Latest news with #JaredKelly
Malaysian Reserve
6 days ago
- Business
- Malaysian Reserve
The $900 Billion Question: Who Will Deliver the Next Cancer Breakthrough?
USA News Group News CommentaryIssued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 26, 2025 /PRNewswire/ — USA News Group News Commentary – With analysts forecasting the global oncology drug market to surpass US$900 billion by 2034, investor interest in cancer-focused biotechs is rapidly intensifying. ResearchAndMarkets and Vision Research Reports both point to strong double-digit growth, citing surging demand for next-gen diagnostics and immunotherapies. Yet even as market potential grows, the U.S. public health sector is facing potential setbacks. Budget proposals suggest National Cancer Institute (NCI) funding could be slashed by up to 40%, while Bloomberg highlights concerns around drug affordability and access. These headwinds are forcing a shift in expectations — placing the burden of innovation on the private sector, where companies like Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), Citius Oncology, Inc. (NASDAQ: CTOR), ADC Therapeutics SA (NYSE: ADCT), and OS Therapies Incorporated (NYSE-American: OSTX). The shift reflects more than a funding gap — it signals a structural realignment in how cancer breakthroughs may be brought to market. As public systems face pressure and timelines extend, nimble biotech firms are advancing targeted treatments, combination trials, and regulatory conversations once dominated by legacy institutions. Against this backdrop, market watchers see a pivotal window opening for investors willing to back the next wave of oncology innovation. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has entered a new chapter with the appointment of Jared Kelly as Chief Executive Officer and member of the Board. With a background in high-value biotech transactions and late-stage development strategy, Kelly brings experience that may help position the company for its next phase of clinical and corporate progress. Prior to joining Oncolytics, Kelly was General Counsel at Ambrx Biopharma, where he played a key role in the company's $2 billion acquisition by Johnson & Johnson. He also advised a range of life sciences firms on partnerships, licensing, and M&A during his tenure at Kirkland & Ellis LLP and Lowenstein Sandler LLP. His arrival comes as Oncolytics continues advancing pelareorep, a viral-based immunotherapy being evaluated in combination with checkpoint inhibitors and other agents across multiple cancer indications. 'Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients,' said Jared Kelly, CEO of Oncolytics Biotech. 'With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy. I am excited to get to work accelerating development and unlocking significant value for stakeholders.' Kelly's appointment appears aligned with a focused strategy: advancing pelareorep through late-stage development while maintaining capital efficiency and openness to potential partnerships. The company's lead program continues to generate data that support further investigation across several difficult-to-treat cancers. Pelareorep already holds FDA Fast Track designation in two separate indications — metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC) — a distinction that highlights regulatory interest in its potential. Across clinical studies, the viral-based immunotherapy has consistently shown signs of immune activation, combinability with checkpoint inhibitors and chemotherapy, and efficacy in heavily pretreated populations. In mPDAC, a Phase 2 cohort from the trial has reported objective response rates (ORR) above 60% in tumor-evaluable patients, exceeding historical benchmarks for this indication. Additional analyses have noted extended two-year survival rates compared to previous benchmarks. In HR+/HER2- mBC, two randomized Phase 2 trials (IND-213 and BRACELET-1) observed overall survival trends that support continued clinical evaluation. Elsewhere, a Phase 2 anal cancer cohort combining pelareorep with a checkpoint inhibitor demonstrated partial or complete response rates that exceeded historical control trials for checkpoint inhibitor monotherapy, suggesting potential utility beyond the company's lead programs. 'Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date,' said Wayne Pisano, Chair of the Board and outgoing Interim CEO of Oncolytics. 'We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors.' Kelly's compensation framework includes equity-based awards and performance-linked incentives tied to future financings and strategic outcomes. The structure is designed to align leadership priorities with long-term shareholder value while reinforcing a disciplined approach to capital and partnership development. As multiple cohorts advance within the GOBLET study — including those in pancreatic and anal cancers backed by external funding and regulatory support — Oncolytics appears positioned to continue its progress with a blend of clinical momentum, financial flexibility, and sharpened strategic direction. Prior to Kelly's appointment, Oncolytics presented new data from its GOBLET trial at the 2025 ASCO Annual Meeting, highlighting pelareorep's ability to stimulate both innate and adaptive immune responses in metastatic pancreatic cancer. With fresh clinical insights and new leadership in place, the company appears positioned to advance both its scientific and strategic priorities in tandem. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) has entered into a strategic partnership with Fosun Pharma to accelerate development of TEV-56278, a novel anti-PD1-IL2 immunotherapy designed using its proprietary ATTENUKINE™ technology. 'This partnership with Fosun Pharma in the development of our internally developed TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy with the potential to treat devastating cancers, is the latest advance to ensuring acceleration of our pipeline,' said Eric Hughes, MD, PhD, Executive Vice President, Teva Global R&D and Chief Medical Officer. 'TEV-56278 demonstrates the strength of Teva's innovative drug development capabilities and how strategic partnerships with companies such as Fosun Pharma play a pivotal role in advancing therapies on behalf of patients.' This investigational fusion protein is aimed at selectively delivering IL-2 to PD-1+ T cells, potentially enhancing anti-tumor response while limiting toxic side effects. Under the agreement, Fosun will lead clinical, manufacturing, and commercial activity in China and parts of Southeast Asia, while Teva retains global rights elsewhere. Citius Oncology, Inc. (NASDAQ: CTOR) recently announced that it expects to commercially launch LYMPHIR™ in 2025 for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL), pending FDA approval. 