Latest news with #cancerimmunotherapy
Associated Press
28-05-2025
- Business
- Associated Press
New study led by Horizon and supported by Roche Canada delivers cancer treatment in the comfort of a patient's home
MISSISSAUGA, ON, May 28, 2025 /CNW/ - For the first time in Canada, a patient has received cancer immunotherapy by subcutaneous (under the skin) injection in their home, thanks to an innovative research initiative by Horizon Health Network (Horizon), in collaboration with Roche Canada, the New Brunswick Extra-Mural Program, and ResearchNB, and with support from Vitalité Health Network. The project originated with a research study led by Horizon medical oncologists Dr. Mahmoud Abdelsalam, Dr. Luisa Galvis and Dr. James Michael whereby New Brunswick patients diagnosed with certain types of lung cancer receive Health Canada-authorized subcutaneous cancer immunotherapy at home, administered by nurses from Medavie's New Brunswick Extra-Mural Program. The initiative was formally announced by the New Brunswick delegation during the annual BIO International Convention in June 2024 in San Diego, California, and the first treatment milestone occurred in New Brunswick this past March. 'This trial marks a turning point in lung cancer care—bringing treatment from the hospital to patients' homes, where they are most comfortable,' said Dr. Abdelsalam, who served as principal investigator of the research initiative. 'We are proud to lead this Canadian-first trial from New Brunswick, showing that innovation in health care can start right here at home, improving the quality of care for New Brunswickers.' The study was initially designed to bring care closer to communities. However, Dr. Abdelsalam challenged the team to go further — to 'close the last mile' by delivering modern cancer therapies directly to patients' homes. Previously, patients travelled to hospital-based infusion centres for intravenous cancer treatments, often spending at least 30 to 60 minutes per visit. The new subcutaneous injection reduces treatment time to about seven minutes, offering a more convenient, less invasive option that minimizes disruptions to patients' daily life, reduces the strain on health care providers, and increases capacity in the health care system. 'The reality is, if patients must leave their communities, take time off work, arrange childcare or organize transportation, it disrupts their lives significantly,' said Jennifer Sheils, Horizon's Vice-President of Strategy, Transformation and Chief Innovation Officer. 'They occupy IV therapy hospital chairs, require nursing and pharmacy resources and often face the challenge of travelling home while feeling unwell. These impacts extend beyond the treatment day and can affect their overall well-being and financial stability.' As industry partners like Roche Canada introduce new therapies that move beyond traditional IV delivery, Horizon is leading the way in rethinking cancer care by putting patient needs first and helping to build a more efficient, responsive health care system. Key benefits of an injection (subcutaneous) formulation to the patient, compared to traditional IV formulations, can include: 'The challenges faced by healthcare systems in Canada have never been greater. Horizon Health's outstanding leadership shows that transforming this system is possible. By thinking differently about how we collaborate, we can deliver better care to patients and their families. We are very proud to partner with Horizon Health on this project, which will help ensure all patients have access to the best innovation in healthcare, when they need it - a key part of Roche's vision,' said Dr. Dan Edgcumbe, Vice President of Medical and Regulatory Affairs at Roche Pharma Canada. 'This experience will help us all better understand the full value of healthcare innovation to provide more accessible, flexible care options while expanding healthcare system capacity.' Through this partnership, patients now have the choice to receive injections at home, reducing disruption to their daily lives and alleviating pressures on hospital resources. This innovative model empowers patients while supporting a more efficient and patient-centered health care system. This approach is also expected to improve health system operations by reducing pressure on infusion clinics, increasing treatment capacity, optimizing workflow and potentially lowering overall costs per patient. Horizon hopes health care systems across Canada will look to this example as a model for accelerating patient-centred innovation. Advancing research and adopting new approaches to care delivery will be critical to building a more sustainable health care system. Horizon is committed to fostering a culture of improving patient outcomes through research and innovation initiatives like this one. Each year, Horizon Research Services supports approximately 117 clinical trials for new treatments and solutions, along with nearly 307 investigator-led studies advancing health care knowledge and practice. Patients interested in participating in this