[212Pb]VMT-α-NET

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, July 23, 2025 /PRNewswire/ -- USA News Group News Commentary – Cancer diagnoses are climbing fastest among younger women, sparking alarm that looming cuts to U.S. research budgets could stall progress in prevention and treatment. Adding to the strain, federal and state regulators are re‑examining mRNA vaccines, creating a cloud of uncertainty over future cancer‑funding priorities. Yet even amid this policy turbulence, a new wave of oncology innovators is lining up near‑term milestones that could reshape the landscape—led by Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Cue Biopharma, Inc. (NASDAQ: CUE), Verastem, Inc. (NASDAQ: VSTM), Allogene Therapeutics, Inc. (NASDAQ: ALLO), and Perspective Therapeutics, Inc. (NYSE-American: CATX). While regulatory red tape tightens, surging diagnoses of colorectal and other GI cancers in young people demand quicker innovation in oncology. Forecasts suggest worldwide cancer‑drug revenues could blow past US$900 billion by 2034. Within that, next‑gen therapies built on precision techniques are slated to reach US$175.2 billion, advancing at a brisk 7.35% annual clip. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) recently held a well‑attended key opinion leader (KOL) webinar where pancreatic and gastrointestinal cancer specialists dissected pelareorep's clinical history, its biomarker data package, and where the oncolytic virus could slot into evolving chemotherapy and immunotherapy regimens. "I want to thank our esteemed panel of oncologists for their meaningful contributions to our KOL event," said Jared Kelly, CEO of Oncolytics. "Their insights underscore a critical and timely message: pelareorep is a compelling immunotherapy platform that is well situated for combination strategies and a highly differentiated asset for pharma partners looking to expand or establish leadership in GI oncology. We are committed to moving forward aggressively toward registrational development while engaging with partners who share our vision of transforming outcomes in these difficult-to-treat cancers." The panel revisited survival gains in metastatic pancreatic ductal adenocarcinoma (mPDAC), reviewed translational evidence of "cold‑to‑hot" tumor conversion, and outlined next steps for a registration-enabling study. Management said feedback from the discussion would inform both upcoming trial designs and partnering talks now underway. The event came on the heels of Oncolytics having rolled out an expanded translational‑data review that tightened the scientific case for pelareorep, an intravenously delivered oncolytic reovirus. Renewed analyses from the GOBLET gastrointestinal cancer study and the AWARE‑1 breast cancer study confirmed that the virus replicates inside tumors, switches on interferon signaling in the immune system, and draws tumor‑infiltrating lymphocytes into the tumor microenvironment. "This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep." Investigators also recorded higher PD‑L1 expression and tracked newly expanded cytotoxic T‑cell clones in blood samples that matched those inside shrinking lesions—molecular fingerprints that point to stronger responses when pelareorep is combined with standard-of-care treatments and checkpoint inhibitors. "The collection of data here show that pelareorep works how a cancer immunotherapy should work," said Jared Kelly, CEO of Oncolytics. "Pelareorep is a versatile product candidate with strong platform potential to enhance immunological responses in multiple indications, including hard-to-treat cancers. Such compelling findings should be exciting to strategic partners focused on finding a platform immunotherapy in large indications with high unmet medical needs." Clinical outcomes already hint at real‑world benefit. In more than 100 first‑line mPDAC patients, pelareorep‑based regimens achieved a 21.9% two‑year overall‑survival rate versus a 9.2% historical benchmark. A separate single‑arm study that paired pelareorep with chemotherapy and a checkpoint blocker produced a 62% objective‑response rate—especially notable given that no checkpoint therapy is approved in this cancer today. In hormone‑receptor‑positive, HER2‑negative metastatic breast cancer (HR+/HER2‑ mBC), two randomized trials added more than ten months of median overall survival, while BRACELET‑1 nearly doubled median progression‑free survival to 12.1 months compared with 6.4 months for control patients. To steer these data toward value‑creating deals and late‑stage trials, the company strengthened its leadership earlier this year by appointing industry veteran Jared Kelly as CEO and naming Andrew Aromando Chief Business Officer. The duo previously helped guide Ambrx Biopharma into a US$2 billion sale to Johnson & Johnson, experience the board believes will support capital‑efficient development and strategic partnering for pelareorep. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications," said Kelly. "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." As CBO, Aromando is now leading global business development and helping shape the company's corporate, clinical, and regulatory strategies. The leadership tandem is expected to prioritize partnering and expansion opportunities while preserving capital efficiency—a strategy well-suited for pelareorep's growing clinical profile. "I'm thrilled to join Oncolytics at such a pivotal moment in its evolution," said Aromando. "With promising data in difficult-to-treat cancers and a compelling body of clinical evidence in over 1,100 patients, I believe the Company is uniquely positioned to deliver meaningful value to patients and other stakeholders in the near term." Pelareorep currently holds FDA Fast Track designations in mPDAC (pancreatic cancer) and HR+/HER2‑ mBC (breast cancer), along with Orphan‑Drug status for pancreatic cancer in the United States and Europe. With mechanistic proof, survival data that outperform historical controls, and fresh validation from the recent KOL event, Oncolytics Biotech is aligning its clinical, regulatory, and business strategies to move pelareorep into registration‑enabling trials and position it as a backbone immunotherapy across solid tumors. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Cue Biopharma, Inc. (NASDAQ: CUE) recently reported that adding CUE‑101 to pembrolizumab produced a 50% overall response rate in patients with recurrent/metastatic HPV‑positive head and neck cancer who had a combined positive score (CPS) ≥ 1, including the same 50% response in those with low CPS 1–19. The regimen has now generated two complete responses, an 88% 12‑month overall survival rate, and a median overall survival of 32 months, handily outperforming historical pembrolizumab data. "The culmination of maturing data further support our conviction that CUE-101, representative of our approach with the CUE-100 series, demonstrates a potential breakthrough therapeutic approach for establishing a new standard of care," said Dan Passeri, CEO of Cue Biopharma. "With this maturing data, we are further emboldened in our conviction that our Immuno-STAT® platform represents transformative potential for selectively modulating the patient's immune system." Verastem, Inc. (NASDAQ: VSTM) recently published Phase 2 RAMP 201 results in the Journal of Clinical Oncology, showing avutometinib + defactinib delivered a 31% confirmed overall response rate in recurrent low‑grade serous ovarian cancer, rising to 44% in KRAS‑mutant tumors. "The publication of the primary analysis of the RAMP 201 study in recurrent low-grade serous ovarian cancer in the Journal of Clinical Oncology reflects the meaningful clinical advancement demonstrated by the combination of avutometinib plus defactinib for patients with recurrent low-grade serous ovarian cancer," said John Hayslip, M.D., Chief Medical Officer at Verastem Oncology. "The findings supported the recent FDA approval of the combination in KRAS-mutated recurrent low-grade serous ovarian cancer and our ongoing global Phase 3 RAMP 301 trial of the combination in recurrent low-grade serous ovarian cancer with and without a KRAS mutation." Median progression‑free survival reached 12.9 months overall and 31.0 months in the KRAS‑mutant subgroup, with 82% of patients experiencing some tumor shrinkage regardless of mutation status. Back in June, Allogene Therapeutics, Inc. (NASDAQ: ALLO) presented updated Phase 1 TRAVERSE data showing a single dose of ALLO‑316 achieved a 31% confirmed response rate in heavily pre‑treated renal cell carcinoma patients whose tumors expressed CD70 in ≥ 50 % of cells. "ALLO-316 is showing clear evidence of targeted antitumor activity in patients who had failed most or all approved therapies for advanced or metastatic renal cell carcinoma," said Zachary Roberts, M.D., Ph.D., EVP, Research and Development and Chief Medical Officer at Allogene. "Our proprietary Dagger technology allows the use of a standard cyclophosphamide and fludarabine-based lymphodepletion regimen with a single dose of ALLO-316. Strong CAR T-cell kinetics and extensive infiltration of tumor tissue by CAR T cells are combining to generate deep and durable remissions. These are results that were previously considered out of reach for patients with advanced solid tumors." Four of five responders remain in remission—including one lasting more than 12 months—while safety remained manageable with no graft‑versus‑host disease observed. Investigators say the results highlight allogeneic CAR T's potential in solid tumors and justify continued expansion of the study. Perspective Therapeutics, Inc. (NYSE-American: CATX) recently began recruiting the third dose‑escalation cohort of its Phase 1/2a trial testing [²¹²Pb]VMT‑α‑NET in unresectable or metastatic somatostatin receptor 2 (SSTR2)‑positive neuroendocrine tumors, raising the fixed dose by 20% to 6 mCi. Earlier cohorts showed anti‑tumor activity with mostly low‑grade adverse events, prompting FDA alignment to explore whether the higher dose can further enhance efficacy. "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." The company plans additional safety and efficacy readouts, including dosimetry analyses, at scientific meetings in 2H 2025. Source: 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. Logo - SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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). Continue Reading Wall Street Eyes Breakout Cancer Therapies Amid Soaring Drug Prices Pelareorep Facts 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 [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. Video - Photo - Logo - SOURCE Equity Insider WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED