Last update 21 Nov 2024

Pelareorep(Oncolytics Biotech, Inc.)

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Oncolytic virus

Synonyms

Pelareorep, REOLYSIN, Reosyn

+ [10]

Target

PKR

Mechanism

PKR inhibitors(eukaryotic translation initiation factor 2 alpha kinase 2 inhibitors), Apoptosis stimulants, Immunostimulants

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesImmune System Diseases+ [6]

Active Indication

Locally advanced breast cancerMetastatic Triple-Negative Breast CarcinomaMetastatic breast cancer+ [15]

Inactive Indication

Advanced Head and Neck CarcinomaAdvanced Pancreatic AdenocarcinomaBladder Cancer+ [26]

Originator Organization

Oncolytics Biotech, Inc.

Active Organization

Oncolytics Biotech, Inc.

National Cancer InstituteAdlai Nortye USA Inc

+ [5]

Inactive Organization

Celgene Corp.

Bristol Myers Squibb Co.

Grupo SOLTI

Drug Highest PhasePhase 2

First Approval Date-

RegulationFast Track (US), Orphan Drug (US)

Clinical Trials associated with Pelareorep(Oncolytics Biotech, Inc.)

NCT05514990 / RecruitingPhase 1/2IIT

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.)

267

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

01 Oct 2024·Virology

Human umbilical cord mesenchymal stem cell exosomes deliver potent oncolytic reovirus to acute myeloid leukemia cells

Article

Author: Wang, Xianyao ; Jin, Lu ; Yang, Na ; Zhao, Xing ; He, Zhixu ; Lin, Xiaojin ; Yang, Zhiru ; Yang, Anqing ; Yang, Yuxin ; Luo, Heyong

In addition to chemotherapy, oncolytic viruses are an efficient treatment for acute myeloid leukemia (AML). Like other oncolytic viruses, the anti-tumor efficacy of reovirus when administered intravenously is reduced due to the presence of neutralizing antibodies. In this study, we evaluated the role of exosomes in human umbilical cord-derived mesenchymal stem cells (UC-MSCs) to deliver reovirus to AML cells. We show that UC-MSCs loaded with reovirus can deliver reovirus to tumor cells without cellular contact. We further demonstrate that the exosome inhibitor, GW4869, inhibits the release of exosomes as well as inhibited the transfer of reovirus from UC-MSCs to tumor cells. Mechanistically, we show that exosomes derived from reovirus-infected UC-MSCs (MSC_REO-EXOs) have a tumor lysis effect and transmit reovirus to tumor cells mainly through clathrin-mediated endocytosis (CME) and macropinocytosis. In addition, we demonstrate the feasibility of using MSC-derived exosomes (MSC-EXOs) as a reovirus carrier to exert an anti-tumor effect on AML cells. Collectively, our data indicate that UC-MSCs transfer reovirus to AML cells via exosome release and prompt further study of MSC-EXOs as a potential reovirus carrier to treat AML.

01 Oct 2024·Virology

Cationic liposomes overcome neutralizing antibodies and enhance reovirus efficacy in ovarian cancer

Article

Author: Ye, Rui ; Lin, Xiaojin ; Yang, Zhiru ; Chen, Liang ; Zhao, Xing ; Liang, Dan ; Zhang, Yingchun ; Yang, Wei ; Zhang, Jing ; Fan, Yuting ; Guan, Weili ; Ouyang, Weiwei ; Yang, Na ; Guo, Ting ; Huang, Lei ; Gong, Chulan ; Yang, Yuxin

Reovirus (Reo) has shown promising potential in specifically killing tumor cells, and offering new possibilities for ovarian cancer (OC) treatment. However, neutralizing antibodies in the ascites from OC patients greatly limit the further application of Reo. In this study, we employed cationic liposomes (Lipo) to deliver Reo, significantly enhancing its ability to enter OC cells and its effectiveness in killing these cells under ascitic conditions. Pre-treatment with the MβCD inhibitor notably decreased Reo-mediated tumor cell death, indicating that Lipo primarily enables Reo's cellular uptake through caveolin-mediated endocytosis. Our results demonstrate that Lipo effectively facilitates the entry of Reo into the cytoplasm and triggers cell apoptosis. The above findings provide a new strategy to overcome the obstacle of neutralizing antibodies in the clinical application of Reo.

