Leukocyte interleukin (CEL-SCI)

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, April 14, 2025 /PRNewswire/ -- Equity Insider News Commentary – Routine medical appointments or cancer screenings—critical for catching the disease in earlier, more treatable stages—has dropped to just over 50% of the population. At the same time, doctors are raising alarm bells over a noticeable increase in cancer diagnoses among younger adults, especially women. With proposed funding cuts to the NIH now on the table and new estimates suggesting that drug tariffs could add $10,000 or more to treatment costs, the path forward may rely less on government programs and more on private-sector breakthroughs. So far in 2025, several oncology innovators have stepped forward with meaningful updates, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), CEL-SCI Corporation (NYSE-American: CVM), OS Therapies Incorporated (NYSE-American: OSTX), BeiGene, Ltd. (NASDAQ: ONC), and Actinium Pharmaceuticals, Inc. (NYSE-American: ATNM). Continue Reading Pelareorep Facts Forecasts show cancer's global footprint expanding sharply, with annual case counts expected to rise 20% by 2030 and swell by 75% by mid-century, according to Statista. Meanwhile, Precedence Research projects the global immunotherapy drugs market will reach nearly US$1.2 trillion by 2033, driven by an 18% compound annual growth rate. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) recently turned heads after securing a new share purchase agreement with Alumni Capital that could provide up to US$20 million in flexible financing, and potentially increase available capital by nearly 45% of the company's valuation at the time of the announcement. The deal gives Oncolytics the right—but not the obligation—to raise capital over a 15-month period through equity sales under its own control. For a clinical-stage company heading toward multiple inflection points, the agreement offers an important advantage: access to cash if and when it's strategically needed. The announcement was met with heightened market interest, driving a notable spike in share price and trading volume on Friday, as investors reacted to the added financial runway and the timing of upcoming trial updates. The capital agreement reinforces a broader narrative taking shape in 2025. Oncolytics continues to advance pelareorep, its intravenously delivered immunotherapy, which triggers a systemic immune response against tumors. Pelareorep is being tested across multiple solid tumor types where outcomes remain poor, including HR-positive HER2-negative metastatic breast cancer, pancreatic ductal adenocarcinoma (PDAC), and advanced anal cancer. All three indications are now being studied in multi-drug combination trials that reflect real-world treatment settings and physician preferences. "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 in a recent update. "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." In breast cancer, the company recently completed a randomized Phase 2 trial called BRACELET-1. In this study, patients treated with pelareorep and paclitaxel outperformed those receiving paclitaxel alone, showing a near doubling in progression-free survival. The company has stated that the data support moving ahead with a larger registrational study, expected to begin later this year. If new results mirror those seen in BRACELET-1, Oncolytics may have the foundation to submit for accelerated approval in this indication. Meanwhile, the company continues to expand its gastrointestinal cancer program. A pancreatic cancer cohort within the GOBLET study is moving toward full enrollment, after clearing safety hurdles with regulators in Germany. Patients will receive pelareorep alongside a modified FOLFIRINOX chemotherapy regimen—with or without the checkpoint inhibitor atezolizumab. Interim efficacy results from this arm are expected later in 2025 and may inform the structure of a future registration-enabling trial. Notably, Oncolytics is working with the Pancreatic Cancer Action Network (PanCAN) on this cohort, as they provided a US$5 million grant to fund it. In advanced anal cancer, pelareorep is being tested with atezolizumab in another GOBLET cohort. Among the first 12 patients, four showed partial responses and one had a complete response lasting over 15 months. Based on these early outcomes—stronger than what's typically seen from checkpoint inhibitors alone—the company has expanded the cohort to include an additional 18 patients. Pelareorep's unique mechanism of action has garnered attention from key opinion leaders in immunotherapy. During a recent event hosted by H.C. Wainwright, Profs. Martine Piccart and Alexander Eggermont emphasized pelareorep's ability to turn so-called "cold" tumors "hot," potentially enhancing the effectiveness of checkpoint inhibitors and other cancer therapies in difficult-to-treat cancers like PDAC and HR+/HER2- metastatic breast cancer. As of the end of Q4 2024, Oncolytics reported $15.9 million in cash on hand, with operations funded into the third quarter of 2025. With late-stage trials being planned, multiple data readouts on the horizon, and a flexible US$20 million equity facility now in place, the company enters Q2 not just with momentum—but with the financial agility to match it. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: CEL-SCI Corporation (NYSE-American: CVM) is gaining traction after a study published in Cancer Cell validated its approach to seeking early approval for Multikine, its lead immunotherapy candidate for head and neck cancer. "The data from both our completed Multikine neoadjuvant Phase 3 study and the study published in Cancer Cell show that newly diagnosed locally advanced head and neck cancer patients who were treated with immune therapies before surgery and had tumor responses, were also likely to have better overall survival," said Geert Kersten, CEO of CEL-SCI. "This is quite logical—when a person's tumor shrinks in response to immunotherapy treatment before the tumor is removed by surgery—their survival outcome is expected to be better." Patients who responded to Multikine before surgery had significantly higher survival rates than those who didn't respond. The FDA has approved a 212-patient confirmatory trial to support the company's regulatory path forward. "We believe that the recent greater availability of peer-reviewed published data specific to neoadjuvant therapy and early tumor response in head and neck cancer supports our development and regulatory efforts," added Kersten. OS Therapies Incorporated (NYSE-American: OSTX), has completed its acquisition of Advaxis Immunotherapies' listeria-based cancer programs, securing full IP ownership and strengthening its leadership in this emerging therapeutic