Core Insights - Lunai Bioworks has secured its first Letter of Intent (LOI) to license its next-generation immune cell therapy, which has shown complete regression of both primary and metastatic pancreatic tumors in humanized preclinical models [1][5][8] - The company is preparing for a Phase I clinical trial for its Dendritic Cell Combination Therapy (DCCT) targeting high-need solid tumors, including pancreatic cancer, which has a five-year survival rate of only 13% [3][8] - The DCCT platform is designed to provide scalable, off-the-shelf treatments, significantly reducing manufacturing timelines and costs [8] Company Developments - Lunai Bioworks has received positive validation from researchers and industry partners, with independent expert analysis confirming the strength of its data [4][6] - The company is advancing its clinical development plans and preparing for formal licensing negotiations and pre-IND activities in early 2026 [7][8] - The DCCT has demonstrated an 80-90% reduction in tumor size and volume in independent studies, with remaining tissue primarily consisting of immune cells [6] Industry Impact - The advancements in Lunai's DCCT are seen as a potential breakthrough in cancer immunotherapy, particularly for treatment-resistant tumors like pancreatic cancer [4][6] - The approach leverages the natural antigen-presenting capabilities of dendritic cells, aiming to overcome longstanding barriers in solid tumor treatment [7] - The company is collaborating with leading investigators to expand the clinical reach of its platform, indicating a strong commitment to advancing cancer treatment options [6][7]

Core Insights - BriaCell Therapeutics Corp. will present positive biomarker and survival data at the 2025 San Antonio Breast Cancer Symposium, highlighting advancements in cancer immunotherapy [1][6] - The company emphasizes its commitment to improving survival and clinical outcomes for cancer patients with unmet medical needs through its innovative therapies [2] Clinical Data and Presentations - The company will showcase three poster presentations at the symposium, focusing on positive Phase 2 safety and efficacy signals, as well as biomarker findings from both Phase 2 and pivotal Phase 3 studies [6] - The pivotal Phase 3 study of Bria-IMT+CPI is ongoing, with an interim analysis expected in the first half of 2026 [6] - The Bria-IMT regimen has received Fast Track Designation from the US FDA, indicating its potential significance in cancer treatment [6] Leadership Statements - William V. Williams, MD, President & CEO, expressed confidence in the pivotal Phase 3 study in metastatic breast cancer, supported by positive clinical data and biomarker findings [2] - Miguel A. Lopez-Lago, PhD, Chief Scientific Officer, highlighted the importance of biomarker data in understanding the mechanism of action of their novel immunotherapy [2] Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [4]

Vir Biotechnology (NasdaqGS:VIR) 2025 Conference November 18, 2025 09:00 AM ET Company ParticipantsMarianne Backer - CEOModeratorGood afternoon, everyone. Thank you for joining Jefferies Healthcare Conference 2025 edition. I'm very happy to have Marianne Backer with us, CEO of Vir Biotechnology. Thank you.Marianne BackerThank you, Juliette. Hello and good afternoon, everyone. Thank you, Jefferies, for the opportunity to provide the latest update on Vir Biotechnology and the rapid progress we are making acro ...

