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]

Core Insights - Anixa Biosciences has received a Notice of Allowance for a new patent related to its breast cancer vaccine technology from the Chinese National Intellectual Property Administration, expanding its global intellectual property coverage [1][2] - The patent will provide composition of matter protection for the breast cancer vaccine in China, extending IP protection into at least the 2040s [1] - The breast cancer vaccine targets human α-lactalbumin, a protein aberrantly expressed in certain breast cancers, aiming to prime the immune system for tumor prevention [4] Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a therapeutic portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [6] - The company’s vaccine platform targets high-incidence cancers and aims to transform cancer prevention strategies [5] - Anixa's business model involves partnerships with renowned research institutions to develop and commercialize innovative cancer therapies [6] Market Context - Breast cancer is the most commonly diagnosed cancer among women in China, with a rising incidence over the past two decades, highlighting the need for innovative preventative solutions like Anixa's vaccine [3] - The new patent complements existing patents in the United States and other jurisdictions, reinforcing Anixa's leadership in cancer immunotherapy [2] - The allowance of the patent strengthens Anixa's ability to pursue strategic global opportunities in regions with high breast cancer burdens [3]

XPro Program for Alzheimer's Disease - XPro1595 is designed to selectively inhibit soluble TNF to treat neurologic disease, with Phase 1b study demonstrating safety and dose-dependent reduction in inflammatory cytokines in cerebrospinal fluid (CSF)[34] - A Phase 2 study of XPro1595 in early Alzheimer's patients with biomarkers of inflammation used an enriched population (n=100) with amyloid and ≥ 2 biomarkers of inflammation, showing a beneficial signal across multiple measures[42, 57] - In the Safety Analysis Set (SAF) population (n=206) for the Phase 2 study, 51% were female, and 95.1% were white[39] - In the mITT population (n=200), 75% were Amyloid-beta (Aβ) positive[39] - The most common Treatment Emergent Adverse Event (TEAE) in the XPro1595 group was Injection Site Reaction (ISR), occurring in 52.5% of patients[54] - The company plans to validate the enriched population in a fully powered trial and anticipates an end-of-Phase 2 meeting with the FDA in Q4 2025[56, 59] CORDStrom Program for RDEB - CORDStrom is an investigational disease-modifying treatment for recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic disease affecting an estimated 4000 people in the US, UK, and EU, representing a > $1B peak sales opportunity[64] - A Phase 2 trial of CORDStrom in 30 pediatric patients with RDEB showed beneficial effects with respect to Itch Man Scale, iscorEB clinician score, skin score, and QOL, with no CORDStrom-related serious adverse events reported[66] - The company plans to compile and file a BLA in the US & MAA in UK/EU in 1H 2026[77] INKmune Program for Cancer - INKmune is an off-the-shelf NK cell therapy candidate designed to convert patient's resting NK cells into cancer-killing memory-like NK cells[78] - An INKmune® mCRPC Phase I/II Trial is ongoing, with safety endpoints met and evidence of in-vivo NK cell activation and regression of some tumor lesions by PSMA-PET[80]

Core Insights - Compugen Ltd. reported its financial results for Q2 2025, highlighting advancements in its immuno-oncology pipeline and a solid financial position with cash expected to fund operations into 2027 [1][4][7]. Corporate Update - The company has initiated the MAIA-ovarian trial, dosing the first patient with COM701 for maintenance therapy in relapsed platinum-sensitive ovarian cancer [2][5]. - Compugen plans to present pooled analysis data from three Phase 1 trials of COM701 at the upcoming ESMO 2025 conference [2][6]. - The Phase 1 trial for GS-0321, an anti-IL18BP antibody licensed to Gilead, is ongoing [2][5]. - AstraZeneca's rilvegostomig program, which includes ten active Phase 3 trials, is progressing well, with data presentations planned for ESMO 2025 [2][6]. Financial Highlights - As of June 30, 2025, Compugen had approximately $93.9 million in cash and cash equivalents, sufficient to fund operations into 2027 [7]. - The company reported revenues of approximately $1.3 million for Q2 2025, a decrease from $6.7 million in Q2 2024, primarily due to the timing of milestone payments [8]. - R&D expenses for Q2 2025 were approximately $5.6 million, down from $6.2 million in the same period of 2024 [9]. - The net loss for Q2 2025 was approximately $7.3 million, compared to a net loss of $2.1 million in Q2 2024 [9]. Future Milestones - Upcoming presentations at ESMO 2025 will include data on COM701 and rilvegostomig, with further data expected in H2 2026 [6][3].