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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
Acquisition focused on lead clinical-stage program ICT01 in acute myeloid leukemia, where data from the ongoing Phase I/II EVICTION trial showed high treatment response ICT01 has the potential to be a new standard of care in combination in first line unfit acute myeloid leukemia, an aggressive blood cancer affecting older adults Ipsen to acquire all issued and outstanding shares of ImCheck Therapeutics, for which ImCheck Therapeutics’ shareholders will be eligible to receive a closing purchase price of 350 ...
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]
Lisata Therapeutics (NasdaqCM:LSTA) Earnings Call Presentation
2025-10-21 11:00
Company Overview - Lisata Therapeutics is a clinical stage pharmaceutical company focused on developing innovative therapies for cancer and other serious diseases[8] - The company's mission is to rapidly develop and commercialize innovative treatments that improve outcomes for patients with cancer or other serious diseases[10] - Lisata has a proprietary field-leading technology with global IP protection extending beyond 2040[12] - The company projects multiple product and business milestones over the next 12 months[12] - Lisata has existing partnerships that validate its platform technology, with potential for many others[12] - The company's cash runway extends into 1Q 2027 with no debt[12] Certepetide Development and Clinical Trials - Certepetide is designed to optimize solid tumor treatment by converting tumor stroma, reducing immunosuppression, and inhibiting metastasis[23, 24] - In mPDAC, two Phase 1b/2a trials showed that Certepetide plus SoC chemotherapy improved overall survival[73] - In the ASCEND Phase 2b study, Cohort A showed a median overall survival of 12.68 months with Certepetide + SoC compared to 9.23 months with Standard of Care[87] - In the ASCEND Phase 2b study, Cohort B showed a median PFS of 7.46 months with Certepetide + SoC compared to 5.29 months with Standard of Care, nearing statistical significance (HR 0.61, p=0.09)[91, 92] - The iLSTA Phase 1b/2a trial in locally advanced PDAC with chemo & IO showed an Overall Response Rate of 69% in Cohort 3[110] Financial Position - As of June 30, 2025, Lisata had $22 million in cash and investments[140]
Lisata Therapeutics (NasdaqCM:LSTA) Conference Transcript
2025-10-20 18:32
Summary of Lisada Therapeutics Conference Call Company Overview - **Company Name**: Lisada Therapeutics (NasdaqCM:LSTA) - **Industry**: Clinical stage pharmaceutical company focused on solid tumor cancer treatment - **Management Team**: Over 200 years of combined experience in drug development across big pharma and emerging companies [2][3] Core Points and Arguments - **Market Need**: Over 90% of newly diagnosed cancers are solid tumors, with a growing prevalence, particularly pancreatic cancer, which is projected to become the second leading cause of cancer death in the U.S. by the end of the decade [4] - **Product Development**: The company is developing **Sotepatide**, a proprietary cyclic peptide designed to penetrate tumor stroma and reduce immunosuppressive environments, enhancing the efficacy of various anticancer therapies [5][6] - **Intellectual Property**: Strong IP portfolio protecting products until 2040, with several strategic alliances and licenses established [3][9][8] - **Clinical Trials**: - Completed Phase 2B and is Phase 3 ready for metastatic pancreatic ductal adenocarcinoma (MPDAC) [12] - Significant improvement in overall survival by 5-6 months compared to standard care, representing a 150% improvement [14] - Cohort A and B data from trials show promising results in overall survival and progression-free survival (PFS) [18][20] - Positive preliminary data from the I LISTA study combining Sotepatide with chemotherapy and immunotherapy [23] Financial Position - **Cash Reserves**: Approximately $20 million available, with a cash runway extending into early 2027 [30] - **Debt-Free**: The company maintains a clean capital structure [30] Regulatory Status - **Designations**: Fast track designation in the U.S. for pancreatic cancer, orphan designations in both the U.S. and Europe, and rare pediatric disease designation for osteosarcoma [27] - **Phase 3 Protocol**: Approved by the FDA, with ongoing discussions with the EMA for global registration [28] Additional Insights - **Combination Therapy**: Sotepatide can be used with various anticancer modalities, showing improved efficacy without increasing safety risks [21][22] - **Future Studies**: Ongoing studies in other cancers, including cholangiocarcinoma and gastroesophageal adenocarcinoma, with data expected in the near future [29] - **Market Strategy**: Plans to raise capital for further development and potential licensing agreements to enhance product offerings [27] Conclusion Lisada Therapeutics is positioned strongly within the oncology market, with innovative therapies addressing significant unmet medical needs, a solid financial foundation, and a robust pipeline of clinical data supporting its product efficacy and safety. The company is actively pursuing strategic partnerships to enhance its market presence and therapeutic offerings [31]
Primary Endpoint Met in EFTISARC-NEO Phase II Evaluating Neoadjuvant Efti in Soft Tissue Sarcoma and Data Presented at ESMO Congress 2025
Globenewswire· 2025-10-20 12:01
Core Insights - Immutep Limited announced positive results from the EFTISARC-NEO Phase II trial, demonstrating significant efficacy of eftilagimod alfa (efti) in combination with radiotherapy and KEYTRUDA® for resectable soft tissue sarcoma (STS) [1][5] - The trial met its primary endpoint, achieving a median tumor hyalinization/fibrosis of 51.5%, significantly exceeding the prespecified target of 35% [1][5] - The results indicate a potential for improved overall survival and recurrence-free survival in STS patients, addressing a substantial unmet medical need in this area [2][5] Company Overview - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, particularly leveraging LAG-3 [7] - The company aims to provide innovative treatment options and maximize shareholder value through its diversified product portfolio [7] Clinical Trial Details - The EFTISARC-NEO Phase II trial was investigator-initiated and involved a diverse population of STS subtypes, showcasing a robust safety profile with minimal severe toxicity [1][2] - The study was primarily funded by a grant from the Polish government through the Polish Medical Research Agency program [2] Eftilagimod Alfa (Efti) Mechanism - Efti is an MHC Class II agonist that activates antigen-presenting cells, stimulating both adaptive and innate immune responses to combat cancer [4][6] - The therapy is under evaluation for various solid tumors, including non-small cell lung cancer and head and neck squamous cell carcinoma, with favorable safety allowing for multiple combination therapies [6]