study, referred to as Subcutaneous Treatment with Immunotherapy for Cancer Patients at Home, or STITCH-01, or another Horizon research study are encouraged to complete a research application form, available on the Horizon website. About Horizon Health Network Horizon Health Network is the largest regional health authority – and one of the largest employers – in New Brunswick, and the second-largest health authority in Atlantic Canada. Our leadership and health care providers are experts in diverse areas of health and community services and provide services to a half a million people. The organization has an annual budget of approximately $1.4 billion and has more than 14,000 employees, 1,242 physicians and 1,300 volunteers, as well as 17 foundations and 16 auxiliaries and alumnae organizations. About Roche Canada At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies. With our combined strength in diagnostics and pharmaceuticals, we're driving healthcare forward, while ensuring we deliver meaningful benefits for patients and sustainable healthcare systems. We are committed to creating a world where we all have more time with the people we love. And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries. Having the courage to reinvent ourselves and question the status quo is what patients and healthcare systems expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs nearly 2,000 people at its offices in Mississauga, Ontario, in Laval, Quebec, and across the country from coast to coast to coast. For more information, please visit or follow Roche Canada on LinkedIn. About ResearchNB ResearchNB is the province's research and innovation enabler. With offices in Fredericton, Saint John and Moncton, it provides New Brunswick's research sector with critical leadership and support including advocacy, initial funding, connections to potential partners, and the translation of science into economic opportunities. Projects developed in partnership with ResearchNB help New Brunswickers to thrive through research that leads to new, innovative business practices and products. About New Brunswick Extra-Mural Program The New Brunswick Extra-Mural Program (EMP) delivers primary health care services to New Brunswickers of all ages in their homes and communities. EMP, known by many as the 'hospital without walls', includes a team of over 850 professionals who provide quality home health care services to eligible residents when their needs can be met safely in the community. EMP operates on a client and family centered model with a focus on building and maintaining partnerships with clients and their families, physicians, agencies, departments and other service providers to best meet patient needs. SOURCE Hoffmann-La Roche Limited (Roche Canada)
Irish Times
27-05-2025
- Business
- Irish Times
Poolbeg Pharma treatment gets FDA backing
The US Food and Drug Administration (FDA) has granted orphan drug designation to Poolbeg's preventative therapy for cancer immunotherapy-induced Cytokine Release Syndrome (CRS). The treatment, named POLB 001, is an oral preventative therapy to treat inflammation in blood and tissues. CRS is a severe side-effect that occurs in more than 70 per cent of patients, leading to severe side-effects or death. Cytokines can sweep throughout the body and cause tissue damage and shut down circulation and other essential organs. Orphan status is granted by the FDA for to support the development of treatments for rare disorders that affect under 200,000 people in the US, and makes the development of the drug less risky for Poolbeg, with the potential for seven-year period of US market exclusivity following approval of the treatment, waiver exemption of some fees and tax credits for qualified clinical trials. READ MORE 'POLB 001 is potentially a breakthrough, orally delivered, preventative therapy for cancer immunotherapy-induced CRS which could significantly impact patients' lives,' said Poolbeg chief executive Jeremy Skillington. 'We were delighted to receive Orphan Drug Designation from the FDA, which is a significant development for Poolbeg and for POLB 001, one that we believe will enhance the commercial appeal for prospective partners and help bring POLB 001 to the market faster. If approved, we believe POLB 001 has the potential to improve quality of life for patients, reduce pressure on healthcare systems, and expand access to cancer immunotherapies.' There are currently no approved preventative therapies for CRS. The first patients are expected to get the drug in the second half of the year, as part of Poolbeg's Phase 2a trial. 'Orphan Drug Designation from the FDA underscores the urgency and importance of developing innovative therapies for this critical unmet medical need,' said Professor Brendan Buckley, Poolbeg non-executive director and a member of the scientific advisory board. 'We look forward to progressing POLB 001 in our upcoming Phase 2a clinical trial and working closely with prospective partners and regulatory agencies to bring this potential therapy to patients as quickly as possible.'
