SEA-CD40

FN Media Group Presents USA News Group News Commentary VANCOUVER, BC, Oct. 20, 2023 /PRNewswire/ -- USA News Group - According to the American Cancer Society in its Cancer Facts & Figures 2023 report, the five-year survival rate for pancreatic cancer increased by 1% from the previous year to 12%. The increase has generated more optimism from the Pancreatic Cancer Action Network (PanCAN), whose President and CEO Julie Fleshman, JD, MBA, stated, "It's an important milestone that shows we're headed in the right direction – and this means so much to all those affected by pancreatic cancer." Several biotech developers have been making strides against the deadly disease, including a new mRNA vaccine in the works from BioNTech SE (NASDAQ:BNTX), as well as promising drug-combo therapies from O ncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Seagen Inc. (NASDAQ:SGEN), and better diagnostics from Myriad Genetics, Inc. (NASDAQ:MYGN) and Illumina, Inc. (NASDAQ:ILMN). Coming off of a late-2022 Fast Track Designation (FTD) from the FDA for the treatment of advanced/metastatic pancreatic cancer with its flagship asset, pelareorep, biotechnology company O ncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) has now been selected to be part of the Precision PromiseSM Phase 3 platform trial by PanCAN. "With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options," said Fleshman. "This urgent unmet need was the driving inspiration behind the Precision Promise platform trial, which was designed specifically to identify, accelerate, and de-risk the development of promising pancreatic cancer treatments. We are thrilled to be bringing pelareorep into Precision Promise as a new investigational therapy to study against the current standard of care." The Precision Promise study is designed to evaluate pelareorep in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nab-paclitaxel. If successful, the clinical study is expected to support approval of the studied combination as a treatment for first-line metastatic pancreatic ductal adenocarcinoma (PDAC). "We are delighted at being selected by the Precision Promise panel of experts," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "Our next step is to engage with stakeholders to finalize the protocol for Precision Promise's pelareorep-containing investigational treatment so that we can enter into this study. We are thrilled to have the opportunity to leverage Precision Promise, which we expect will allow us to reduce the time and costs needed to reach a potential approval." Pelareorep is a first-in-class intravenously delivered immunotherapeutic agent for the treatment of solid tumors and hematological malignancies, which demonstrated an objective response rate (ORR) of 69% in advanced/metastatic pancreatic cancer patients, including a complete response last year through its reported interim clinical data before receiving its FTD from the FDA. "Prior trials in pancreatic cancer show pelareorep-based combinations outperforming historical controls on key metrics such as one and two-year survival and objective response rate," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics Biotech. "In addition, mechanistic data from these studies highlight how pelareorep's immunologic mechanism of action allows it to synergize with chemotherapy and checkpoint inhibition in this indication. I look forward to working with the Precision Promise team of investigators to seek to confirm the therapeutic value of pelareorep in a randomized setting so that we can potentially provide pancreatic cancer patients with a new treatment option." For reference, pelareorep's ORR of 69% was recognized as delivering nearly triple the average ORR of ~25% reported in historical control trials evaluating gemcitabine in combination with nab-paclitaxel in pancreatic cancer. However, it was the complete response that was pleasantly unexpected. Ahead of its potential $43-billion acquisition by Pfizer, SEA-CD40 developer Seagen Inc. (NASDAQ:SGEN) saw its own combo of the drug with gemcitabine, nab-paclitaxel and pembrolizumab demonstrate efficacy in patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The SEA-CD40 combo showed a total confirmed ORR of 44%, with comparable response rates observed at both evaluated dose levels of SEA-CD40. "Patients with pancreas cancer need more and better treatments," lead study author Andrew L. Coveler, MD, of Fred Hutchinson Cancer Center and the University of Washington School of Medicine, both in Seattle, said to OncLive®. "The combination of SEA-CD40, pembrolizumab, gemcitabine, and nab-paclitaxel compared favorably with historical controls, demonstrating that immunotherapy may one day be a treatment for patients with pancreas cancer." Earlier this year, Myriad Genetics, Inc. (NASDAQ:MYGN) and Illumina, Inc. (NASDAQ:ILMN) expanded their strategic partnership aimed at broadening access to oncology homologous recombination deficiency (HRD) testing for oncology, making it available in the USA. Through an agreement that aligns Myriad's MyChoice CDx HRD technology with Illumina's pan-cancer test, TSO 500 HRD research test. The resulting product is available to order now and ready to ship in the US. "Research continues to reveal the growing relevance of HRD status across multiple cancers," said Kevin Keegan, vice president and general manager, Oncology Business Unit, at Illumina. "Now with this test, we are empowering labs in the US to unlock the most comprehensive tumor analysis from a single sample." TSO 500 HRD is a single, comprehensive pan-cancer test to identify key genetic variants and homologous recombination deficiency critical for understanding cancer development and progression. HRD status is an important biomarker in tumors that harbor high levels of DNA damage, such as those present in ovarian, breast, prostate, and pancreatic cancers. Illumina and Myriad