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Cision Canada
3 days ago
- Business
- Cision Canada
Biotech Underdogs Line Up for Pivotal Shots at Game-Changing Cancer Treatments
Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, B.C., /CNW/ -- Equity Insider News Commentary – The average age of cancer patients is getting younger, as experts are urgently examining the rise of early-onset incidence across several different cancer types. According to the Cancer Discovery study from the National Cancer Institute (NCI), the largest increases were seen in female breast, colorectal, kidney, uterine, and pancreatic cancers. Biotechs in the oncology space are responding with optimistic new treatments with potential milestones in the near future that may shift the tide in the sector, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Celcuity Inc. (NASDAQ: CELC), Evaxion A/S (NASDAQ: EVAX), Lyell Immunopharma, Inc. (NASDAQ: LYEL), and Agenus Inc. (NASDAQ: AGEN). Globally, the cancer‑drug sector is projected to surpass US$900billion in sales by 2034, according to Vision Research Reports. Next‑generation therapeutics (those powered by precision and personalized medicine) are pegged by Precedence Research to hit US$175.2billion during that same time period, growing at a 7.35% CAGR. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has officially entered the most critical phase of its journey yet—pursuing a potential registration-enabled trial in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), for its flagship asset, pelareorep. The company announced it has begun formal discussions with the U.S. Food and Drug Administration (FDA) aimed at finalizing a pivotal study design, with trial start-up activities expected to begin before the end of 2025. For investors and potential partners, this marks a clear shift from promising data to regulatory execution in one of the deadliest solid tumors in medicine. "We expect to move quickly and decisively down a clear regulatory path," said Jared Kelly, CEO of Oncolytics. "This is about execution and focus. Our goal is to win on survival—and this pivotal study is how we do it. We believe this program not only creates significant value for shareholders but also positions Oncolytics as a highly attractive partner for pharma companies seeking to break open the immunotherapy landscape in mPDAC and other GI tumors." The move comes as Oncolytics sharpens its focus on pelareorep, a systemically delivered oncolytic virus designed to convert so-called "cold" tumors—those that are typically invisible to the immune system—into "hot" tumors that can respond to immunotherapy. Pelareorep has been studied across over 1,100 patients and has demonstrated promising results in difficult cancers like mPDAC and HR+/HER2- breast cancer, particularly when used in combination with chemotherapy and immune checkpoint inhibitors. In first-line pancreatic cancer, pelareorep-based regimens have shown a notable 21.9% two-year overall survival rate, compared to a 9.2% historical benchmark. In a separate study pairing pelareorep with chemotherapy and a checkpoint inhibitor, researchers recorded a 62% objective response rate—remarkable given that checkpoint inhibitors are not currently approved for use in this indication. This robust efficacy signal, along with impressive translational data, helped lay the groundwork for this regulatory step. "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." Earlier this month, Oncolytics hosted a key opinion leader event featuring gastrointestinal cancer experts who reviewed survival outcomes, biomarker validation, and the drug's potential role in combination therapy. That expert panel helped reinforce the view that pelareorep's mechanism—activating innate and adaptive immune responses in patients—is both biologically sound and commercially relevant. Oncolytics' execution-focused strategy is being led by Jared Kelly and Andrew Aromando, who both played key roles in Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Kelly was appointed CEO earlier this year, while Aromando recently joined as Chief Business Officer. Together, along with Oncolytics' already-established team, they're guiding the company into late-stage development with a sharp focus on capital efficiency and strategic alignment. Regulatory designations are already in place to accelerate development. Pelareorep holds Fast Track and Orphan Drug designations for pancreatic cancer (and Fast Track for HR+/HER2‑ mBC breast cancer) from the FDA, meaning the agency has already recognized both the drug's potential and the serious unmet need in this patient population. These statuses not only streamline review processes but also increase the attractiveness of the program to potential pharmaceutical partners. For context, pancreatic cancer is one of the deadliest common cancers, with a five-year survival rate of less than 14%. Most patients are diagnosed at a metastatic stage, and current treatment options provide limited benefit. Unlike other cancers where immunotherapies like checkpoint inhibitors have transformed care, mPDAC remains largely resistant to those approaches—making