From Crisis to Opportunity: How Advances in Immunotherapy Are Shaping the Oncology Sector December 19, 2024 - Baystreet.ca Issued on behalf of Oncolytics Biotech Inc. VANCOUVER – USA News Group News Commentary – Despite significant advances in oncology research, challenges remain as the American Cancer Society recently highlighted a sharp rise in early-onset colorectal cancer cases globally, signaling a growing cause for concern. At the same time, the Society’s Advances in Oncology – 2024 Research Highlights report showcased how their scientists are driving innovation and setting the standard for groundbreaking cancer research. Adding to the conversation, a new Nature article revealed that disruptions caused by the COVID-19 pandemic delayed cancer diagnoses, treatments, and screenings, leading to more advanced disease stages, poorer survival rates, and difficulties in assessing long-term cancer data. While the oncology landscape continues to face these issues, new developments are offering hope, with recent progress coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), CEL-SCI Corporation (NYSE-American: CVM), Immuneering Corporation (NASDAQ: IMRX), Repare Therapeutics Inc. (NASDAQ: RPTX), and Pyxis Oncology, Inc. (NASDAQ: PYXS). The article continued: Recently, the American Cancer Society also sounded the alarm over a concerning increase in cancer diagnoses and deaths among younger age groups. According to Exactitude Consultancy, the Cancer Immunotherapy Market is expected to expand at a 12.84% compound annual growth rate (CAGR), with projections estimating it will reach $258.22 billion by 2031, underscoring oncology’s role as a fast-growing and transformative sector. Oncolytics Biotech® to Present Promising Pelareorep Data in Pancreatic and Anal Cancers at ASCO GI Symposium Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, recently announced the presentation of two data sets through two abstracts showcasing pelareorep’s potential in difficult-to-treat gastrointestinal cancers, which were accepted and will be presented at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco January 23-25, 2025. “We are enthusiastic about pelareorep’s applicability across multiple gastrointestinal cancer indications, including pancreatic and anal cancer,” said Tom Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. “Pelareorep engages patients’ immune systems to help make commonly used chemotherapies and checkpoint inhibitors, such as atezolizumab, more effective in fighting cancer. This offers the promise of delaying disease progression and improving survival in patients with these devasting diseases. Given the versatility of pelareorep, we see multiple clinical and regulatory options for bringing this promising medicine to patients.” Oncolytics will present two key data sets from the GOBLET study, with preliminary safety and tumor response results for the relapsed anal carcinoma cohort treated with pelareorep and atezolizumab presented in Poster Session C on January 25, 2025, from 7:00 to 7:55 a.m. PT. Additionally, results from the safety run-in phase for first-line metastatic pancreatic ductal adenocarcinoma patients treated with pelareorep, modified FOLFIRINOX, with and without atezolizumab will be presented in Poster Session B on January 24, 2025, from 11:30 a.m. to 1:00 p.m. PT. Both abstracts will be available on the ASCO Gastrointestinal Cancers Symposium website at 5:00 p.m. ET on January 21, 2025. Pelareorep is an intravenously delivered immunotherapeutic agent, which is in phase 3 clinical trial for the treatment of hormone receptor-positive / human epidermal growth factor 2-negative metastatic breast cancer and advanced/metastatic pancreatic ductal adenocarcinoma. It has a co-development agreement with Merck KGaA and Pfizer Inc. to co-develop pelareorep, as well as with Roche Holding AG. CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ In other recent industry developments and happenings in the market include: CEL-SCI Corporation (NYSE-American: CVM), a clinical-stage biotechnology company, recently highlighted strong biological rationale for the use of Multikine (Leukocyte Interleukin, Injection) —an immunotherapy intended for use in treating cancer—in the confirmatory registration head and neck cancer study. The study, involving 212 newly diagnosed locally advanced, resectable head and neck cancer patients, was given the go-ahead as a confirmatory registration study by FDA and will focus on those patients who showed a 73% survival with Multikine