Core Insights - TuHURA Biosciences is advancing its Phase 3 trial of IFx-2.0 as an adjunctive therapy to Keytruda for advanced Merkel cell carcinoma, with potential for accelerated and regular FDA approval [2][7] - The company is also preparing to submit a Phase 2 study protocol for TBS-2025, a VISTA inhibiting antibody, targeting NPM1 mutated acute myeloid leukemia (AML) [2][8] - TuHURA's Delta Opioid Receptor (DOR) technology has been recognized for its potential in overcoming resistance to cancer immunotherapy, with presentations scheduled at the ASH 2025 Annual Meeting [3][15] Clinical Development - The Phase 3 trial of IFx-2.0 is designed to evaluate its effectiveness as an adjunctive therapy to pembrolizumab in first-line treatment for advanced or metastatic Merkel cell carcinoma [7] - The company is on track to submit the Phase 2 plan for TBS-2025 to the FDA next month and aims to initiate the trial in the first quarter of next year [2][8] Financial Performance - For the third quarter ended September 30, 2025, research and development expenses were reported at $4.9 million, compared to $2.9 million for the same period in 2024 [5] - Net cash outflows from operating activities for the nine months ended September 30, 2025, were ($22.1) million, up from ($12.1) million in 2024 [5] Corporate Developments - TuHURA appointed Dr. Michael Turner as Vice President of Immunology, bringing over 20 years of experience in the field [3] - The company has filed for a $50 million At-The-Market (ATM) facility, allowing it to sell shares under the facility once the registration statement becomes effective [3] Upcoming Milestones - Anticipated milestones include preliminary results from the Phase 1b/2a trial of IFx-2.0 in Q2 2026 and completion of enrollment in the Phase 3 trial by Q4 2026 [11] - The company expects to initiate the Phase 2 trial of TBS-2025 in combination with a menin inhibitor in Q1 2026 [11]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Insights - Compugen Ltd. reported its third quarter 2025 financial results, highlighting a significant decrease in revenue compared to the same period in 2024, alongside advancements in its clinical pipeline and a strong cash position [1][5][3]. Financial Performance - Revenue for Q3 2025 was approximately $1.9 million, a decrease from $17.1 million in Q3 2024, primarily due to the recognition of upfront and milestone payments from Gilead [5]. - Research and Development (R&D) expenses were approximately $5.8 million in Q3 2025, down from $6.3 million in Q3 2024 [6]. - General and Administrative (G&A) expenses were approximately $2.2 million in Q3 2025, compared to $2.6 million in Q3 2024 [6]. - The net loss for Q3 2025 was approximately $6.98 million, or $0.07 per share, contrasting with a net profit of approximately $1.28 million, or $0.01 per share, in Q3 2024 [7]. Clinical Developments - Compugen's COM701, an Fc-reduced anti-PVRIG antibody, showed promising Phase 1 data at ESMO 2025, indicating it is well tolerated and delivers durable responses in heavily pretreated platinum-resistant ovarian cancer patients [2][4]. - The ongoing MAIA-ovarian platform trial is evaluating COM701 maintenance therapy in platinum-sensitive ovarian cancer, with interim analysis expected in Q1 2027 [4]. - AstraZeneca presented positive results for its rilvegostomig program at ESMO 2025, reinforcing the potential of Fc-reduced anti-TIGIT antibodies [2][4]. Financial Position - As of September 30, 2025, Compugen had approximately $86.1 million in cash and cash equivalents, sufficient to fund operations into Q3 2027 [3]. - The company has no debt and recently raised approximately $1.6 million through the sale of shares [3]. Strategic Partnerships - Compugen has established partnerships with AstraZeneca and Gilead, which could provide over $1 billion in potential milestones and royalties, enhancing the company's financial outlook and pipeline development [2][3].

Core Insights - Elicio Therapeutics announced new immunogenicity data from the Phase 2 AMPLIFY-7P trial for ELI-002 7P, showing strong T cell responses in patients with mKRAS pancreatic ductal adenocarcinoma [1][3][6] - The company also presented preclinical data for ELI-004, indicating over 90% tumor eradication in advanced solid tumors [1][8] Group 1: ELI-002 7P Immunogenicity Data - In the AMPLIFY-7P trial, 99% of 90 evaluable patients achieved robust mKRAS-specific T cell responses, with a mean increase of 145-fold over baseline [4][6] - 85% of patients exhibited combined CD4 and CD8 T cell activation, correlating with clinical activity [4][6] - 88% of patients generated responses to their own tumor-specific mutations, indicating personalized immune activation [4][6] Group 2: ELI-004 Preclinical Data - ELI-004 demonstrated complete tumor eradication in over 90% of cases in preclinical studies, with long-term protection against recurrence [3][8] - The efficacy of ELI-004 was linked to the presence of CD8 T cells and effective lymphocyte trafficking from lymph nodes [8] - This approach suggests a promising off-the-shelf strategy for solid tumor immunotherapy [8] Group 3: Presentation Details - The findings will be presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting [2] - The late-breaking abstract for ELI-002 7P highlights its potential to induce robust T cell immunity across diverse HLA backgrounds [6][7] Group 4: Company Overview - Elicio Therapeutics focuses on developing novel immunotherapies targeting high-prevalence cancers, particularly those driven by KRAS mutations [14] - The company's AMP platform aims to enhance immune responses by delivering therapeutics directly to lymph nodes [12][13] - Elicio plans to expand its pipeline to include additional indications for ELI-002 and other candidates targeting different mutations [14]

