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USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, March 8, 2025 /PRNewswire/ -- As the global cancer crisis intensifies, the demand for breakthrough treatments is reaching new heights. Statista data projects a 20% rise in annual cases by 2030 and a staggering 75% increase by 2050. According to the World Health Organization (WHO), breast cancer cases are projected to rise by nearly 40% by 2050. Despite the concerning trends in cancer incidence, 2025 has seen key advancements from biotech companies at the forefront of oncology research, with Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Exelixis, Inc. (NASDAQ: EXEL), Cardiff Oncology, Inc. (NASDAQ: CRDF), ALX Oncology Holdings Inc. (NASDAQ: ALXO), and Verastem, Inc. (NASDAQ: VSTM) continuing to push the boundaries of cancer treatment. Continue Reading Pelareorep Facts (PRNewsfoto/USA News Group) The article continued: Within a new research report on the Global Oncology Market from Vision Research Reports, cancer therapies are projected to surpass US$903.81 billion by 2034, growing at a 10.9% CAGR along the way. The World Economic Forum is optimistic, recently touting 12 new breakthroughs in the fight against cancer. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage company focused on immunotherapy for cancer, has just released its Q4 and full-year 2024 financial results, providing investors with a clearer picture of its progress as it moves toward potential future FDA approvals for its lead drug, pelareorep, a promising immunotherapy designed to help the immune system recognize and destroy cancer cells more effectively. "With multiple clinical trials surpassing expectations in 2024, 2025 is shaping up to be a defining year for Oncolytics," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO. "Our top priority is HR+/HER2- metastatic breast cancer, in which two randomized trials involving over 100 patients have shown substantial clinical benefit for patients receiving pelareorep and paclitaxel compared to paclitaxel monotherapy. We believe that if we can approximate the benefit we saw in BRACELET-1 in our planned registrational study, the progression-free survival benefit alone would support an accelerated approval submission." The data mentioned by Pisano from BRACELET-1 showed that patients receiving pelareorep and paclitaxel lived longer and responded better to treatment compared to those receiving paclitaxel alone. Given the consistency of these results, Oncolytics believes that its upcoming registration-enabling trial could pave the way for an accelerated approval submission with the FDA. This is an important development, as HR+/HER2- breast cancer is one of the most commonly diagnosed and treated breast cancers worldwide, representing a massive market opportunity for the company. Beyond breast cancer, Oncolytics is making significant progress in two other hard-to-treat cancers: pancreatic cancer and anal carcinoma. "When adding pancreatic and anal carcinoma to the list of addressable indications where we have generated compelling efficacy signals, pelareorep could have a meaningful impact for a multitude of patients," added Pisano. Oncolytics recently presented new data at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, showcasing pelareorep's potential to improve patient outcomes in these aggressive diseases. In anal cancer, results from the ongoing GOBLET study showed that 33% of patients responded to treatment when pelareorep was combined with atezolizumab, a checkpoint inhibitor. Notably, one patient experienced a complete response, with their cancer disappearing and staying undetectable for over 15 months. This level of response in such a difficult-to-treat cancer is highly encouraging, leading Oncolytics to expand the trial to enroll additional patients. Meanwhile, in pancreatic cancer, the company successfully cleared a critical safety review for its combination study using pelareorep with modified FOLFIRINOX with and without atezolizumab, allowing the trial to progress to the next phase. Pancreatic cancer has one of the lowest survival rates of any major cancer, and with few effective treatments available, pelareorep's continued success in this area could position Oncolytics as a key player in gastrointestinal oncology. From a financial standpoint, Oncolytics reported a cash position of $15.9 million at the end of 2024, giving it enough runway to continue executing on its clinical development strategy through the third quarter of 2025. While the company operates at a loss—as is typical for clinical-stage biotechs—it has been strategically managing its spending to ensure that key trials remain funded. Research and development expenses remained stable compared to the previous year, reflecting a disciplined financial approach that prioritizes high-impact studies. With several potentially transformative catalysts on the horizon, including the initiation of a registration-enabling study in breast cancer and new pancreatic cancer data