolytics' Board of Directors, will serve as the interim CEO during Dr. Coffey's absence. "On behalf of the Board, I would like to wish Matt a swift recovery. In the interim, the Board and I are highly confident in our tenured executive team's ability to continue executing our mission, achieve our strategic priorities, and drive forward our registration-enabling clinical plans for pelareorep, a differentiated and potentially leading immunotherapeutic agent in breast and pancreatic cancers," said Wayne Pisano, Chair of Oncolytics' Board of Directors. "Together, we will continue to deliver on our long-term goals to ultimately bring pelareorep to patients with cancer." Wayne Pisano, Chair of the Board since 2013, has more than 30 years of experience as a pharmaceutical industry executive and over 12 years of experience in the biotech industry. Mr. Pisano served as the president of VaxInnate, a privately held biotech company, and has served as a Board Director of several biotech companies, including Provention Bio and Altimmune Inc. He served as Chairman of Provention Bio for four years, overseeing the company's acquisition by Sanofi in April 2023. Mr. Pisano is the former President and CEO of Sanofi Pasteur, one of the largest vaccine companies in the world. He is credited with driving Sanofi Pasteur's leadership within the worldwide influenza market, capturing 50% of global sales. He also laid the foundation for the company's global pediatric vaccines strategy and bolstered the Sanofi Pasteur pipeline with the acquisition of Acambis PLC, a biotech based in Boston, in 2008 and Shantha Biotechnics, a highly regarded Indian vaccine company in 2010. Prior to joining Sanofi Pasteur, he spent 11 years with Novartis (formerly Sandoz). He has a bachelor's degree in biology from St. John Fisher University in New York and an MBA from the University of Dayton in Ohio. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot." This allows the anti-tumor immune cells, induced by pelareorep, to attack the cancer. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: or follow the company on social media on LinkedIn and on X @oncolytics. 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 contained in this press release include Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our belief in our executive team's ability to continue executing our mission, achieve our strategic priorities and drive forward our registration-enabling clinical plans for pelareorep; our expectation that we will continue to deliver on our long-term goals to ultimately bring pelareorep to patients with cancer; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' 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, Oncolytics' 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. We may incur expenses or delays relating to such events outside of our control, including public health crises such as pandemics and epidemics, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' 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 any obligation to update these forward-looking statements, except as required by applicable laws. Logo: Company Codes: Toronto:ONC, NASDAQ-NMS:ONCY

Clinical ResultVaccinePhase 2Executive ChangeFast Track

100 Deals associated with Pelareorep(Oncolytics Biotech, Inc.)

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R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 3	CN	Hangzhou Adlai Nortye Biopharma Co. Ltd.	01 Oct 2021
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	US	Oncolytics Biotech, Inc.	01 Jun 2010
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	BE	Oncolytics Biotech, Inc.	01 Jun 2010
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	CA	Oncolytics Biotech, Inc.	01 Jun 2010
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	FR	Oncolytics Biotech, Inc.	01 Jun 2010
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	DE	Oncolytics Biotech, Inc.	01 Jun 2010
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	GR	Oncolytics Biotech, Inc.	01 Jun 2010
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	HU	Oncolytics Biotech, Inc.	01 Jun 2010
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	IT	Oncolytics Biotech, Inc.	01 Jun 2010
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	PL	Oncolytics Biotech, Inc.	01 Jun 2010