Core Insights - Elicio Therapeutics announced new immunogenicity data from the Phase 2 AMPLIFY-7P trial for ELI-002 7P, showing strong T cell responses in patients with mKRAS pancreatic ductal adenocarcinoma [1][3][5] - The company also presented preclinical data for ELI-004, indicating its potential to eradicate advanced solid tumors in over 90% of cases [1][8] ELI-002 7P Trial Results - In the AMPLIFY-7P trial, 99% of 90 evaluable patients achieved robust mKRAS-specific T cell responses, with a mean increase of 145-fold over baseline [4][5] - 85% of patients exhibited combined CD4 and CD8 T cell activation, which correlates with clinical activity [5] - 67% of patients responded to all seven mKRAS epitopes, with over 80% response rates to each individual KRAS mutation [4][5] ELI-004 Preclinical Data - ELI-004 demonstrated complete tumor eradication in over 90% of cases in preclinical studies, suggesting long-term protection against recurrence [3][8] - The efficacy of ELI-004 was linked to the presence of CD8 T cells and effective lymphocyte trafficking from lymph nodes [8] HLA Diversity and T Cell Responses - High-resolution HLA typing revealed a diverse HLA repertoire among patients, with 1,132 unique HLAs identified [6] - No significant associations were found between specific HLA types and the magnitude of mKRAS-specific T cell responses, indicating broad applicability of ELI-002 7P [6] Company Overview - Elicio Therapeutics focuses on developing novel immunotherapies targeting high-prevalence cancers, particularly those driven by KRAS mutations [15] - The company's AMP technology aims to enhance immune responses by delivering immunotherapeutics directly to lymph nodes [12][14]

Core Insights - BriaCell Therapeutics Corp. is presenting strong evidence of immune system engagement and anti-cancer activity of its Bria-OTS+ platform at the Society for Immunotherapy of Cancer Annual Meeting [1][2] Preclinical Findings - Bria-OTS+ demonstrates fast-acting and potent anti-cancer immune system activation, inducing coordinated innate and adaptive immune responses to kill cancer cells [3][7] - The platform produces sustained and durable anti-cancer immune responses, potentially leading to prolonged clinical benefits for patients [4][6] - Positive results from lead candidates Bria-BRES+ (breast cancer) and Bria-PROS+ (prostate cancer) indicate broad applicability of the Bria-OTS+ platform across multiple solid tumor indications [5][7] Platform Overview - Bria-OTS+ is an advanced immunotherapy platform, enhancing the previous Bria-OTS™ version, designed to express multiple immune-activating cytokines and co-stimulatory molecules [6][8] - The platform's unique mechanism of action supports the development of personalized cancer immunotherapies, with planned clinical trials for Bria-BRES+ and Bria-PROS+ [2][6]

Core Insights - AIM ImmunoTech Inc. announced that data from its Phase 2 clinical study on cisplatin-resistant advanced recurrent ovarian cancer using Ampligen (rintatolimod) was accepted for presentation at the 40th Annual SITC Meeting [1] - The study focuses on a combination locoregional chemoimmunotherapy approach and its correlation with clinical outcomes [1] Company Overview - AIM ImmunoTech Inc. is an immuno-pharma company dedicated to developing therapeutics for various cancers, immune disorders, and viral diseases, including COVID-19 [2] - The company's lead product, Ampligen (rintatolimod), is a first-in-class investigational drug that acts as a dsRNA and highly selective TLR3 agonist immuno-modulator [2]