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]

Core Insights - OS Therapies announced statistically significant positive final 2-year overall survival data from the Phase 2b trial of OST-HER2, showing 75% of treated patients achieved 2-year overall survival compared to 40% in historical controls [1][4] - The company is on track to file for conditional marketing authorization in the UK, the US, and the EU, with key regulatory meetings planned for December 2025 [3][6] Group 1: Clinical Trial Results - 75% of OST-HER2 treated patients achieved 2-year overall survival, significantly higher than the 40% in historical controls (p < 0.0001) [1][4] - Subgroup analysis indicated that 100% of patients who achieved 12-month Event Free Survival (EFS) also achieved 2-year overall survival [1][4] Group 2: Regulatory Path and Future Plans - The company plans to submit a conditional Marketing Authorization Application (MAA) to the MHRA in December 2025 and a Biologics Licensing Application (BLA) to the FDA in January 2026 [3][6] - OS Therapies is analyzing patient samples to confirm correlations between clinical outcomes and immune system biomarker activation, with results expected in November 2025 [3] Group 3: Company Overview and Product Pipeline - OS Therapies focuses on developing treatments for Osteosarcoma and other solid tumors, with OST-HER2 as its lead asset, which has received multiple designations from regulatory agencies [6][7] - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced treatment delivery [7]

Core Insights - OS Therapies received a positive regulatory update from the European Medicines Agency (EMA) following a meeting with the Dutch Medicines Evaluation Board (MEB) on October 6, 2025, regarding its OST-HER2 Phase 2b clinical trial for osteosarcoma [2][3] Regulatory Developments - The meeting aligned on key areas such as safety, non-clinical data, and chemistry, manufacturing, and controls (CMC) data, supporting the ongoing clinical trial [3][8] - The overall survival results from the trial, showing statistically significant final two-year data, may serve as a primary endpoint for conditional marketing authorization (CMA) [3][8] - A formal EMA Scientific Advice is anticipated in December 2025, establishing a potential pathway for a confirmatory randomized clinical development program [4][10] Clinical Trial Insights - The safety profile from the Fully Resected Osteosarcoma clinical study was confirmed as positive, with data from over 500 patients treated across four other therapeutic indications potentially supporting a CMA [8] - The rapporteur indicated that overall survival (OS) could provide a stronger measure of clinical benefit compared to 12-month Event-Free Survival (EFS) [8] - Efficacy data from other settings, such as recurrent, unresectable pulmonary metastatic osteosarcoma, could be incorporated into a post-market confirmatory clinical development program [8] Market Access and Future Plans - OS Therapies has commenced the Marketing Authorisation Application (MAA) submissions process with the UK MHRA, which has granted an expedited Market Access Scientific Advice Meeting [6] - The company plans to pursue a conditional marketing authorization while advancing a global randomized clinical study to evaluate OST-HER2 in various osteosarcoma clinical settings [10] - OST-HER2 has received multiple designations from the U.S. FDA and EMA, including Rare Pediatric Disease Designation and Fast-Track status [11]

Core Insights - OS Therapies is actively participating in multiple conferences and events in October 2025, showcasing its commitment to advancing cancer treatment and engaging with industry stakeholders [1][2][3][4][5]. Company Overview - OS Therapies Inc. is a clinical-stage biotechnology company focused on developing treatments for Osteosarcoma and other solid tumors, with its lead asset being OST-HER2, an immunotherapy targeting the HER2 protein [5][6]. - OST-HER2 has received several designations from the U.S. FDA, including Rare Pediatric Disease Designation, Fast-Track, and Orphan Drug designations, indicating its potential significance in treating rare diseases [5]. - The company reported positive results from its Phase 2b clinical trial of OST-HER2, demonstrating statistically significant benefits in the 12-month event-free survival primary endpoint for patients with recurrent, fully resected, lung metastatic osteosarcoma [5]. Upcoming Events - OS Therapies will participate in the Cell and Gene Meeting on the Mesa from October 6-8, 2025, in Phoenix, AZ, focusing on partnering and one-on-one meetings [2]. - The company will also attend the Roth Annual Healthcare Opportunities Conference on October 9, 2025, in New York City, where it will engage in meetings with potential investors [2]. - A workshop on advancing osteosarcoma drug development will take place on October 10, 2025, in Washington, DC, where OS Therapies management will be available for discussions [2]. - The BIOFuture 2025 event is scheduled for October 13-15, 2025, in New York City, featuring a spotlight panel and one-on-one meetings [3]. - The company will be present at the 52nd Daytime Emmy Awards on October 17, 2025, where its documentary "Shelter Me: Cancer Pioneers" has received two nominations [3]. - The Maxim Growth Summit will occur on October 22, 2025, in New York City, where corporate presentations and meetings will be held [4]. - OS Therapies will also participate in BIO - Europe from November 3-5, 2025, in Vienna, Austria, focusing on partnering and meetings [5]. Product Development - OST-HER2 has shown preclinical efficacy in various models of breast cancer and has been conditionally approved by the U.S. Department of Agriculture for treating canines with osteosarcoma [5]. - The company is advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [6].