vs. a 45% for the control patients not treated with Multikine in the prior Phase 3 study. "I am hopeful that this report will help investors understand why we believe that we have developed a potentially very effective and safe new medicine for newly diagnosed head and neck cancer, a horrible disease with very few treatment options," said Geert Kersten, CEO of CEL-SCI. “Our goal is to make the first cancer treatment more successful by activating an anti-tumor immune response BEFORE surgery, radiotherapy and chemotherapy weaken the immune system.” Immuneering Corporation (NASDAQ: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead clinical-stage program, IMM-1-104, as a treatment for patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1 based immune checkpoint inhibitors. IMM-1-104 is currently being evaluated in a Phase 2a clinical trial in patients with advanced solid tumors, including melanoma. “As we presented at the European Society for Medical Oncology 2024 congress, IMM-1-104 is a new kind of MEK inhibitor that was observed to be uniquely well tolerated in our Phase 1 trial, relative to MEK inhibitors currently used to treat melanoma,” said Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering. “We believe this creates opportunities for IMM-1-104 to benefit melanoma patients both alone and in combination with RAF inhibitors and/or immune checkpoint inhibitors. Against this backdrop, we are pleased with the FDA’s decision to grant Fast Track designation for IMM-1-104 in advanced melanoma, an area of significant unmet need. Melanoma patients are actively enrolling in one of the five arms of our Phase 2a clinical trial, and this designation follows our announcements earlier this year that IMM-1-104 has also been granted Fast Track designations for the treatment of both first and second-line pancreatic cancer.” Repare Therapeutics Inc. (NASDAQ: RPTX), a leading clinical-stage precision oncology company, recently reported positive data from its MYTHIC Phase 1 gynecologic expansion clinical trial evaluating the combination of lunresertib (a first-in-class precision oncology small molecule PKMYT1 inhibitor) and camonsertib (Lunre+Camo) (a potential best-in-class oral small molecule inhibitor of ATR) at the recommended Phase 2 dose (RP2D) in patients with endometrial cancer and platinum-resistant ovarian cancer (PROC) harboring lunre-sensitizing biomarkers. "We are encouraged by the strong response and the clear benefit we observed in patients with endometrial and platinum-resistant ovarian cancers in the MYTHIC clinical trial," said Lloyd M. Segal, President and CEO of Repare. "These patients need new treatment options and our results support the potential for Lunre+Camo to make a real, positive difference if approved, particularly as a chemotherapy alternative. We have positive feedback from regulatory agencies in both the US and Europe and we look forward to getting started on a registrational Phase 3 trial of Lunre+Camo in endometrial cancer in the second half of 2025." Pyxis Oncology, Inc. (NASDAQ: PYXS), a clinical stage company focused on developing next generation therapeutics to target difficult-to-treat cancers, recently announced positive preliminary data from the ongoing Phase 1 clinical dose escalation study evaluating PYX-201 in multiple types of solid tumors. PYX-201, the Company’s lead clinical drug candidate, is a first-in-concept antibody-drug conjugate (ADC) with a microtubule inhibitor (optimized auristatin) payload that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix (ECM). "These positive data represent a significant milestone for Pyxis Oncology as our novel ECM-targeting ADC, PYX-201, has demonstrated clinical responses by RECIST 1.1 in six tumor types of interest: HNSCC, ovarian, NSCLC, HR+/HER2- breast, TNBC, and Sarcoma," said Lara S. Sullivan, M.D., President and CEO of Pyxis Oncology. “The breadth and depth of our clinical responses clearly indicate the potential of PYX-201 to provide meaningful clinical benefits to patients with difficult-to-treat cancers. In addition to the monotherapy expansion studies we are launching in 1Q25 in HNSCC, I am thrilled to announce our new Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada) to evaluate the combination of PYX-201 and Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with HNSCC, HR+/HER2- breast, TNBC and Sarcoma with first patients expected to dose in 1Q25." Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ 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.
