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 - Tevogen Bio Holdings Inc. is expanding its artificial intelligence initiative, Tevogen.AI, in collaboration with Microsoft and Databricks to develop the beta version of the PredicTcell model [1][2] - The new dataset being curated focuses on oncology and aims to enhance the accuracy of the existing model, which previously utilized a virology dataset [2] - The development phase is supported by a recently published international patent application that details novel machine learning systems for predicting immunologically active peptides, crucial for targeted cancer therapies [3] Company Developments - Tevogen.AI is leveraging the Databricks Data Intelligence Platform to improve its foundational AI model, particularly in the complex field of oncology [2][4] - The company is also exploring external market opportunities as a potential revenue source, which may include enhanced analytics and visualization tools for the PredicTcell model [7] Strategic Collaborations - The collaboration with Microsoft and Databricks is highlighted as a significant advantage in building the alpha version of the AI model, emphasizing the importance of high-quality datasets in drug discovery [4]

Core Insights - Oncolytics Biotech Inc. has presented biomarker and translational data supporting the efficacy of pelareorep, an oncolytic virus that enhances immune responses in cancer treatment [1][2][3] - The data indicates that pelareorep can convert "cold" tumors into "hot" tumors, making them more responsive to immunotherapy [1][5] - The company is advancing towards registration-enabling trials for pelareorep in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA [4] Group 1: Mechanism of Action - Pelareorep demonstrates the ability to replicate in cancer cells, activate immune pathways, and drive T cell expansion and infiltration in tumors resistant to immunotherapy [1][2] - The treatment has shown consistent immune activation signatures across various studies, confirming its immune-mediated mechanism of action [2][5] - The upregulation of interferons and PD-L1, along with the mobilization of tumor-infiltrating lymphocytes, correlates with tumor size reduction [5] Group 2: Clinical Studies and Data - The GOBLET study is currently enrolling patients with pancreatic ductal adenocarcinoma (PDAC) and anal carcinoma, with additional data expected next year [2] - Previous studies have shown promising results in metastatic breast cancer and pancreatic cancer, reinforcing pelareorep's potential as a versatile immunotherapeutic agent [3][4] - The company anticipates that the clinical data will support its regulatory path and serve as a foundation for future studies in immunotherapy-resistant solid tumors [2][4]

Core Insights - BriaCell Therapeutics Corp. has reported updated survival data from its ongoing Phase 2 clinical study of Bria-IMT in patients with metastatic breast cancer, indicating a robust survival signal and well-tolerated profile for the treatment [1][4]. Patient Survival Data - The Phase 2 study included 54 heavily pre-treated metastatic breast cancer patients, with a median of 6 prior treatment lines [7]. - The most recent cohort of 25 patients achieved a one-year survival rate of 52%, with 11 patients remaining alive, including one at 38.3 months and another at 30.3 months [6][7]. - Survival rates in this cohort exceed current standard of care therapies for similar patient populations [6]. Expert Commentary - Experts have highlighted the potential of Bria-IMT to improve survival and tolerability for late-stage patients, especially those who have progressed despite treatment with checkpoint inhibitors and antibody-drug conjugates [4][6]. - The ongoing investigation in a Phase 3 randomized clinical trial aims to further assess the efficacy of Bria-IMT in combination with checkpoint inhibitors [4]. Comparative Analysis - Bria-IMT plus checkpoint inhibitors showed a 52% one-year survival rate compared to approximately 38-40% for other studies with fewer prior treatment lines [5][6]. - The study indicates that Bria-IMT may provide significant benefits for patients who have failed multiple lines of therapy, including those treated with ENHERTU and TRODELVY [6][7]. Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [8].

Core Points - TuHURA Biosciences, Inc. has been added to the Russell 3000® Index and automatically included in the Russell 2000® Index as part of the 2025 annual reconstitution, effective June 27, 2025 [1][2] - The inclusion in the Russell indexes signifies the company's progress in its first year as a publicly traded entity and reflects its potential for continued development [2] - TuHURA is currently enrolling patients in a Phase 3 accelerated approval trial of its lead product IFx-2.0, which is being tested as an adjunctive therapy to Keytruda® for advanced or metastatic Merkel cell carcinoma [2][11] - The company has also acquired a novel anti-VISTA antibody from Kineta, Inc. and plans to advance it into a Phase 2 clinical trial for treating NMPL1-mutated Acute Myeloid Leukemia [2] Company Overview - TuHURA Biosciences, Inc. is focused on developing novel technologies to overcome resistance to cancer immunotherapy, addressing both primary and acquired resistance [10] - The company's lead product, IFx-2.0, is designed to enhance the effectiveness of checkpoint inhibitors [11] - TuHURA is also leveraging its Delta Opioid Receptor technology to create bi-specific antibody drug conjugates aimed at inhibiting immune suppression in the tumor microenvironment [12]

Acquisition Overview - TuHURA Biosciences has successfully completed the acquisition of Kineta, Inc., which includes a novel VISTA inhibiting monoclonal antibody (mAb) now named TBS-2025, enhancing TuHURA's late-stage immuno-oncology pipeline [1][2] - The acquisition allows TuHURA to initiate a Phase 2 randomized trial for TBS-2025 in the second half of 2025 [1] Financial Details - The completion of the acquisition unlocks the fourth tranche of funds from a $12.5 million aggregate PIPE financing announced on June 3, 2025 [1] - Each share of Kineta common stock was converted into the right to receive 0.185298 shares of TuHURA common stock, totaling 2,868,169 shares [3] Product Development - TBS-2025 is positioned to overcome acquired resistance to cancer immunotherapy, particularly in patients with NPM1 mutated acute myeloid leukemia (AML) [2] - The drug is being investigated in combination with a menin inhibitor, aiming to improve response rates and reduce relapse in AML patients [2] Mechanism of Action - VISTA is a significant immune checkpoint expressed on myeloid cells, contributing to immunosuppression in the tumor microenvironment [5] - TBS-2025 is designed to block VISTA, potentially enhancing T cell function and improving treatment outcomes in cancer therapy [5][6] Clinical Trials - TBS-2025 has shown promising results in a Phase 1/2 trial, demonstrating good tolerance and over 90% receptor occupancy [7] - The drug is administered intravenously every two weeks and has been tested both as a monotherapy and in combination with pembrolizumab [6][7] Company Background - TuHURA Biosciences focuses on developing technologies to address primary and acquired resistance to cancer immunotherapy [8] - The company is also working on bi-specific antibody drug conjugates targeting myeloid derived suppressor cells to enhance immune response [10]

Core Insights - Provectus Biopharmaceuticals announced the publication of preclinical research on PV-10 for head and neck squamous cell carcinoma (HNSCC) [1][2] - The study reveals novel mechanistic findings that could support future clinical development of PV-10 in locally recurrent HNSCC [2] - PV-10 is an investigational cancer immunotherapy derived from pharmaceutical-grade rose bengal sodium [3] Group 1: Research and Development - The research conducted by the Chung Lab at Moffitt Cancer Center demonstrates PV-10's ability to induce immunogenic cell death in HNSCC through endoplasmic reticulum stress and apoptosis [2][4] - Provectus plans to initiate a Phase 1 trial of intratumoral PV-10 in pre-operative penile squamous cell carcinoma later this year [4] Group 2: Company Overview - Provectus is a clinical-stage biotechnology company focused on developing immunotherapy medicines based on synthetic small molecules known as halogenated xanthenes [5] - The company's lead molecule is Rose Bengal Sodium, which is central to its medical science platform that includes oncology, dermatology, and ophthalmology programs [6] Group 3: Clinical Trials and Information - Information regarding Provectus's clinical trials can be accessed through the National Institutes of Health registry, ClinicalTrials.gov [7]

January 2025 ImmunityBio Investor Presentation Forward-Looking Statements and Intended Use This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding data and results from clinical trials and potential implications therefrom, commercialization plans and timelines, including product availability and shipments, potential regulatory pathways and approval requests and submissions, FDA, UK MHRA, EU EMA and other r ...

Core Viewpoint - TuHURA Biosciences and Kineta have successfully completed stockholder meetings, approving a merger and key proposals, including an increase in authorized shares and reincorporation in Delaware [1][2]. Company Overview - TuHURA Biosciences, Inc. is a Phase 3 immuno-oncology company focused on developing technologies to overcome resistance to cancer immunotherapy [4]. - Kineta, Inc. is a clinical-stage biotechnology company dedicated to creating next-generation immunotherapies to address challenges in current cancer treatments [8]. Merger Details - TuHURA stockholders approved all proposals at the TuHURA Special Meeting, including increasing authorized shares to 200 million [1]. - Kineta stockholders also approved the merger with TuHURA at their Special Meeting [2]. - The merger is expected to close soon after satisfying remaining conditions [2]. Product Development - TuHURA's lead product, IFx-2.0, aims to overcome primary resistance to checkpoint inhibitors and is preparing for a Phase 3 trial in advanced Merkel Cell Carcinoma [5]. - TuHURA is also developing bi-specific antibody drug conjugates targeting Myeloid Derived Suppressor Cells to enhance immune response [6]. - Kineta's pipeline includes KVA12123, a VISTA blocking immunotherapy in Phase 1/2 trials, showing strong tumor growth inhibition in preclinical models [9]. Financial and Strategic Context - Kineta underwent a corporate restructuring in February 2024 to reduce expenses and preserve cash, including workforce reductions and halting new patient enrollment in trials [10]. - The merger aims to maximize stockholder value and enhance the combined company's capabilities in immunotherapy [10].

Core Insights - Compugen Ltd. is a clinical-stage cancer immunotherapy company that utilizes AI/ML driven predictive computational research to enhance understanding of complex cancer biology [1][2]. Group 1: Conference Presentations - Compugen will present at the 2025 Annual Congress of the European Association for Cancer Research in Lisbon, Portugal, from June 16-19, with a poster titled "Prediction of immune evasion and immunotherapy resistance mechanisms associated with distinct TNBC subtypes" [2]. - Another presentation will occur at the International Society for Computational Biology and European Conference on Computational Biology in Liverpool, UK, from July 20-24, featuring a poster titled "Computational prediction of TNBC tumor subtypes from an integrative single cell atlas elucidates immune evasion and immunotherapy resistance mechanisms" [2]. Group 2: Company Overview - Compugen employs a predictive computational discovery platform (UnigenTM) to identify new drug targets and biological pathways for cancer immunotherapy development [3]. - The company has two proprietary product candidates in Phase 1 development: COM701, an anti-PVRIG antibody, and COM902, an antibody targeting TIGIT for solid tumors [3]. - Rilvegostomig, a PD-1/TIGIT bispecific antibody, is in Phase 3 development by AstraZeneca under a licensing agreement [3]. - GS-0321, a high affinity anti-IL-18 binding protein antibody, is also in Phase 1 development and licensed to Gilead [3]. - Compugen's therapeutic pipeline includes early-stage immuno-oncology programs aimed at enhancing anti-cancer immunity [3].