Yahoo
23-05-2025
- Business
- Yahoo
Iovance Presents Five-Year Amtagvi Data at ASCO for Advanced Melanoma
Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) presented five-year data from its Phase 2 C-144-01 trial of Amtagvi (lifileucel) during the 2025 ASCO Annual Meeting. A medical staff in white coats monitoring the progress of cancer immunotherapy trials. A five-year overall survival rate of 19.7% and a median overall survival of 13.9 months were reported in 153 patients with advanced melanoma who had previously received anti-PD-1 and targeted treatments. The intended response rate was 31.4%, with a median response duration of 36.5 months, and 5.9% complete and 25.5% partial responses. At five years, 31.3% of respondents remained active. There were no novel late-onset adverse events, and safety results were in line with established profiles of IL-2 and lymphodepletion. Amtagvi is still the only one-time T cell treatment for solid tumors that has received FDA approval. In February 2024, Amtagvi was given accelerated FDA approval for melanoma that was metastatic or unresectable following PD-1 and targeted treatments. Patients who had not responded to at least one systemic treatment were selected for the vital C-144-01 trial. Cohorts 2 and 4 of the trial followed the identical manufacturing method and regimen. Iovance Biotherapeutics, Inc. (NASDAQ:IOVA)'s TIL platform, which targets a market where 90% of cancers are solid tumors, is the first to be approved for solid tumors. Tumor tissue is surgically removed, billions of T cells are produced in 34 days, and then the cells are infused following lymphodepletion and IL-2. Moreover, Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) is assessing lifileucel in NSCLC and conducting the TILVANCE-301 Phase 3 trial in frontline melanoma. While we acknowledge the potential of IOVA to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than IOVA and that has 100x upside potential, check out our report about this READ NEXT: and . Sign in to access your portfolio
Yahoo
23-05-2025
- Business
- Yahoo
Great Novel Therapeutics Biotech & Medicals Corporation (GNTbm) Presented Preclinical Data on GNTnm-38, an Novel Epigenetic Immune Activator, at the 2025 ASCO Annual Meeting
TAIPEI, May 22, 2025 /PRNewswire/ -- GNTbm (stock code: 7427, Taiwan) announced the preclinical data on GNTbm-38, an novel epigenetic immune activator for cancer immunotherapy. GNTbm-38 was presented as posters at the 2025 American Association of Clinical Oncology (ASCO) Annual Meeting, which is held in Chicago, USA, from May 30 to Jun 04, 2025. Abstract: 2574 Title: Preclinical development of GNTbm-38, a novel class I histone deacetylase inhibitor, while combined with anti-VEGFR TKI or anti-PD-1 Ab: Assessment of immune activation and immune memory in cancer immunotherapy. Session Date/Time: 6/2/2025, 1:30 PM-4:30 PM CT Poster Board Number: 221 At present, there is no ICI-based drug combination for the treatment of advanced MSS colorectal cancer, which is a cold tumor. Studies have shown that epigenetic regulators such as class I HDAC inhibitors are an emerging and important drug component for combination therapy that can greatly increase the anti-cancer benefits of cancer immunotherapy. Therefore, rational drug combinations, containing class I HDACi, may provide opportunities in cancer immunotherapy. GNTbm-38 is a new drug candidate independently developed by GNTbm. GNTbm-38 acts as a TME reprogramming regulator in immunotherapy. When combined with TKI, GNTbm-38 significantly improved tumor response rate and survival rate through synergistic effect by normalizing tumor vessels, increasing tumor antigen presentation, increasing activated CD8+ T cell infiltration into tumors, inducing memory T cell persistence, and inhibiting mobilization of immunosuppressive cells into tumors. On the other hand, treatment with GNTbm-38 plus anti-PD-1 antibody in the CT-26 model showed greatly improved tumor response rate and survival rate with a strong synergistic effect. Furthermore, in B-hPD-1/hPD-L1 mice (humanized model) subcutaneously injected with B-hPD-L1 CT-26 cells, treatment of pembrolizumab and GNTbm-38 resulted in a 46.5% inhibition on tumor growth. Therefore, our data provided a strong rationale to explore the combination of GNTbm-38 with anti-VEGF TKI with or without ICI. From these data GNTm-38 has been shown to display powerful induction of immune activation and immune memory in combination therapy with TKI/ICI against colon CT-26 cold tumor. Based on the in vitro, in vivo and preclinical studies, these data show that GNTbm-38 exhibits markedly superior