Core Insights - Elicio Therapeutics announced new immunogenicity data from the Phase 2 AMPLIFY-7P trial for ELI-002 7P, showing strong T cell responses in patients with mKRAS pancreatic ductal adenocarcinoma [1][3][5] - The company also presented preclinical data for ELI-004, indicating its potential to eradicate advanced solid tumors in over 90% of cases [1][8] ELI-002 7P Trial Results - In the AMPLIFY-7P trial, 99% of 90 evaluable patients achieved robust mKRAS-specific T cell responses, with a mean increase of 145-fold over baseline [4][5] - 85% of patients exhibited combined CD4 and CD8 T cell activation, which correlates with clinical activity [5] - 67% of patients responded to all seven mKRAS epitopes, with over 80% response rates to each individual KRAS mutation [4][5] ELI-004 Preclinical Data - ELI-004 demonstrated complete tumor eradication in over 90% of cases in preclinical studies, suggesting long-term protection against recurrence [3][8] - The efficacy of ELI-004 was linked to the presence of CD8 T cells and effective lymphocyte trafficking from lymph nodes [8] HLA Diversity and T Cell Responses - High-resolution HLA typing revealed a diverse HLA repertoire among patients, with 1,132 unique HLAs identified [6] - No significant associations were found between specific HLA types and the magnitude of mKRAS-specific T cell responses, indicating broad applicability of ELI-002 7P [6] Company Overview - Elicio Therapeutics focuses on developing novel immunotherapies targeting high-prevalence cancers, particularly those driven by KRAS mutations [15] - The company's AMP technology aims to enhance immune responses by delivering immunotherapeutics directly to lymph nodes [12][14]

Core Insights - BriaCell Therapeutics Corp. is presenting strong evidence of immune system engagement and anti-cancer activity of its Bria-OTS+ platform at the Society for Immunotherapy of Cancer Annual Meeting [1][2] Preclinical Findings - Bria-OTS+ demonstrates fast-acting and potent anti-cancer immune system activation, inducing coordinated innate and adaptive immune responses to kill cancer cells [3][7] - The platform produces sustained and durable anti-cancer immune responses, potentially leading to prolonged clinical benefits for patients [4][6] - Positive results from lead candidates Bria-BRES+ (breast cancer) and Bria-PROS+ (prostate cancer) indicate broad applicability of the Bria-OTS+ platform across multiple solid tumor indications [5][7] Platform Overview - Bria-OTS+ is an advanced immunotherapy platform, enhancing the previous Bria-OTS™ version, designed to express multiple immune-activating cytokines and co-stimulatory molecules [6][8] - The platform's unique mechanism of action supports the development of personalized cancer immunotherapies, with planned clinical trials for Bria-BRES+ and Bria-PROS+ [2][6]

Core Insights - AIM ImmunoTech Inc. announced that data from its Phase 2 clinical study on cisplatin-resistant advanced recurrent ovarian cancer using Ampligen (rintatolimod) was accepted for presentation at the 40th Annual SITC Meeting [1] - The study focuses on a combination locoregional chemoimmunotherapy approach and its correlation with clinical outcomes [1] Company Overview - AIM ImmunoTech Inc. is an immuno-pharma company dedicated to developing therapeutics for various cancers, immune disorders, and viral diseases, including COVID-19 [2] - The company's lead product, Ampligen (rintatolimod), is a first-in-class investigational drug that acts as a dsRNA and highly selective TLR3 agonist immuno-modulator [2]

Core Insights - BriaCell Therapeutics Corp. is set to present strong evidence of immune system engagement and anti-cancer activity of its Bria-OTS+ platform at the Society for Immunotherapy of Cancer (SITC) Annual Meeting from November 7-9, 2025 [1][2][3] Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [6] - The Bria-OTS+ platform is an advanced version of Bria-OTS™, designed to enhance immune engagement through multiple immune-activating cytokines and co-stimulatory molecules [4] Upcoming Presentation Details - The poster presentation titled "Redefining Cancer Vaccines: Bria-OTS+ Integrates Trained Innate Immunity and Adaptive Memory to Overcome Immune Resistance" will take place on November 7, 2025, at the Prince George ABC Exhibit Halls [2] - The presentation will showcase extensive data on immune system activation and cytotoxicity, validating the potential of the personalized cancer immunotherapy platform [3] Clinical Development - Lead candidates Bria-BRES+ (for breast cancer) and Bria-PROS+ (for prostate cancer) have completed GMP manufacturing and are expected to enter Phase 1/2a clinical studies [4] - Bria-PROS+ is supported by a $2 million National Cancer Institute (NCI) Small Business Innovative Research (SBIR) award, announced on August 25, 2025 [4] Strategic Importance - The Bria-OTS+ platform represents a novel, cost-effective, off-the-shelf cancer therapy, aiming to provide new hope for patients with unmet medical needs [7]