01 Oct 2024·Journal of Controlled Release

Small extracellular vesicles carrying reovirus, tumor antigens, interferon-β, and damage-associated molecular patterns for efficient tumor treatment

Article

Author: Sakurai, Fuminori ; Ishigami, Ikuho ; Tsujikawa, Kazutake ; Mizuguchi, Hiroyuki ; Inoue, Chieko ; Kawakami, Shigeru ; Kamiya, Mariko ; Shuwari, Naomi ; Tachibana, Masashi ; Jingushi, Kentaro

Small extracellular vesicles (SEV) have attracted much attention both as mediators of intercellular communication and as drug delivery systems. In addition, recent studies have shown that SEV containing virus components and virus particles are released from virus-infected cells. Oncolytic viruses, which efficiently kill tumor cells by tumor cell-specific replication, have been actively studied as novel anticancer agents in clinical and preclinical studies. However, it remains to be fully elucidated whether SEV released from oncolytic virus-infected cells are involved in the antitumor effects of oncolytic viruses. In this study, we examined the tumor cell killing efficiencies and innate immune responses following treatment with SEV released from oncolytic reovirus-infected tumor cells in vitro and in vivo. Reovirus-infected B16 cells secreted SEV associated with or containing reovirus particles (Reo-SEV) with a diameter of approximately 130 nm and a zeta potential of -17 mV, although death of reovirus-infected B16 cells was not observed. The secreted Reo-SEV also contained interferon (IFN)-β, tumor antigens, and damage-associated molecular patterns (DAMPs), including heat shock proteins (HSPs). Reo-SEV were secreted from the tumor tissues of reovirus-injected mice. Inhibition of the SEV secretion pathway using GW4869, which is a neutral sphingomyelinase inhibitor, resulted in significant reduction in the infectious titers of reovirus in the culture supernatants, suggesting that the cells released progeny virus via the SEV secretion pathway. Reo-SEV more efficiently killed mouse tumor cells and induced innate immune responses in mouse bone marrow-derived dendritic cells than reovirus. Reovirus and Reo-SEV mediated efficient and comparable levels of growth suppression of B16 subcutaneous tumors and induction of tumor infiltration of CD8+ T cells following intravenous administration. These results indicate that Reo-SEV are a promising oncolytic agent and that SEV are an effective delivery vehicle for oncolytic virus.

