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Oncolytics Biotech® Reports Updated Anal Cancer Data Showing Objective Response Rate More Than Double the Current Standard of Care
Prnewswire· 2025-10-28 11:30
Core Insights - The combination of pelareorep and atezolizumab achieved a 30% objective response rate (ORR) in patients with second-line or later squamous cell anal carcinoma (SCAC), significantly higher than the historical benchmark of 13.8% for the only FDA-approved treatment [1][2] - The median duration of response for this combination therapy was 15.5 months, compared to 9.5 months for the current standard of care [3] - Oncolytics Biotech plans to discuss a single-arm accelerated approval study with the FDA in Q1 2026 [1][6] Efficacy Results - Among 20 evaluable patients, six achieved a response, resulting in a 30% ORR, which is more than double the historical benchmark [2] - Two durable complete responses were observed, with one lasting over two years and another lasting 15 months; an additional patient has an ongoing response at 64 weeks [3] - The results indicate the potential for pelareorep to provide durable immunologic tumor control in gastrointestinal tumors without chemotherapy [4] Company Strategy - The SCAC cohort is part of the broader GOBLET study, which evaluates pelareorep in combination with checkpoint inhibitors and standard therapies across multiple gastrointestinal cancer indications [5] - Oncolytics intends to engage with the FDA regarding a potential single-arm study for accelerated approval in SCAC, with a possible launch in the first half of 2026 [6] - The GOBLET study includes multiple treatment groups targeting various gastrointestinal cancers, assessing both efficacy and safety [7][8] Company Background - Oncolytics Biotech is a clinical-stage biotechnology company focused on developing pelareorep, an investigational immunotherapeutic agent designed to activate immune responses against cancer [10] - The company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in various cancer types, including pancreatic and breast cancers [11]
AlphaTON Capital and Cyncado Therapeutics Share New Mesothelioma Data Supporting TT-4's Path to First- Patient Dosing
Globenewswire· 2025-10-25 16:30
Core Insights - AlphaTON Capital Corp and its subsidiary Cyncado Therapeutics presented new findings at the AACR-NCI-EORTC conference, demonstrating that selective adenosine A2B receptor inhibition has a direct anti-tumor effect in mesothelioma cells, reducing PD-L1 expression and modulating YAP signaling [1][2][3] Clinical Development - The new data supports the efficacy of Cyncado's selective A2B receptor antagonist TT-4, which showed better monotherapy activity than anti-PD-1 and improved tumor control when combined with anti-PD-1, leading to increased immune infiltration [2][3] - TT-4 is advancing towards first-patient dosing expected in Q1 2026, with a focus on translating these findings into clinical applications [4][10] Research Collaboration - The research was conducted in collaboration with the Italian Group for Mesothelioma and other institutions, highlighting the importance of partnerships in advancing cancer therapeutics [1][5] Mechanistic Insights - In human mesothelioma models, hypoxia-linked adenosine signaling was found to increase tumor growth and PD-L1 expression, while selective A2B receptor inhibition effectively reduced cell growth and PD-L1 protein levels [3][4] - In vivo studies demonstrated that TT-4 significantly inhibited tumor growth in immunocompetent models, further enhanced by combination therapy with anti-PD-1 [3][4] Company Overview - AlphaTON Capital is focused on building a strategic reserve of TON tokens and developing the Telegram ecosystem, providing institutional-grade exposure to the TON ecosystem while maintaining transparency as a Nasdaq-listed company [6][7] - Cyncado Therapeutics is developing small molecule adenosine receptor antagonists targeting A2A and A2B receptors to overcome immune suppression in oncology, with TT-4 being the lead program [10]
AlphaTON Capital Appoints Wes Levitt as Chief Financial Officer
Globenewswire· 2025-10-24 12:05
Core Insights - AlphaTON Capital Corp. has appointed Wes Levitt as Chief Financial Officer, effective immediately, to support its growth in the TON ecosystem and digital asset markets [1][2]. Company Overview - AlphaTON Capital is a specialized digital asset treasury company focused on building and managing a strategic reserve of TON tokens and developing the Telegram ecosystem [5][6]. - The company implements a comprehensive treasury strategy that includes direct token acquisition, validator operations, and strategic ecosystem investments to generate sustainable returns for shareholders [5]. Leadership and Strategy - Wes Levitt brings extensive experience in finance, investment management, and blockchain strategy, having previously served as Co-CIO at Alpha Sigma Capital Advisors and Head of Strategy at Theta Labs [2][3]. - In his new role, Levitt will oversee finance, accounting, and capital markets operations, while also supporting strategic initiatives to enhance AlphaTON's position within the TON ecosystem [4]. Business Activities - AlphaTON's activities include network validation, staking operations, and the development of Telegram-based applications, as well as potential investments in TON-based decentralized finance protocols and gaming platforms [6]. - The company is also involved in advancing therapies targeting checkpoint resistance pathways, contributing to drug development and strategic counsel for immunotherapy assets [7].
Updated MDNA11 Clinical Data from the ABILITY-1 Study to be Presented at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2025
Globenewswire· 2025-10-23 21:12
Core Insights - Medicenna Therapeutics Corp. is set to present updated clinical data for MDNA11 at the ESMO Immuno-Oncology Congress 2025 in London from December 10-12, 2025 [1][2] - The presentation will focus on the Phase 1/2 ABILITY-1 Study, evaluating MDNA11 as a monotherapy and in combination with pembrolizumab for advanced solid tumors [2] Company Overview - Medicenna is a clinical-stage immunotherapy company specializing in the development of Superkines targeting cancer and autoimmune diseases [1][3] - The company’s lead product, MDNA11, is a long-acting IL-2 Superkine designed to preferentially stimulate cancer-killing effector T cells and NK cells [3] - Medicenna is also developing MDNA113, a bispecific targeting PD-1 and IL-2 for solid tumors, utilizing proprietary platforms BiSKITs™ and T-MASK™ [3] - Bizaxofusp, an IL-4 Empowered Superkine, has been studied in five clinical trials with over 130 patients and has received FastTrack and Orphan Drug status from the FDA and EMA [3]
AACR Abstract: First Evidence that Selective A2B Receptor Inhibition Lowers PD-L1 Tumor Expression and also Directly Suppresses Mesothelioma Tumor Growth
Globenewswire· 2025-10-22 16:00
Core Insights - AlphaTON Capital Corp and its subsidiary Cyncado Therapeutics are presenting new findings on A2B receptor inhibition and its effects on PD-L1 expression in mesothelioma at the AACR-NCI-EORTC International Conference [1][2][4] Group 1: Research Findings - The research indicates that A2B receptor inhibition leads to a reduction in adenosine-mediated PD-L1 increase in a human mesothelioma cell line, correlating with decreased CREB phosphorylation [2] - In vivo studies show that TT-4 monotherapy outperforms anti-PD-1, and the combination of TT-4 with anti-PD-1 demonstrates significantly enhanced anti-tumor activity compared to either treatment alone, with increased T-cell infiltration observed [2][3] Group 2: Company Overview - AlphaTON Capital is a digital asset treasury company focused on managing a strategic reserve of TON tokens and developing the Telegram ecosystem, providing institutional-grade exposure to the TON ecosystem [5][6] - The company is involved in network validation, staking operations, and developing Telegram-based applications, with potential investments in decentralized finance protocols and gaming platforms [6] - Cyncado Therapeutics is developing small molecule adenosine receptor antagonists, with its lead program TT-4 targeting mesothelioma and expected to begin first-patient dosing in Q1 2026 [8]
AACR Abstract: First Evidence that Selective A2B Receptor Inhibition Lowers PD-L1 Tumor Expression and also Directly Suppresses Mesothelioma Tumor Growth
Globenewswire· 2025-10-22 16:00
Core Insights - AlphaTON Capital Corp and its subsidiary Cyncado Therapeutics have announced promising results regarding the efficacy of TT-4, an A2B receptor antagonist, in treating human epithelioid mesothelioma, showing superior performance compared to anti-PD-1 therapy [1][2][3] Group 1: Research Findings - The abstract published indicates that A2B receptor inhibition leads to a reduction in adenosine-mediated PD-L1 expression in mesothelioma cells, which is associated with decreased CREB phosphorylation [1][2] - In vivo studies demonstrated that TT-4 monotherapy outperformed anti-PD-1, and the combination of TT-4 with anti-PD-1 exhibited significantly enhanced anti-tumor activity compared to either treatment alone, with increased T-cell infiltration observed [2][3] Group 2: Presentation Details - The findings will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics on October 25, 2025, in Boston, Massachusetts [4] Group 3: Company Overview - AlphaTON Capital is focused on building a strategic reserve of TON tokens and developing the Telegram ecosystem, providing institutional-grade exposure to the TON ecosystem while maintaining governance standards of a Nasdaq-listed company [5][6] - Cyncado Therapeutics is developing small molecule adenosine receptor antagonists targeting A2A and A2B receptors, with TT-4 being the lead program aimed at overcoming immune suppression in oncology, particularly mesothelioma [8]
HCW Biologics Inc. (NASDAQ: HCWB) Participates in Virtual Investor “What This Means” Segment
Globenewswire· 2025-10-22 13:00
