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Portage Biotech Reports Confirmatory Preclinical Results in Mesothelioma Supporting First-In-Human Trial of PORT-7
Globenewswire· 2025-04-28 10:00
Group 1: Core Insights - Portage Biotech Inc. reports confirmatory preclinical efficacy data for PORT-7, a selective adenosine A2B receptor inhibitor, demonstrating superior single-agent activity compared to anti-PD1 antibody in a murine mesothelioma model [1] - The combination of PORT-7 and anti-PD1 showed enhanced efficacy over either agent alone, indicating a favorable immune response with increased immune effector cells and the formation of tertiary lymphoid structures [1] - Portage is preparing to initiate a first-in-human clinical trial for PORT-7, addressing the need for novel treatments in aggressive mesothelioma [1] Group 2: Ongoing Developments - Portage is advancing the dose escalation of PORT-6, a selective A2A adenosine receptor inhibitor, with plans to co-administer it with PORT-7 in the ADPORT-601 trial [2] - This combination aims to achieve complete blockade of adenosine-induced immunosuppression in the tumor microenvironment, enhancing anti-tumor responses and broadening the impact of immunotherapy in solid tumors [2] Group 3: Company Overview - Portage Biotech is a clinical-stage immuno-oncology company focused on advancing a pipeline of novel biologics to enhance the immune system's ability to combat cancer [3]
Bolt Biotherapeutics Presents Results from the Phase 1 Dose-Escalation Clinical Study of BDC-3042 at AACR Annual Meeting 2025
Newsfilter· 2025-04-25 17:00
Core Insights - BDC-3042 demonstrated a favorable safety profile and biological activity in a Phase 1 clinical study, with no dose-limiting toxicities or serious adverse events reported [1][4][5] - The drug showed signs of anti-tumor activity, particularly in non-small cell lung cancer (NSCLC) patients, with 80% of evaluable patients achieving stable disease or better [1][4] - Bolt Biotherapeutics is seeking a partnership to accelerate the development and commercialization of BDC-3042, highlighting its significant commercial potential [2][6] Clinical Study Findings - The Phase 1 study enrolled 17 patients across seven dose cohorts, with a median of four prior lines of therapy [3] - The recommended Phase 2 dose (RP2D) was established at 10 mg/kg every two weeks, with further exploration of other doses and schedules planned [3] - Evidence of target engagement was confirmed, with 100% of patient samples showing detectable dectin-2 staining [4] Safety and Efficacy - BDC-3042 was well tolerated, with no grade 4 or 5 drug-related adverse events reported [4] - The most common drug-related adverse events included fatigue, flatulence, and nausea, each occurring in 12% of patients [4] - The study indicated that patients previously treated with PD-(L)1 inhibitors may have improved outcomes due to higher dectin-2 expression [3][5] Company Overview - Bolt Biotherapeutics is focused on developing novel immunotherapies for cancer treatment, with BDC-3042 being a first-in-class agonist antibody targeting dectin-2 [6] - The company is also advancing BDC-4182, a next-generation immune-stimulating antibody conjugate, with clinical trials expected to begin in the second quarter of 2025 [6]
CERo Therapeutics Holdings, Inc. to Present Poster on Lead Program, CER-1236, at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting
Globenewswire· 2025-04-25 12:15
Core Insights - CERo Therapeutics Holdings, Inc. is presenting a poster at the ASCO 2025 Annual Meeting, showcasing its innovative approach to engineered T cell therapeutics targeting cancer [1][2] - The poster details a first-in-human study of CER-1236, an autologous chimeric engulfment receptor T-cell therapy aimed at treating acute myeloid leukemia [2] - The study is a multi-center, open-label, Phase 1/1b trial focusing on safety and preliminary efficacy, with primary outcome measures including adverse events and overall response rates [2] Company Overview - CERo is focused on developing next-generation engineered T-cell therapeutics that integrate characteristics of both innate and adaptive immunity [3] - The company’s proprietary technology aims to redirect patient-derived T cells to eliminate tumors through phagocytic mechanisms, creating Chimeric Engulfment Receptor T cells (CER-T) [3] - CERo believes that CER-T cells will have broader therapeutic applications compared to current CAR-T therapies, potentially addressing both hematological malignancies and solid tumors [3]
AbbVie Reports First-Quarter 2025 Financial Results
Prnewswire· 2025-04-25 11:43
Core Insights - AbbVie reported strong first-quarter results for 2025, exceeding expectations and indicating a solid start to the year, with a focus on pipeline advancements and strategic investments [2][3] Financial Performance - First-quarter diluted EPS was $0.72 on a GAAP basis, a decrease of 6.5%, while adjusted diluted EPS was $2.46, an increase of 6.5% [3][19] - Net revenues for the first quarter reached $13.343 billion, an increase of 8.4% on a reported basis and 9.8% on an operational basis [3][4] - The immunology portfolio generated global net revenues of $6.264 billion, up 16.6% on a reported basis and 18.1% operationally [3][4] - Skyrizi net revenues were $3.425 billion, reflecting a 70.5% increase on a reported basis, while Rinvoq net revenues were $1.718 billion, up 57.2% [4][19] - Humira net revenues decreased by 50.6% to $1.121 billion [4][19] - Neuroscience portfolio revenues were $2.282 billion, an increase of 16.1% [4][19] - Oncology portfolio revenues reached $1.633 billion, up 5.8% [4][19] - Aesthetics portfolio revenues were $1.102 billion, a decrease of 11.7% [4][19] Guidance and Outlook - AbbVie raised its 2025 adjusted diluted EPS guidance from $11.99 - $12.19 to $12.09 - $12.29, accounting for an unfavorable impact of $0.13 per share related to acquired IPR&D and milestones expense [3][9] Recent Developments - The European Commission granted marketing authorization to Rinvoq for treating giant cell arteritis in adults, marking the eighth approved indication for the drug in the EU [7] - AbbVie announced a collaboration with Xilio Therapeutics to develop novel immunotherapies for cancer [7] - A Biologics License Application was submitted to the FDA for trenibotulinumtoxinE for treating moderate to severe glabellar lines, which could be the first neurotoxin of its kind available [7][8]
BriaCell Confirms 100% Resolution of Lung Metastasis with Bria-OTS™
Newsfilter· 2025-04-24 11:30
Core Insights - BriaCell Therapeutics Corp. has confirmed the complete resolution of lung metastasis in a patient with metastatic breast cancer after treatment with its Bria-OTS immunotherapy, marking a significant milestone in the ongoing Phase 1/2a study [1][6][8] Group 1: Treatment Efficacy - The Bria-OTS monotherapy resulted in a 100% resolution of lung tumors in a 78-year-old female patient after two months of therapy, with confirmation of this resolution at the four-month follow-up [2][5] - The patient had extensive metastases prior to treatment and showed stable disease in other areas after receiving Bria-OTS injections [5][6] - The treatment was well-tolerated, and the patient remains in the study with stable disease elsewhere [6][8] Group 2: Study Details - Bria-OTS is currently being investigated in a Phase 1/2a dose escalation study for metastatic recurrent breast cancer, with a focus on safety and efficacy as a monotherapy [9] - This study represents a next-generation advancement of BriaCell's lead candidate, Bria-IMT™, which is in a pivotal Phase 3 study for metastatic breast cancer [9] Group 3: Industry Context - The results from the Bria-OTS study are particularly significant given the limited treatment options available for patients with hormone receptor-positive metastatic breast cancer, despite advancements in antibody-drug conjugates and immune checkpoint inhibitors [8] - The initial data from the Bria-OTS study demonstrates promising anti-tumor activity, providing early validation for BriaCell's personalized immunotherapy approach [8][9]
Oncolytics Biotech® to Showcase New Pancreatic Cancer Data at ASCO Highlighting Pelareorep's Tumor-Fighting Mechanism of Action
Prnewswire· 2025-04-24 11:00
"Pelareorep continues to deliver encouraging results in pancreatic cancer, where few effective treatments exist," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "In multiple studies, pelareorep has repeatedly demonstrated its ability to engage the immune system to attack pancreatic cancer tumors, which has the potential to improve outcomes for patients battling this difficult-to-treat cancer." Ongoing updates support potential of pelareorep combination therapies in one of t ...
BriaCell Announces Four Clinical Data Presentations at ASCO 2025
Newsfilter· 2025-04-23 11:30
Core Insights - BriaCell Therapeutics Corp. is set to present four clinical data presentations at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, highlighting its advancements in immunotherapy for cancer treatment [1][2]. Presentation Details - The first abstract titled "Update on phase III pivotal trial of Bria-IMT + CPI vs physician's choice in advanced metastatic breast cancer (BRIA-ABC)" will be presented on June 2, 2025, from 9:00 AM to 12:00 PM CDT, with the abstract number TPS1138 and poster board number 108a [2]. - The second abstract, "Bria-IMT + checkpoint inhibitor: Phase I/II survival results compared to benchmark trials in metastatic breast cancer," will also be presented on June 2, 2025, during the same time frame, with the abstract number 1096 and poster board number 75 [2]. - The third abstract, "Trial in progress: A study of Bria-OTS cellular immunotherapy in metastatic recurrent breast cancer," is scheduled for the same session, with the abstract number TPS1136 and poster board number 107a [2]. - A publish-only abstract titled "Impact of HLA Matching on Clinical Outcomes in a Phase 2 Trial of Bria-IMT™ Plus Anti PD1 in Advanced Breast Cancer" will be released on May 22, 2025, at 5:00 PM ET [2]. Company Overview - BriaCell Therapeutics Corp. is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [4].
