Pelareorep(Oncolytics Biotech, Inc.)

USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 19, 2024 /PRNewswire/ -- USA News Group – This year's 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO) has now come and gone, but not without increasing hope for cancer patients around the world. This year's ASCO 2024 theme was 'The Art and Science of Cancer Care: From comfort to cure,' with attendees hearing presentations from experts and receiving a wide range of important clinical results for the first time. According to analysts at Spherical Insights, the Global Oncology Drugs Market is projected to be worth $564.5 billion by 2033, growing at a CAGR of 11.5%. Because a new drug typically might take 10-15 years to complete all 3 phases of clinical trials, the developments of today directly impact the results of tomorrow. This is why retail investors are wise to pay attention to the milestones and data shared by this year's ASCO attendees, which included O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), AbbVie Inc. (NYSE: ABBV), AstraZeneca PLC (NASDAQ: AZN), Pfizer Inc. (NYSE: PFE), and Bristol-Myers Squibb Company (NYSE: BMY). Updating the audience for its flagship novel immunotherapy, pelareorep, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) presented two abstracts demonstrating further potential for the intravenously delivered immunotherapeutic agent in pancreatic cancer and its immunotherapeutic mechanism of action across multiple cancer indications. Oncolytics' first abstract presented was for a trial-in-progress of cohort 5 of the company's GOBLET study, evaluating the effectiveness of combining pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with and without Roche's atezolizumab (Tecentriq®) in newly diagnosed patients with metastatic pancreatic ductal adenocarcinoma (PDAC). "The first abstract outlines the design of a new GOBLET PDAC cohort that could significantly expand the potential of the company's pancreatic cancer program," said Dr. Matt Coffey, President and CEO of Oncolytics. "The chemotherapy regimens of mFOLFIRINOX and gemcitabine/nab-paclitaxel are the two most common standards of care in metastatic pancreatic cancer. We previously reported that the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab yielded tumor response rates nearly triple historical results. Should the combination of pelareorep and mFOLFIRINOX produce a similarly positive outcome, an even broader range of metastatic PDAC patients may benefit from pelareorep-based therapy." Funded by a US$5 million Therapeutic Accelerator Award grant from the Pancreatic Cancer Action Network (PanCAN), Oncolytics Biotech plans to start enrolling patients this quarter following regulatory clearance received in May. The GOBLET cohort 5 abstract and poster detail a study assessing innovative treatments for patients newly diagnosed with metastatic PDAC. Utilizing a Simon two-stage design, the study aims to determine if the treatments are promising enough for further investigation. Initially, 15 patients per treatment arm will be randomly assigned to receive either pelareorep with mFOLFIRINOX or pelareorep with mFOLFIRINOX and atezolizumab. The study's primary goals include evaluating the effectiveness and safety of these treatments. Researchers will measure progression-free survival (the length of time patients live without the cancer worsening), overall survival (the total length of time patients live), and biomarkers (biological indicators of treatment response). Should the first stage yield positive results, one or both treatment groups may progress to the second stage, which will involve an additional 17 patients per arm. Throughout the study, blood and tumor samples will be collected for in-depth analysis. This approach aims to provide a comprehensive understanding of how the treatments impact patient outcomes and pave the way for potential future advancements in PDAC therapy. Among the big pharma contenders that presented at ASCO 2024 was AbbVie Inc. (NYSE: ABBV), which took the opportunity at the meeting to showcase its robust solid tumor pipeline, with new data from its innovative antibody-drug conjugate (ADC) platform. AbbVie's ADCs are designed to target unique protein biomarkers such as c-Met (MET protein) and SEZ6 (seizure-related homolog 6 protein), which are over-expressed across various tumor types. The biotech giant states that by utilizing these biomarkers as targets, ADCs are designed to deliver potent cancer cell death-inducing agents called 