'We've made steady and meaningful progress toward commercialization over the past several months,' said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharma. 'With our supply chain secured, market access supported, and no anticipated impediments to reimbursement, we are encouraged by the momentum we've built. These efforts are pivotal as we transition into a commercial-stage company and believe the planned 2025 launch of LYMPHIR has the potential to be an important inflection point for both the company and the CTCL community.' ADC Therapeutics SA (NYSE: ADCT) recently reported updated Phase 2 data from an investigator-initiated trial of ZYNLONTA® in relapsed/refractory marginal zone lymphoma (r/r MZL), showing an 84.6% overall response rate and a 69.2% complete response rate. 'Based on the updated Phase 2 IIT data to be shared at ICML, we are encouraged by the potential opportunity in r/r MZL and look forward to seeing additional data, as the trial expands to other sites.' said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. 'As this trial progresses, assuming the results continue to be positive, we plan to potentially pursue a regulatory pathway and compendia in parallel as soon as sufficient data are available.' The trial also showed encouraging durability, with complete responses maintained in 17 of the 18 patients who achieved a complete response and progression-free survival of 92.9% at 12 months. ZYNLONTA was generally well tolerated, with safety findings consistent with its existing clinical profile. OS Therapies Incorporated (NYSE-American: OSTX) received positive written feedback from the FDA following a Type D meeting regarding its lead candidate, OST-HER2, for pediatric lung metastatic osteosarcoma. 'We are pleased with the feedback we received from the FDA regarding the use of external control comparators in settings where placebo-controlled randomization trials are not feasible – particularly in rare pediatric diseases such as the indication treated by OST-HER2 ,' said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. 'Moreover, we received additional collaborative input regarding suggested statistical methods as we seek to compare OST-HER2 active treatment with external control arm(s) to support a Biologics Licensing Application (BLA) via the Accelerated Approval Program. Taken together, the feedback gives us insight on the FDA's current position and allows us to be fully prepared for the End of Phase 2 Meeting.' The agency supported the company's proposed use of external comparators in its Phase 2b trial, potentially laying groundwork for accelerated approval. OS Therapies has submitted requests for an End of Phase 2 Meeting and Breakthrough Therapy Designation, with regulatory filings expected to advance in late 2025. Source: CONTACT:USA NEWS GROUPinfo@ 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. Video – – View original content:
Cision Canada
6 days ago
- Business
- Cision Canada
The $900 Billion Question: Who Will Deliver the Next Cancer Breakthrough?
VANCOUVER, BC, June 26, 2025 /CNW/ -- USA News Group News Commentary – With analysts forecasting the global oncology drug market to surpass US$900 billion by 2034, investor interest in cancer-focused biotechs is rapidly intensifying. ResearchAndMarkets and Vision Research Reports both point to strong double-digit growth, citing surging demand for next-gen diagnostics and immunotherapies. Yet even as market potential grows, the U.S. public health sector is facing potential setbacks. Budget proposals suggest National Cancer Institute (NCI) funding could be slashed by up to 40%, while Bloomberg highlights concerns around drug affordability and access. These headwinds are forcing a shift in expectations — placing the burden of innovation on the private sector, where companies like Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), Citius Oncology, Inc. (NASDAQ: CTOR), ADC Therapeutics SA (NYSE: ADCT), and OS Therapies Incorporated (NYSE-American: OSTX). The shift reflects more than a funding gap — it signals a structural realignment in how cancer breakthroughs may be brought to market. As public systems face pressure and timelines extend, nimble biotech firms are advancing targeted treatments, combination trials, and regulatory conversations once dominated by legacy institutions. Against this backdrop, market watchers see a pivotal window opening for investors willing to back the next wave of oncology innovation. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has entered a new chapter with the appointment of Jared Kelly as Chief Executive Officer and member of the Board. With a background in high-value biotech transactions and late-stage development strategy, Kelly brings experience that may help position the company for its next phase of clinical and corporate progress. Prior to joining Oncolytics, Kelly was General Counsel at Ambrx Biopharma, where he played a key role in the company's $2 billion acquisition by Johnson & Johnson. He also advised a range of life sciences firms on partnerships, licensing, and M&A during his tenure at Kirkland & Ellis LLP and Lowenstein Sandler LLP. His arrival comes as Oncolytics continues advancing pelareorep, a viral-based immunotherapy being evaluated in combination with checkpoint inhibitors and other agents across multiple cancer indications. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients," said Jared Kelly, CEO of Oncolytics Biotech. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy. I am excited to get to work accelerating development and unlocking significant value for stakeholders." Kelly's appointment appears aligned with a focused strategy: advancing pelareorep through late-stage development while maintaining capital efficiency and openness to potential partnerships. The company's lead program continues to generate data that support further investigation across several difficult-to-treat cancers. Pelareorep already holds FDA Fast Track designation in two separate indications — metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC) — a distinction that highlights regulatory interest in its potential. Across clinical studies, the viral-based immunotherapy has consistently shown signs of immune activation, combinability with checkpoint inhibitors and chemotherapy, and efficacy in heavily pretreated populations. In mPDAC, a Phase 2 cohort from the trial has reported objective response rates (ORR) above 60% in tumor-evaluable patients, exceeding historical benchmarks for this indication. Additional analyses have noted extended two-year survival rates compared to previous benchmarks. In HR+/HER2- mBC, two randomized Phase 2 trials (IND-213 and BRACELET-1) observed overall survival trends that support continued clinical evaluation. Elsewhere, a Phase 2 anal cancer cohort combining pelareorep with a checkpoint inhibitor demonstrated partial or complete response rates that exceeded historical control trials for checkpoint inhibitor monotherapy, suggesting potential utility beyond the company's lead programs. "Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date," said Wayne Pisano, Chair of the Board and outgoing Interim CEO of Oncolytics. "We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors." Kelly's compensation framework includes equity-based awards and performance-linked incentives tied to future financings and strategic outcomes. The structure is designed to align leadership priorities with long-term shareholder value while reinforcing a disciplined approach to capital and partnership development. As multiple cohorts advance within the GOBLET study — including those in pancreatic and anal cancers backed by external funding and regulatory support — Oncolytics appears positioned to continue its progress with a blend of clinical momentum, financial flexibility, and sharpened strategic direction. Prior to Kelly's appointment, Oncolytics presented new data from its GOBLET trial at the 2025 ASCO Annual Meeting, highlighting pelareorep's ability to stimulate both innate and adaptive immune responses in metastatic pancreatic cancer. With fresh clinical insights and new leadership in place, the company appears positioned to advance both its scientific and strategic priorities in tandem. In other recent industry developments and happenings in the market include: Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) has entered into a strategic partnership with Fosun Pharma to accelerate development of TEV-56278, a novel anti-PD1-IL2 immunotherapy designed using its proprietary ATTENUKINE™ technology. "This partnership with Fosun Pharma in the development of our internally developed TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy with the potential to treat devastating cancers, is the latest advance to ensuring acceleration of our pipeline," said Eric Hughes, MD, PhD, Executive Vice President, Teva Global R&D and Chief Medical Officer. "TEV-56278 demonstrates the strength of Teva's innovative drug development capabilities and how strategic partnerships with companies such as Fosun Pharma play a pivotal role in advancing therapies on behalf of patients." This investigational fusion protein is aimed at selectively delivering IL-2 to PD-1+ T cells, potentially enhancing anti-tumor response while limiting toxic side effects. Under the agreement, Fosun will lead clinical, manufacturing, and commercial activity in China and parts of Southeast Asia, while Teva retains global rights elsewhere. Citius Oncology, Inc. (NASDAQ: CTOR) recently announced that it expects to commercially launch LYMPHIR™ in 2025 for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL), pending FDA approval. "We've made steady and meaningful progress toward commercialization over the past several months," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharma. "With our supply chain secured, market access supported, and no anticipated impediments to reimbursement, we are encouraged by the momentum we've built. These efforts are pivotal as we transition into a commercial-stage company and believe the planned 2025 launch of LYMPHIR has the potential to be an important inflection point for both the company and the CTCL community." ADC Therapeutics SA (NYSE: ADCT) recently reported updated Phase 2 data from an investigator-initiated trial of ZYNLONTA® in relapsed/refractory marginal zone lymphoma (r/r MZL), showing an 84.6% overall response rate and a 69.2% complete response rate. "Based on the updated Phase 2 IIT data to be shared at ICML, we are encouraged by the potential opportunity in r/r MZL and look forward to seeing additional data, as the trial expands to other sites." said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "As this trial progresses, assuming the results continue to be positive, we plan to potentially pursue a regulatory pathway and compendia in parallel as soon as sufficient data are available." The trial also showed encouraging durability, with complete responses maintained in 17 of the 18 patients who achieved a complete response and progression-free survival of 92.9% at 12 months. ZYNLONTA was generally well tolerated, with safety findings consistent with its existing clinical profile. OS Therapies Incorporated (NYSE-American: OSTX) received positive written feedback from the FDA following a Type D meeting regarding its lead candidate, OST-HER2, for pediatric lung metastatic osteosarcoma. "We are pleased with the feedback we received from the FDA regarding the use of external control comparators in settings where placebo-controlled randomization trials are not feasible – particularly in rare pediatric diseases such as the indication treated by OST-HER2 ," said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. "Moreover, we received additional collaborative input regarding suggested statistical methods as we seek to compare OST-HER2 active treatment with external control arm(s) to support a Biologics Licensing Application (BLA) via the Accelerated Approval Program. Taken together, the feedback gives us insight on the FDA's current position and allows us to be fully prepared for the End of Phase 2 Meeting." The agency supported the company's proposed use of external comparators in its Phase 2b trial, potentially laying groundwork for accelerated approval. OS Therapies has submitted requests for an End of Phase 2 Meeting and Breakthrough Therapy Designation, with regulatory filings expected to advance in late 2025. 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.