expected later in the year, investors will be watching closely to see how Oncolytics navigates its next steps. The coming months will be crucial for Oncolytics as it pushes forward in its mission to bring pelareorep to market. With strong clinical results, growing regulatory support, and a well-managed cash position, the company is well-positioned to capitalize on its momentum. If its upcoming breast cancer study confirms the benefits seen in BRACELET-1, Oncolytics could find itself on a fast track to regulatory approval, potentially opening the door to a major commercial opportunity. Infographic - CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Exelixis, Inc. (NASDAQ: EXEL), reported promising results earlier this year from a subgroup analysis of its Phase 3 CABINET trial, which evaluated cabozantinib in patients with advanced gastrointestinal (GI) neuroendocrine tumors (NETs). The data presented at ASCO GI 2025 showed that cabozantinib significantly improved progression-free survival (PFS) compared to placebo, with a median PFS of 8.5 months versus 5.6 months. The findings highlight cabozantinib's potential to become a new standard of care for GI NETs, an area with limited treatment options. The FDA is currently reviewing Exelixis' supplemental New Drug Application (sNDA), with a decision expected by April 3, 2025. "These new data add to the robust results from the CABINET trial that demonstrate the benefits of cabozantinib across a wide range of patients with neuroendocrine tumors and further underscore the potential of cabozantinib to become a much-needed new option for those with GI NET, which accounts for the majority of real-world patients with this tumor type," said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. "We look forward to continuing to work with the U.S. FDA as they review our regulatory application for cabozantinib for the treatment of patients with previously treated advanced neuroendocrine tumors." Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, recently shared its Q4 2024 and FY 2024 results and business update as it continues to advance its lead program, onvansertib, a promising PLK1 inhibitor targeting RAS-mutated metastatic colorectal cancer (mCRC). "2024 was a significant year for Cardiff Oncology as we shared positive data from the first 30 patients in our lead program in first-line RAS-mut mCRC," said Mark Erlander, Ph.D., CEO of Cardiff Oncology. In its latest Phase 2 trial (CRDF-004), patients receiving the 30mg dose of onvansertib showed a 64% objective response rate, nearly doubling the 33% response rate in the control group. Cardiff also secured a new U.S. patent covering the use of onvansertib in combination with bevacizumab (bev) for previously untreated KRAS-mutant mCRC patients, adding long-term value to its intellectual property. ALX Oncology Holdings Inc. (NASDAQ: ALXO) is pushing forward with key advancements in its clinical pipeline, including the continued development of evorpacept, a CD47-blocking immunotherapy designed to enhance the effects of existing cancer treatments. The company announced plans to expand clinical trials into breast and colorectal cancer, aiming to evaluate evorpacept in combination with trastuzumab for HER2-positive breast cancer and with cetuximab for colorectal cancer. "Our conviction in evorpacept's potential to deepen responses to important available anti-cancer antibody therapies, particularly in patients with HER2-positive cancers, has been strengthened by recent data," said Jason Lettmann, CEO at ALX Oncology. "We look forward to our near-term milestones with ASPEN-03 and ASPEN-04 topline results in head and neck cancer and discussion with the FDA regarding the registrational path in gastric cancer based on the ASPEN-06 data." In addition to its immunotherapy efforts, ALX Oncology is preparing to advance ALX2004, a novel EGFR-targeted antibody-drug conjugate (ADC), into the clinic, with an Investigational New Drug (IND) application planned for Q1 2025. Verastem, Inc. (NASDAQ: VSTM) is making strides in RAS/MAPK pathway-driven cancers, with new Phase 2 trial data on its lead combination therapy, avutometinib plus defactinib, set to be presented at the 2025 Society of Gynecologic Oncology (SGO) Annual Meeting. The investigational treatment has already earned Priority Review from the FDA, with a PDUFA decision expected by June 30, 2025, for patients with KRAS-mutant low-grade serous ovarian cancer (LGSOC). "The presentation of the RAMP 201 primary analysis, which served as the basis of the acceptance of our NDA that is under Priority Review with the FDA, includes additional subgroup analysis by KRAS mutational status," said Dan Paterson, President, and CEO of Verastem Oncology. "We also recognize the importance of these findings to the broader cancer community as part of our growing pool of data reinforcing the potential to change expectations in managing RAS/MAPK pathway-driven cancers." As Verastem moves forward with its RAMP clinical trials, the company continues to expand its pipeline, including a Phase 3 confirmatory trial (RAMP 301) in LGSOC and a collaboration with Amgen to evaluate its therapy in combination with LUMAKRAS™ for KRAS G12C mutant lung cancer. 