Core Insights - Xilio Therapeutics announced a preliminary objective response rate (ORR) of 26% in heavily pre-treated patients with metastatic microsatellite stable colorectal cancer (MSS CRC) without liver metastases, demonstrating deep and durable responses lasting up to 37 weeks [1][4][10] - The combination therapy of vilastobart and atezolizumab showed a differentiated safety profile with a low incidence of immune-related adverse events, particularly colitis [2][7][11] - The ongoing Phase 2 trial is evaluating vilastobart in combination with atezolizumab, with plans to expand the study to include a higher dose level [9][13] Patient Data - As of May 12, 2025, 44 patients with metastatic MSS CRC were treated with vilastobart at 100 mg every six weeks and atezolizumab at 1200 mg every three weeks, with a median age of 55 years [3][5] - 80% of patients had previously received three or more lines of anti-cancer therapy, indicating a heavily pre-treated population [3] Anti-Tumor Activity - The preliminary ORR of 26% included seven partial responses, with six confirmed responses, and substantial decreases in tumor biomarkers such as circulating tumor DNA [4][10] - In patients without liver metastases, responses were deep and durable, with reductions in target lesions of up to 71% from baseline [10] Safety Profile - The combination therapy exhibited a low incidence of immune-mediated adverse events, with only 7% of patients experiencing colitis [7][11] - Common treatment-related adverse events included fatigue (30%), infusion-related reactions (23%), and diarrhea (18%) [11] Future Development Plans - Xilio is enrolling a cohort of patients at a higher dose level of 150 mg Q6W for vilastobart in the ongoing Phase 2 trial, with additional data expected in the first half of 2026 [9][12] - The company is seeking partnership opportunities to accelerate the development of the vilastobart program [12]

PRINCETON, N.J., May 01, 2025 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the "Company" or "Sonnet"), a clinical-stage company developing immunotherapeutic drugs targeting the tumor microenvironment (TME), today announced it will present at the 6th Annual Cytokine-Based Drug Development Summit being held May 15-16, 2025 in Boston, MA. Details of the presentation are as follows: Title: Managing Toxicity Caused by The Over Expression of Cytokines to Widen the Therapeutic WindowSes ...

Core Insights - Xilio Therapeutics, Inc. is set to present updated data from its Phase 2 clinical trial of vilastobart, an anti-CTLA-4 therapy, in combination with atezolizumab for metastatic microsatellite stable colorectal cancer at the 2025 ASCO Annual Meeting [1] - The presentation will take place on May 31, 2025, during a poster session focused on gastrointestinal cancer [2] Company Overview - Xilio Therapeutics is a clinical-stage biotechnology company focused on developing tumor-activated immuno-oncology therapies aimed at improving cancer treatment outcomes while minimizing systemic side effects [3] - The company utilizes a proprietary platform to create novel tumor-activated immuno-oncology molecules that enhance localized anti-tumor activity within the tumor microenvironment [3] Clinical Trial Details - Vilastobart is designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment [2] - In 2023, Xilio entered a collaboration with Roche to co-fund a clinical trial evaluating vilastobart in combination with atezolizumab in a multi-center, open-label Phase 1/2 trial [2] - The ongoing trials include a Phase 1C dose escalation for advanced solid tumors and a Phase 2 trial for metastatic microsatellite stable colorectal cancer, with and without liver metastases [2]

- Raghu Rao, Interim Chief Executive Officer and Dr. Richard Kenney, Chief Medical Officer, of Sonnet discuss the recently announced safety data related to SON-1010 - Watch the "What This Means" video here PRINCETON, N.J., April 16, 2025 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the "Company" or "Sonnet"), a clinical-stage company developing immunotherapeutic drugs targeted to the tumor microenvironment (TME), today announced that members of the Sonnet management team partici ...

Core Viewpoint - Tempest Therapeutics, Inc. is exploring a range of strategic alternatives to advance its clinical programs and maximize stockholder value, including potential mergers, acquisitions, partnerships, and licensing arrangements [1][2]. Company Overview - Tempest Therapeutics is a clinical-stage biotechnology company focused on developing targeted and immune-mediated therapeutics for cancer treatment [7]. - The company is headquartered in Brisbane, California, and has a diverse portfolio of small molecule product candidates [7]. Strategic Alternatives - The company has engaged MTS Health Partners, L.P. to assist in evaluating strategic alternatives [1]. - No specific timeline has been set for the evaluation process, and no agreements for transactions have been reached yet [2]. Clinical Programs - Amezalpat (TPST-1120) is ready for Phase 3 trials, having received Orphan Drug and Fast Track designations from the FDA for hepatocellular carcinoma (HCC) [3][4]. - TPST-1495 is set to enter a Phase 2 trial for familial adenomatous polyposis (FAP) in 2025, with FDA clearance obtained [6][9]. Recent Developments - Amezalpat has shown a six-month improvement in median overall survival when combined with atezolizumab and bevacizumab compared to the standard of care [4][5]. - Positive feedback from the FDA was received regarding the pivotal Phase 3 trial for amezalpat in combination with existing therapies for HCC [4]. Future Outlook - The company believes there is significant commercial potential in its pipeline, particularly with the positive data from ongoing clinical trials [2].