are offering distributable kits and centralized laboratory service, respectively. Built to be patient-specific, a new tailored neoantigen pancreatic cancer vaccine from BioNTech SE (NASDAQ:BNTX) through a study conducted at Memorial Sloan Kettering Cancer Center (MSKCC) demonstrated an immune response in 50% of patients and prevented relapse. The personalized mRNA vaccine is designed to help immune cells recognize specific neoantigens on patients' pancreatic cancer cells. "It's exciting to see that a personalized vaccine could enlist the immune system to fight pancreatic cancer—which urgently needs better treatments," said research team lead Dr. Vinod Balachandran from MSKCC. "It's also motivating as we may be able to use such personalized vaccines to treat other deadly cancers." Customized vaccines were successfully created for 18 of the 19 study participants. The process, from surgery to delivery of the first dose of the vaccine, took an average of about nine weeks. All patients received an immune checkpoint inhibitor called atezolizumab before vaccination. Atezolizumab prevents cancer cells from suppressing the immune system. The vaccine was then given in nine doses over several months. Article Source: 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. USA News Group is Source of all content listed above. FN Media Group, LLC (FNM), is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with USA News Group or any company mentioned herein. The commentary, views and opinions expressed in this release by USA News Group are solely those of USA News Group and are not shared by and do not reflect in any manner the views or opinions of FNM. FNM is not liable for any investment decisions by its readers or subscribers. FNM and its affiliated companies are a news dissemination and financial marketing solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. FNM was not compensated by any public company mentioned herein to disseminate this press release. This release contains "forward-loking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNM undertakes no obligation to update such statements. Media Contact Information: FN Media Group, LLC Media Contact e-mail: [email protected] U.S. Phone: +1(954)345-0611 SOURCE USA News Group

FN Media Group Presents USA News Group News Commentary VANCOUVER, British Columbia, Oct. 11, 2023 /PRNewswire/ -- USA News Group - Researchers are becoming increasingly concerned with the rates of cancer on the rise among people under 50. A recent study found a nearly 80% global increase in the number of under-50s getting diagnosed with cancer from 1990 to 2019. And among the most worrying rise is in pancreatic cancer, which comes with extremely low survival rates. However, with strategies such as the "Cancer Moonshot," a $200M boost from a newly formed VC firm, and sustained efforts from the Pancreatic Cancer Action Network ( PanCAN), a leading pancreatic cancer organization, which this year noted the 5-year survival rate is approximately 12%. Many new developments are currently underway from biotech firms searching for new treatments and methods of diagnosis, including those from O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Genelux Corporation (NASDAQ: GNLX), Crinetics Pharmaceuticals, Inc. (NASDAQ: CRNX), Pfizer Inc. (NYSE: PFE) and Seagen Inc. (NASDAQ: SGEN). In the process of championing its potentially revolutionary Precision Promise study, PanCAN recently selected the leading drug candidate of Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) known as pelareorep for their pivotal Phase 3 trial. Signalling even more confidence in pelareorep's potential, PanCAN also followed up the selection by rewarding Oncolytics with its second annual PanCAN Therapeutic Accelerator Award, which comes with a US$5 million grant to further develop leading-edge treatments. "This generous grant will enable early and late-stage patients with pancreatic cancer to potentially benefit from another commonly employed chemotherapy backbone, as FOLFIRINOX and gemcitabine + nab-paclitaxel are the most frequently used chemotherapy standards of care in both the first and second-line setting," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "By teaming up with PanCAN, we believe we may be able to expedite development and provide pancreatic cancer patients with a bespoke immunotherapeutic treatment option." Near the end of 2022, pelareorep delivered a big win when the FDA rewarded it with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer. The FDA's decision came almost immediately after an update on ONCY's GOBLET study, which delivered amazing results, including a 69% objective response rate (ORR) in the first group of patients tested and one even having a rare complete response (CR). "Our core programs in pancreatic and breast cancer are both progressing rapidly towards registrational studies on the back of the impressive clinical data showing the potential of pelareorep as a backbone immunotherapy," said Dr. Coffey. The $5M grant enables Oncolytics Biotech to continue the next stage of its research focused pelareorep, including pursuing a new combination with modified FOLFIRINOX chemotherapy with or without an immune checkpoint inhibitor. The award came swiftly on the heels of another US$15 million ONCY successfully raised in order to continue the advancement of its pelareorep clinical programs in both pancreatic and metastatic breast cancers, with significant support from an institutional investor. "With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options," said Julie Fleshman, JD, MBA, President and CEO of PanCAN. "This urgent unmet need was the driving inspiration behind the Precision Promise platform trial, which was designed specifically to identify, accelerate, and de-risk the development of promising pancreatic cancer treatments. We are thrilled to be bringing pelareorep into Precision