Atezolizumab

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, July 8, 2025 /PRNewswire/ -- Equity Insider News Commentary – As cancer rates climb and drug costs continue to soar, pressure is mounting on the private sector to drive innovation. Now, cancer experts are alarmed over a "gut wrenching" plan from the U.S. government to cut nearly 40% of National Cancer Institute funding, even as the price of oncology treatments pushes new limits—raising urgent concerns about access and affordability. In this shifting landscape, investors are turning their attention to a new wave of biotechs and specialty care providers developing breakthrough therapies and smarter care models, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Celcuity Inc. (NASDAQ: CELC), Citius Oncology, Inc. (NASDQ: CTOR), Exelixis, Inc. (NASAQ: EXEL), and The Oncology Institute, Inc. (NASDAQ: TOI). Continue Reading Amid NCI Budget Fears, Emerging Oncology Stocks Gain Attention Market forecasts suggest oncology could be one of the decade's fastest-growing sectors. Nova One Advisor projects the global oncology drug market will reach US$366.24 billion by 2034, with a 7.4% CAGR. Other firms are even more bullish— ResearchAndMarkets sees the market hitting US$866.1 billion, while Vision Research Reports expects revenue in 2034 to surpass US$903.81 billion, fueled by rising demand for advanced diagnostics and targeted therapies. For emerging cancer stocks, the timing couldn't be better. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has highlighted survival data that may redefine expectations for immunotherapy in cold tumors, especially in metastatic pancreatic and breast cancers, where treatment options remain limited. In first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), Oncolytics's flagship pelareorep, an intravenously delivered immunotherapeutic agent, has a two-year overall survival rate of 21.9% across pooled data from more than 100 patients—more than double the historical benchmark of 9.2%. "We are no longer in the business of funding proof-of-concept studies," said Jared Kelly, newly-appointed CEO of Oncolytics. "We have meaningful clinical data in hand—not just signals. The survival benefit across multiple tumor types demands a focused approach to take pelareorep directly into registration-enabling trials. We will use our fast-track status to find the most efficient regulatory path forward this summer to advance our platform in a product technology." In a single-arm study combining pelareorep with chemotherapy and a checkpoint inhibitor, the objective response rate reached 62% in evaluable patients. No immunotherapy is currently approved in first-line metastatic pancreatic ductal adenocarcinoma. Breast cancer results are also very impressive. In HR+/HER2- metastatic breast cancer (mBC), pelareorep extended median overall survival by more than 10 months across two randomized trials compared to standard chemotherapy. In the BRACELET-1 trial, pelareorep plus paclitaxel delivered median progression-free survival of 12.1 months—nearly doubling the 6.4 months observed in the control arm. "Pelareorep represents a tipping point for immunotherapy in cold tumors," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "It is delivering consistent immunologic and clinical responses in multiple tumor types. Most impressively, pelareorep activates the immune system to produce clinical benefits in cancers that are typically unresponsive to immunotherapies." With over 1,100 patients studied to date, pelareorep continues to demonstrate a favorable safety profile, with most side effects limited to transient, flu-like symptoms. The company says it is now preparing for registration-enabling trials, leveraging its existing Fast Track designations in both mPDAC and HR+/HER2- mBC, as well as Orphan Drug status for pancreatic cancer in both the U.S. and Europe. The company recently reinforced its leadership bench with two high-profile appointments—naming Jared Kelly as Chief Executive Officer and Andrew Aromando as Chief Business Officer—as the company sharpens its focus on late-stage development and strategic transactions. Both men previously played key roles in Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson and bring a track record of value creation in oncology-focused biotechs. Their arrival signals a deliberate pivot toward unlocking the value of pelareorep, Oncolytics' virus-based immunotherapy currently in multiple mid-to-late-stage studies. "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 CEO Jared 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 holds FDA Fast Track designation in both metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC), and has shown encouraging synergy with checkpoint inhibitors and chemotherapy. In mPDAC, Phase 2 data showed objective response rates above 60% in tumor-evaluable patients, exceeding historical benchmarks, with survival at two years also outperforming expectations. Meanwhile, in HR+/HER2- mBC, two randomized phase 2 trials (IND-213 and BRACELET-1) demonstrated overall survival trends that support continued development. The drug's potential may extend even further. A Phase 2 anal cancer cohort combining pelareorep with a checkpoint inhibitor produced responses that surpassed historical checkpoint monotherapy outcomes, suggesting broader utility. Most recently, new data from the GOBLET trial presented at ASCO 2025 highlighted pelareorep's ability to activate both innate and adaptive immune responses in metastatic pancreatic cancer—reinforcing its potential as a backbone immunotherapy. With experienced leadership now in place and a growing clinical footprint, Oncolytics is advancing toward potential partnership, planning registration-enabling trials, and commercialization readiness—all while maintaining a disciplined, investor-aligned approach to capital and growth. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Celcuity Inc. (NASDAQ: CELC) has reported encouraging early-phase data from two separate clinical trials evaluating gedatolisib in prostate and breast cancer. In metastatic castration-resistant prostate cancer, a Phase 1 trial combining gedatolisib with darolutamide showed a 66% six-month radiographic progression-free survival rate. "We are very encouraged by this preliminary efficacy and safety data," said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. "The 66% six-month rPFS rate for this novel combination therapy compares favorably to published data for androgen receptor inhibitors in this setting. With no treatment-related discontinuations and less than 3% of patients experiencing Grade 3 stomatitis, we believe it is important to explore additional dose options for gedatolisib." In HER2+ metastatic breast cancer, a Phase 2 trial of gedatolisib plus standard doses of trastuzumab-pkrb showed a 43% objective response rate in patients who had received at least three prior lines of therapy. Citius Oncology, Inc. (NASDQ: CTOR) is preparing to launch LYMPHIR, an FDA-approved immunotherapy for relapsed or refractory cutaneous T-cell lymphoma, in the second half of 2025. "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." The company has completed commercial-scale manufacturing, secured distribution partnerships, and built a launch strategy with AI-enhanced targeting of key oncology centers. With regulatory infrastructure in place and early clinical interest, Citius is positioned to transition into full commercial operations this year. Exelixis, Inc. (NASAQ: EXEL) reported positive Phase 3 results from its STELLAR-303 trial, showing that zanzalintinib combined with atezolizumab significantly improved overall survival versus regorafenib in patients with metastatic colorectal cancer. "The STELLAR-303 results, which showed a survival benefit with the combination of zanzalintinib and atezolizumab versus regorafenib across all randomized patients with previously treated metastatic colorectal cancer, marks an important first milestone for our zanzalintinib pivotal development program," said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. "We look forward to discussing the findings with regulatory authorities and presenting the detailed results at an upcoming medical conference." The combination met one of the trial's dual primary endpoints, and a final analysis for the second—overall survival in patients without liver metastases—is still pending. No new safety signals were observed, and full results are expected at an upcoming medical conference. The Oncology Institute, Inc. (NASDAQ: TOI) has entered into a major partnership with SilverSummit Healthplan to provide oncology care to over 80,000 Medicaid members across Nevada. "We couldn't be more excited about the opportunity to expand our partnership with SilverSummit and help create improved access and quality of cancer care to their Medicaid patient population," said Daniel Virnich, MD, CEO of The Oncology Institute. "We have a longstanding track record of providing outstanding care to Medicaid patients in other markets, and we look forward to broadening these efforts within the Las Vegas community." Effective July 1, TOI is now the exclusive provider of cancer services for SilverSummit's patient base, with dedicated clinics already open in Las Vegas, Henderson, and Spring Valley. The expansion reflects TOI's ongoing growth in value-based oncology, particularly among underserved populations. Both organizations emphasized the importance of delivering high-quality, community-based cancer care tailored to the needs of Medicaid patients. 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"). 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NetworkNewsWire Editorial Coverage NEW YORK, July 7, 2025 /PRNewswire/ -- An estimated 20 million people are diagnosed annually with cancer, while cancer kills almost 10 million people a year worldwide () with these numbers expected to grow. The American Cancer Society projects that by 2050, 35 million people will be diagnosed with cancer every year. Despite significant progress made in treating the disease, there is still a desperate need — and an enormous market potential — for new and more effective cancer drugs. Calidi Biotherapeutics Inc. (NYSE American: CLDI) (Profile) is committed to developing a novel approach to treating cancer through the precise delivery of genetic medicines to both primary tumors and metastatic sites of disease. This cutting-edge platform, which harnesses engineered viruses that can target sites of cancer in the body and deliver potent genetic medicines to attack tumors, has the potential to revolutionize the way cancer is treated. And while cancer is the initial focus for Calidi, the company has also begun to assess the potential of this technology in other areas of large unmet need such as autoimmune disease. Calidi is joining an elite group of high-quality companies focused on making a difference in the world of cancer and genetic medicines, including Regeneron Pharmaceuticals Inc. (NASDAQ: REGN), CG