Core Insights - BioInvent International AB is presenting new data on its ongoing trial of BI-1206 in combination with rituximab and Calquence for non-Hodgkin's lymphoma at the 2025 ASH Annual Meeting [1] Company Summary - BioInvent is focused on the discovery and development of novel immune-modulatory antibodies for cancer immunotherapy [1] - The trial data indicates that the triple combination regimen is safe and well-tolerated [1] - Encouraging efficacy data has been reported as part of the trial findings [1] Industry Context - The presentation will take place at the American Society of Hematology Annual Meeting, highlighting the significance of the findings within the hematology field [1]

Core Insights - OS Therapies announced additional overall and event-free survival data from its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, pulmonary metastatic osteosarcoma, highlighting statistically significant positive outcomes [2][4] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, with its lead asset OST-HER2 being an immunotherapy that targets the HER2 protein [4][6] - OST-HER2 has received several designations from regulatory agencies, including Rare Pediatric Disease Designation and Fast-Track status from the U.S. FDA [4] Clinical Trial Results - The Phase 2b Osteosarcoma Trial involved 41 patients, with subgroup analyses revealing: - For patients with a lung-only second or greater metastatic event, the 2-year overall survival rate was 80.0% [5] - For patients with a lung-only first metastatic event, the 2-year overall survival rate was 73.8%, significantly higher than the 30% natural history comparator (p < 0.0001) [5] - The company anticipates submitting a Biologics License Application (BLA) to the U.S. FDA for OST-HER2 in 2025 [6] Future Plans - OS Therapies is preparing for regulatory meetings with the FDA, MHRA, and EMA to discuss overall survival data and trial design for OST-HER2 [3] - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [7]

Core Insights - Nxera Pharma's partner, Cancer Research UK, presented data from the completed Phase 1 part of the Phase 1/2a clinical trial of the immunotherapy drug HTL0039732 at the ESMO 2025 Congress [1][2] - The trial evaluates HTL0039732 as a monotherapy and in combination with atezolizumab in patients with advanced solid tumors resistant to standard therapy [2][5] Clinical Trial Details - The Phase 1 trial involved 13 patients receiving HTL0039732 as a monotherapy and 22 patients receiving it in combination with atezolizumab [2] - The trial's primary objectives were to assess safety and determine the recommended Phase 2 dose (RP2D) [6] - The Phase 2a trial will expand to four cohorts of patients with specific cancer types, including MSS CRC, gastric adenocarcinoma, clear cell renal cell carcinoma, and metastatic castration-resistant prostate cancer [2][3] Safety and Efficacy Results - HTL0039732 was well-tolerated, with no grade 4/5 treatment-related adverse events and no dose-limiting toxicities observed [6] - Grade 3 treatment-related adverse events occurred in 14% of combination patients, comparable to established data for atezolizumab monotherapy [6] - Confirmed partial responses were observed in 50% of ccRCC patients and approximately 9% of MSS-CRC patients, indicating early efficacy [6] Future Development - The recommended Phase 2 dose for the expansion studies is set at 160mg QD in combination with atezolizumab [6] - The trial is being managed by Cancer Research UK's Centre for Drug Development, with recruitment ongoing across multiple sites [3][5] Company Overview - Nxera Pharma is a biopharma company focused on developing innovative medicines to address unmet medical needs globally [10][11] - The company utilizes its NxWave™ platform to advance a pipeline of over 30 active programs targeting various medical areas, including oncology [11][12]