From Crisis to Opportunity: How Advances in Immunotherapy Are Shaping the Oncology Sector December 19, 2024 - Baystreet.ca Issued on behalf of Oncolytics Biotech Inc. VANCOUVER – USA News Group News Commentary – Despite significant advances in oncology research, challenges remain as the American Cancer Society recently highlighted a sharp rise in early-onset colorectal cancer cases globally, signaling a growing cause for concern. At the same time, the Society’s Advances in Oncology – 2024 Research Highlights report showcased how their scientists are driving innovation and setting the standard for groundbreaking cancer research. Adding to the conversation, a new Nature article revealed that disruptions caused by the COVID-19 pandemic delayed cancer diagnoses, treatments, and screenings, leading to more advanced disease stages, poorer survival rates, and difficulties in assessing long-term cancer data. While the oncology landscape continues to face these issues, new developments are offering hope, with recent progress coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), CEL-SCI Corporation (NYSE-American: CVM), Immuneering Corporation (NASDAQ: IMRX), Repare Therapeutics Inc. (NASDAQ: RPTX), and Pyxis Oncology, Inc. (NASDAQ: PYXS). The article continued: Recently, the American Cancer Society also sounded the alarm over a concerning increase in cancer diagnoses and deaths among younger age groups. According to Exactitude Consultancy, the Cancer Immunotherapy Market is expected to expand at a 12.84% compound annual growth rate (CAGR), with projections estimating it will reach $258.22 billion by 2031, underscoring oncology’s role as a fast-growing and transformative sector. Oncolytics Biotech® to Present Promising Pelareorep Data in Pancreatic and Anal Cancers at ASCO GI Symposium Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, recently announced the presentation of two data sets through two abstracts showcasing pelareorep’s potential in difficult-to-treat gastrointestinal cancers, which were accepted and will be presented at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco January 23-25, 2025. “We are enthusiastic about pelareorep’s applicability across multiple gastrointestinal cancer indications, including pancreatic and anal cancer,” said Tom Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. “Pelareorep engages patients’ immune systems to help make commonly used chemotherapies and checkpoint inhibitors, such as atezolizumab, more effective in fighting cancer. This offers the promise of delaying disease progression and improving survival in patients with these devasting diseases. Given the versatility of pelareorep, we see multiple clinical and regulatory options for bringing this promising medicine to patients.” Oncolytics will present two key data sets from the GOBLET study, with preliminary safety and tumor response results for the relapsed anal carcinoma cohort treated with pelareorep and atezolizumab presented in Poster Session C on January 25, 2025, from 7:00 to 7:55 a.m. PT. Additionally, results from the safety run-in phase for first-line metastatic pancreatic ductal adenocarcinoma patients treated with pelareorep, modified FOLFIRINOX, with and without atezolizumab will be presented in Poster Session B on January 24, 2025, from 11:30 a.m. to 1:00 p.m. PT. Both abstracts will be available on the ASCO Gastrointestinal Cancers Symposium website at 5:00 p.m. ET on January 21, 2025. Pelareorep is an intravenously delivered immunotherapeutic agent, which is in phase 3 clinical trial for the treatment of hormone receptor-positive / human epidermal growth factor 2-negative metastatic breast cancer and advanced/metastatic pancreatic ductal adenocarcinoma. It has a co-development agreement with Merck KGaA and Pfizer Inc. to co-develop pelareorep, as well as with Roche Holding AG. CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ In other recent industry developments and happenings in the market include: CEL-SCI Corporation (NYSE-American: CVM), a clinical-stage biotechnology company, recently highlighted strong biological rationale for the use of Multikine (Leukocyte Interleukin, Injection) —an immunotherapy intended for use in treating cancer—in the confirmatory registration head and neck cancer study. The study, involving 212 newly diagnosed locally advanced, resectable head and neck cancer patients, was given the go-ahead as a confirmatory registration study by FDA and will focus on those patients who showed a 73% survival with Multikine