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. 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iStock/ Bulat Silvia More than a decade after Merck’s Keytruda and BMS’ Yervoy ushered in the immuno-oncology revolution, the space is at a crossroads, with experts highlighting novel targets, combinations and pre-emptive immunization as the next wave for IO. Last year marked 10 years since Keytruda’s seminal approval . That FDA greenlight signaled a new day in immuno-oncology and set the stage for the subsequent approvals of several more checkpoint inhibitors. Now, the field is looking for its next breakthrough—but it’s been a bumpy road. Overall, the immuno-oncology (IO) space “continues to be quite disappointing,” Graig Suvannavejh, senior biopharmaceuticals and biotechnology equity research analyst at Mizuho Americas, told BioSpace . “Industry is in search of that next great IO target, and they just haven’t been able to identify one that works.” In the last 15 years, the FDA has approved 11 checkpoint inhibitors — therapies targeting immune checkpoint proteins, including PD-1 and its partner protein PD-L1, plus CTLA-4 and LAG-3—to help the immune system locate and attack cancer cells. While Keytruda, an anti-PD-1, gets the most credit for having kickstarted the IO revolution, it was preceded by a CTLA-4 inhibitor called Yervoy, which BMS picked up in its $2.4 billion acquisition of Medarex in 2009. Two years later, the FDA approved Yervoy as the first anti-CTLA-4 drug. “That, really, along with the anti-PD-1s, kind of ushered in this whole immuno-oncology revolution,” Suvannavejh said. Jeremy Levin, now CEO of Ovid Therapeutics who was instrumental in BMS’ transformation to an immuno-oncology company in the aughts, agreed: “It became increasingly clear that there was science that said that this whole concept of immune modulation was beginning to evolve, and that CTLA-4 was breaking open the first concepts behind it.” Lately, however, the industry appears to have hit the proverbial therapeutic wall. But it’s not for a lack of trying, according to Christiana “Chris” Bardon, co-managing partner of MPM BioImpact. “When PD-1 was first released, we spent a lot of energy as an industry looking for the next PD-1 and we must have had tens of thousands of combinations of drugs in the clinic, testing everything with PD-1,” she told BioSpace . “Basically, we were looking for the next-generation IO checkpoint inhibitor.” But despite the emergence of more therapeutic options targeting the immune system, IO treatment response rates have plateaued at around 30%, Caroline Loew, CEO of Mural Oncology, wrote in a November 2024 opinion piece for BioSpace , meaning that 70% of patients do not respond to these therapies. “Despite the incredible efficacy of PD-1,” Bardon said, there is still a huge unmet need. “We still have many cancers that don’t respond to PD-1, things that are immunologically cold.” Striking Out With TIGITs Branching out has proven difficult, however. In the IO space, Suvannavejh said anti-TIGIT checkpoint therapies have been “probably the biggest disappointment” in the past two years. In December 2021, Roche ignited the field with promising results from the Phase II CITYSCAPE study of its anti-TIGIT drug tiragolumabin in metastatic non-small cell lung cancer (NSCLC). When combined with the company’s anti-PD-L1 blocker Tecentriq, tiragolumabin reduced the risk of disease worsening or death by 38% compared to Tecentriq alone. “I think the IO space was in kind of a low place about five years ago until Roche announced positive Phase II data for their TIGIT antibody,” he said. “All of a sudden, people were like, ‘oh my god, IO is back.” But in the Phase II/III data reported last year, the tiragolumab/Tecentriq combo failed to significantly improve progression-free and overall survival versus Keytruda and chemotherapy in patients with NSCLC and Roche elected to terminate that study. The excitement fizzled after that, Suvannavejh said. It was almost the nail in the coffin for TIGITs, or at least the buzz around the drug class. Seven months earlier, in December 2023, Merck had struck out in NSCLC with its experimental anti-TIGIT antibody vibostolimab when the candidate, in combination with Keytruda, failed to hit the endpoints in a mid-stage study. Recent results have breathed new life into the space, however. In September 2024, iTeos and GSK sparked excitement with Phase II results from patients with NSCLC taking a combination of iTeos’ anti-TIGIT candidate belrestotug and GSK’s anti-PD-1 therapy Jemperli. The combo elicited a 30% better confirmed objective response rate versus Jemperli alone. The partners are now studying the regimen as a first-line therapy for NSCLC in a Phase III trial . While it remains to be seen if TIGIT-targeting checkpoint inhibitors will reach the market, Bardon noted