BriaCell Enrollment Pace Accelerating in Phase 3 Clinical Study in Advanced Metastatic Breast Cancer (Bria-ABC)
Newsfilter· 2025-04-22 11:30
Core Insights - BriaCell Therapeutics Corp. is conducting a pivotal Phase 3 clinical study for its lead candidate, Bria-IMT, in advanced metastatic breast cancer, with over 75 patients enrolled and more than 100 consented [1][2][9] - The company expects to complete patient enrollment by late 2025 or early 2026 and may report top-line data as early as the first half of 2026 [1][5] - The study is being conducted at 54 clinical sites across 15 states in the US, with a focus on evaluating overall survival compared to physician's choice treatment [4][5][9] Company Statements - Dr. William V. Williams, President & CEO, expressed optimism about the expanding patient enrollment and the potential of Bria-IMT to transform cancer care for metastatic breast cancer patients [3] - Dr. Giuseppe Del Priore, Chief Medical Officer, noted that the enrollment pace and clinical investigator interest are higher than previously observed, highlighting the dedication of clinical investigators and patients [3] Study Details - The primary endpoint of the study is overall survival, with interim data analysis planned once 144 patient events occur [5] - The Bria-IMT combination regimen has received FDA Fast Track designation, indicating its potential for expedited development and review [5] - Positive results from the Phase 3 study could lead to full approval and marketing authorization for Bria-IMT in metastatic breast cancer patients [5]
Vaccinex to Report Promising New Clinical Data Revealing Pepinemab's Unique Mechanism to Enhance Immunotherapy at Annual Meeting of American Association for Cancer Research (AACR)
Newsfilter· 2025-04-21 12:45
Core Insights - Pepinemab, a Semaphorin 4D blocking immunotherapy, shows promise in enhancing immune responses and improving survival in patients with metastatic melanoma and head and neck cancer [1][2][4] Company Overview - Vaccinex, Inc. is a clinical-stage biotechnology company focused on innovative treatments for cancer and Alzheimer's disease through the inhibition of Semaphorin 4D [2][8] - The lead drug candidate, pepinemab, is designed to block SEMA4D, which is believed to prevent immune cell infiltration in tumors and trigger inflammation in neurodegenerative diseases [7][8] Clinical Data and Presentations - New data on pepinemab's mechanism to enhance immune responses will be presented at the 2025 Annual Meeting of the American Association for Cancer Research (AACR) [2][3] - Pepinemab has been shown to enhance the maturity of tertiary lymphoid structures (TLS) and correlate with longer recurrence-free survival when combined with immune checkpoint inhibitors in metastatic melanoma patients [5][6] Mechanism of Action - Pepinemab facilitates immune cell interactions within organized centers of immunity, known as tertiary lymphoid structures, by blocking the SEMA4D inhibitory signal to dendritic cells [3][4] - The presence of TLS has been associated with clinical benefits and positive responses to immune checkpoint therapy, making pepinemab a potential solution for inducing TLS in "cold" tumors [4][5] Ongoing Studies - Evaluation of pepinemab in the neoadjuvant setting for head and neck cancer is ongoing, with results expected to be reported at upcoming scientific meetings [6]
Elicio Therapeutics Reports Inducement Grant to New Chief Strategy and Financial Officer and Other New Hires
Globenewswire· 2025-04-16 20:05
Core Insights - Elicio Therapeutics has granted inducement awards to its newly appointed Chief Strategy and Financial Officer, Preetam Shah, and two additional employees as part of their employment agreement [1][2] - The inducement awards consist of 191,624 stock options for Dr. Shah and a total of 21,000 stock options for the other two employees, with an exercise price of $4.98 per share [2] - The stock options will vest over four years, with 25% vesting on the first anniversary of the respective start dates and the remainder vesting monthly thereafter [3] Company Overview - Elicio Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies for high-prevalence cancers, including mKRAS-positive pancreatic and colorectal cancers [4] - The company aims to leverage its Amphiphile ("AMP") technology to enhance the activation of cancer-specific T cells, promoting durable cancer immunosurveillance [4] - Elicio's lead program, ELI-002, targets common KRAS mutations found in approximately 25% of all solid tumors and is currently in a randomized clinical trial for patients with mKRAS-positive pancreatic cancer [4]