vs. a 45% for the control patients not treated with Multikine in the prior Phase 3 study. "I am hopeful that this report will help investors understand why we believe that we have developed a potentially very effective and safe new medicine for newly diagnosed head and neck cancer, a horrible disease with very few treatment options," said Geert Kersten, CEO of CEL-SCI. “Our goal is to make the first cancer treatment more successful by activating an anti-tumor immune response BEFORE surgery, radiotherapy and chemotherapy weaken the immune system.” Immuneering Corporation (NASDAQ: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead clinical-stage program, IMM-1-104, as a treatment for patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1 based immune checkpoint inhibitors. IMM-1-104 is currently being evaluated in a Phase 2a clinical trial in patients with advanced solid tumors, including melanoma. “As we presented at the European Society for Medical Oncology 2024 congress, IMM-1-104 is a new kind of MEK inhibitor that was observed to be uniquely well tolerated in our Phase 1 trial, relative to MEK inhibitors currently used to treat melanoma,” said Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering. “We believe this creates opportunities for IMM-1-104 to benefit melanoma patients both alone and in combination with RAF inhibitors and/or immune checkpoint inhibitors. Against this backdrop, we are pleased with the FDA’s decision to grant Fast Track designation for IMM-1-104 in advanced melanoma, an area of significant unmet need. Melanoma patients are actively enrolling in one of the five arms of our Phase 2a clinical trial, and this designation follows our announcements earlier this year that IMM-1-104 has also been granted Fast Track designations for the treatment of both first and second-line pancreatic cancer.” Repare Therapeutics Inc. (NASDAQ: RPTX), a leading clinical-stage precision oncology company, recently reported positive data from its MYTHIC Phase 1 gynecologic expansion clinical trial evaluating the combination of lunresertib (a first-in-class precision oncology small molecule PKMYT1 inhibitor) and camonsertib (Lunre+Camo) (a potential best-in-class oral small molecule inhibitor of ATR) at the recommended Phase 2 dose (RP2D) in patients with endometrial cancer and platinum-resistant ovarian cancer (PROC) harboring lunre-sensitizing biomarkers. "We are encouraged by the strong response and the clear benefit we observed in patients with endometrial and platinum-resistant ovarian cancers in the MYTHIC clinical trial," said Lloyd M. Segal, President and CEO of Repare. "These patients need new treatment options and our results support the potential for Lunre+Camo to make a real, positive difference if approved, particularly as a chemotherapy alternative. We have positive feedback from regulatory agencies in both the US and Europe and we look forward to getting started on a registrational Phase 3 trial of Lunre+Camo in endometrial cancer in the second half of 2025." Pyxis Oncology, Inc. (NASDAQ: PYXS), a clinical stage company focused on developing next generation therapeutics to target difficult-to-treat cancers, recently announced positive preliminary data from the ongoing Phase 1 clinical dose escalation study evaluating PYX-201 in multiple types of solid tumors. PYX-201, the Company’s lead clinical drug candidate, is a first-in-concept antibody-drug conjugate (ADC) with a microtubule inhibitor (optimized auristatin) payload that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix (ECM). "These positive data represent a significant milestone for Pyxis Oncology as our novel ECM-targeting ADC, PYX-201, has demonstrated clinical responses by RECIST 1.1 in six tumor types of interest: HNSCC, ovarian, NSCLC, HR+/HER2- breast, TNBC, and Sarcoma," said Lara S. Sullivan, M.D., President and CEO of Pyxis Oncology. “The breadth and depth of our clinical responses clearly indicate the potential of PYX-201 to provide meaningful clinical benefits to patients with difficult-to-treat cancers. In addition to the monotherapy expansion studies we are launching in 1Q25 in HNSCC, I am thrilled to announce our new Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada) to evaluate the combination of PYX-201 and Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with HNSCC, HR+/HER2- breast, TNBC and Sarcoma with first patients expected to dose in 1Q25." Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ 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.