'payloads' to the tumor. "Building upon our strong commitment to patients and existing leadership in hematological malignancies, we are rapidly advancing a differentiated pipeline in solid tumors," said Daejin Abidoye, M.D., Vice President, Head of Solid Tumors, Oncology Development, for AbbVie. "Our ADC platform allows us to utilize selected biomarkers such as c-Met and SEZ6 to induce targeted cancer cell death by delivering potent anti-cancer agents." At the meeting, Abbvie presented positive Phase I and II trial data for three ADC therapies, Teliso-V, ABBV-400 and ABBV-706, in solid tumour patients—with Teliso-V being the company's most advanced c-Met targeted ADC in development. The LUMINOSITY study enrolled 172 patients with c-Met protein overexpression and epidermal growth factor receptor wild type, advanced/metastatic non-squamous NSCLC. The Teliso-V results showed a mean overall response rate (ORR) of 28.6%, with ORRs of 34.6% in c-Met high patients and 22.9% in c-Met intermediate patients. The therapy demonstrated a median duration of response (DOR) of 9 months in c-Met high patients and 7.2 months in c-Met intermediate patients. Another ADC gaining attention was Enhertu, developed by British multinational AstraZeneca PLC (NASDAQ: AZN) and Japanese multinational Daiichi Sankyo. In a clinical trial, Enhertu reduced the risk of breast cancer progression by 37% compared to chemotherapy in patients who are HER2-positive, HER2-low, and HER2-ultralow. "DESTINY-Breast06 represents another potential paradigm shift in how we treat patients across the spectrum of HR-positive metastatic breast cancer," said Susan Galbraith, Executive Vice President, Oncology R&D, of AstraZeneca. "The results reinforce the potential for Enhertu to improve outcomes earlier in the treatment landscape and in a broader population of patients with HER2-expressing breast cancer who have never before been eligible for a HER2-directed therapy." AstraZeneca achieved multiple successes at ASCO this year. Among the highlights was the impressive performance of Tagrisso in a phase 3 lung cancer trial. The kinase inhibitor significantly reduced the risk of disease progression by 84% compared to the placebo. "Tagrisso extended progression-free survival by more than three years in this potentially curative setting, reinforcing the need to test and diagnose patients early," said Galbraith. "These practice-changing data cement the powerful impact Tagrisso can make as backbone therapy in EGFR-mutated lung cancer, especially in the lives of these patients who have historically experienced early progression following chemoradiotherapy." Another highlight at ASCO 2024 came from Pfizer Inc.'s (NYSE: PFE) phase 3 clinical trial results for Lorbrena, a drug approved by the U.S. Food and Drug Administration (FDA) for non-small cell lung cancer (NSCLC) in 2021. The five-year follow-up of patients with the ALK mutation showed that Lorbrena reduced the risk of disease progression by 81% compared to Xalkori, a recognized first-line treatment for NSCLC. Lorbrena's readout was among the most impressive at ASCO as 60% of the patients showed a five-year progression-free survival. "These results from the CROWN trial are unprecedented, as the majority of patients on LORBRENA are living beyond five years without disease progression," said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer. "These results are an excellent example of Pfizer's long-standing commitment to discovering and developing scientific breakthroughs for patients, and support LORBRENA as a standard of care for the first-line treatment of people with ALK-positive advanced NSCLC." Another class of drugs that garnered attention at ASCO 2024 was KRAS inhibitors. However, the trial results from Bristol-Myers Squibb Company (BMS) (NYSE: BMY) and Amgen each experienced challenges. Although KRAS mutations are common in non-small cell lung cancer (NSCLC), and despite the drug being granted accelerated approval by the FDA in 2022, BMS's Krazati underperformed when looking at median progression-free survival, even though it reduced tumor progression risk by 42%. Krazati's median progression-free survival (PFS) – the period during which a patient's condition remains stable after treatment – extended beyond chemotherapy by 1.7 months in a confirmatory study. "The accelerated approval of KRAZATI from the FDA in 2022 was welcome news for patients with KRASG12C-mutated locally advanced or metastatic NSCLC," said Abderrahim Oukessou, M.D., Vice President, Global Program Lead, KRAZATI, Bristol Myers Squibb. "These confirmatory results further support KRAZATI as an efficacious, targeted treatment option for these patients. We look forward to further sharing these results, while also continuing to evaluate KRAZATI in other advanced KRASG12C-mutated solid tumors." Article Source: 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

USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 12, 2024 /PRNewswire/ -- After looking at public health records for 3.8 million patients with invasive spreading cancer, researchers recently discovered that Generation X may be experiencing larger per-capita increases in the incidence of leading cancers, including the very deadly pancreatic cancer, compared to previous generations. The startling revelations come from a study conducted by experts at the National Cancer Institute's Division of Epidemiology and Genetics and was published in JAMA Network Open. Compared with baby boomers, Gen X women had projected increases in pancreatic, thyroid, kidney, rectal, uterine, colon, and ovarian cancers, as well as non-Hodgkin's lymphoma and leukemia. Among those, pancreatic cancer is generally considered the deadliest, with its very low five-year survival rate, typically late diagnosis, and aggressive nature. In order to significantly enhance patient health outcomes, several biotech developers are actively working on innovative solutions, including recent developments coming from O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Verastem, Inc. (NASDAQ: VSTM), Candel Therapeutics, Inc. (NASDAQ: CADL), FibroGen, Inc. (NASDAQ: FGEN), and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN). Presented recently at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) presented two abstracts related to their novel immunotherapy, pelareorep, an intravenously delivered immunotherapeutic agent. One of the abstracts presented was a trial-in-progress for cohort 5 of the GOBLET study. This cohort will examine the effectiveness of combining pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab —made by Roche Holding AG (OTCQX: RHHBY)— in newly diagnosed patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The cohort is funded by a US$5 million Therapeutic Accelerator Award grant from the Pancreatic Cancer Action Network (PanCAN). Oncolytics Biotech expects to begin enrollment for this cohort this quarter, having received regulatory clearance to begin the enrollment process in May. "The first abstract outlines the design of a new GOBLET PDAC cohort that could significantly expand the potential of the company's pancreatic cancer program," said Dr. Matt Coffey, President and CEO of Oncolytics. "The chemotherapy regimens of mFOLFIRINOX and gemcitabine/nab-paclitaxel are the two most common standards of care in metastatic pancreatic cancer. We previously reported that the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab yielded tumor response rates nearly triple historical results. Should the combination of pelareorep and mFOLFIRINOX produce a similarly positive outcome, an even broader range of metastatic PDAC patients may benefit from pelareorep-based therapy." The GOBLET cohort 5 abstract and poster outline a study evaluating new treatments for patients with newly diagnosed metastatic PDAC using a Simon two-stage design. This design helps determine if a treatment is promising enough to continue testing. In the first stage, 15 patients in each treatment arm will be randomly assigned to receive either pelareorep with mFOLFIRINOX or pelareorep with mFOLFIRINOX and atezolizumab. The main goals are to measure how well the treatments work and their safety. Additionally, the study will look at progression-free survival (how long patients live without the cancer getting worse), overall survival (how long patients live overall), and biomarkers (indicators of how the body responds to the treatment). If the first stage is successful, one or both groups may proceed to Stage 2, which will include 17 more patients per treatment arm. Blood and tumor samples will be collected for further analysis throughout the study. Also presented at ASCO's meeting were positive initial interim safety and efficacy results from Verastem, Inc. (NASDAQ: VSTM) in an ongoing Phase 1/2 trial evaluating its avutometinib plus defactinib in combination with gemcitabine and Nab-paclitaxel for first-line treatment in patients with metastatic pancreatic cancer. Like Oncolytics' pelareorep, Verastem's avutometinib