Salute e Benessere
Amid NCI Budget Fears, Emerging Oncology Stocks Gain Attention
Market forecasts suggest oncology could be one of the decade's fastest-growing sectors. 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— sees the market hitting US$866.1 billion , while 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.
(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), 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 . "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 . "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 $2 billion acquisition by and bring a track record of value creation in oncology-focused biotechs. Their arrival signals a deliberate pivot toward unlocking the value of pelareorep, 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 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 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 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, is advancing toward potential partnership, planning registration-enabling trials, and commercialization readiness—all while maintaining a disciplined, investor-aligned approach to capital and growth.
https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
(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 . "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.
(NASDQ: CTOR) is preparing to launch LYMPHIR, an -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 and . "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.
(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, . "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.
(NASDAQ: TOI) has entered into a major partnership with to provide oncology care to over 80,000 members across Nevada .
"We couldn't be more excited about the opportunity to expand our partnership with and help create improved access and quality of cancer care to their Medicaid patient population," said Daniel Virnich , MD, CEO of . "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 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 patients.
https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
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