Notice of Allowance marks first Chinese patent to be issued on Anixa Breast Cancer Vaccine Expands global intellectual property coverage in markets with high breast cancer incidence New patent will provide IP protection of Breast Cancer Vaccine in China into at least the 2040s SAN JOSE, Calif., Aug. 20, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that the Chinese National In ...

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].

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]