126

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

14 Nov 2024

·www.prnewswire.com

Biotech Companies' Q3 Updates: Promising Cancer Treatments on the Horizon

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Nov. 14, 2024 /PRNewswire/ -- USA News Group News Commentary – As many biotech companies within the oncology space begin to roll out their end-of-quarter results, the American Medical Association is pointing out the alarming trend of rising cancer rates, especially with younger people. According to data released from the National Cancer Institute (NCI), a division of the National Institutes of Health (NIH), a map shared by Newsweek showed that the prevalence of cancer varies significantly from state to state. Thankfully, there are plenty of new breakthroughs in the fight against cancer that the World Economic Forum recently highlighted, which are giving hope. Behind the scenes, biotech companies are making strides, with several touting their recent wins in their Q3 2024 financial results, including developments from O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), ImmunityBio, Inc. (NASDAQ: IBRX), Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX), and SpringWorks Therapeutics, Inc. (NASDAQ: SWTX). The article continued: As reported by The Guardian, a new study is raising hopes of treating aggressive cancers by zapping rogue DNA that helps tumors thrive and become resistant to chemotherapy. Showing the shifting market, researchers at Statista recently released a report showing the Top 5 Oncology Products Worldwide by Market Share in 2017 and 2024. Oncolytics Biotech® Reports Third Quarter 2024 Financial Results and Operational Highlights Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, recently reported their Q3 2024 financial results and operational highlights. Among these highlights included impressive overall survival benefit results from BRACELET-1 data in HR+/HER2- metastatic breast cancer affirming its pelareorep + paclitaxel combination should be evaluated in a registrational study. "With positive BRACELET-1 results, we have two randomized phase two studies confirming pelareorep's potential in HR+/HER2- metastatic breast cancer," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO of Oncolytics. "After discussions with regulators and key opinion leaders and based on an estimated overall survival benefit of more than a year provided by pelareorep-based therapy, a registration-enabling study that is designed to support an accelerated approval is the next logical step for the development of pelareorep." In the BRACELET-1 study, pelareorep combined with paclitaxel significantly improved outcomes for patients with advanced HR+/HER2- breast cancer. Patients receiving this treatment lived without cancer progression for an average of 12.1 months, compared to just 6.4 months with paclitaxel alone—showing a benefit of nearly six months. Additionally, 64% of patients treated with pelareorep and paclitaxel lived for at least two years, compared to only 33% for paclitaxel alone. Median overall survival could not be calculated because over half of the patients on pelareorep were still alive at the study's end, but if they only lived to their next follow-up, their survival would average 32.1 months, notably higher than the 18.2 months for paclitaxel alone. Oncolytics also highlighted upcoming milestones in its GOBLET study to include efficacy data from the anal cancer cohort and safety run-in data from the modified FOLFIRINOX pancreatic cancer cohort. "We continue to develop our gastrointestinal cancer program and look forward to presenting updated efficacy data from our anal cancer cohort and safety data from our new modified FOLFIRNOX pancreatic cancer cohort," continued Pisano. "Both of these indications represent a significant unmet medical need, and we have shown pelareorep provides the potential to meaningfully improve patient outcomes. This coming year will be critical for pelareorep, as well as for Oncolytics, and I've never been more confident in the potential pelareorep can deliver to cancer patients in need." Also, as of September 30, 2024, Oncolytics had a cash position of $19.6 million, providing a cash runway through key milestones and into 2025. Looking ahead, in H1 2025, Oncolytics is set to finalize the 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. Oncolytics also expects in 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; and updated efficacy data from cohort 4 of the GOBLET study, investigating pelareorep and atezolizumab in second-line or later anal cancer. As well, mid 2025 should see the first patient enrolled in registration-enabling study evaluating pelareorep and paclitaxel in metastatic HR+/HER2- breast cancer, and H2 2025 should see initial efficacy results from