Zanzalintinib

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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Investors sent Exelixis’ share price up 12% to about $45 on Monday.\n A combination featuring Exelixis’ experimental drug zanzalintinib has beaten Bayer’s gastrointestinal cancer med Stivarga in a phase 3 trial. The overall survival win moves Exelixis a step closer to its ambition of turning the oral tyrosine kinase inhibitor into a $5 billion-a-year product.Exelixis is developing zanzalintinib as the successor to its flagship oncology medicine Cabometyx. By improving attributes including pharmacokinetic half-life, the company has designed a molecule that it believes can win approval in a range of diseases and blast past Cabometyx’s peak sales. The phase 3 colorectal cancer trial was a key early proving ground for zanzalintinib.Investigators randomized 901 patients to receive Stivarga or zanzalintinib in combination with Roche’s checkpoint inhibitor Tecentriq. Overall survival in previously treated non-microsatellite instability-high metastatic colorectal cancer was significantly longer on the combination than on Stivarga.William Blair analysts said in a note to investors that the hit on the trial’s co-primary endpoint ensures a “meaningful commercial opportunity for the budding franchise.” The patient population covered by the endpoint represents the largest commercial opportunity open to zanzalintinib, according to analysts, who estimated risk-adjusted U.S. peak sales of $875 million. The analysts will be looking out for relative and absolute risk reduction when the full results are shared, because “these metrics could help us ascertain the clinical meaningfulness of the survival benefit.” But the available results are positive, leading investors to send Exelixis’ share price up 12% to about $45 on Monday.Exelixis will, however, need to rack up more clinical wins to deliver its major vision for zanzalintinib. The biotech expects GI cancers, including colorectal tumors, to account for 45% of the $5 billion in sales it hopes to generate in 2033. GI cancers accounted for 10% of Cabometyx sales last year, making the indications central to Exelixis’ ambitions to improve on the $1.8 billion generated by its current product.The biotech’s pursuit of the phase 3 colorectal cancer population could put it in competition with drugs including Amgen’s Lumakras, Bayer’s Stivarga, Taiho Oncology’s Lonsurf and Takeda’s Fruzaqla.