Malaysian Reserve
24-06-2025
- Business
- Malaysian Reserve
Wall Street Eyes Breakout Cancer Therapies Amid Soaring Drug Prices
Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 24, 2025 /PRNewswire/ — Equity Insider News Commentary – Rising rates of cancer are going to come at a major cost, and it's looking more and more like the solution is going to have to come from the private sector. Recent reports suggest the U.S. government may slash National Cancer Institute (NCI) funding by nearly 40%, while Bloomberg reports growing concern over affordability and access to cancer drugs whose prices are rising sharply. From Wall Street's point of view, the focus needs to shift towards up-and-coming treatments being developed by promising candidates, including from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Indaptus Therapeutics, Inc. (NASDAQ: INDP), Perspective Therapeutics, Inc. (NYSE-American: CATX), SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), and Autolus Therapeutics plc (NASDAQ: AUTL). Analysts at Nova One Advisor are currently projecting the global oncology drug market to hit US$366.24 billion by 2034, expanding at a 7.4% CAGR. Others are even more optimistic, with ResearchAndMarkets estimating the sector will reach US$866.1 billion by 2034, growing at a 10.8% CAGR, and Vision Research Reports anticipating the market will top US$903.81 billion by the same year, driven by accelerating demand for advanced diagnostics and treatments. All this points to an optimal timing period for breakout cancer stocks. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has entered a new chapter with the appointment of Jared Kelly as Chief Executive Officer and member of the Board. With a background in high-value biotech transactions and late-stage development strategy, Kelly brings experience that may help position the company for its next phase of clinical and corporate progress. Prior to joining Oncolytics, Kelly was General Counsel at Ambrx Biopharma, where he played a key role in the company's $2 billion acquisition by Johnson & Johnson. He also advised a range of life sciences firms on partnerships, licensing, and M&A during his tenure at Kirkland & Ellis LLP and Lowenstein Sandler LLP. His arrival comes as Oncolytics continues advancing pelareorep, a viral-based immunotherapy being evaluated in combination with checkpoint inhibitors and other agents across multiple cancer indications. 'Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients,' said Jared Kelly, CEO of Oncolytics Biotech. 'With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy. I am excited to get to work accelerating development and unlocking significant value for stakeholders.' Kelly's appointment appears aligned with a focused strategy: advancing pelareorep through late-stage development while maintaining capital efficiency and openness to potential partnerships. The company's lead program continues to generate data that support further investigation across several difficult-to-treat cancers. Pelareorep already holds FDA Fast Track designation in two separate indications — metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC) — a distinction that highlights regulatory interest in its potential. Across clinical studies, the viral-based immunotherapy has consistently shown signs of immune activation, combinability with checkpoint inhibitors and chemotherapy, and efficacy in heavily pretreated populations. In mPDAC, a Phase 2 cohort from the trial has reported objective response rates (ORR) above 60% in tumor-evaluable patients, exceeding historical benchmarks for this indication. Additional analyses have noted extended two-year survival rates compared to previous benchmarks. In HR+/HER2- mBC, two randomized Phase 2 trials (IND-213 and BRACELET-1) observed overall survival trends that support continued clinical evaluation. Elsewhere, a Phase 2 anal cancer cohort combining pelareorep with a checkpoint inhibitor demonstrated partial or complete response rates that exceeded historical control trials for checkpoint inhibitor monotherapy, suggesting potential utility beyond the company's lead programs. 'Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date,' said Wayne Pisano, Chair of the Board and outgoing Interim CEO of Oncolytics. 'We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors.' Kelly's compensation framework includes equity-based awards and performance-linked incentives tied to future financings and strategic outcomes. The structure is designed to align leadership priorities with long-term shareholder value while reinforcing a disciplined approach to capital and partnership development. As multiple cohorts advance within the GOBLET study — including those in pancreatic and anal cancers backed by external funding and regulatory support — Oncolytics appears positioned to continue its progress with a blend of clinical momentum, financial flexibility, and sharpened strategic direction. Prior to Kelly's appointment, Oncolytics presented new data from its GOBLET trial at the 2025 ASCO Annual Meeting, highlighting pelareorep's ability to stimulate both innate and adaptive immune responses in metastatic pancreatic cancer. With fresh clinical insights and new leadership in place, the company appears positioned to advance both its scientific and strategic priorities in tandem. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Indaptus Therapeutics, Inc. (NASDAQ: INDP) recently initiated dosing in a Phase 1b/2 study arm testing its lead candidate Decoy20 with PD-1 inhibitor tislelizumab in advanced solid tumors. 'This is an important milestone in our clinical development,' said Jeffrey Meckler, CEO of Indaptus. 