Malignant glioma of brain

KØBENHAVN, DK / ACCESSWIRE / January 15, 2025 / FluoGuide A/S (STO:FLUO) Copenhagen, Denmark - FluoGuide A/S (\"FluoGuide\" or the \"Company\"), a biotech company specializing in precision cancer surgery, announces approval of its phase II Clinical Trial Application for FG001 in head and neck cancer (oral squamous cell carcinoma cancer).The Phase II Clinical Trial Application (CTA) for FG001 in head and neck cancer, announced on October 7, 2024, has been granted approval under the new European process by the Dutch Central Committee on Research Involving Human Subjects and the Medical Ethical Committee of the University Medical Center Groningen.The CTA submission followed strong clinical topline data from a proof-of-concept Phase II clinical trial of FG001 in patients with head and neck cancer. The trial evaluated surgical precision using various surgical equipment and advanced FG001 to help patients with head and neck cancer.\"Morten Albrechtsen, CEO at FluoGuide states: \"The approval is a significant milestone to advance FG001 helping patients with head and neck cancer. We are on track to enroll first patient in first quarter of 2025 and the key data trigger point is expected in the second half of 2025 with the interim data.\"FluoGuide and Principal Investigator Prof. Dr. Max Witjes are now preparing to initiate the Phase II trial (CT-005) in head and neck cancer, which will be conduct a single center trial to:Evaluate multiple endpoints for measuring surgical completeness with FG001 in patients with head and neck cancerExplore different benefits of FG001 in assisting these patientsAccess the use of various surgical equipment typesEnroll 25-30 patients, with enrollment starting in Q1 2025The interim data is expected in the second half of 2025 being the data trigger pointThe trial completing in H2 2026Depending on trial data and regulatory feedback, the FluoGuide plans to conduct a multisite registration trial as the next step toward approval and commercialization.For further information, please contact:Morten Albrechtsen, CEOFluoGuide A/SPhone: +45 24 25 62 66E-mail: [email protected]Certified Adviser:Svensk Kapitalmarknadsgransking ABWebsite: www.skmg.seAbout FluoGuideFluoGuide takes precision surgery to the next level improving the outcome for cancer patients. The Company\'s lead product, FG001, is designed to improve surgical precision by illuminating cancer intraoperatively. This improved precision enabled by FluoGuide\'s products is expected to have a dual benefit - it reduces both the frequency of local recurrence post-surgery and lessens surgical sequelae. This improved precision will increase a patient\'s chance of achieving a complete cure and will lower system-wide healthcare costs. FG001 binds to the receptor uPAR being extensively expressed on most solid cancer types. The photothermal potential of FG001 could add a direct treatment effect of FG001 to further benefit for patients with cancer undergoing surgery.The Company has published strong results from phase II trials demonstrating the efficacy of FG001 as well as showing it was well tolerated and safe from clinical trials in patients undergoing surgery to remove aggressive brain (high-grade glioma), head & neck and lung cancers. Based on this strong foundation, FluoGuide expands the scope of application of FG001 and advances the development toward approval in aggressive brain cancer.FluoGuide is listed on Nasdaq First North Growth Market, Stockholm under the ticker \"FLUO\". Read more about FluoGuide\'s pipeline, technology, and upcoming events on www.fluoguide.comAttachmentsFluoGuide A/S receives approval for phase II trial in head and neck cancerSOURCE: FluoGuide A/SRelated Documents:

MB-108 (HSV-1 oncolytic virus) is active and well tolerated in patients with recurrent glioblastoma in ongoing Phase 1 clinical trial Preclinical data support a novel combination of MB-108 (HSV-1 oncolytic virus) and MB-101 (IL13Rα2‐targeted CAR-T cell therapy) to optimize clinical results Nov. 07, 2024 -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell therapies into potential cures for difficult-to-treat cancers, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to Mustang for MB-108, a herpes simplex virus type 1 (“HSV-1”) oncolytic virus, for the treatment of malignant glioma. The FDA grants Orphan Drug Designation to drugs and biologics that are intended for safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain incentives, such as tax credits toward the cost of clinical trials upon approval and prescription drug user fee waivers. If a product receives Orphan Drug Status from the FDA, that product is entitled to seven years of market exclusivity for the disease in which it has Orphan Drug designation, which is independent from intellectual property protection. Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “The Orphan Drug Designation for MB-108 is significant for Mustang, as it could provide additional market exclusivity and we hope to advance MB-108, in combination with MB-101, as a potential treatment option for patients living with malignant glioma, including patients with recurrent glioblastoma (“GBM”) and high-grade astrocytomas, where there is historically a median overall survival of six months. Our novel therapeutic strategy, combining our MB-108 oncolytic virus with MB-101 CAR-T cell therapy, could be the first-ever industry-sponsored trial of its kind for the treatment of malignant glioma. As such, Mustang plans to also request Orphan Drug Designation from the FDA for MB-101 (IL13Rα2‐targeted CAR-T cell therapy) in malignant gliomas. These advancements highlight our dedication to potentially improving outcomes for patients battling difficult-to-treat cancers.” As previously reported, preclinical data presented at the American Association for Cancer Research (“AACR”) Annual Meeting in 2022 supported a combination therapy to potentially optimize results to treat recurrent GBM. The combination leverages MB-108 to reshape the tumor microenvironment (“TME”) and make cold tumors “hot,” thereby potentially improving the efficacy of MB-101 CAR-T cell therapy. Data presented separately on MB-101 and MB-108 showed that administration of these therapies was well tolerated in recurrent GBM patients. Two patients treated solely with MB-101 who had high levels of intratumoral CD3+ T cells pre-therapy (i.e., “hot” tumors) achieved complete responses lasting 7.5 and 31+ months, respectively. Importantly, of the 53 City of Hope Phase 1 patients disclosed at AACR in 2022, these 2 complete responses were observed in the 2 patients with the “hottest” tumors prior to treatment with MB-101. Phase 1 clinical trials of MB-101 at City of Hope and of MB-108 at The University of Alabama at Birmingham continue to enroll patients. The Company’s ability to further develop the MB-109 program for recurrent GBM and high-grade astrocytomas is contingent upon raising additional funding and / or consummating a strategic partnership. MB-109 is Mustang’s designation for the treatment regimen combining MB-101 (IL13Rα2‐targeted CAR-T cell therapy licensed from City of Hope) with MB-108 (HSV-1 oncolytic virus licensed from Nationwide Children’s Hospital). The combination is designed to leverage MB-108 to make cold tumors “hot” and potentially improve the efficacy of MB-101 CAR-T cell therapy. MB-108 oncolytic virus is first injected to infect tumor cells which, in turn, leads to reshaping of the TME through recruitment of endogenous CD8- and CD3-positive effector T-cells. This inflamed TME potentially permits MB-101 CAR-T cells injected into and around the tumor to better infiltrate into and throughout the tumor mass, undergo activation and, ideally, effect tumor cell killing. Mustang Bio, Inc. is a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell therapies into potential cures for difficult-to-treat cancers. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with top medical institutions to advance the development of CAR-T therapies. Mustang’s common stock is registered under the Securities Exchange Act of 1934, as amended, and Mustang files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). Mustang was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.mustangbio.com. The content above comes from the network. if any infringement, please contact us to modify.

CHARLOTTE, NC, USA I September 04, 2024 I Adaptin Bio , a biotechnology company focused on developing precision cancer therapies with improved delivery to the brain and other tissues, has emerged from stealth today with the announcement that FDA has cleared an Investigational New Drug (IND) application for its APTN-101 program in glioblastoma (GBM), the most common and aggressive primary brain tumor. The clearance will enable the initiation of a first-in-human Phase 1 clinical trial to evaluate this investigational candidate in GBM. APTN-101 is a proprietary BRiTE (Brain Bispecific T cell Engager) therapeutic designed to target EGFRvIII, a specific protein linked to aggressive brain tumors. In preclinical studies, APTN-101 has shown a greater than 7-fold increase in distribution into the brain, with significant potential in eradicating malignant glioma tumors as a potentially best-in-class therapy. The Phase 1 clinical trial will assess the safety and efficacy of APTN-101 in patients diagnosed with WHO Grade IV Malignant Glioma, also known as GBM. Current treatment options for GBM include surgery, radiotherapy, and chemotherapy, which aim to remove or destroy tumor cells within the brain but fail to completely eliminate the disease due to its invasive nature. GBM deeply infiltrates the brain and despite aggressive treatment, residual tumor cells often lead to disease recurrence. GBM represents one of the most aggressive and challenging forms of brain cancer, with a median survival rate of just 12-18 months post-diagnosis, with only 5% of patients surviving beyond five years. The disease accounts for approximately 15,000 new cases per year in the US. Secondary malignant brain tumors account for about 200,000 new cases annually. This critical unmet need demands innovative therapies that can overcome the limitations of current treatments that do not cross the blood brain barrier. “The FDA clearance is a significant achievement for our collaboration with Adaptin. Based on results from preclinical models in orthotopic malignant glioma, we are excited to begin this clinical trial to evaluate the safety and efficacy of APTN-101,” said Mustafa Khasraw, M.D., Professor of Neurosurgery, Medicine, Integrative Immunobiology, Cancer Biology and Pharmacology at Duke University. “APTN-101’s ability to cross the blood-brain barrier and target glioma cells directly offers a promising new approach.” “We’re thrilled to initiate clinical trials with APTN-101 following FDA clearance of our first-in-human trial,” said Michael J. Roberts, Ph.D., CEO, Adaptin Bio. “Our proprietary BRiTE technology harnesses the immune system’s remarkable ability to target and deliver therapeutics to specific tissues, including the brain, potentially revolutionizing treatment for difficult-to-treat cancers. APTN-101 validates the BRiTE platform and its ability to enhance transfer of therapeutics into the brain. We are committed to advancing this novel therapy as a new potential therapy for glioblastoma patients who desperately need new therapies.” “Adaptin’s innovative delivery technology has the potential to revolutionize treatment for cancer and central nervous system disorders. We are proud to support Adaptin Bio as part of our ongoing commitment to partnering with visionary entrepreneurs and translating groundbreaking technologies from leading academic institutions into impactful solutions,” said James Ahern, Managing Partner of Laidlaw & Company and Founding Partner of Lucius Partners, who is an investor in Adaptin Bio. In preclinical studies, APTN-101 has shown impressive efficacy in eliminating malignant glioma tumors across various aggressive orthotopic models. The BRiTE platform, developed by researchers in the Department of Neurosurgery at Duke University under the leadership of Dr. John H. Sampson, harnesses the ability of T cells to precisely target and destroy glioma cells while effectively navigating the brain’s unique environment. Adaptin Bio’s proprietary BRiTE technology leverages the enhanced “hitchhiking” capabilities of manipulated immune cells to deliver therapeutic agents directly to brain tumors. This innovative approach has demonstrated high specificity for EGFRvIII expressing glioma cells, dose-responsive efficacy against diverse patient-derived glioma cell lines, and a favorable safety profile. Additional BRiTE targets are being evaluated. By manipulating the immune system either in vivo or ex vivo, BRiTE aims to overcome traditional treatment barriers and offer a promising new therapeutic option for patients with intracerebral malignancies. About Adaptin Bio Adaptin Bio is a biotechnology company developing novel therapies for oncology and central nervous system disorders with improved drug delivery to the brain and other tissues. The company’s proprietary Brain Bispecific T cell Engager (BRiTE) technology was developed by researchers at the Department of Neurosurgery at Duke University. The company’s mission is to develop novel therapies to improve patient outcomes in difficult-to-treat cancers. For more information, visit www.adaptinbio.com . SOURCE: Adaptin Bio