Core Insights - The SB221 study demonstrates positive safety results for SON-1010 in combination with atezolizumab for patients with platinum-resistant ovarian cancer (PROC) [1][5] - The maximum tolerated dose (MTD) of SON-1010 was established at 1200 ng/kg without dose-limiting toxicity or cytokine release syndrome [1][3] - The study showed a partial response (PR) in one patient and stable disease (SD) in 33% of evaluable patients at four months [1][5] Study Design and Results - The SB221 study aimed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SON-1010 with atezolizumab, focusing on establishing the MTD [2][8] - A total of 19 subjects were treated, with one patient achieving a PR at the highest dose [2] - Common adverse effects included fatigue, fevers, and gastrointestinal symptoms, with no significant toxicity observed [3][5] Clinical Implications - The results indicate that SON-1010 may enhance the efficacy of immune checkpoint inhibitors (ICIs) in treating 'cold' tumors like ovarian cancer [4][5] - The study's findings are encouraging given the historical safety concerns associated with rhIL-12, suggesting a potential for improved tumor control [5][6] - The ongoing trial will assess longer-term safety and tumor responses, with a focus on expanding the dataset for efficacy evaluation [6][8] Company Overview - Sonnet BioTherapeutics is focused on developing targeted biologic drugs using its Fully Human Albumin-Binding (FHAB) platform [10][11] - SON-1010 is designed to deliver IL-12 to tumor tissues, potentially improving the safety and efficacy profile of immunomodulators [7][10] - The company is also exploring partnerships to support the later stages of SON-1010's development [6][11]

Company Overview - Enlivex Therapeutics Ltd. is a clinical-stage company focused on macrophage reprogramming immunotherapy, specifically developing Allocetra™ [1][6] - Allocetra™ is designed as a universal, off-the-shelf cell therapy aimed at restoring macrophage homeostasis, which is critical for immune system balance and addressing life-threatening conditions [4][6] Clinical Trial Announcement - The first patient has been dosed in a Phase I trial to evaluate the safety, tolerability, and initial efficacy of Allocetra™ for treating temporomandibular joint (TMJ) osteoarthritis [1][3] - The trial is being conducted by the Rheumatology Unit and the Department of Oral and Maxillofacial Surgery at Sheba Medical Center, which is ranked among the top 10 hospitals globally [2] Trial Details - The trial aims to recruit six patients who have not adequately responded to conventional therapies for TMJ osteoarthritis [3] - Primary safety endpoints will measure the frequency and severity of adverse events, while efficacy endpoints will assess changes in TMJ pain, joint functionality, and other disease parameters over 12 months [3] TMJ Osteoarthritis Insights - TMJ disorders affect 5% to 12% of the global population, with an annual health cost estimated at $4 billion [5][8] - TMJ osteoarthritis is the most common form of arthritis in the TMJ, leading to pain and stiffness, and currently lacks effective long-term treatments [5][8]

For more details visit: www.aacr.org/meeting/aacr-annual-meeting-2025/abstracts. About IN8bio IN8bio is a clinical-stage biopharmaceutical company developing gamma-delta T cell-based immunotherapies for cancer and autoimmune diseases. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The company's lead program, INB-100, is focused on acute myeloid leukemia evaluating haplo-matched allogeneic ...

Core Insights - CG Oncology's BOND-003 study of cretostimogene monotherapy has been selected as a late breaker for the AUA's Practice-changing, Paradigm-shifting Clinical Trials in Urology, highlighting its potential impact on bladder cancer treatment [1] - The AUA Annual Meeting will take place from April 26-29, 2025, in Las Vegas, where CG Oncology will present various updates on ongoing clinical trials related to cretostimogene [1][7] Clinical Trial Presentations - The BOND-003 Cohort C study is a Phase 3, single-arm study focusing on high-risk BCG-unresponsive non-muscle invasive bladder cancer, with a presentation scheduled for April 26, 2025 [2] - An updated analysis from the BOND-003 and CORE-001 trials will be presented, focusing on translational correlates using urinary genomic disease burden [3] - Updates to the CORE-008 trial protocol will be discussed, which evaluates intravesical cretostimogene in patients with high-risk non-muscle invasive bladder cancer [3] Additional Studies - A multi-national, single-arm study of intravesical cretostimogene for high-risk, papillary only, BCG-unresponsive non-muscle invasive bladder cancer will also be presented [4] - The PIVOT-006 study, a Phase 3 randomized trial comparing adjuvant intravesical cretostimogene versus surveillance for intermediate-risk non-muscle invasive bladder cancer, will be discussed [5] Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing innovative therapies for bladder cancer, aiming to improve the quality of life for patients [7]

Core Insights - Portage Biotech Inc. presented new preclinical data for PORT-7, a selective Adenosine A2B receptor inhibitor, demonstrating over 90% inhibition of tumor growth when combined with an anti-PD1 antibody in a murine mesothelioma model [1][3] - The data marks the first report of antitumor activity against mesothelioma using a selective A2B receptor inhibitor, with plans for a first-in-human clinical trial for PORT-7 [3] - Portage is also advancing PORT-6, a selective A2A adenosine receptor inhibitor, with plans to co-administer it with PORT-7 in the ongoing ADPORT-601 trial to achieve complete blockade of adenosine-induced immunosuppression [4][5] Company Developments - Portage Biotech is preparing to commence a first-in-human clinical trial for PORT-7, following promising preclinical results [3] - The company is negotiating a definitive option agreement with Immunova LLC for the acquisition of its subsidiary, iOx Therapeutics, which focuses on developing liposomal iNKT agonists [5] - Portage Biotech's stock price increased by 102.93%, reaching $9.60 at the time of publication [6]

Core Insights - LIXTE Biotechnology Holdings, Inc. has initiated two new clinical trials in collaboration with MD Anderson and the Netherlands Cancer Institute, focusing on treatments for ovarian and colorectal cancer [1][3] - The company has secured an exclusive patent license agreement with the NIH for LB-100, which aims to enhance cancer immunotherapies [1] - Recent publications in prominent medical journals EMBO and Cancer Discovery support LIXTE's clinical trial program, highlighting the potential of LB-100 in cancer treatment [1][6] Clinical Trials - LIXTE is conducting trials for ovarian cancer at M.D. Anderson Cancer Center and Northwestern University, with support from GSK [2][3] - A colorectal cancer trial is being conducted at the Netherlands Cancer Institute, supported by F. Hoffmann-La Roche [3][6] - The first patient has been dosed in a Phase 1b/2 trial combining LB-100 with GSK's immunotherapy for ovarian clear cell carcinoma [6] Intellectual Property and Research - LIXTE has received a Notice of Allowance from the USPTO for a patent related to the modulation of immune response using LB-100 [6] - Studies published in Cancer Discovery and EMBO indicate that LB-100 can alter cancer cells to enhance their vulnerability to immunotherapy [6] Financial Activities - The company completed a registered direct offering, raising approximately $1,050,000 for working capital and corporate purposes [6]

Core Insights - SON-1010 is being evaluated as a combination therapy with trabectedin (Yondelis) for advanced soft tissue sarcoma, showing potential for immune mechanism synergies and enhanced progression-free survival [1][2] - The initial safety review indicated no unexpected toxicities in early dosing, allowing for full enrollment of up to 18 patients [1][2] - SON-1010 monotherapy demonstrated clinical benefit in 83% of patients at the maximum tolerated dose, including a confirmed partial response in a patient with clear cell sarcoma [1][2] Company Overview - Sonnet BioTherapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on developing targeted immunotherapeutic drugs [1][8] - The company utilizes the Fully Human Albumin Binding (FHAB) platform to enhance the safety and efficacy of its drug candidates, including SON-1010 [6][8] - SON-1010 is designed to deliver interleukin-12 to local tumor tissue, potentially converting 'cold' tumors to 'hot' tumors and stimulating immune responses [6][8] Clinical Trial Details - The Phase 1 SB101 trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SON-1010, with a maximum tolerated dose established at 1200 ng/kg [7] - The trial includes an expansion cohort for patients with unresectable, metastatic leiomyosarcoma or liposarcoma, with a goal to assess the combination therapy's effectiveness [3][5] - The study has treated 7 patients so far, with plans to enroll up to 18 patients in total [3][7] Market Opportunity - The global market opportunity for trabectedin is estimated at $2.1 billion, highlighting significant unmet medical needs in the treatment of sarcomas [1][5] - The combination of SON-1010 and trabectedin is positioned for potential advancement into larger Phase 2 studies, which could establish a new treatment paradigm for soft tissue sarcomas [5][9]

Company Overview - Compugen Ltd. is a clinical-stage cancer immunotherapy company specializing in computational target discovery [3] - The company utilizes its predictive computational discovery platform, UnigenTM, to identify new drug targets and biological pathways for cancer immunotherapies [3] - Compugen has two proprietary product candidates in Phase 1 development: COM701, an anti-PVRIG antibody, and COM902, an antibody targeting TIGIT for solid tumors [3] Upcoming Events - Compugen will participate in several virtual investor conferences in April 2025, including: - H.C. Wainwright 2nd Annual AI Based Drug Discovery & Development Conference on April 2, 2025, with a fireside chat at 9:30 am ET [1] - 24th Annual Needham Virtual Healthcare Conference on April 7, 2025, with a fireside chat at 8:00 am ET [2] - Stifel's 2025 Virtual Targeted Oncology Forum on April 9, 2025, with a fireside chat at 12:00 pm ET [2] - Live webcasts of the fireside chats will be available on Compugen's Investor Relations website, with replays accessible after the events [2] Product Development - Rilvegostomig, a PD-1/TIGIT bispecific antibody, is in Phase 3 development by AstraZeneca under a license agreement [3] - GS-0321 (previously COM503), an anti-IL-18 binding protein antibody, is in Phase 1 development and licensed to Gilead [3] - The company has a pipeline of early-stage immuno-oncology programs aimed at enhancing anti-cancer immunity [3]

Tivic Health Systems, Inc. (NASDAQ:TIVC) Q4 2024 Results Conference Call March 21, 2025 4:30 PM ET Company Participants Jennifer Ernst - Chief Executive Officer Lisa Wolf - Interim Chief Financial Officer Operator Welcome to Tivic Health Systems year-end 2024 financial results and operational update conference call. This call has been prerecorded, and the questions you have submitted in advance will be answered following the prior remarks. This call is being webcast and the replay will be available on the I ...

NEW YORK, March 18, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (NASDAQ:INDP), a clinical-stage biotechnology company dedicated to developing novel treatments for cancer and viral infections, today announced that it has advanced to a new expansion arm of its Phase 1b/2 clinical trial of Decoy20. This expansion will evaluate the combination of Decoy20 with BeiGene's PD-1 checkpoint inhibitor, tislelizumab, with a focus on safety, dose optimization, and early signs of anti-tumor activity. Jeffrey Mec ...