'We have long believed the Decoy platform has the potential to be a game-changing approach to treating solid tumors.' The combination is being evaluated in patients previously treated with checkpoint inhibitors or with tumor types typically unresponsive to immunotherapy. Early preclinical findings showed Decoy20 could synergize with PD-1 blockade to activate stronger anti-tumor immunity. The trial will monitor safety and preliminary signals of efficacy before broader enrollment. Perspective Therapeutics, Inc. (NYSE-American: CATX) has recently opened enrollment for Cohort 3 of its Phase 1/2a trial testing [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor 2 (SSTR2)-positive neuroendocrine tumors. 'We are excited to start exploring a higher dose level of VMT-α-NET after successfully completing an interaction with the FDA that was agreed prior to commencement of this trial,' commented Markus Puhlmann, Chief Medical Officer of Perspective. 'We are encouraged by the overall clinical profile observed at the second dose level of VMT-α-NET—including evidence of anti-tumor activity and primarily low-grade adverse events—and we believe it is important to assess whether a higher dose could further improve the therapeutic profile. Meanwhile, we remain committed to engaging with the FDA to evaluate the clinical utility of dosimetry estimates and analyses in the development of our proprietary RPTs.' The newly approved dose level represents a 20% increase over the previous cohort and will be evaluated for safety and early signals of efficacy. Interim results presented at American Society of Clinical Oncology (ASCO) Annual Meeting and Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting showed evidence of anti-tumor activity and favorable tolerability at lower doses. The company expects to submit additional clinical updates in the second half of 2025 following extended patient follow-up. SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) recently presented new preclinical data at the 2025 ASCO Annual Meeting showing that its CDK9 inhibitor SLS009 demonstrated potent activity in ASXL1-mutated colorectal cancer cell lines. 'These results provide strong rationale for continued advancement of SLS009 as a potential treatment for ASXL1-mutated cancers,' said Dr. Dragan Cicic, Senior Vice President, Chief Development Officer at SELLAS. 'The ability to selectively target ASXL1-driven tumors at concentrations well below the known safety threshold opens the door for tolerable and effective therapy. Based on the findings, we believe that ASXL1 mutation status could serve as a potential biomarker for response to SLS009 inhibition, which may allow us to further refine patient selection and improve outcomes. We look forward to presenting these results at ASCO.' In the study, 75% of lines with ASXL1 frameshift mutations responded at low nanomolar concentrations, while no response was observed in wild-type lines. These findings suggest that ASXL1 mutation status may serve as a potential biomarker for patient selection. Autolus Therapeutics plc (NASDAQ: AUTL) has released updated results from its FELIX study, showing that obe-cel, a next-generation CAR T cell therapy, may provide long-term remission for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). With a median follow-up of nearly 33 months, more than 50% of patients were still in remission at 24 months, and 38% had not needed any additional therapy. 'Obe-cel's durability of response without any subsequent therapy in two out of every five responders is a key factor leading the transformation of therapy for adult r/r B-ALL patients. At a median follow up of 33 months, we are encouraged to see a continuation of the long-term plateau we observed at the last data cut,' said Dr. Christian Itin, CEO of Autolus. 'A well-tolerated, effective, durable treatment option for ALL patients who often have a poor prognosis and have had multiple prior treatments is of significant clinical benefit.' The data suggested obe-cel could serve as a standalone option for some patients, reducing the need for transplants or further treatment. The company also reported a strong safety profile and plans to continue advancing obe-cel as a potential cornerstone in adult B-ALL care. Source: CONTACT: Equity Insider info@ 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. Equity Insider 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. Video – – – View original content:
Cision Canada
24-06-2025
- Business
- Cision Canada
Wall Street Eyes Breakout Cancer Therapies Amid Soaring Drug Prices
Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 24, 2025 /CNW/ -- Equity Insider News Commentary – Rising rates of cancer are going to come at a major cost, and it's looking more and more like the solution is going to have to come from the private sector. Recent reports suggest the U.S. government may slash National Cancer Institute (NCI) funding by nearly 40%, while Bloomberg reports growing concern over affordability and access to cancer drugs whose prices are rising sharply. From Wall Street's point of view, the focus needs to shift towards up-and-coming treatments being developed by promising candidates, including from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Indaptus Therapeutics, Inc. (NASDAQ: INDP), Perspective Therapeutics, Inc. (NYSE-American: CATX), SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), and Autolus Therapeutics plc (NASDAQ: AUTL). Analysts at Nova One Advisor are currently projecting the global oncology drug market to hit US$366.24 billion by 2034, expanding at a 7.4% CAGR. Others are even more optimistic, with ResearchAndMarkets estimating the sector will reach US$866.1 billion by 2034, growing at a 10.8% CAGR, and Vision Research Reports anticipating the market will top US$903.81 billion by the same year, driven by accelerating demand for advanced diagnostics and treatments. All this points to an optimal timing period for breakout cancer stocks. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has entered a new chapter with the appointment of Jared Kelly as Chief Executive Officer and member of the Board. With a background in high-value biotech transactions and late-stage development strategy, Kelly brings experience that may help position the company for its next phase of clinical and corporate progress. Prior to joining Oncolytics, Kelly was General Counsel at Ambrx Biopharma, where he played a key role in the company's $2 billion acquisition by Johnson & Johnson. He also advised a range of life sciences firms on partnerships, licensing, and M&A during his tenure at Kirkland & Ellis LLP and Lowenstein Sandler LLP. His arrival comes as Oncolytics continues advancing pelareorep, a viral-based immunotherapy being evaluated in combination with checkpoint inhibitors and other agents across multiple cancer indications. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients," said Jared Kelly, CEO of Oncolytics Biotech. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy. I am excited to get to work accelerating development and unlocking significant value for stakeholders." Kelly's appointment appears aligned with a focused strategy: advancing pelareorep through late-stage development while maintaining capital efficiency and openness to potential partnerships. The company's lead program continues to generate data that support further investigation across several difficult-to-treat cancers. Pelareorep already holds FDA Fast Track designation in two separate indications — metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC) — a distinction that highlights regulatory interest in its potential. Across clinical studies, the viral-based immunotherapy has consistently shown signs of immune activation, combinability with checkpoint inhibitors and chemotherapy, and efficacy in heavily pretreated populations. In mPDAC, a Phase 2 cohort from the trial has reported objective response rates (ORR) above 60% in tumor-evaluable patients, exceeding historical benchmarks for this indication. Additional analyses have noted extended two-year survival rates compared to previous benchmarks. In HR+/HER2- mBC, two randomized Phase 2 trials (IND-213 and BRACELET-1) observed overall survival trends that support continued clinical evaluation. Elsewhere, a Phase 2 anal cancer cohort combining pelareorep with a checkpoint inhibitor demonstrated partial or complete response rates that exceeded historical control trials for checkpoint inhibitor monotherapy, suggesting potential utility beyond the company's lead programs. "Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date," said Wayne Pisano, Chair of the Board and outgoing Interim CEO of Oncolytics. "We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors." Kelly's compensation framework includes equity-based awards and performance-linked incentives tied to future financings and strategic outcomes. The structure is designed to align leadership priorities with long-term shareholder value while reinforcing a disciplined approach to capital and partnership development. As multiple cohorts advance within the GOBLET study — including those in pancreatic and anal cancers backed by external funding and regulatory support — Oncolytics appears positioned to continue its progress with a blend of clinical momentum, financial flexibility, and sharpened strategic direction. Prior to Kelly's appointment, Oncolytics presented new data from its GOBLET trial at the 2025 ASCO Annual Meeting, highlighting pelareorep's ability to stimulate both innate and adaptive immune responses in metastatic pancreatic cancer. With fresh clinical insights and new leadership in place, the company appears positioned to advance both its scientific and strategic priorities in tandem. In other recent industry developments and happenings in the market include: Indaptus Therapeutics, Inc. (NASDAQ: INDP) recently initiated dosing in a Phase 1b/2 study arm testing its lead candidate Decoy20 with PD-1 inhibitor tislelizumab in advanced solid tumors. "This is an important milestone in our clinical development," said Jeffrey Meckler, CEO of Indaptus. "We have long believed the Decoy platform has the potential to be a game-changing approach to treating solid tumors." The combination is being evaluated in patients previously treated with checkpoint inhibitors or with tumor types typically unresponsive to immunotherapy. Early preclinical findings showed Decoy20 could synergize with PD-1 blockade to activate stronger anti-tumor immunity. The trial will monitor safety and preliminary signals of efficacy before broader enrollment. Perspective Therapeutics, Inc. (NYSE-American: CATX) has recently opened enrollment for Cohort 3 of its Phase 1/2a trial testing [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor 2 (SSTR2)-positive neuroendocrine tumors. "We are excited to start exploring a higher dose level of VMT-α-NET after successfully completing an interaction with the FDA that was agreed prior to commencement of this trial," commented Markus Puhlmann, Chief Medical Officer of Perspective. "We are encouraged by the overall clinical profile observed at the second dose level of VMT-α-NET—including evidence of anti-tumor activity and primarily low-grade adverse events—and we believe it is important to assess whether a higher dose could further improve the therapeutic profile. Meanwhile, we remain committed to engaging with the FDA to evaluate the clinical utility of dosimetry estimates and analyses in the development of our proprietary RPTs." The newly approved dose level represents a 20% increase over the previous cohort and will be evaluated for safety and early signals of efficacy. Interim results presented at American Society of Clinical Oncology (ASCO) Annual Meeting and Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting showed