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].

Core Insights - Candel Therapeutics, Inc. is set to present findings from its enLIGHTEN™ Discovery Platform and data from the CAN-2409 program in non-small cell lung cancer (NSCLC) at the Society for Immunotherapy of Cancer's 40th Anniversary Annual Meeting in November 2025 [1][2] Group 1: Clinical Trials and Presentations - Candel will showcase positive phase 3 clinical trial data of CAN-2409 for intermediate-to-high-risk localized prostate cancer during an invited faculty presentation [2][3] - Two poster presentations will occur on November 7, 2025, focusing on the integration of machine learning in cancer immunotherapy and the immune response to CAN-2409 in NSCLC [2][3] Group 2: Product Development and Regulatory Designations - CAN-2409 is the lead candidate from Candel's adenovirus platform, having completed successful phase 2a trials in NSCLC and pancreatic ductal adenocarcinoma (PDAC) [4] - The FDA has granted multiple designations to CAN-2409, including Regenerative Medicine Advanced Therapy Designation for localized prostate cancer and Fast Track Designation for both NSCLC and prostate cancer [4] Group 3: Company Overview and Research Focus - Candel Therapeutics specializes in developing off-the-shelf multimodal biological immunotherapies aimed at eliciting systemic anti-tumor immune responses [4][5] - The company has established two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) gene constructs [4][5]

Core Insights - Roche announced FDA approval for Tecentriq® and Tecentriq Hybreza® in combination with lurbinectedin for maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC) [1][3] - This marks the first and only combination therapy approved for first-line maintenance treatment of ES-SCLC, addressing a significant unmet need in a highly aggressive disease [1][3] - The approval is based on the phase III IMforte study, demonstrating a 46% reduction in the risk of disease progression or death and a 27% reduction in the risk of death compared to Tecentriq alone [1][2] FDA Approval Details - The FDA approved the combination therapy for adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy [1] - The National Comprehensive Cancer Network (NCCN) has updated its guidelines to include this regimen as a category 2A preferred option for maintenance treatment [1][3] Study Findings - The IMforte study involved 660 patients in the induction phase, with 483 patients randomized for maintenance therapy [2] - Median overall survival for the combination therapy was 13.2 months compared to 10.6 months for Tecentriq alone, with a stratified hazard ratio of 0.73 [1][2] - Median progression-free survival was 5.4 months for the combination versus 2.1 months for Tecentriq alone, with a stratified hazard ratio of 0.54 [1][2] Company Commitment - Roche emphasizes its commitment to improving outcomes in difficult-to-treat cancers through innovative therapies [1][3] - The company has a history of developing treatments for aggressive cancer types, including various formulations of Tecentriq [5]

Core Insights - CytoDyn Inc. is advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor, with potential applications in multiple cancer types, including triple-negative breast cancer (TNBC) and colorectal cancer (CRC) [1][3] - The company will present findings on leronlimab's effects on PD-L1 expression and patient survival in metastatic TNBC at the AACR Special Conference in Cancer Research [1][3] - A retrospective analysis indicated that leronlimab treatment led to PD-L1 expression in 88% of patients treated with doses greater than 525 mg/week, suggesting improved survival outcomes when combined with immune checkpoint inhibitors (ICIs) [1][4] Presentation Details - The oral and poster presentations will take place on September 26 and 27, 2025, respectively, focusing on the association between CCR5 inhibition, enhanced PD-L1 expression, and long-term survival in metastatic TNBC [3][4] Clinical Implications - The findings suggest that leronlimab may enhance the effectiveness of ICIs in patients with metastatic TNBC, a group historically resistant to such treatments [2][4] - The study showed that 18% of heavily pretreated metastatic TNBC patients were alive after a median of approximately 60 months, indicating a potential survival benefit from CCR5 inhibition [4] Company Overview - CytoDyn is dedicated to developing leronlimab as a versatile therapeutic platform aimed at addressing serious unmet medical needs across various high-value markets [5] - The company emphasizes its commitment to improving patients' quality of life through innovative therapies [5]

Core Insights - OS Therapies has been invited to participate in the "Beyond the Cure: The Brave New World of Revolutionary Cancer Therapeutics" Spotlight Panel at BioFuture 2025, highlighting its focus on innovative cancer treatments [1][3] - The company plans to submit a Biologics Licensing Application (BLA) to the FDA in Q4 2025, aiming for approval that could lead to a Priority Review Voucher (PRV) sale to fund further clinical development [2][4] - OS Therapies' lead asset, OST-HER2, is an immunotherapy targeting HER2 protein, showing promising results in clinical trials for osteosarcoma and breast cancer [4][5] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, leveraging a unique listeria monocytogenes platform technology [3][4] - The company has received multiple designations from the FDA, including Rare Pediatric Disease Designation and Fast-Track status for OST-HER2, which has shown statistically significant benefits in clinical trials [4] - OS Therapies is also advancing next-generation Antibody Drug Conjugates (ADCs) and Drug Conjugates (DCs) through its proprietary technology [5][6]