the promise of pelareorep especially notable. What distinguishes pelareorep is its dual capability: it acts as both a viral therapy that replicates in cancer cells and a biological agent that activates the body's own immune response. Tumor samples have shown increased PD-L1 expression, heightened interferon signaling, and infiltration of tumor-killing T cells—all hallmark indicators that the immune system is being mobilized against cancer. These features are seen as essential for the next generation of immuno-oncology approaches. With this latest milestone, Oncolytics is entering a phase where the outcomes of FDA interaction will shape not only clinical plans but also potential commercial partnerships. If the agency accepts the company's proposed trial framework and endpoints—centered around overall survival—the resulting study could become the definitive test for pelareorep's market potential in mPDAC. More details on the trial design and timing are expected once FDA feedback is received, but the goal is clear: initiate the pivotal trial start-up activities before the end of 2025 and establish pelareorep as a cornerstone immunotherapy in one of the most underserved cancer settings. In the meantime, the company remains active in its ongoing breast cancer program and is continuing to explore pelareorep's potential in other gastrointestinal cancers, including KRAS-mutated colorectal cancer. However, first-line pancreatic cancer has now emerged as the lead strategic focus. The transition from early-stage promise to registration-stage planning marks a decisive evolution in the Oncolytics story. With data in hand, regulatory engagement underway, and a seasoned leadership team at the helm, Oncolytics is advancing into its most consequential chapter yet. In other recent industry developments and happenings in the market include: Celcuity Inc. (NASDAQ: CELC) recently announced that its Phase 3 VIKTORIA-1 trial met both progression-free survival (PFS) primary endpoints in patients with HR+/HER2- breast cancer without PIK3CA mutations. Gedatolisib-based combinations showed significant PFS improvements compared to standard therapies, including a 7.3-month gain for the triplet arm (9.3 vs. 2.0 months for fulvestrant monotherapy) and a 5.4-month gain for the doublet (7.4 vs. 2.0 months for fulvestrant monotherapy). "The efficacy improvement relative to the control that each of the gedatolisib regimens demonstrated was historic for this patient population," said Brian Sullivan, Chairman, CEO and co-founder of Celcuity. "We are excited about the potential opportunity to provide a breakthrough therapeutic option for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer." The company plans to discuss a potential NDA submission with the FDA following a full data presentation later this year. Lyell Immunopharma, Inc. (NASDAQ: LYEL) announced impressive new data from its LYL314 trial in relapsed/refractory large B-cell lymphoma, showing an 88% overall response rate and 72% complete response rate in the 3L+ setting. Over 70% of complete responders remained disease-free at 6 months. "Based on these robust data, and our recent End-of-Phase 1 meeting with the FDA, we have initiated PiNACLE, a single-arm pivotal trial of LYL314 in patients with large B-cell lymphoma in the third- or later-line setting and remain on track to initiate a pivotal trial to evaluate LYL314 in the second-line setting by the beginning of 2026," said Lynn Seely, MD, President and CEO of Lyell. The pivotal PiNACLE trial is now underway to support potential approval of this next-generation dual-targeting CAR T therapy. Later this year in October, Evaxion A/S (NASDAQ: EVAX) shared it will be presenting two-year data at ESMO 2025 from its Phase 2 trial of EVX-01, an AI-designed personalized cancer vaccine, showing durable responses in advanced melanoma. Results included a 69% overall response rate and a strong correlation between AI predictions and immune activity. The study supports EVX-01's role as a first-line immunotherapy candidate when paired with checkpoint inhibitors like pembrolizumab. "We are delighted to have the two-year data from the EVX-01 phase 2 trial accepted for presentation at the ESMO Congress 2025," said Birgitte Rønø, CSO and interim CEO of Evaxion. "As one of the most important and prestigious medical oncology conferences in the world, the congress will be a great place for us to present the data to a large audience, including potential partners." Also at ESMO 2025, Agenus Inc. (NASDAQ: AGEN) will present survival data from its botensilimab/balstilimab program, including an oral session highlighting survival plateaus across five refractory tumor types. With over 1,200 patients treated, the agents are showing promising results in historically cold tumors like mCRC and non-melanoma skin cancer. These data continue to support botensilimab as a backbone immunotherapy candidate for solid tumors. 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. 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Washington Post
15-07-2025
- Health
- Washington Post
Blood tests promise to detect cancer early. How well do they work?