evidence of anti-tumor activity and favorable tolerability at lower doses. The company expects to submit additional clinical updates in the second half of 2025 following extended patient follow-up. SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) recently presented new preclinical data at the 2025 ASCO Annual Meeting showing that its CDK9 inhibitor SLS009 demonstrated potent activity in ASXL1-mutated colorectal cancer cell lines. "These results provide strong rationale for continued advancement of SLS009 as a potential treatment for ASXL1-mutated cancers," said Dr. Dragan Cicic, Senior Vice President, Chief Development Officer at SELLAS. "The ability to selectively target ASXL1-driven tumors at concentrations well below the known safety threshold opens the door for tolerable and effective therapy. Based on the findings, we believe that ASXL1 mutation status could serve as a potential biomarker for response to SLS009 inhibition, which may allow us to further refine patient selection and improve outcomes. We look forward to presenting these results at ASCO." In the study, 75% of lines with ASXL1 frameshift mutations responded at low nanomolar concentrations, while no response was observed in wild-type lines. These findings suggest that ASXL1 mutation status may serve as a potential biomarker for patient selection. Autolus Therapeutics plc (NASDAQ: AUTL) has released updated results from its FELIX study, showing that obe-cel, a next-generation CAR T cell therapy, may provide long-term remission for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). With a median follow-up of nearly 33 months, more than 50% of patients were still in remission at 24 months, and 38% had not needed any additional therapy. "Obe-cel's durability of response without any subsequent therapy in two out of every five responders is a key factor leading the transformation of therapy for adult r/r B-ALL patients. At a median follow up of 33 months, we are encouraged to see a continuation of the long-term plateau we observed at the last data cut," said Dr. Christian Itin, CEO of Autolus. "A well-tolerated, effective, durable treatment option for ALL patients who often have a poor prognosis and have had multiple prior treatments is of significant clinical benefit." The data suggested obe-cel could serve as a standalone option for some patients, reducing the need for transplants or further treatment. The company also reported a strong safety profile and plans to continue advancing obe-cel as a potential cornerstone in adult B-ALL care. CONTACT: Equity Insider [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. Equity Insider 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.
Globe and Mail
20-06-2025
- Business
- Globe and Mail
With Public Funding Under Pressure, Biotech Innovators Are Picking Up the Slack in Oncology
USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC , June 20, 2025 /CNW/ -- USA News Group News Commentary – The costs of cancer drugs is skyrocketing, according to a recent report from Bloomberg. Analysts at Nova One Advisor estimate that the global oncology drugs market will grow at a 7.4% CAGR through to US$366.24 billion by 2034. Help doesn't appear to be coming from the public sector, as reports state that the current US administration could drastically reduce funding of the National Cancer Institute (NCI) by nearly 40%, the market is looking towards the private sector to pick up the slack and continue to make advancements in cancer treatment. For investors to note, plenty of oncology innovators have provided recent developments, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Immuneering Corporation (NASDAQ: IMRX), GRAIL, Inc. (NASDAQ: GRAL), Intensity Therapeutics, Inc. (NASDAQ: INTS), and Relay Therapeutics, Inc. (NASDAQ: RLAY). The global oncology market is expected to see strong growth over the next decade, with ResearchAndMarkets forecasting it to reach US$866.1 billion by 2034 at a 10.8% CAGR. A separate estimate from Vision Research Reports projects the market will surpass US$903.81 billion by the same year, growing at a 10.9% CAGR. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has entered a new phase of leadership with the appointment of Jared Kelly as Chief Executive Officer and member of the Board. Kelly brings a background in high-stakes biotech transactions and strategic immuno-oncology development, positioning him to guide the company through its next stage of clinical and business evolution. Before joining Oncolytics, Kelly served as General Counsel at Ambrx Biopharma, where he played a key role in its $2 billion acquisition by Johnson & Johnson. His earlier work includes advising life sciences firms on licensing, partnerships, and M&A while at Kirkland & Ellis LLP and Lowenstein Sandler LLP. Now leading Oncolytics, he steps into a company advancing pelareorep, a virus-based immunotherapeutic designed to work synergistically with checkpoint inhibitors and other agents across a range of solid and blood cancers. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients," said Jared Kelly , CEO of Oncolytics Biotech. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy. I am excited to get to work accelerating development and unlocking significant value for stakeholders." Kelly's appointment signals a clear strategic focus: advancing pelareorep toward key late-stage milestones through a capital-conscious approach that remains open to strategic collaboration. Pelareorep currently holds FDA Fast Track designation for both metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC) —a rare dual recognition that underscores its regulatory momentum. Across multiple studies, the virus-based therapy has demonstrated consistent immune activation, broad combinability with checkpoint inhibitors and chemotherapies, and encouraging response rates in challenging cancer types. In mPDAC, pelareorep has achieved over 60% objective response rates in tumor-evaluable patients across Phase 1 and 2 trials—more than double what's typically seen in historical benchmarks. Separate analyses also reported two-year survival rates four to six times higher than control arms or prior studies. In HR+/HER2- mBC, two randomized Phase 2 trials (IND-213 and BRACELET-1) showed survival benefits supportive of further investigation. Meanwhile, a Phase 2 cohort in anal cancer pairing pelareorep with a checkpoint inhibitor reported partial or complete responses in nearly half of evaluable patients—substantially higher than historical norms for monotherapy in this setting. "Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date," said Wayne Pisano , Chair of the Board and outgoing Interim CEO of Oncolytics. "We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors." Kelly's compensation package includes equity grants and milestone-linked incentives tied to future financings and potential strategic transactions—aligning leadership priorities with long-term shareholder interests. The structure signals a commitment to advancing both clinical and corporate goals while preserving balance sheet discipline and maintaining appeal for potential partners. With multiple cohorts progressing in the GOBLET study—including those in pancreatic and anal cancer supported by external funding and regulatory engagement— Oncolytics is positioned to move forward with a combination of scientific momentum, financial agility, and renewed strategic focus. In other recent industry developments and happenings in the market include: Immuneering Corporation (NASDAQ: IMRX) reported positive Phase 2a data for atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients. At six months, the study showed 94% overall survival and 72% progression-free survival in 34 patients, with no median OS or PFS reached yet. "These exceptional data demonstrate the potential of atebimetinib plus mGnP to dramatically extend the lives of patients with advanced pancreatic cancer," said Ben Zeskind , Ph.D., Co-founder and CEO of Immuneering. "Our ultimate goal is to help cancer patients outlive their disease, and today's announcement represents an important milestone on that journey." The combination also demonstrated a 39% overall response rate, an 81% disease control rate, and a notably favorable tolerability profile. Many patients experienced deep, durable tumor regressions, including lesions rendered undetectable. The regimen was well tolerated, with an adverse event profile suggesting potential best-in-class positioning among MEK inhibitors. GRAIL, Inc. (NASDAQ: GRAL), recently announced strong top-line results from the PATHFINDER 2 registrational study evaluating its Galleri® multi-cancer early detection test in over 25,000 adults. "We are delighted to see very encouraging performance of the Galleri MCED test as a cancer screening tool in broad intended use populations of asymptomatic adults over 50 years of age in both the PATHFINDER 2 study and the NHS-Galleri trial's prevalent screening round," said Josh Ofman , MD, MSHS, President at GRAIL. "We would like to extend our sincere gratitude to all of the participants and investigators in both of these pivotal studies, who are collectively helping to realize the potential of this groundbreaking technology for population-scale multi-cancer early detection and move the field forward." The study showed a substantially higher positive predictive value (PPV) compared to the original PATHFINDER trial, with consistent specificity and cancer signal origin accuracy, and no serious safety concerns reported. GRAIL plans to submit these results to the FDA as part of its ongoing premarket approval process under Breakthrough Device Designation. Intensity Therapeutics, Inc. (NASDAQ: INTS) announced that the first patients in its ongoing Phase 2 INVINCIBLE-4 trial achieved high levels of tumor necrosis within eight days of receiving two doses of INT230-6, before starting standard-of-care immunochemotherapy for triple-negative breast cancer (TNBC). "We are excited to see that INT230-6 is achieving meaningful levels of necrosis in patients with evidence of immune activation," said Lewis H. Bender , President and CEO of Intensity. "TNBC patients risk their lives to achieve a pCR, and about forty percent fail to achieve the desired result." MRI scans showed substantial tumor destruction and inflammation, suggesting immune activation following direct intratumoral injection. The randomized study compares INT230-6 followed by standard treatment versus standard treatment alone, with pathological complete response (pCR) as the primary endpoint. Relay Therapeutics, Inc. (NASDAQ: RLAY) reported updated interim data from its Phase 1/2 study of RLY-2608 plus fulvestrant, showing a median progression-free survival (PFS) of 11.0 months in second-line patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer. "We are encouraged by the consistency of these updated RLY-2608 + fulvestrant data, which continue to show the potential benefit of a mutant-selective PI3Kα inhibitor for improving both the tolerability profile and progression free survival compared to standard of care," said Don Bergstrom , M.D., Ph.D., President of R&D at Relay Therapeutics. "We look forward to starting the first mutant-selective PI3Kα Phase 3 trial, ReDiscover-2, in the middle of this year." Among patients at the recommended Phase 3 dose, the clinical benefit rate reached 67%, and 39% had confirmed partial responses, with notably higher response rates in those with kinase mutations. The combination maintained a favorable tolerability profile, with low rates of high-grade adverse events and minimal treatment discontinuations. 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.