Core Insights - Medicenna Therapeutics Corp. is a clinical-stage cancer immunotherapy company focused on developing Superkines [1][4] - Dr. Fahar Merchant, President and CEO, will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025 [1][2] - The company is developing novel versions of IL-2, IL-4, and IL-13 Superkines, with a focus on enhancing cancer treatment [4] Presentation Details - The presentation is scheduled for September 9, 2025, from 2:30 PM to 3:00 PM (Eastern Standard Time) at the Lotte New York Palace Hotel [2] - A webcast of the presentation will be available for 90 days on Medicenna's investor relations website [2] Company Overview - Medicenna's long-acting IL-2 Superkine, MDNA11, has superior affinity toward CD122 and preferentially stimulates cancer-killing effector T cells and NK cells [4] - The IL-4 Empowered Superkine, bizaxofusp, has been studied in five clinical trials with over 130 patients, including a Phase 2b trial for recurrent GBM [4] - Bizaxofusp has received FastTrack and Orphan Drug status from the FDA and EMA [4] - Medicenna is also developing early-stage BiSKITs™ and T-MASK™ programs aimed at treating immunologically "cold" tumors [4]

Core Insights - Purple Biotech Ltd. is advancing its tri-specific antibody IM1240, targeting the tumor-associated antigen 5T4, towards first-in-human clinical trials with an IND submission planned for 2026 [1][6] - The collaboration with Dr. Amir Horowitz focuses on evaluating the CAPTN-3 antibody's effects on patient-derived tumor biopsies, particularly in treatment-resistant cancers [2][3] - IM1240 has shown to induce cancer cell apoptosis in resistant head and neck cancer biopsies, demonstrating a unique synergistic effect not observed in related bispecific antibodies [3][4] Company Overview - Purple Biotech is a clinical-stage company developing therapies to overcome tumor immune evasion and drug resistance, with a pipeline that includes CAPTN-3, CM24, and NT219 [6] - The CAPTN-3 platform utilizes conditionally activated tri-specific antibodies to engage T cells and NK cells, aiming for a strong immune response localized within the tumor microenvironment [6] - IM1240 is the first tri-specific antibody targeting the 5T4 antigen, which is associated with advanced disease and poor clinical outcomes in various solid tumors [6] Research and Development - Dr. Horowitz's research indicates that targeting NKG2A provides a selective checkpoint inhibition strategy, enhancing antitumor activity while minimizing off-target effects [4][5] - Analysis of approximately 26,000 human transcriptomes supports the design of IM1240, showing consistent expression of NKG2A with 5T4 in solid tissues [1][4] - The CAPTN-3 platform's unique design allows for the activation of immune cell subsets with high anti-tumor activity, potentially improving safety and efficacy [4][5]

Core Viewpoint - OS Therapies is progressing towards the submission of a rolling Biologics Licensing Application (BLA) for its OST-HER2 program targeting recurrent, fully resected, pulmonary metastatic osteosarcoma, following a productive End of Phase 2 meeting with the FDA [1][2][6] Group 1: FDA Meeting Outcomes - The FDA and OS Therapies reached alignment on several critical areas necessary for a successful BLA, including clinical trial efficacy endpoints and statistical analysis plans [2] - A public meeting with key osteosarcoma stakeholders is scheduled for October 10, 2025, to discuss advancing drug development for osteosarcoma [2] - The FDA is committed to working closely with the Company, prioritizing both formal and informal meetings, with the first informal meeting set for mid-September 2025 [2][6] Group 2: Clinical Data and Safety Profile - No significant safety concerns were identified for OST-HER2 based on the clinical data available to date, indicating an excellent safety profile [3] - The Company is preparing necessary data for submission to the FDA as part of the rolling BLA submission expected in Q4 2025 [3] Group 3: Designations and Financial Aspects - OST-HER2 has received Rare Pediatric Disease Designation (RPDD) and is eligible for a Prescription Drug User Fee Act (PDUFA) small business fee waiver, with a decision expected by the end of Q3 2025 [5][7] - The Company anticipates significant progress towards Breakthrough Therapy designation (BTD) and either Accelerated Approval or full approval during the upcoming FDA/OSI workshop [4] Group 4: Future Developments - OS Therapies is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced treatment delivery [8] - The Company is actively compiling data for the OST-400 natural history database to support the development of a synthetic control arm for future trials [2][6]