For years, it has been one of the most tantalizing ideas in medicine: One day, a simple blood test will detect nascent cancers — allowing doctors to intervene when tumors may be easier to treat. A study published this month in Cancer Discovery found that three years before a handful of cancer patients were diagnosed, some promising tests could detect trace amounts of cancer genetic material floating in their blood, shed by tumors the people didn't yet know existed. Start-up companies have developed different versions of these 'multi-cancer early detection' tests designed to flag the errant genetic signatures of more than a dozen cancers. Some doctors and medical practices are already using them, and the field has been propelled forward by innovation and hype. Turning these innovative technologies into usable medical tools for the broader population has been complex. But a study recruiting subjects this summer, funded by the National Cancer Institute, seeks to begin to do that by answering basic questions about how the tests perform in comparison to more conventional cancer screening. A screening test given to millions of healthy people has to be accurate to avoid costly and anxiety-inducing follow-ups. And for it to become part of routine medical care, there needs to be evidence that the test can reliably find cancers — perhaps far earlier than routine methods. Most importantly, scientists want to see clear evidence that earlier detection leads to longer lives. To begin to fill this knowledge gap, scientists at nine sites around the country are recruiting up to 24,000 people between the ages of 45 and 75 for the Vanguard Study. Participants will be randomly assigned to receive either regular screening or one of two multi-cancer detection tests. All of the groups will be told to continue with regular cancer screenings and will be followed over two years. The blood tests used in the study will screen for a variety of cancers, including many for which there aren't more traditional screening tests: bladder, breast, colorectal, esophageal, stomach, liver, lung, ovarian, pancreatic and prostate. Researchers, guided by what they learn from this first trial, hope to launch a much larger trial, with about 150,000 people, to definitively establish the effectiveness of these tests in preventing deaths. Bert Vogelstein has been working on these ideas for 30 years at Johns Hopkins Medicine and is a scientific founder of Exact Sciences, a company working to make blood tests for cancer screenings, but is not involved in the new trial. He said the field is still in its adolescence. 'But adolescents can do a lot of great things, that's clear in athletics and it's clear in science,' Vogelstein said. 'I think what NCI is doing is great. And I applaud those efforts, because tests can do good or harm.' The benefit of early cancer detection is intuitive. People could roll up their sleeves and get a blood test to flag 20 cancers, allowing physicians to give early treatments when they have no symptoms. That could dramatically reduce the need for people to go through years of illness and advanced cancer treatments. 'That dream, to me, is decades off, but we're starting on it now — which is why it's so exciting,' said Scott Ramsey, a physician and researcher at the Fred Hutchinson Cancer Center and a principal investigator with the Cancer Screening Research Network, which will be running the Vanguard Study. 'We're not talking about treating people who are sick; we're talking about preventing people of dying in cancer in the first place.' The harms of screening are not always as clear to the public, but they show the trade-offs inherent when providing a medical intervention to healthy people. Ramsey pointed to the history around prostate specific antigen (PSA) tests, which identified many prostate cancers early — some of which would have never shown symptoms or caused death. That meant that many men were aggressively treated, with surgery and radiation that caused them to be incontinent or impotent for years or decades. The recommendations on how to test for prostate cancer changed as these trends became clear over decades. Ramsey said that now is the right moment to be subjecting these cancer blood tests to scrutiny. The potential for the tests is enormous, but there are fundamental questions that need to be answered about how and when they should be used — and, perhaps, when they shouldn't. The recent study in Cancer Discovery illustrated one of the major problems facing the field. To detect cancers early, the tests need a big boost in sensitivity, because they need to find fragments of cancer tumor DNA that are scarce. That study found that it was possible to detect cancer three or more years than a traditional diagnosis. 'It can be done — and that's an important part of the article, much earlier than had ever been shown before,' said Vogelstein, part of the team behind the study. But to detect those trace amounts of genetic material, the sensitivity of the test had to be roughly 50 times higher than what it is in tests today, he said — and would likely cost a few thousand dollars. Ramsey said current tests can be $900 or more. Health insurance carriers typically won't pay for them yet, because it isn't clear what their benefits and harms are. 'The bottom line is we don't know whether when taking one of these tests will give you an opportunity to live longer without cancer — or longer overall,' Ramsey said. 'There's never been a study that established that.'