Oncology Inc. (NASDAQ: CGON), Roche (OTCQX: RHHBY) and Merck & Co. Inc. (NYSE: MRK). Cancer remains one of the most devastating health challenges facing the globe today, responsible for about one in six deaths worldwide. Calidi's decade-long development journey has culminated in novel precision genetic medicine delivery platforms with real therapeutic promise. The company has taken a decisive step in the fight against advanced and hard-to-treat cancers with CLD-401, its first compound designed for systemic administration that delivers IL-15 superagonist directly to tumor sites, including metastatic cancers . Calidi Biotherapeutics has unveiled compelling preclinical data this year at two of the most influential oncology conferences. Click here to view the custom infographic of the Calidi Biotherapeutics Inc. editorial. Sustained Investment in Research, Development Cancer remains one of the most devastating health challenges facing the globe today, responsible for about one in six deaths worldwide (). The most common cancer types worldwide include lung cancer (accounting for around 2.2 million new cases and 1.8 million deaths in 2020), breast cancer (2.26 million new cases), colorectal cancer (1.93 million) and prostate cancer (1.41 million). In the United States, cancer claims more than 600,000 lives each year, with more than two million new cases expected in 2025 alone. These figures highlight both the scale of human suffering and the enormous burden cancer places on health systems around the world. These statistics underscore the importance of sustained investment in research and development. The global oncology drugs market was valued at approximately $190.1 billion in 2023 and is projected to grow to more than $564.5 billion by 2033, reflecting a compound annual growth rate (CAGR) of 11.5% over the forecast period (). This rapid expansion highlights the critical role of sustained investment in research and development, which drives advancements in early detection, targeted therapies, immunotherapies and personalized medicine — key tools in reducing the overwhelming global cancer burden Advancing Precision Delivery of Genetic Medicines Calidi Biotherapeutics Inc (NYSE American: CLDI) has spent more than a decade developing a breakthrough technology platform that enables the systemic delivery of genetic medicines to targeted tumor sites, including metastatic sites in cancer patients. At the core of this innovation is the company's proprietary engineered viral system, which cloaks therapeutic payloads in a protective human cell membrane (the "envelope") designed to evade the immune system and reach distant metastases with precision where genetic medicines that can drive tumor clearance are expressed. Calidi's decade-long development journey, from stem cell-based delivery systems to the enveloped systemic virotherapies, has culminated in novel precision genetic delivery platforms with real therapeutic promise. The company's preclinical breakthroughs have been detailed in peer-reviewed conferences and investor communications, leading to upcoming IND filing goals and potential partnerships on the horizon. Calidi appears to be well positioned to pioneer a new era of targeted cancer treatment, where genetic payloads reach disease sites directly, immune activation is localized, and patients benefit from safer, more effective therapies. Understanding the Platform Calidi Biotherapeutics is clinical stage biotechnology company that is developing genetic medicines and proprietary genetically engineered oncolytic viruses. Calidi's RedTail systemic antitumor virotherapy platform is a novel tumor-selective vaccinia virus strain designed to target all tumor sites (). The platform is capable of producing a high amount of enveloped vaccinia viruses resistant to humoral immunity. The technology allows the therapy to reach tumor sites and kill tumors by expressing genetic medicines in the tumor microenvironment. According to the company, the lead candidate from the RedTail platform, CLD-401, targets lung cancer and other tumor types with high unmet medical need. Pioneering Systemic Cancer Targeting Calidi Biotherapeutics has taken a decisive step in the fight against advanced and hard-to-treat cancers with CLD-401, its first compound designed for systemic administration. This lead candidate harnesses the company's decade-long innovation in enveloped viral delivery to simultaneously destroy cancer cells and deliver genetic medicine aimed at preventing disease recurrence at metastatic sites. By enabling intravenous administration, CLD–401 ushers in a new era of precision oncology where genetic payloads reach tumors throughout the body, rather than relying on localized injections. Central to CLD–401's mechanism is the company's proprietary RedTail platform. CLD–401 is an enveloped oncolytic vaccinia virus engineered to express a chimeric CD55 receptor, significantly enhancing its resistance to immune clearance and enabling systemic circulation to metastatic tumors. Loaded with an IL–15 superagonist payload, the virus not only lyses tumor cells but also delivers powerful genetic material directly into the tumor. This cytokine-based genetic medicine activates CD8+ T cells and natural killer cells, effectively transforming "cold" tumors into immunologically "hot" targets. Preclinical data has confirmed the platform's potential. "Of particular excitement is the rapid progress we have made with RedTail, the company's approach to systemically delivering genetic