cohort 5 of the GOBLET study, investigating pelareorep and mFOLFIRINOX with or without atezolizumab in newly diagnosed pancreatic cancer. CONTINUED… Read this and more news for Oncolytics Biotech at: In other industry developments and happenings in the market this week include: ImmunityBio, Inc. (NASDAQ: IBRX), an immunotherapy innovator, recently reported its Q3 2024 financial results, which included highlights such as its ANKTIVA® receiving a J-code (HCPCS Level II Code) effective January 1, 2025, and becoming widely accessible to patients through commercial and government insurance programs (VA, DoD, Medicare), leading ImmunityBio to secure coverage for over 200 million medical lives through medical reimbursement policies. "The U.S. launch of ANKTIVA for [non-muscle invasive bladder cancer with carcinoma in situ] (NMIBC CIS) continues to gain momentum, and we are pleased to see the clinical impact for patients," said Richard Adcock, President and CEO of ImmunityBio. "Our permanent J-code has been issued by Centers for Medicare and Medicaid Services and will be effective January 1, 2025. Our submission of ANKTIVA for NMIBC CIS to the MHRA in the UK for potential approval demonstrates our plans for global expansion. Further, we anticipate an EU submission this quarter." The financial results came just weeks after ImmunityBio announced that the first patients had been dosed in an initial trial studying the potential of the company's CAR-NK cell therapy targeting CD-19 in the treatment of non-Hodgkin's lymphoma (NHL). Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, recently reported its Q3 2024 financial results and corporate updates. Among the highlights were the reporting that significant demand for Amtagvi™ (Lifileucel) continues with $58.6M in Total 3Q24 Product Revenue and Iovance reaffirming guidance of $160-$165 million for FY 2024 and $450-$475 million for FY 2025 of total product revenue. " Iovance is executing a successful U.S. commercial launch of Amtagvi™ for patients with previously treated advanced melanoma," said Frederick Vogt, Ph.D., J.D., Interim President and CEO of Iovance. "Robust demand for Amtagvi and Proleukin® continues to grow as our expanding network of authorized treatment centers (ATCs) and outreach to community oncologists broaden the utilization of Amtagvi, driving a higher volume of patient referrals. Demand trends are expected to accelerate growth throughout the remainder of the year and over the following years. As a fully integrated company, Iovance is well positioned to remain the global leader in innovating, developing, and delivering current and future generations of TIL cell therapy for patients with cancer." Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, recently reported its Q3 2024 financial results and business update. Within the highlights were the mention that new revumenib and Niktimvo™ clinical data will be highlighted at the 66th ASH Annual Meeting and that mNPM1 AML topline data from AUGMENT-101 is expected in Q4 2024, with a potential sNDA filing in H1 2025. "This has been a historic period for Syndax as we transitioned to a commercial-stage company with the approval of Niktimvo," said Michael A. Metzger, CEO of Syndax. "We have a very exciting quarter ahead with the anticipated FDA approval and U.S. launch of revumenib for adults and pediatrics with R/R KMT2Ar acute leukemia, as well as the expected readout of topline pivotal data from patients with R/R mNPM1 AML. Our commercial organization is well-prepared to launch revumenib and leverage our first-to-market position to drive long-term value creation." SpringWorks Therapeutics, Inc. (NASDAQ: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, recently reported their Q3 2024 financial results and provided an update on recent company developments that included achieving $49.3 million in OGSIVEO® (nirogacestat) net product revenue in the quarter, and being granted FDA Priority Review on NDA and received validation of EU Marketing Authorization Application for mirdametinib for the treatment of adults and children with NF1-PN. "As we approach nearly one full year on market, we are very encouraged by the metrics we are seeing regarding the breadth of physician prescribing, the number of patients on OGSIVEO, and the number of patients identified who may stand to benefit in the future from our medicine," said Saqib Islam, CEO of SpringWorks. "Our focus for the remainder of the year is to continue building on OGSIVEO's momentum in the U.S. while working to also bring it to patients in Europe, to advance our commercial preparations for mirdametinib in anticipation of serving patients with NF1-PN in the U.S. and Europe, and to progress our emerging portfolio." 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyFinancial Statement

11 Nov 2024

·www.prnewswire.com

Oncolytics Biotech® to Host Conference Call to Discuss Third Quarter Financial Results and Recent Operational Highlights

Conference call and webcast to take place on Tuesday, November 12, 2024, at 8:30 a.m. ET SAN DIEGO and CALGARY, AB, Nov. 11, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that it will host a conference call and webcast on Tuesday, November 12, 2024, at 8:30 a.m. ET to discuss a corporate update and financial results for the third quarter 2024. Conference Call & Webcast Date: Tuesday, November 12, 2024 Time: 8:30 a.m. ET Dial In – North American Toll-Free: (888) 510-2154 Dial In – International: (437) 900-0527 RapidConnect: to join the conference call without operator assistance, please click here Conference ID (if needed): 68336 Webcast: please click here A webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 660-6345 (North America) or (289) 819-1450 (International) and using replay code: 68336#. 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" -- through innate and adaptive immune responses to treat a variety of cancers. 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. Logo - SOURCE Oncolytics Biotech® Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyFinancial StatementFast TrackPhase 2Clinical Result

07 Oct 2024

·www.pharmaceutical-technology.com

Oncolytics targets accelerated approval for oncolytic virus therapy

Oncolytics’s pelareorep is an intravenously delivered oncolytic reovirus that specifically targets cancer cells and induces inflammatory responses. Image credit: MiniStocker / Shutterstock. Oncolytics Biotech is seeking accelerated approval for its lead cancer therapy, pelareorep, with plans to start a registrational Phase II breast cancer trial. The US-based company noted that its decision to seek accelerated approval is based on the positive data from the Phase II BRACELET-1 trial (NCT04215146) and feedback Oncolytics received from the US Food and Drug Administration (FDA). The registrational Phase II trial is expected to start in 2025 and will evaluate the combination treatment of pelareorep and chemotherapy, paclitaxel. The news was received well by Oncolytics’ investors, as the company’s stock was up by 18.22% at the market close on 4 October, compared to the market close on the previous day. Oncolytics’ stock is continuing its upward swing and is up by 8.18% in premarket trading today (7 October). The company’s market cap currently stands at $84.5m. Oncolytic virus therapies have struggled to find a sure footing in the cancer immunotherapy landscape, which is dominated by checkpoint inhibitors like Merck & Co’s Keytruda (pembrolizumab). GlobalData expects sales of oncolytic virus therapies to increase by up to 20 times from $114m in 2023 to $2.4bn by 2029. GlobalData is the parent company of Pharmaceutical Technology . See Also: Biogen scores breakthrough status for anti-rejection transplant medication Lilly and insitro team up to develop AI-powered siRNA metabolic drugs The planned registrational Phase II trial is expected to enrol 180 patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced/metastatic breast cancer. The study evaluates the combination therapy in patients who have either progressed on antibody-drug conjugates (ADCs), who are not eligible for ADCs, or who cannot tolerate ADCs. Trial recruitment is expected to start in the first half of 2025. Oncolytics noted that the study should be sufficiently powered to show statistical significance with a progression-free survival (PFS) benefit of at least 4.3 months. The median overall survival (OS) was not reached in the Phase II BRACELET-1 study. However, the company ”conservatively” estimates the median OS for the pelareorep arm to be 32.1 months, compared to the 18.2 months median OS seen in the paclitaxel control arm. The final PFS of the pelareorep treatment arm was 12.1 months, compared to 6.4 months for the chemotherapy-only arm. “Our first randomised study in breast cancer, IND-213, demonstrated the ability of pelareorep combination therapy to improve survival in heavily pre-treated patients with advanced or metastatic HR+/HER2- disease,” said Oncolytics’ chief medical officer, Dr. Thomas Heineman. “The subsequent randomised BRACELET-1 study showed that pelareorep combination therapy could improve outcomes in HR+/HER2- breast cancer patients who had received prior CDK4/6 inhibitors. Based on the success of these studies, we are now ready to pursue a large Phase II study powered to support accelerated approval in the setting of ADC therapies such as AstraZeneca and Daiichi Sankyo ’s Enhertu (fam-trastuzumab deruxtecan-nxki),” Heineman added.

