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Anixa Biosciences Receives Notice of Allowance from Chinese National Intellectual Property Administration for Patent Covering Breast Cancer Vaccine Technology
Prnewswire· 2025-08-20 12:37
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]
INmune Bio(INMB) - 2025 Q2 - Earnings Call Presentation
2025-08-07 20:30
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]
Compugen Reports Second Quarter 2025 Results
Prnewswire· 2025-08-06 11:00
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].
Tevogen.AI Expands Collaboration With Databricks and Microsoft to Build the Beta Version of Its PredicTcell™ Model With a Focus on Oncology
Globenewswire· 2025-08-05 18:32
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]
Compugen Announces First Patient Dosed in COM701 Global Platform Trial in Platinum Sensitive Ovarian Cancer
Prnewswire· 2025-07-21 11:00
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]
Oncolytics Biotech® Presents Aggregated Translational Data Providing Evidence of Pelareorep's Effectiveness Across Multiple Tumor Types
Prnewswire· 2025-07-16 12:30
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]
BriaCell Phase 2 Survival Achievement: 52% of Patients Surpass One-Year Milestone in Metastatic Breast Cancer
Globenewswire· 2025-07-08 11:30
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].
Affimed (AFMD) Earnings Call Presentation
2025-07-03 07:10
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]
TuHURA Biosciences, Inc. Announces Inclusion in the Russell 3000® and Russell 2000® Indexes
Prnewswire· 2025-07-01 12:50
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]
TuHURA Biosciences Completes Acquisition of Kineta
Prnewswire· 2025-06-30 12:50
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]