Newsweek
23-06-2025
- Health
- Newsweek
Routine Blood Test Can Catch Cancer Years Sooner, Breakthrough Study Suggests
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. A routine blood test may be able to detect cancer more than three years before diagnosis, a new study suggests. In the study, published May 22 in Cancer Discovery, researchers at Johns Hopkins University analyzed blood samples from the long-running Atherosclerosis Risk in Communities study. Using a multicancer early detection test, they identified tumor-derived genetic mutations in blood samples collected more than three years before patient diagnosis. Stock image. Stock image. Photo by Wildpixel / Getty Images Lead study author Dr. Yuxuan Wang, an assistant professor of oncology at Johns Hopkins, told Newsweek the study is important because most cancer deaths occur when the cancer has spread. "For cancers of all stages, therapy is more effective when delivered earlier," she explained. "So we wanted to see how early we can detect cancers with a blood test before symptoms and clinical diagnosis." Why It Matters The Johns Hopkins study shows that blood tests could significantly shift how and when cancer is detected. Researchers were able to identify circulating tumor DNA in blood samples collected 3.1 to 3.5 years before clinical diagnosis in four of six cases where earlier samples were available. "Our study showed that it is possible to detect cancers three years prior to symptoms [starting to show], because the cancer 'signal' is already present in blood at that time," Wang told Newsweek. What To Know The new study used highly sensitive DNA sequencing techniques to test blood samples from 52 people—26 who developed cancer within six months of collection, and 26 who did not. Eight of those samples tested positive using the blood test, and all eight individuals were diagnosed with cancer within four months. For six of the eight, earlier blood samples were available from three years prior. In four of those six cases, the same cancer-associated mutations were detected at much lower concentrations—up to 79 times lower—demonstrating the potential for ultra-early detection. 'This is a difficult conversation' "As a medical oncologist, I see mostly patients who have advanced cancers," Wang told Newsweek. "For the majority of these patients, treatments are only palliative—aimed at prolonging life rather than curing them of their disease. "As you can imagine, this is a difficult conversation to have with patients. However, if cancers can be detected years earlier, they are much more likely to be curable by surgery or other therapies." She added that in oncology, researchers "get excited" about new drugs or therapies that can prolong a patient's life by even a few months. "Yet earlier cancer detection, which potentially could save lives, is often overlooked," Wang added. "With our study, we hope to encourage more efforts and resources devoted to earlier cancer detection, so that someday, we'll have a test that would dramatically reduce cancer deaths." What's Next While the results were promising, researchers need larger tests to validate the findings. "We have to make sure that the test is affordable and can be implemented for mainstream use," Wang said. "Finally, we need to do studies to determine what is the best follow-up for a positive test, especially if the test is so sensitive that cancers are detected before they are visible on scans and before any symptoms."
Time of India
20-06-2025
- Health
- Time of India
Cancer could be detected 3 years before symptoms appear with a simple blood test; new study reveals
One of the leading causes of death in recent years, cancer, is claiming to take millions of lives each year. Despite the significant advancements in the treatment, the biggest challenge in fighting cancer is that the detection is often too late. Detecting cancer earlier may dramatically improve survival rates and offer more treatment options. But, this is yet harder to diagnose at the earliest stage and is one of the crucial reasons for rising deaths worldwide. Now, a new study by Johns Hopkins University researchers suggests that a simple blood test could help identify cancer years before symptoms even begin to show, potentially transforming the future of early diagnosis and prevention. According to the study published in the peer-reviewed journal Cancer Discovery , this breakthrough might be a push in early diagnosis of cancer. A simple blood test may detect cancer early, before any symptoms start Cancer outcomes are heavily dependent on how early the disease is detected. When tumours are caught in their initial stages, they tend to be smaller, less aggressive, and more responsive to treatment. As researcher Yuxuan Wang from Johns Hopkins explains, 'Three years earlier provides time for intervention. The tumours are likely to be much less advanced and more likely to be curable.' This time advantage could make the difference between curable and life-threatening cancer, especially in aggressive forms of the disease. At the heart of the research is a type of genetic material called circulating tumour DNA (ctDNA). Tumours naturally shed fragments of their DNA into the bloodstream, but these traces are extremely minute and hard to detect, especially in the early stages. Science behind detecting cancer in blood To identify these fragments, scientists used multi-step algorithms and cross-checks to scan blood samples for modifications in DNA patterns that are commonly linked to tumours. The technique forms the basis of a Multi-Cancer Early Detection (MCED) test, designed to look for cancer-specific genetic changes in the blood. The research team analysed blood samples from 52 individuals, split into two groups: 26 people who were later diagnosed with cancer within six months of sample collection. 