that the industry has seen some progress with drugs that hit CTLA-4 and LAG-3. In October 2022, the FDA greenlit AstraZeneca’s anti-CTLA-4 drug Imjudo, in combination with its first-generation PD-L1 inhibitor Imfinzi, for hepatocellular carcinoma, while the LAG-3 space saw its first approval in March of that year in BMS’ relatlimab (in combination with Opdivo and marketed as Opdualag) in unresectable or metastatic melanoma. Looking ahead, Bardon said ivonescimab—a PD-1/VEGF bispecific antibody in development by Summit Therapeutics, “is really the new . . . wave of checkpoint inhibitors.” “Ivonescimab has shown superiority to PD-1 alone, which is incredible,” she said. In September, Summit presented Phase III data at the International Association for the Study of Lung Cancer’s 2024 World Conference on Lung Cancer, showing that ivonescimab outperformed Keytruda in first-line advanced NSCLC. In the HARMONi-2 trial, Summit’s candidate cut the risk of disease progression or death by nearly 50% compared with Keytruda. While the results sent Summit’s stock skyrocketing by as much as 140%, some analysts urged caution , particularly noting that the data were from a trial run only in China. “Results may or may not be generalizable beyond the China-focused patient population initially assessed,” BMO Capital Markets wrote in an investor note at the time. Summit is currently studying ivonescimab in a multi-regional Phase III NSCLC study in the U.S. Bardon added that ivonescimab has the potential to work in multiple tumor types outside of lung cancer and predicted that it would be “a huge blockbuster in the future.” Pfizer appears to agree. Last week, the New York–based pharma struck a deal with Summit to combine its vedotin-based antibody-drug conjugates with ivonescimab. Part of the reason the industry has not been successful in developing checkpoint inhibitors “is that the development path is very, very hard,” Bardon said. One key challenge, she explained, is that most checkpoint therapies do not have monotherapy efficacy and therefore need to be developed in combination with PD-1 drugs. Definitive combination therapy can only be demonstrated in a comparator trial. “It’s just a very difficult and long path to de-risk the drug.” In this way, ivonescimab benefited from being created and developed in China, where there are faster enrollment times, limited treatment options and clinical trials are less expensive, Bardon said. Other IO targets of particular interest, Suvannavejh said, are PRAME (preferentially expressed antigen of melanoma) and the “very complicated RAS pathway, which includes the commonly mutated KRAS.” “This is a pathway that people have been trying to target for decades,” Suvannavejh said. “[It is] very difficult to do, trying to get that mix of efficacy and safety.” Amgen and BMS already have KRAS drugs — Lumakras and Krazati —on the market for NSCLC. The developmental “darling” of this space, Suvannavejh said, is Revolution Medicines, whose daraxonrasib is currently in a registrational trial to treat cancers with a wide range of common RAS mutations. Other players include Eli Lilly, Immuneering Corporation and Erasca. IO Developments On the Horizon Levin indicated that the IO space is at a crossroads. “The first wave of immuno-oncology has passed us by,” he said. “We know what we know about it.” Biopharma’s appetite for IO is certainly understandable. For Merck, Keytruda brought in a cool $29.5 billion in global sales in 2024 and ranks among the best selling drugs of all time. With that drug going off patent in just a few years’ time, many companies are eager to grab more of a market that is projected to be worth more than $17 billion by 2032. So, how does biopharma catch the next wave? For Suvannavejh, the answer lies in identifying novel targets—potentially through artificial intelligence and machine learning. As an example, he offered Compugen , a Tel Aviv–based biotech that uncovered a previously unidentified checkpoint called PVRIG using its proprietary computational discovery platform. Compugen is currently studying the resulting asset, COM701 , in trials of ovarian, gastric and other cancers. “That’s what companies can do if they want to go down this path of like, hey, maybe there’s another checkpoint inhibitor that we just haven’t identified yet,” Suvannavejh said. Meanwhile, Levin said the current focus is on combination therapies. “The world teaches you this repeatedly for complex diseases,” he continued, citing childhood leukemia, hypertension and congestive heart failure as examples of where combinations have ultimately been the answer. However it’s done, Levin continued, the holy grail for IO is pre-emptively engaging the human body to defeat a cancer cell before it has even proliferated. “Immuno-oncology is the clue that you can do this,” he told BioSpace . “It says that you can absolutely galvanize the human tissue to reawaken attack on a cancer cell. The big question is, can you actually pre-emptively immunize us such that we can be ready for this?”