SEA-CD40

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

FN Media Group Presents USA News Group News Commentary VANCOUVER, BC, Nov. 15, 2022 /PRNewswire/ -- Roughly five years after selling its flagship cancer asset Onivyde from to French biotech giant Ipsen S.A. for approximately $1 billion, Merrimack Pharmaceuticals, Inc. (NASDAQ:MACK) is still reaping the drug's benefit despite being a shuttered drug company with no employees or any active research programs. As Ipsen prepares to file a supplemental New Drug Application (sNDA) for pancreatic cancer, Merrimack saw its shares soar toward a 4.5-year high on account of future cash payments that were contingent on Onivyde winning additional regulatory approvals. As the Centers for Disease Control and Prevention reports cancer deaths trending downward, there have been modest improvements in survival for pancreatic cancer, thanks to developments from the biotech sector from innovators such as O ncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Mirati Therapeutics, Inc. (NASDAQ:MRTX), Amgen Inc. (NASDAQ:AMGN), and Seagen Inc. (NASDAQ:SGEN). For O ncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) a catalyst event may be on the horizon sparked by promising data sets coming from the company's flagship asset pelareorep. The optimism comes from statistically significant results from Oncolytics Biotech's ongoing multi-indication phase 1/2 GOBLET study, patients treated with a combination of pelareorep, with chemotherapy (gemcitabine, and nab-paclitaxel) and atezolizumab. "The robust efficacy signal in GOBLET markedly exceeded expectations based on historical results and is especially encouraging as most responding patients had their tumor regressions confirmed by subsequent evaluations," said Thomas C. Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech. "We were particularly excited to see a partial response deepen into a confirmed complete response as of the latest data cut, since this further indicates potentially durable anti-cancer effects from the combination therapy." The "historical results" the company is comparing to come from 2013 study titled Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine study by Dr. Von Hoff in the New England Journal of Medicine, which later that year led to the FDA approval of the chemotherapy combination of nab-paclitaxel with gemcitabine to treat patients with metastatic pancreatic cancer. Using the 2013 data as a historical control, analysts can now see how the pelareorep combination's data truly stands out—delivering nearly triple the objective response rate (ORR) with 69% vs the 2013 study's 23-29%. "Even the company didn't anticipate this type of news" said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc in an interview with Departures Capital. While the near 70% ORR is statistically significant, so too was the confirmed presence of a complete response (CR)—defined as the disappearance of all signs of cancer in response to treatment. "In talking with key opinion leaders, they were astounded with these results, [with one saying] anything that approaches 40% will get everyone in the community excited. We're reporting at 69% ORR, with a complete response," added Dr. Coffey added. "Now in terms of this complete response, I think it's important to recognize, we've looked at over 1000 patients of historical responses, and a complete response is typically seen in 0.2-0.4% of the population, and we're reporting 1 out of 13 (7.69%). So, I think this is a very encouraging clinical sign." For comparison, Oncolytic Biotech's pelareorep trials produced a 7.7% CR (1 in 13) of test patients, compared to only 0.12% CR (1 in 861) from the 2013 group. Earlier in 2022, the biotech sector also received positive clinical data from multiple other developers, beginning with Seagen Inc. (NASDAQ:SGEN) in mid-January that reported data from its phase 1 clinical trial combining their asset SEA-CD40 with chemotherapy (same as Oncolytics) and an anti-PD-1 (pembrolizumab) in patients with pancreatic ductal adenocarcinoma (PDAC). Activity of SEA-CD40 in combination with chemotherapy and the anti-PD-1 was observed in both doses of SEA-CD40 tested. The overall (N = 61) cORR was 44%, median progressions free survivability (PFS) was 7.4 months (95% CI: 5.6-9.0), and median overall survival (OS) was 15.0 months (95% CI: 7.8-19.9). This combination also showed evidence of immune activation consistent with the SEA-CD40 mechanism of action. "Preliminary activity is encouraging based on historical chemotherapy outcomes," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "Further survival follow up is required to inform our next steps in pancreatic cancer." Later in January 2022, Mirati Therapeutics, Inc. (NASDAQ:MRTX) presented its own positive clinical data with investigational adagrasib in patients with KRASG12C-Mutated Gastrointestinal cancers. The data came from a Phase 2 cohort of the KRYSTAL-1 study evaluating the drug at the 600mg BID dose in patients with pretreated PDAC and other gastrointestinal tumors harboring a KRAS mutating. Of the evaluable patients (n=27), the ORR was 41% and the disease control rate (DCR) was 100%. In evaluable patients with pancreatic cancer (n=10), the RR was 50%, including 1 unconfirmed PR; the median duration of response (mDOR) was 7.0 months, with a median follow up of 8.1 months. "New clinical data presented at ASCO GI show that adagrasib, an inhibitor of KRASG12C, demonstrated promising clinical activity in patients with pancreatic cancer and other GI tumors," said Dr. Tanios S. Bekaii-Saab, an investigator of the KRYSTAL-1 study. "These findings build on the previously reported positive adagrasib clinical data in colorectal and pancreatic cancers, and are highly encouraging, warranting further investigation of adagrasib in this setting." The following month, Amgen Inc. (NASDAQ:AMGN) reportedly saw potential for its own KRAS drug LUMAKRAS in treating pancreatic cancer, through encouraging and clinically meaningful anticancer activity from its CodeBreaK 100 Phase 1/2 trial in patients with KRASG12C mutated advanced pancreatic cancer. Within the February 2022 data, Amgen reported LUMAKRAS demonstrated centrally confirmed ORR of 21% and DCR of 84% across 38 heavily pre-treated advanced pancreatic cancer patients. Nearly 80% of patients received LUMAKRAS as a third-line or later therapy. "CodeBreaK is the largest and broadest global clinical trial program to date with one of the most robust, centrally reviewed datasets," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "As we learn more from the extensive data that we collect, we'll continue to invest in the program by expanding cohorts and exploring new combinations so that we can help as many patients as possible." As the market witnesses these developments, it has shown it rewards successes in the field of pancreatic cancer. Upon the Ipsen's latest data release from its Onivyde regimen demonstrating statistically significant improvement in OS in previously untreated metastatic PDAC patients, the market responded by more than doubling shares of Merrimack Pharmaceuticals, Inc. (NASDAQ:MACK) sending them to a 4-year high. Because Ipsen and Onivyde met its primary and key secondary endpoint, Merrimack is eligible for up to $450 million in milestone payments for the pancreatic cancer treatment. "During the third quarter we continued to see the benefits of reduced operating expenses," said Gary Crocker, Chairman of Merrimack's Board of Directors in the company's Q3 2022 financial results press release. "We will continue to monitor developments in Ipsen's Onivyde® (irinotecan liposomal injection) program and Elevation's seribantumab program." As of this publication, the FDA has officially approved 18 drugs or pancreatic cancer, and 4 drug combinations used in pancreatic cancer, as well as 5 drugs approved for gastroenteropancreatic neuroendocrine tumors, and 2 drugs for pancreatic neuroendocrine tumors. For more information please visit: 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-looking 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