Core Insights - HCW Biologics Inc. is focused on developing novel immunotherapies aimed at extending healthspan by addressing inflammation and age-related diseases [1][4] - The company's lead product candidate, HCW11-040, is a second-generation immune checkpoint inhibitor that combines pembrolizumab with interleukin-7, interleukin-15, and TGF-β receptor components [2][4] - HCW Biologics will present data on HCW11-040 at the upcoming SITC annual meeting on November 8, 2025 [3] Company Overview - HCW Biologics is a clinical-stage biopharmaceutical company that aims to treat diseases associated with chronic inflammation, particularly those related to aging [4] - The company has developed a new drug discovery platform called TRBC, which allows for the creation of various classes of immunotherapeutics [4] - HCW Biologics has constructed over 50 molecules using the TRBC platform, including HCW11-002, HCW11-006, HCW11-018, and HCW11-040, with ongoing preclinical evaluations [4]
BriaCell Receives Positive Recommendation from Data Safety Monitoring Board (DSMB) for Phase 3 Study in Metastatic Breast Cancer
Globenewswire· 2025-10-22 11:30
Core Insights - BriaCell Therapeutics Corp. has received its fourth consecutive positive recommendation from the independent Data Safety Monitoring Board (DSMB) for its pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor in patients with metastatic breast cancer [1][2][6] - The DSMB raised no safety concerns and recommended that the study continue without modifications, indicating a favorable safety profile for the BriaCell regimen [2][6] - The ongoing Phase 3 study is being conducted under Fast Track designation by the FDA, highlighting the significant unmet medical need in metastatic breast cancer [2][6] Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [1][3] - The company is committed to addressing urgent medical needs for patients with metastatic breast cancer through its innovative treatment approach [3]
Ipsen to acquire ImCheck Therapeutics, expanding its leadership in oncology, strengthening its pipeline
Globenewswire· 2025-10-22 05:00
Core Viewpoint - Ipsen has entered into a definitive share purchase agreement to acquire ImCheck Therapeutics, focusing on the development of next-generation immuno-oncology therapies, particularly the lead program ICT01 for acute myeloid leukemia (AML) patients who cannot tolerate intensive chemotherapy [1][3]. Company Overview - Ipsen is a global biopharmaceutical company dedicated to transformative medicines in oncology, rare diseases, and neuroscience, with nearly 100 years of development experience [11]. - ImCheck Therapeutics is a private French biotechnology company developing immunotherapeutic antibodies targeting butyrophilins, with a focus on enhancing the immune response against cancer [13][14]. Acquisition Details - The acquisition involves a payment of 350 million euros at closing, with potential total consideration up to 1 billion euros based on regulatory approvals and sales milestones [5][8]. - The transaction is expected to close by the end of Q1 2026, pending regulatory approvals [6]. Clinical Program Focus - The lead program ICT01 is a first-in-class monoclonal antibody targeting BTN3A, which has shown promising interim data in the Phase I/II EVICTION trial for AML, achieving high treatment responses [3][8]. - ICT01 is designed to activate γ9δ2 T cells, enhancing the immune response against tumors, and has received Orphan Drug Designations from both the U.S. FDA and European Medicines Agency [1][10]. Market Need - There is a significant unmet medical need for new therapies in AML, particularly for patients who are unfit for intensive chemotherapy, highlighting the urgency for innovative treatments [2].
BriaCell Adds Key Clinical Sites in Phase 3 Metastatic Breast Cancer Study
Globenewswire· 2025-10-21 11:50
Core Insights - BriaCell Therapeutics Corp. is expanding its pivotal Phase 3 clinical study by adding major cancer centers, which is expected to enhance patient enrollment and support the development of its immunotherapy, Bria-IMT [1][4][10] - The study is focused on advanced metastatic breast cancer, comparing Bria-IMT combined with an immune checkpoint inhibitor against physician's choice of treatment [3][5] - The company anticipates reporting top-line data as early as the first half of 2026, with interim data analysis planned after 144 patient events [1][6] Company Overview - BriaCell is a clinical-stage biotechnology company dedicated to developing novel immunotherapies aimed at transforming cancer care [8] - The company has received FDA Fast Track designation for the Bria-IMT combination regimen, which could lead to full approval and marketing authorization if positive results are achieved [6] Clinical Study Details - The pivotal Phase 3 study is currently enrolling patients at 79 clinical sites across 23 US states, with the addition of Dartmouth Cancer Center, Cedars-Sinai Medical Center, and Winship Cancer Institute of Emory University [10] - The primary endpoint of the study is overall survival (OS) in patients treated with the Bria-IMT regimen compared to those receiving physician's choice treatment [6]