Gemcitabine Hydrochloride

Phase 2 highlights robust biomarker identification and survival correlations in first-line metastatic pancreatic cancer (mPDAC) treated with elraglusib CHICAGO, IL and FORT WORTH, TX, USA I June 20, 2025 I Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced biomarker data from a recent poster presentation at the American Society of Clinical Oncology (ASCO) annual meeting from the Phase 2 (Actuate-1801 Part 3B) trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in first-line metastatic pancreatic adenocarcinoma (mPDAC). The study demonstrated the use of machine learning and statistical models to predict overall survival (OS) based on pre-dose plasma biomarkers. The poster described an analysis of 40 cytokines, chemokines, soluble cell receptors, and growth factors (CCSGs) from plasma samples obtained prior to treatment from all patients enrolled in Actuate-1801 Part 3B. The analysis identified 7 biomarkers as uniquely significant predictors of favorable survival in the elraglusib-treated cohort, including one, CXCL2, with an inverse survival trend compared to the GnP control arm. This indicates that in patients not treated with elraglusib, high CXCL2 was unfavorable, but this trend is reversed with elraglusib treatment, highlighting the potential of elraglusib to favorably affect the immune microenvironment. Univariate analysis revealed strong predictive performance with CXCL2 emerging as a consistently reliable biomarker for survival across multiple cross-validation analyses. Elevated levels of CXCL2 and TRAIL were associated with improved OS, while lower levels of CCL3, IL-1α, IL-18, TGF-β, and TRAIL R3 were similarly linked to better survival. These signatures were combined into multivariate machine learning models that accurately predicted patients who would survive for greater than one year if treated with elraglusib and GnP. “These results represent an important advance in our biomarker strategy,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “They support the ability to use simple, non-invasive blood-based markers to potentially identify patients more likely to benefit from elraglusib. The pre-dose biomarker signatures identified in the 1801 Part 3B study, particularly involving high CXCL2 and low TGF-β, CCL3, and IL-18, which were all associated with a survival benefit, suggests that elraglusib may exert pleiotropic immunomodulatory effects regulating cytotoxic T cells, NK cells and cells of the myeloid lineage including macrophages and neutrophils. Crosstalk between components of the immune system support the growing body of evidence that elraglusib enhances immune response mechanisms critical to its antitumor efficacy.” “The application of unbiased mathematical and machine learning models allowed us to pinpoint the strongest biomarker signals free from pre-conceived notions of elraglusib’s mechanisms. What is so exciting about this project is that the unbiased approach aligns with prior mechanistic studies. The congruence of our clinical data analytics and the preclinical research combined with the strength of our predictive models gives us confidence that these biomarkers could be extremely beneficial in identifying the right patients at the right time,” said Taylor Weiskittel, MD, Ph.D., the lead author on this study. “We look forward to applying this approach to guide the development of elraglusib in mPDAC as well as other advanced cancer indications in the future.” The company plans to test the identified biomarkers prospectively in future trials. Additional efforts will focus on optimizing sequential univariate combinations for patient stratification, refining multivariate machine learning models for predictive accuracy, and comparing these approaches head-to-head. About Actuate Therapeutics, Inc. Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate’s lead investigational drug, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy through the inhibition of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and DNA Damage Response (DDR). Elraglusib may also mediate anti-tumor immunity through the regulation of multiple immune checkpoints and immune cell function. For additional information, please visit the Company’s website at http://www.actuatetherapeutics.com. SOURCE: Actuate Therapeutics

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 20, 2025 /PRNewswire/ -- USA News Group News Commentary – The costs of cancer drugs is skyrocketing, according to a recent report from Bloomberg. Analysts at Nova One Advisor estimate that the global oncology drugs market will grow at a 7.4% CAGR through to US$366.24 billion by 2034. Help doesn't appear to be coming from the public sector, as reports state that the current US administration could drastically reduce funding of the National Cancer Institute (NCI) by nearly 40%, the market is looking towards the private sector to pick up the slack and continue to make advancements in cancer treatment. For investors to note, plenty of oncology innovators have provided recent developments, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Immuneering Corporation (NASDAQ: IMRX), GRAIL, Inc. (NASDAQ: GRAL), Intensity Therapeutics, Inc. (NASDAQ: INTS), and Relay Therapeutics, Inc. (NASDAQ: RLAY). Continue Reading With Public Funding Under Pressure, Biotech Innovators Are Picking Up the Slack in Oncology Pelareorep Factsheet The global oncology market is expected to see strong growth over the next decade, with ResearchAndMarkets forecasting it to reach US$866.1 billion by 2034 at a 10.8% CAGR. A separate estimate from Vision Research Reports projects the market will surpass US$903.81 billion by the same year, growing at a 10.9% CAGR. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has entered a new phase of leadership with the appointment of Jared Kelly as Chief Executive Officer and member of the Board. Kelly brings a background in high-stakes biotech transactions and strategic immuno-oncology development, positioning him to guide the company through its next stage of clinical and business evolution. Before joining Oncolytics, Kelly served as General Counsel at Ambrx Biopharma, where he played a key role in its $2 billion acquisition by Johnson & Johnson. His earlier work includes advising life sciences firms on licensing, partnerships, and M&A while at Kirkland & Ellis LLP and Lowenstein Sandler LLP. Now leading Oncolytics, he steps into a company advancing pelareorep, a virus-based immunotherapeutic designed to work synergistically with checkpoint inhibitors and other agents across a range of solid and blood cancers. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients," said Jared Kelly, CEO of Oncolytics Biotech. "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. I am excited to get to work accelerating development and unlocking significant value for stakeholders." Kelly's appointment signals a clear strategic focus: advancing pelareorep toward key late-stage milestones through a capital-conscious approach that remains open to strategic collaboration. Pelareorep currently holds FDA Fast Track designation for both metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC)—a rare dual recognition that underscores its regulatory momentum. Across multiple studies, the virus-based therapy has demonstrated consistent immune activation, broad combinability with checkpoint inhibitors and chemotherapies, and encouraging response rates in challenging cancer types. In mPDAC, pelareorep has achieved over 60% objective response rates in tumor-evaluable patients across Phase 1 and 2 trials—more than double what's typically seen in historical benchmarks. Separate analyses also reported two-year survival rates four to six times higher than control arms or prior studies. In HR+/HER2- mBC, two randomized Phase 2 trials (IND-213 and BRACELET-1) showed survival benefits supportive of further investigation. Meanwhile, a Phase 2 cohort in anal cancer pairing pelareorep with a checkpoint inhibitor reported partial or complete responses in nearly half of evaluable patients—substantially higher than historical norms for monotherapy in this setting. "Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date," said Wayne Pisano, Chair of the Board and outgoing Interim CEO of Oncolytics. "We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors." Kelly's compensation package includes equity grants and milestone-linked incentives tied to future financings and potential strategic transactions—aligning leadership priorities with long-term shareholder interests. The structure signals a commitment to advancing both clinical and corporate goals while preserving balance sheet discipline and maintaining appeal for potential partners. With multiple cohorts progressing in the GOBLET study—including those in pancreatic and anal cancer supported by external funding and regulatory engagement— Oncolytics is positioned to move forward with a combination of scientific momentum, financial agility, and renewed strategic focus. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Immuneering Corporation (NASDAQ: IMRX) reported positive Phase 2a data for atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients. At six months, the study showed 94% overall survival and 72% progression-free survival in 34 patients, with no median OS or PFS reached yet. "These exceptional data demonstrate the potential of atebimetinib plus mGnP to dramatically extend the lives of patients with advanced pancreatic cancer," said Ben Zeskind, Ph.D., Co-founder and CEO of Immuneering. "Our ultimate goal is to help cancer patients outlive their disease, and today's announcement represents an important milestone on that journey." The combination also demonstrated a 39% overall response rate, an 81% disease control rate, and a notably favorable tolerability profile. Many patients experienced deep, durable tumor regressions, including lesions rendered undetectable. The regimen was well tolerated, with an adverse event profile suggesting potential best-in-class positioning among MEK inhibitors. GRAIL, Inc. (NASDAQ: GRAL), recently announced strong top-line results from the PATHFINDER 2 registrational study evaluating its Galleri® multi-cancer early detection test in over 25,000 adults. "We are delighted to see very encouraging performance of the Galleri MCED test as a cancer screening tool in broad intended use populations of asymptomatic adults over 50 years of age in both the PATHFINDER 2 study and the NHS-Galleri trial's prevalent screening round," said Josh Ofman, MD, MSHS, President at GRAIL. "We would like to extend our sincere gratitude to all of the participants and investigators in both of these pivotal studies, who are collectively helping to realize the potential of this groundbreaking technology for population-scale multi-cancer early detection and move the field forward." The study showed a substantially higher positive predictive value (PPV) compared to the original PATHFINDER trial, with consistent specificity and cancer signal origin accuracy, and no serious safety concerns reported. GRAIL plans to submit these results to the FDA as part of its ongoing premarket approval process under Breakthrough Device Designation. Intensity Therapeutics, Inc. (NASDAQ: INTS) announced that the first patients in its ongoing Phase 2 INVINCIBLE-4 trial achieved high levels of tumor necrosis within eight days of receiving two doses of INT230-6, before starting standard-of-care immunochemotherapy for triple-negative breast cancer (TNBC). "We are excited to see that INT230-6 is achieving meaningful levels of necrosis in patients with evidence of immune activation," said Lewis H. Bender, President and CEO of Intensity. "TNBC patients risk their lives to achieve a pCR, and about forty percent fail to achieve the desired result." MRI scans showed substantial tumor destruction and inflammation, suggesting immune activation following direct intratumoral injection. The randomized study compares INT230-6 followed by standard treatment versus standard treatment alone, with pathological complete response (pCR) as the primary endpoint. Relay Therapeutics, Inc. (NASDAQ: RLAY) reported updated interim data from its Phase 1/2 study of RLY-2608 plus fulvestrant, showing a median progression-free survival (PFS) of 11.0 months in second-line patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer. "We are encouraged by the consistency of these updated RLY-2608 + fulvestrant data, which continue to show the potential benefit of a mutant-selective PI3Kα inhibitor for improving both the tolerability profile and progression free survival compared to standard of care," said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. "We look forward to starting the first mutant-selective PI3Kα Phase 3 trial, ReDiscover-2, in the middle of this year." Among patients at the recommended Phase 3 dose, the clinical benefit rate reached 67%, and 39% had confirmed partial responses, with notably higher response rates in those with kinase mutations. The combination maintained a favorable tolerability profile, with low rates of high-grade adverse events and minimal treatment discontinuations. 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. 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. USA News Group 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. 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