category. "We are thrilled to have now consolidated all of the intellectual property for the listeria cancer immunotherapy platform into OS Therapies, positioning us to fully expand it in the years ahead and improve the standard of care across cancer treatment in the years ahead," said Paul Romness, CEO of OS Therapies. "We now have late-stage, mid-stage and early-stage cancer immunotherapy candidates, a rich pipeline of preclinical cancer immunotherapy candidates and a long IP runway to in order to fully leverage this powerful cancer immunotherapy platform." The company's pipeline now includes three clinical-stage immunotherapies and eight additional preclinical assets aimed at more than 30 cancer types. Its lead candidate, OST-HER2, is expected to be submitted for FDA accelerated approval by year-end for recurrent, lung-metastatic osteosarcoma. If approved, the company would become eligible for a Priority Review Voucher, currently valued at $150 million. BeiGene, Ltd. (NASDAQ: ONC) recently received a positive opinion from the European Medicines Agency's CHMP for TEVIMBRA (tislelizumab) in combination with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer, based on a Phase 3 study showing a significant overall survival benefit. Weeks earlier, the FDA approved TEVIMBRA with chemo for first-line treatment of PD-L1-positive esophageal squamous cell carcinoma after another Phase 3 trial showed a 34% reduction in the risk of death. "Today's positive CHMP opinion marks another important step for TEVIMBRA to potentially expand its indications in a fourth disease area in Europe to reach more patients affected by cancer," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "TEVIMBRA is the cornerstone of our solid tumor portfolio with 58 regulatory approvals in 18 months and is being studied in combination with multiple novel molecules with the potential to herald the next wave of cancer therapeutics." TEVIMBRA is now approved in over 45 countries and remains the backbone of BeiGene's expanding solid tumor portfolio. Actinium Pharmaceuticals, Inc. (NYSE-American: ATNM) recently unveiled ATNM-400, a first-in-class, non-PSMA targeting prostate cancer radiotherapy powered by the potent alpha-emitter Actinium-225, showing 99.8% tumor inhibition in preclinical models. The company plans to present these data at AACR 2025, targeting a major unmet need in patients who progress after Pluvicto. "The current era of radiotherapy is built on the clinical and commercial success of Pluvicto in prostate cancer," said Sandesh Seth, Chairman and CEO of Actinium. "The field is now looking to address patients that do not respond or progress after Pluvicto therapy. We believe ATNM-400 can address this high unmet need and we are incredibly excited by our data to date." Alongside ATNM-400, Actinium is advancing clinical programs across AML, solid tumors, and cell therapy conditioning—backed by a robust patent portfolio and expanding in-house manufacturing infrastructure. 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. 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VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today announced that a study titled “Distinct CD8+ T cell dynamics associate with response to neoadjuvant cancer immunotherapies” by Li Housaiyin et. al., Cancer Cell (2025) provides support for CEL-SCI’s approach aimed at seeking early regulatory approval for Multikine* (Leukocyte Interleukin, Injection) as a neoadjuvant in the treatment of newly diagnosed previously untreated locally advanced head and neck cancer based on early tumor responses. We believe that the recent greater availability of peer-reviewed published data specific to neoadjuvant therapy and early tumor response in head and neck cancer supports our development and regulatory efforts. The concept that tumor responses predict survival has been acknowledged for many cancer types and has led to accelerated approval of many cancer drugs. The study in Cancer Cell, which had 41 evaluable patients, gives further support that this is also true in the neoadjuvant pre-surgical immunotherapy treatment of head and neck cancer. “The data from both our completed Multikine neoadjuvant Phase 3 study and the study published in Cancer Cell show that newly diagnosed locally advanced head and neck cancer patients who were treated with immune therapies before surgery and had tumor responses, were also likely to have better overall survival. This is quite logical—when a person’s tumor shrinks in response to immunotherapy treatment before the tumor is removed by surgery—their survival outcome is expected to be better,” stated CEL-SCI CEO Geert Kersten. “We believe that the recent greater availability of peer-reviewed published data specific to neoadjuvant therapy and early tumor response in head and neck cancer supports our development and regulatory efforts.” CEL-SCI’s 212-patient Confirmatory Registration Study, which has received the FDA’s go-ahead, is designed to verify the statistically significant efficacy and safety results from the Company’s previously completed Phase 3 randomized controlled Multikine trial. During the Multikine Phase 3 clinical trial, the 5-year survival rate of the target patient population for the confirmatory study increased to 73% when patients were treated with Multikine before surgery vs 45% for control patients who received only the standard of care treatments [Log rank p=0.0015 and a hazard ratio of 0.35 (0.18, 0.65; Wald p=0.0012)]. As a neoadjuvant therapy, Multikine is given to patients right after diagnosis, prior to surgery. In the Phase 3 study, pre-surgery objective early tumor response to treatment with Multikine was confirmed by pathology at surgery. There were 45 objective early responders, of which 5 were complete pathological responders, whose tumors completely disappeared in the Multikine treated group, within the 3-weeks of Multikine treatment. There were zero responders reported in the control group pre-surgery. Pre-surgical responders exhibited a 306% overall survival prolongation and had a significantly lowered death rate -vs- non-responders 22.2% vs 54.1% (2-sided Fisher Exact Test, p <0.0001) in support of pre-surgical response being prognostic. About CEL-SCI Corporation CEL-SCI has been a pioneer in advocating the use of neoadjuvant cancer immunotherapy. We believe that the greatest benefit for patients can only be achieved if you boost a patient’s immune system before surgery, radiotherapy and chemotherapy have damaged it. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital, inability to finalize a partnering agreement and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2024. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. * Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.