medicines to metastatic sites in patients with advanced cancer using our proprietarily engineered enveloped virus," reported Calidi CEO Dr. Eric Poma in a recent shareholder letter (). "RedTail represents the culmination of over a decade of meticulous research and innovation at Calidi to create what we believe is the most advanced systemic virotherapy platform. Advancing this novel platform is the company's main focus and priority." Sharing Compelling Preclinical Data Calidi Biotherapeutics has unveiled compelling preclinical data at two of the most influential oncology conferences — the American Association of Cancer Research (AACR) and the American Association of Clinical Oncology (ASCO) — highlighting the tumor-clearing and recurrence-blocking potential of CLD–401. At the AACR Annual Meeting, held in April 2025, Calidi presented key findings under the title "Development of a Systemic Enveloped Virotherapy for Targeting All Metastatic Sites" (). The data revealed that RedTail's enveloped vaccinia virus, coated with a human-like extracellular envelope, can survive immune defenses, access multiple tumor sites following intravenous administration and induce strong tumor killing even in traditionally hard-to-treat metastatic lung models, by delivering genetic medicines such as IL-15 superagonist directly to the tumor. The abstract emphasized the platform's ability to evade complement activation, substantially improving systemic circulation time and therapeutic impact. The momentum continued into the ASCO Annual Meeting in June 2025, where Calidi presented results demonstrating that CLD–401, enhanced with a chimeric CD55 receptor, further resists immune clearance and delivers its IL-15 superagonist payload directly into tumors (). This immune payload triggered robust expansion of CD8+ T cells and natural killer cells in the tumor microenvironment, key players in sustained anti-tumor immunity. Collectively, these data sets presented at AACR and ASCO illustrate the dual potency of CLD–401: it both breaks down tumor tissue and educates the immune system to prevent relapse. The systemic reach of RedTail, along with its tumor-targeted immune stimulation, positions Calidi's platform as a significant advancement in the field of immuno-oncology, especially for metastatic cancers with high unmet needs. "Looking ahead, our roadmap for the next 18 months includes multiple critical milestones," said Poma. "We are working to complete IND-enabling studies ahead of an IND filing by the end of 2026 for our lead RedTail candidate that delivers IL-15 superagonist to tumor sites, CLD-401. Our clinical strategy includes an optimized dose-escalation study designed to swiftly demonstrate efficacy and validate the systemic administration of RedTail in patients with metastatic disease." With promising results in hand and strategic plans in place, Calidi is positioning itself to enter human trials that may redefine how genetic medicines reach and treat cancer throughout the body. Leading Biotech Firms Share Promising Advances The global effort to transform cancer care continues to accelerate as leading biopharmaceutical companies report groundbreaking clinical data across multiple tumor types. Industry leaders are showcasing the progress of novel immunotherapies and targeted treatments aimed at some of the most challenging cancers. Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) shared new and updated data from its oncology and hematology portfolio at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (). According to the company, its 18 presentations will share the latest insights from ongoing research of approved and investigational treatment regimens across a range of difficult-to-treat cancers including non-melanoma and melanoma skin cancer, lung cancer, lymphoma and multiple myeloma. CG Oncology Inc . (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, presented key data at the 2025 American Urological Association (AUA) Annual Meeting (). The data was from the phase 3 BOND-003 Cohort C study of patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) treatment with carcinoma in situ (CIS) with or without Ta or T1 disease. Roche (OTCQX: RHHBY) is reporting positive results from its phase 3 IMforte study of Tecentriq(R) (atezolizumab) in combination with lurbinectedin (Zepzelca(R)) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and Tecentriq (). The company noted that the data showed that this combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to Tecentriq maintenance therapy alone. Merck & Co. Inc. (NYSE: MRK) announced that its phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, met its primary endpoint of progression-free survival (PFS) for the treatment of patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 and in all comers (). The study also met a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1. The study is evaluating KEYTRUDA(R) (pembrolizumab), Merck's anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab for these patients. Together, these data presentations and reports underscore the power of innovation in oncology, where immunotherapy combinations, genetic medicine therapies and personalized treatment approaches are driving new standards of care. With each development, the cancer research community moves one step closer to achieving more durable responses, longer survival and, ultimately, potential cures. For more information, visit Calidi Biotherapeutics Inc. 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