Promise as a new investigational therapy to study against the current standard of care." The two capital injections combined have left Oncolytics with an excellent cash runway position. According to their Q2 2023 financial results, on a pro forma basis, including the net proceeds from the public offering, Oncolytics had CAD$42.7 million on June 30, 2023, which should last them into the second half of 2024. So far, 2023 has been a great year for Genelux Corporation (NASDAQ: GNLX), which has seen positive results from trials of its lead therapy Olvi-Vec (olvimulogene nanivacirepvec) that's primarily been active in studies pertaining to ovarian cancer. However, Genelux has also been forthcoming about its V2ACT Immunotherapy, which incorporates Olvi-Vec and adoptive cell therapy in targeting newly diagnosed, surgically resectable pancreatic cancer patients. Launched in late 2020, Genelux's pancreatic cancer program is a joint venture with TVAX Biomedical to develop the V2ACT Immunotherapy, housed under the JV company called V2ACT Therapeutics LLC. It was at that time that V2ACT announced FDA clearance of an IND application to proceed with a Phase 1/2a Study of V2ACT for the treatment of pancreatic cancer. "It is generally accepted there is no effective monotherapy for the treatment of pancreatic cancer, a devastating disease," said Gary Wood, Chief Science Officer of V2ACT Therapeutics. " V2ACT provides complementary immunotherapies in a unique process designed to transform non-immunoreactive pancreatic cancer into an immunoreactive 'hot spot' with cancer neoantigen-specific T cell infiltration and cancer cell killing. Therefore, V2ACT has the potential to effectively treat any type of cancer, even those considered to be resistant to immunotherapy." Back in May 2022, Crinetics Pharmaceuticals, Inc. (NASDAQ: CRNX) launched a study to evaluate the safety, PK, and dose response of its treatment paltusotine in subjects with carcinoid syndrome, which includes the potential for carcinoid tumor of pancreas. Now in 2023, paltusotine is in Phase 3 clinical development for acromegaly and the above-mentioned Phase 2 clinical development for carcinoid syndrome associated with neuroendocrine tumors, and the company was able to successfully raise $350M in new funds. Preliminary data from the Phase 2 carcinoid syndrome study is anticipated in Q4 2023. Paltusotine has already demonstrated stable biochemical and symptom levels with two-years oral administration. Approximately 90% of participants said they preferred once-daily, oral paltusotine over current standard of care of injected SRLs when asked after one year of treatment. "At Crinetics, our discovery scientists strive to optimize every atom in each drug candidate to craft the best possible medicine we can for patients with endocrine diseases," said Dr. Scott Struthers, founder and CEO of Crinetics. "These efforts yielded paltusotine, which entered into its first clinical studies in 2017. Since then, the Crinetics team has developed a rich pipeline of additional small molecule drug candidates hoping to improve treatment options for patients with endocrine disorders." Earlier this year Pfizer Inc. (NYSE: PFE) (NEO: PFE) made a huge splash in the biotech sector by investing $43 billion to battle cancer, by acquiring Seagen Inc. (NASDAQ: SGEN). " Pfizer is deploying its financial resources to advance the battle against cancer, a leading cause of death worldwide with a significant impact on public health," said Dr. Albert Bourla, Chairman and CEO of Pfizer. "Together, Pfizer and Seagen seek to accelerate the next generation of cancer breakthroughs and bring new solutions to patients by combining the power of Seagen's antibody-drug conjugate (ADC) technology with the scale and strength of Pfizer's capabilities and expertise. Oncology continues to be the largest growth driver in global medicine, and this acquisition will enhance Pfizer's position in this important space and contribute meaningfully to the achievement of Pfizer's near- and long-term financial goals." Seagen has been working on SGN-STNV, which is currently in Phase I for pancreatic cancer and other solid tumor indications. The study was launched in 2021, and is still in progress, and in 2022 reported data from preclinical models of SEA-CD40 in combination with other therapies in metastatic pancreatic ductal adenocarcinoma (PDAC), and provided an update in January 2023—two months before the Pfizer acquisition. "Preliminary activity is encouraging based on historical chemotherapy outcomes. Further survival follow up is required to inform our next steps in pancreatic cancer," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "We are continuing to advance the ongoing phase 2 trial of SEA-CD40 in melanoma and in non-small cell lung cancer." Article Source: Article Source: USA News Group [email protected] 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. USA News Group is Source of all content listed above. FN Media Group, LLC (FNM), is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with USA News Group or any company mentioned herein. The commentary, views and opinions expressed in this release by USA News Group are solely those of USA News Group and are not shared by and do not reflect in any manner the views or opinions of FNM. FNM is not liable for any investment decisions by its readers or subscribers. FNM and its affiliated companies are a news dissemination and financial marketing solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. FNM was not compensated by any public company mentioned herein to disseminate this press release. This release contains "forward-loking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNM undertakes no obligation to update such statements. Media Contact Information: FN Media Group, LLC Media Contact e-mail: [email protected] U.S. Phone: +1(954)345-0611 SOURCE USA News Group