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AWARE-1 (PRNewswire) Manual	Not Applicable	Hormone receptor positive HER2 negative breast cancer First line HER2 Negative \| HR Positive	-	pelareorep plus letrozole	wacvsbraqr(tomhrgcber) = ibsnjkvqve yxebgwaxsy (elmoulhxxe )	Positive	07 Dec 2023
AWARE-1 (PRNewswire) Manual	Not Applicable		-	pelareorep + letrozole+atezolizumab	vymcnmbpxe(kncvvujuzx) = kmbaesgljg uzjajahpfy (mmzkheypzm ) View more	Positive	07 Dec 2023
GOBLET (Corporate Publications) Manual	Phase 1/2	Anus Neoplasms Second line	-	Pelareorep +Atezolizumab	adfttgrjcz(vpudjlgrka) = khaqonrqib tbxonevloz (btjdegkrcg )	Positive	09 Nov 2023
GOBLET (Corporate Publications) Manual	Phase 1/2	Pancreatic Cancer First line	13	Pelareorep+Atezolizumab+Gemcitabine+Nab-paclitaxel	xlcqhsqjgh(wrzuctqdlp) = vfyhvxffca vxyemwvnjd (adefegesnw ) View more	Positive	23 Oct 2023
GOBLET (ESMO2023) Manual	Phase 1/2	Pancreatic Ductal Adenocarcinoma First line	13	Pelareorep + Atezolizumab + Gemcitabine +nab-paclitaxel	txqoahbbpo(uyojbaomoe) = tqwfakpfta uxorviwzhc (fbtgqucrnv ) View more	Positive	23 Oct 2023
GOBLET (ESMO2023) Manual	Phase 1/2	Metastatic Colorectal Carcinoma	15	Pelareorep + atezolizumab + trifluridine/tipiracil	bmcsmdmdhc(vmxikqdwdx) = brlkprbjus oicsezmify (jbqzrsyrih ) View more	Positive	22 Oct 2023
BRACELET-1 (Corporate Publications) Manual	Phase 2	Hormone receptor positive HER2 negative breast cancer HER2 Negative \| HR Positive	48	Paclitaxel	kjutfzjgda(dnupvukjlp) = xklojzohck baqzkehabm (stvxnrwnyl, 3.9 ~ NR) View more	Positive	05 Jun 2023
BRACELET-1 (Corporate Publications) Manual	Phase 2		48	Paclitaxel + Pelareorep	kjutfzjgda(dnupvukjlp) = bxtfpvjpim baqzkehabm (stvxnrwnyl, 6.5 ~ NR) View more	Positive	05 Jun 2023
NCT04215146 (PrE0113, ASCO2023) Manual	Phase 2	Hormone receptor positive HER2 negative breast cancer HR Positive \| HER2 Negative	48	paclitaxel	dprzaegeqh(pgxnvdyqrb) = ydciaigxgx jwpjocjchn (wdyunonevo ) View more	Positive	26 May 2023
NCT04215146 (PrE0113, ASCO2023) Manual	Phase 2		48	paclitaxel+pelareorep	dprzaegeqh(pgxnvdyqrb) = efvueyixkj jwpjocjchn (wdyunonevo ) View more	Positive	26 May 2023
ReoGlio (AACR2022)	Phase 1	Glioblastoma Multiforme Adjuvant	15	Pelareorep + GM-CSF + standard chemoradiotherapy	qdojjvgjtp(bmmbxtgcdy) = tdboldieah nysgopvabb (kqeoxaynyo )	-	15 Jun 2022
ReoGlio (AACR2022)	Phase 1	Glioblastoma Multiforme Adjuvant	15	Standard chemoradiotherapy	qdojjvgjtp(bmmbxtgcdy) = bwxcunartk nysgopvabb (kqeoxaynyo )	-	15 Jun 2022
NCT03723915 (ASCO2021) Manual	Phase 2	Advanced Pancreatic Adenocarcinoma Second line	13	Pembrolizumab+pelareorep	msrosbmnmm(glpmqmztrf) = wbxtffvwal xnyhmzyspj (vdltlgiwbr ) View more	Positive	28 May 2021
NCT03723915 (CTgov)	Phase 2	Pancreatic adenocarcinoma \| Advanced Pancreatic Adenocarcinoma	17	Pelareorep+Pembrolizumab	wlrzzkmign(txyjovjwvc) = xzxnmbaidm jkgcxqldmq (veaupzxvzs, myrwbquytr - udqworopdl) View more	-	20 Jan 2021

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Pelareorep(Oncolytics Biotech, Inc.)

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