Core Insights - Xilio Therapeutics announced a 40% objective response rate (ORR) in heavily pre-treated patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) without liver metastases and with high plasma tumor mutational burden (TMB) [1][2][9] - Approximately 55% of patients with MSS CRC are estimated to have high plasma TMB, indicating a significant patient population with unmet medical needs [1][2][5] - The company will host a conference call on November 10, 2025, to discuss these findings with leading cancer experts [1][12] Clinical Data - The Phase 2 trial evaluated vilastobart, a tumor-activated anti-CTLA-4, in combination with atezolizumab (Tecentriq) [1][15] - A statistically significant correlation was found between plasma TMB status and response, with a p-value of 0.05 [9][13] - Among evaluable patients, 62.5% were classified as TMB-high, and all responders were TMB-high, demonstrating deep and durable responses with reductions in target lesions of up to 71% [13] Safety Profile - The combination of vilastobart and atezolizumab showed a differentiated and generally well-tolerated safety profile, with treatment-related adverse events primarily being Grade 1 or 2 [10] - Only 5% of patients discontinued treatment due to adverse events, and 7% experienced colitis of any grade [10] Biomarker Potential - Plasma-based TMB assays are more sensitive than traditional tissue-based assays and can provide a comprehensive assessment of mutational load, accounting for tumor heterogeneity [4][6] - The use of plasma TMB as a predictive biomarker could help identify MSS mCRC patients who may benefit from vilastobart treatment [2][3] Development Plans - Xilio is actively seeking a partner to further develop vilastobart in combination with PD-(L)1 or PD1-VEGF for MSS CRC and other tumor types [11]

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]

Core Insights - Sonnet BioTherapeutics Holdings, Inc. announced positive safety results for SON-1010 in a Phase 1b/2a clinical trial for advanced solid tumors and platinum-resistant ovarian cancer [2][5] - The management team, including Interim CEO Raghu Rao and Chief Medical Officer Dr. Richard Kenney, discussed the implications of these results and future steps for the program [2] Company Overview - Sonnet is a clinical-stage biotechnology company focused on developing immunotherapeutic drugs targeting the tumor microenvironment (TME) [1][4] - The company utilizes a proprietary FHAB (Fully Human Albumin-Binding) platform designed to enhance the safety and efficacy of biologic drugs by targeting tumor and lymphatic tissues [4] Product Development - SON-1010 (IL-12-FHAB) is the lead program aimed at treating solid tumors, certain sarcomas, and ovarian cancer, currently in a Phase 1/2a study in collaboration with Roche [5] - The company is also developing SON-1210 (IL12-FHAB-IL15) for solid tumors, with plans for an investigator-initiated Phase 1/2a study for pancreatic cancer [5]

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 - Sonnet BioTherapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on developing immunotherapeutic drugs targeted to the tumor microenvironment (TME) [1] - The company utilizes a proprietary platform known as FHAB (Fully Human Albumin-Binding) for developing targeted biologic drugs, which enhances the safety and efficacy of immune-modulating biologic drugs [2] Lead Programs - Sonnet's lead program, SON-1010 (IL-12-FHAB), is in development for treating solid tumors, certain types of sarcoma, and ovarian cancer, currently undergoing a Phase 1/2a study in collaboration with Roche [2] - The second program, SON-1210 (IL12-FHAB-IL15), is being evaluated for solid tumors, with an upcoming investigator-initiated Phase 1/2a study for pancreatic cancer in collaboration with the Sarcoma Oncology Center [2]

Company Overview - Sonnet BioTherapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on developing targeted immunotherapeutic drugs, utilizing a proprietary platform known as FHAB (Fully Human Albumin-Binding) [4] - The FHAB technology employs a fully human single chain antibody fragment that binds to human serum albumin for targeted transport to tumor and lymphatic tissues, enhancing the safety and efficacy of immune-modulating biologic drugs [4] Product Development - The lead program, SON-1010 (IL-12-FHAB), is in development for advanced solid tumors, certain sarcomas, and platinum-resistant ovarian cancer, currently undergoing a Phase 1/2a study in collaboration with Roche [5] - A second product candidate, SON-1210 (IL12-FHAB-IL15), is being evaluated for solid tumors in partnership with the Innovative Immuno-Oncology Consortium, with plans to initiate a Phase 1/2a study for pancreatic ductal adenocarcinoma [5] - The SON-080 program, a low dose of rhIL-6, is in development for Chemotherapy-Induced Peripheral Neuropathy and Diabetic Peripheral Neuropathy, showing promising results in a Phase 1b/2a trial and is advancing to a Phase 2 study in India under a license agreement with Alkem Laboratories [6] Recent Events - The company participated in the Virtual Investor "Top 5 for '25" On-Demand Conference, where the CEO presented key reasons for investment interest in Sonnet for 2025 [2][3]