Phase 2Clinical Result

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

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-	Pelareorep(Oncolytics Biotech, Inc.)	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Squamous Cell Carcinoma of the Head and Neck	Discovery	HU	Oncolytics Biotech, Inc.	01 Jun 2010
Recurrent Squamous Cell Carcinoma of the Head and Neck	Discovery	CA	Oncolytics Biotech, Inc.	01 Jun 2010
Recurrent Squamous Cell Carcinoma of the Head and Neck	Discovery	ES	Oncolytics Biotech, Inc.	01 Jun 2010
Recurrent Squamous Cell Carcinoma of the Head and Neck	Discovery	SI	Oncolytics Biotech, Inc.	01 Jun 2010
Recurrent Squamous Cell Carcinoma of the Head and Neck	Discovery	GB	Oncolytics Biotech, Inc.	01 Jun 2010
Recurrent Squamous Cell Carcinoma of the Head and Neck	Discovery	BE	Oncolytics Biotech, Inc.	01 Jun 2010
Recurrent Squamous Cell Carcinoma of the Head and Neck	Discovery	GR	Oncolytics Biotech, Inc.	01 Jun 2010
Recurrent Squamous Cell Carcinoma of the Head and Neck	Discovery	DE	Oncolytics Biotech, Inc.	01 Jun 2010
Recurrent Squamous Cell Carcinoma of the Head and Neck	Discovery	FR	Oncolytics Biotech, Inc.	01 Jun 2010
Recurrent Squamous Cell Carcinoma of the Head and Neck	Discovery	IT	Oncolytics Biotech, Inc.	01 Jun 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04215146 (BRACELET-1, PRNewswire) Manual	Phase 2	Hormone receptor positive HER2 negative breast cancer HR+ \| HER2-	48	Paclitaxel+ Pelareorep	(bkpwgfzjxu) = pnblmxfjso ilpfamavzl (iskczsahym ) View more	Positive	19 Sep 2024
NCT04215146 (BRACELET-1, PRNewswire) Manual	Phase 2		48	Paclitaxel+Pelareorep+Avelumab	(bkpwgfzjxu) = bfnibthsca ilpfamavzl (iskczsahym ) View more	Positive	19 Sep 2024
AWARE-1 (PRNewswire) Manual	Not Applicable	Hormone receptor positive HER2 negative breast cancer First line \|	-	pelareorep plus letrozole	ikqhhhjufs(byeaulpbnd) = dqlavjvzaa ufrpvvsivx (dpqmilkvpo )	Positive	07 Dec 2023
AWARE-1 (PRNewswire) Manual	Not Applicable		-	pelareorep + letrozole+atezolizumab	vfygtmatex(jpxzovepoj) = xdrwfzueee hzjlgggeyr (kujlgznpwi ) View more	Positive	07 Dec 2023
GOBLET (Corporate Publications) Manual	Phase 1/2	Anus Neoplasms Second line	-	Pelareorep +Atezolizumab	(ggduyhvszm) = qnjvscznzm xawkvrnrzi (glfgxxtczy )	Positive	09 Nov 2023
GOBLET (Corporate Publications) Manual	Phase 1/2	Pancreatic Cancer First line	13	Pelareorep+Atezolizumab+Gemcitabine+Nab-paclitaxel	(qyhpytvupu) = okdoixbhbo yusbopvqmo (gausgtmsrl ) View more	Positive	23 Oct 2023
GOBLET (ESMO2023) Manual	Phase 1/2	Pancreatic Ductal Adenocarcinoma First line	13	Pelareorep + Atezolizumab + Gemcitabine +nab-paclitaxel	(dkpgjpafiz) = valdqovomq xkztqvvzpn (khgirvigtq ) View more	Positive	23 Oct 2023
GOBLET (ESMO2023) Manual	Phase 1/2	Metastatic Colorectal Carcinoma	15	Pelareorep + atezolizumab + trifluridine/tipiracil	(rujpnsehvz) = ocllhctdlr drccsxummp (sbqtozoibj ) View more	Positive	22 Oct 2023
NCT03723915 (Pubmed)	Phase 2	Advanced Pancreatic Adenocarcinoma	12	Pelareorep and pembrolizumab	(nrbscratjd) = ldwxnchtyq rdgsfjicat (sftusehjse )	Positive	13 Jul 2023
BRACELET-1 (Corporate Publications) Manual	Phase 2	Hormone receptor positive HER2 negative breast cancer \|	48	Paclitaxel	(xfrgpfpifi) = mwrqlcetcb mjreptewyj (muxhofcrms, 3.9 - NR) View more	Positive	05 Jun 2023
BRACELET-1 (Corporate Publications) Manual	Phase 2	Hormone receptor positive HER2 negative breast cancer \|	48	Paclitaxel + Pelareorep	(xfrgpfpifi) = xaakqrjdga mjreptewyj (muxhofcrms, 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	(xxkgbhylbh) = vhjsfizptx arznrjqytn (lnwjjtforc ) View more	Positive	26 May 2023
NCT04215146 (PrE0113, ASCO2023) Manual	Phase 2		48	paclitaxel+pelareorep	(xxkgbhylbh) = dffpzeulst arznrjqytn (lnwjjtforc ) View more	Positive	26 May 2023
GOBLET (SITC2022)	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma First line PD-L1 expression	12	Pelareorep + Atezolizumab + Gemcitabine/nab-paclitaxel	iaippvtccn(aaztuvfgip) = yvgpskvnjt wwqljfgilw (jpeicojtrc ) View more	Positive	07 Nov 2022

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