received funding from PanCAN through its Therapeutic Accelerator Award. " Verastem was the inaugural recipient of the PanCAN Therapeutic Accelerator Award, which has been an important part of PanCAN's approach to advancing innovative treatments for pancreatic cancer," said Anna Berkenblit, M.D., MMSc, Chief Scientific and Medical Officer at PanCAN. "There is a critical need for new treatment options in this disease, and we hope that the results from this study lead to improved outcomes for patients with pancreatic cancer." As of May 14, 2024, Verastem reported that patients receiving the combination therapy achieved a confirmed overall response rate (ORR) of 83%, with 5 out of 6 patients responding positively. The release of these results led to a positive market reaction, boosting Verastem's shares in pre-market trading in the process. Notably, there was one case of dose-limiting toxicity (febrile neutropenia) in the dose level 1 cohort. However, this dose level was cleared after enrolling additional patients in three other cohorts of the study. "The initial interim results from the RAMP 205 trial evaluating avutometinib and defactinib in combination with standard of care first-line chemotherapy are encouraging and demonstrate the importance of targeting the RAS/MAPK pathway, as more than 90% of pancreatic tumors have a KRAS mutation," said John Hayslip, M.D., Chief Medical Officer of Verastem Oncology. "We continue to progress the study evaluating other dose and schedule regimens to determine the recommended Phase 2 dose in the trial." In another recent update, Candel Therapeutics, Inc. (NASDAQ: CADL) reported "very encouraging results" from its phase 2 clinical trial of CAN-2409, which targets borderline resectable pancreatic cancer. The data showed that patients treated with CAN-2409 had an estimated median overall survival of 28.8 months, compared to just 12.5 months for the control group. Furthermore, at 24 months, the survival rate was 71.4% for those treated with CAN-2409, whereas the control group had a survival rate of only 16.7% following chemoradiation. "Given the frequent recurrence and short survival with SoC chemotherapy for non-metastatic PDAC, effective new treatment options are urgently needed," said Garrett Nichols, MD, MS, Chief Medical Officer of Candel. "We are very encouraged by the improved survival associated with CAN-2409, which has been shown to be durable after prolonged follow-up based on the updated data in this randomized clinical trial. CAN-2409 was generally well tolerated without significant additional local or systemic toxicity when added to SoC chemoradiation." Because pancreatic cancer is considered a solid tumor, news of a joint effort between FibroGen, Inc. (NASDAQ: FGEN) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announcing a supply agreement to evaluate FG-3165 as a monotherapy and in combination with LIBTAYO in patients with select solid tumors is relevant. Under the clinical study collaboration and supply agreement, Regeneron will provide drug supply to FibroGen, who will be the sponsor of each Phase 1 monotherapy and combination trial. Each company retains all rights to their respective compounds, including as a monotherapy or as combination therapies. "We are very excited to collaborate with Regeneron Pharmaceuticals to evaluate two separate novel combination approaches to treat patients with select solid tumors," said Deyaa Adib, M.D., Chief Medical Officer of FibroGen. "We believe that the mechanisms of action for both FG-3165 (anti-Gal9) and FG-3175 (anti-CCR8) have the potential to be synergistic with cemiplimab, providing the possibility for an improvement in clinical outcomes for patients. We look forward to building a collaborative relationship with Regeneron, who is a leader in oncology therapeutic products development and commercialization." In their Q1 2024 financial results, FibroGen announced several upcoming milestones. The company expects to release topline data from the PanCAN Precision Promise Phase 2/3 study of pamrevlumab in metastatic pancreatic cancer by mid-2024. Additionally, they anticipate delivering topline data from the LAPIS Phase 3 study of pamrevlumab in locally advanced unresectable pancreatic cancer (LAPC) in Q3 2024. "Looking ahead, we expect to report topline data from our two late-stage clinical trials of pamrevlumab in pancreatic cancer in the coming months," said Thane Wettig, CEO of FibroGen. Article Source: 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