pharmacokinetics, tolerability, and efficacy in animal models. It is expected to complete the US IND application by the end of 2025 and enter the clinical study. About GNTbm-38 GNTbm-38 is a new chemical entity with potential as a pivotal drug component of a new generation of cancer immunotherapy independently developed by GNTbm. It is a drug candidate selected by an immuno-competent tumor-bearing animal testing platform, and has undergone many preclinical research studies to confirm that it has very outstanding anti-cancer activity in tumor microenvironment. GNTbm-38 is an oral drug with dual effects of epigenetic regulation of gene expression and immune activation, which is unique when compared to the mechanism of other epigenetic drugs. GNTbm-38 can remodel the tumor microenvironment (TME) through a unique epigenetic regulatory mechanism, including the cell composition and gene expression that affect the TME, so that "cold tumors" can be transformed into "hot tumors", which can attract CTL to infiltrate into the TME, and at the same time, it can also reduce the attraction of immunosuppressive cells (such as : TAM, Treg, and MDSCs) into the TME, so as to achieve the remodeling of the TME, which is more conducive to obtaining the therapeutic benefits of cancer immunotherapy. GNTbm-38 monotherapy can be used in the treatment of hematological tumors, and GNTbm-38 can also be combined with a unique multi-kinase inhibitor or immune checkpoint inhibitor for treatment of a variety of solid tumors, mainly through a unique anti-cancer immune-regulating mechanism to achieve anti-cancer treatment goals. About GNTbm GNTbm (stock code: 7427, Taiwan) is a company that has conducted clinical trials and developed a new drug against advanced breast cancer on the market in Taiwan. The GNTbm R&D team has the ability to independently develop new drugs, and has multiple anti-cancer drug candidates with global development rights, with the goal of meeting the unmet clinical needs of patients with advanced cancers. GNTbm mainly focuses on the development of drugs with innovative mechanisms for the new generation of cancer immunotherapy, conducts clinical validation, and hopes to successfully provide novel immunotherapy with excellent efficacy and safety for varieties of cancer indications, to fulfil the unmet medical needs of patients around the world and improve the quality of life of patients. View original content: SOURCE Great Novel Therapeutics Biotech & Medicals Corporation Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
22-05-2025
- Business
- Yahoo
CEL-SCI Announces Pricing of Public Offering
VIENNA, Va., May 22, 2025--(BUSINESS WIRE)--CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE American: CVM), a clinical stage cancer immunotherapy company, today announced the pricing of an underwritten public offering of 2,000,000 shares of its common stock at a public offering price of $2.50 per share. Total gross proceeds from the offering, before deducting the underwriting discount and other offering expenses, are expected to be $5,000,000. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 190,000 shares to cover over-allotments at the public offering price, less the underwriting discount. The offering is expected to close on May 23, 2025, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from this offering to fund the continued development of Multikine*, for general corporate purposes, and working capital. ThinkEquity is acting as sole book-running manager for the offering. The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-265995), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2022 and declared effective on July 15, 2022. The offering will be made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the offering has been or will be filed with the SEC on its website at Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About CEL-SCI Corporation CEL-SCI believes that boosting a patient's immune system before surgery, radiotherapy and chemotherapy have damaged it should provide the greatest possible impact on survival. 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. Such statements include, but are not limited to, statements about the expected proceeds, use of proceeds and closing of the offering. 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 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, except as may be required under applicable securities law. * 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. View source version on Contacts COMPANY CONTACT:Gavin de WindtCEL-SCI Corporation(703) Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
