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 - Compugen Ltd. has initiated the first patient dosing in a global randomized sub-trial of its adaptive platform trial, MAIA-ovarian, focusing on the maintenance therapy with COM701 for relapsed platinum-sensitive ovarian cancer [1][2][5] Group 1: Trial Details - MAIA-ovarian is designed to evaluate the safety and efficacy of COM701 as maintenance monotherapy or in combination therapy for patients with relapsed platinum-sensitive ovarian cancer [3][5] - Sub-trial 1 is a double-blind, randomized placebo-controlled trial involving 60 patients, randomized in a 2:1 ratio to receive COM701 or placebo [3][5] - An interim analysis of sub-trial 1 is scheduled for the second half of 2026, which may inform a registration path for COM701 monotherapy [2][5] Group 2: Clinical Rationale and Expectations - The trial is supported by strong biological rationale, with high PVRIG pathway expression levels observed in ovarian cancer, indicating a significant unmet medical need [2][3] - Historical data suggests a benchmark for progression-free survival of around six months, with a clinically meaningful improvement of three months over placebo anticipated [2][5] - COM701 has shown durable responses in previous clinical data, including a response duration of over 18 months in a patient treated as a single agent [2][5] Group 3: Company Overview - Compugen is a clinical-stage therapeutic discovery and development company utilizing AI/ML for predictive computational target discovery, focusing on cancer immunotherapies [4][6] - The company has two proprietary product candidates in Phase 1 development: COM701 and COM902, targeting different pathways in cancer treatment [4][6] - Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN [6]

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].

AFM24 (EGFR) + atezolizumab in NSCLC - In EGFRwt NSCLC, the Disease Control Rate (DCR) was 76% (25/33 patients), with 48% (16/33) showing tumor shrinkage and an Objective Response Rate (ORR) of 21% (1 CR, 6 PRs)[16] - In EGFRmut NSCLC, the DCR was 71%, with 41% (7/17) showing tumor shrinkage and an ORR of 24% (1 CR, 3 PRs)[16] - Preliminary median Progression-Free Survival (PFS) in EGFRwt NSCLC was 5.6 months, with 36% of patients ongoing[33, 49] - Patients without prior taxane exposure in EGFRwt NSCLC showed a 25% ORR and a preliminary median PFS of 74 months[47, 53] - Post-hoc analysis showed increasing AFM24 exposure resulted in higher ORR, with the highest exposure group (Q4) achieving a 5455% ORR and a 9091% DCR[68] Acimtamig (AFM13) + AlloNK® in r/r HL - In relapsed/refractory Hodgkin Lymphoma (r/r HL), the ORR was 864% (19/22 patients), including a 545% Complete Response (CR) rate[16, 91] - All patients in the LuminICE-203 study were refractory to brentuximab vedotin (BV) and checkpoint inhibitors (CPIs)[80] AFM28 in r/r AML - In the highest dose level (300 mg), a composite complete remission rate (CRcR) of 40% (4/10 patients) was achieved in relapsed/refractory Acute Myeloid Leukemia (r/r AML)[16, 107]

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]

ANKTIVA Mechanism and Applications - ANKTIVA activates NK cells and rescues T cells, serving as a foundational cytokine for universal cancer immunotherapy across multiple tumor types[18] - ANKTIVA, combined with BCG, is approved for bladder cancer and is being investigated in lung cancer, prostate cancer, colon cancer, and hematologic malignancies[20, 22] - ANKTIVA's mechanism overcomes tumor evasion by activating NK cells and rescuing T cells[12] Clinical Trial Results and Regulatory Status - In BCG-unresponsive NMIBC-CIS, ANKTIVA demonstrated a 71% complete response rate[25] - In BCG-unresponsive papillary NMIBC, ANKTIVA showed a disease-free rate of 55.4% at 12 months, 51.1% at 18 months, and 48.3% at 24 months, with 93% cystectomy avoidance[50] - In the NMIBC BCG-naive setting, ANKTIVA + BCG resulted in 100% complete response and disease-free status for at least 9.5 years in 6 out of 6 patients[54, 55] - An interim analysis of a Phase 3 trial in NMIBC BCG-naive patients showed an 84% complete response rate with ANKTIVA + BCG compared to 52% with BCG alone[57] - A BLA submission is planned for the QUILT-3.055 study (N=83) for lung cancer checkpoint progressors[70] Market Access and Launch - ANKTIVA received J-Code 9028 effective January 2025[35] - Market access covers 240 million medical lives as of November 2024[37] Intellectual Property - ImmunityBio has over 700 issued patents worldwide covering its immunotherapy portfolio[75]

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].