Core Insights - Nxera Pharma's partner, Cancer Research UK, presented data from the completed Phase 1 part of the Phase 1/2a clinical trial of the immunotherapy drug HTL0039732 at the ESMO 2025 Congress [1][2] - The trial evaluates HTL0039732 as a monotherapy and in combination with atezolizumab in patients with advanced solid tumors resistant to standard therapy [2][4] Clinical Trial Details - The Phase 1 trial involved 13 patients receiving HTL0039732 as a monotherapy and 22 patients receiving it in combination with atezolizumab [2] - The Phase 2a trial will expand to four cohorts: MSS CRC, gastric or gastroesophageal junction adenocarcinoma, clear cell renal cell carcinoma, and metastatic castration-resistant prostate cancer [2] - The first patient in the Phase 2a trial was dosed in September 2025 [2] Safety and Efficacy Results - HTL0039732 demonstrated a robust safety profile with no grade 4/5 treatment-related adverse events and no dose-limiting toxicities [5] - Grade 3 treatment-related adverse events occurred in 14% of combination patients, aligning with established data for atezolizumab monotherapy [5] - Confirmed partial responses were observed in two patients, one with metastatic renal cell cancer and another with MSS-CRC, indicating early efficacy [5] Future Development - The recommended Phase 2 dose for cohort expansion studies is set at 160mg QD in combination with atezolizumab [5] - The trial's data suggests HTL0039732 has the potential to be best-in-class among drugs with the same mechanism of action [6] Company Overview - Nxera Pharma is a biopharma company focused on developing specialty medicines for unmet medical needs [9] - The company utilizes its NxWave™ discovery platform to advance a pipeline of over 30 active programs across various therapeutic areas [10] - Nxera employs approximately 400 people across key locations including Tokyo, Osaka, London, Cambridge, Basel, and Seoul [11]

Core Insights - OS Therapies has received a second Type C Meeting from the FDA to discuss clinical efficacy data endpoints for OST-HER2, aimed at supporting a Biologics Licensing Application under the Accelerated Approval Program following a successful Phase 2b trial for metastatic osteosarcoma [1][2] - The UK MHRA has granted a pre-MAA Meeting for the same program, with the company planning to align BLA and MAA submission timelines as part of Project Orbis [2] - The company reported positive results from its Phase 2b clinical trial, demonstrating statistically significant benefits in the 12-month event-free survival primary endpoint [6] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, with its lead asset OST-HER2 being an immunotherapy targeting the HER2 protein [4][6] - OST-HER2 has received multiple designations from regulatory agencies, including Rare Pediatric Disease Designation and Fast-Track status from the FDA [4] - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [7] Clinical Development and Regulatory Strategy - The FDA meeting is scheduled for December 11, 2025, allowing time for the company to gather biomarker data to correlate immune activation with clinical outcomes [1][5] - The recent FDA/Osteosarcoma Institute Workshop emphasized the importance of overall survival data as a key efficacy endpoint and discussed appropriate clinical trial designs for future immunotherapies [3][5] - The company anticipates submitting a BLA for OST-HER2 in 2025, which, if approved, would make it eligible for a Priority Review Voucher [6]

Core Insights - Compugen Ltd. announced a pooled analysis supporting the anti-tumor activity and safety profile of COM701 in heavily pre-treated patients with platinum-resistant ovarian cancer, published as an abstract by the European Society of Medical Oncology (ESMO) [1][2][3] Company Developments - The pooled analysis included 60 evaluable patients from prior COM701 Phase 1 clinical trials, focusing on clinical benefits and progression-free survival data [2][3] - COM701 demonstrated good tolerance and durable responses, especially in patients without liver metastases, indicating a potential for lower disease burden and less immunosuppressive tumor microenvironment [3] - Compugen is conducting the MAIA-ovarian trial to evaluate COM701 as maintenance therapy in relapsed platinum-sensitive ovarian cancer, with an interim analysis planned once data from approximately 60 participants is available [3][6] Future Plans - The MAIA-ovarian trial aims to assess the median progression-free survival, with sites activated in the U.S., Israel, and France to support enrollment [3][6] - Compugen anticipates interim analysis results by the end of 2026, with sufficient cash flow to support operations into 2027 [3][6] Industry Context - ESMO 2025 will feature presentations from companies with differentiated Fc-reduced TIGIT programs, including oral presentations from Compugen's partner AstraZeneca [5]