26 people who remained cancer-free. When subjected to the MCED test , eight cancer cases were flagged, indicating a 31% detection rate. While not perfect, this detection occurred before any formal diagnosis or visible symptoms appeared. Testing the method: What the study revealed What makes the findings even more groundbreaking is the analysis of older blood samples from some of the participants. Six of the eight individuals who were detected by the MCED test had blood samples available from 3.1 to 3.5 years before their diagnosis. Amazingly, cancer signals were found in four of those six samples. The ctDNA was present, although at levels up to 80 times lower than what the current test threshold requires. This suggests that tumours begin shedding DNA into the blood long before symptoms arise. if the tests are sensitive enough, these early signs could be caught. While the results are promising, they also highlight a key hurdle that the current technology needs to improve its sensitivity. The earlier the stage of cancer, the lower the ctDNA levels, making detection difficult. 'This study shows the promise of MCED tests in detecting cancers very early,' says Dr. Bert Vogelstein, a senior cancer researcher involved in the project. 'But it also sets the benchmark sensitivities required for these tests to succeed.' In simpler terms, we now know what we should aim for—but we're not quite there yet. What happens after a positive cancer blood test Even though the science is encouraging, moving from lab to the clinic is not straightforward. Blood-based cancer screening tests must undergo rigorous clinical trials to prove their reliability and safety. Once proven effective, they still require regulatory approvals before being adopted into regular medical practice. There's also the question of what comes after a positive test. Dr. Nickolas Papadopoulos from the Ludwig Centre notes, 'We need to determine the appropriate clinical follow-up after a positive test result. That includes further scans, biopsies, or even preventive treatments.' Despite the current limitations, this research represents a hopeful shift in cancer diagnostics. Combined with ongoing advances in treatment, especially therapies targeting multiple cancer types, the future holds the potential for significantly improved survival rates. This could mark a revolutionary step forward in how cancer is screened and treated. Also Read | 10 common monsoon diseases that might cause serious health problems; know symptoms and how to protect yourself One step to a healthier you—join Times Health+ Yoga and feel the change
India Today
19-06-2025
- Health
- India Today
Blood test detects cancer DNA three years before diagnosis
Researchers at Johns Hopkins University have found that tiny traces of cancer can be found in a person's blood up to three years before they are officially means doctors might one day be able to catch cancer much earlier, when it's easier to treat or even study, published in Cancer Discovery, was led by scientists from several Johns Hopkins institutions, and partly funded by the US National Institutes of WHAT DID THE STUDY FIND?When someone has cancer, their tumors release small bits of genetic material into the bloodstream. The researchers discovered that this material can show up in blood samples long before any signs of illness appear."We were surprised to find cancer signals in the blood so early. Finding cancer three years earlier gives us a chance to treat it before it spreads,' said Dr. Yuxuan Wang, one of the study team used blood samples from a large health study called ARIC, which has tracked people's heart and health data for many looked at blood from 52 people:26 people who were later diagnosed with cancer26 people who stayed cancer-freeOut of these, 8 people showed signs of cancer in their blood using a special lab test called MCED (Multicancer Early Detection). All 8 of these people were diagnosed with cancer within four months after their blood was 6 of those cases, researchers went back and checked older blood samples from the same people, taken more than three years before the diagnosis. In 4 of those cases, cancer markers were already present even back DOES THIS MEAN?The study highlights that a simple blood test might one day be able to spot cancer early, giving doctors and patients more time to act.'This kind of early detection could improve treatment and save lives," said Dr. Nickolas Papadopoulos, one of the senior the researchers stated that they need to determine the appropriate clinical follow-up after a positive test for such cancers.
