Core Insights - PDS Biotechnology Corporation announced that the National Cancer Institute (NCI) will present new clinical data at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting, focusing on its investigational immunotherapy platforms [1][4] - The presentations will include three abstracts that highlight clinical and translational findings related to PDS Biotech's immunotherapy candidates, including PDS0101 and PDS01ADC [1][4] Company Overview - PDS Biotechnology is a late-stage immunotherapy company dedicated to transforming immune system responses to cancer [4] - The company is advancing its lead program, PDS0101, in pivotal clinical trials for treating advanced HPV16-positive head and neck squamous cell cancers [5] Clinical Data Presentation - The NCI will present three abstracts at SITC, including: 1. Early changes in serum proteomic profiles predicting anti-tumor activity in patients with advanced HPV-associated malignancies [3] 2. A tumor-targeting IL-12 immunocytokine therapy that increases peripheral natural killer (NK) cells associated with enhanced tumor cell lysis [3] 3. Increases in peripheral memory T cells with self-renewing properties in patients treated with IL-12 immunocytokine therapy [3] Leadership Commentary - The CEO of PDS Biotechnology expressed optimism about the collaboration with NCI and the potential of their platforms to enhance immune system recognition and elimination of cancer [2]

Not for distribution by US newswire or in United States NESS-ZIONA, ISRAEL, Oct. 29, 2025 (GLOBE NEWSWIRE) -- VAXIL BIO LTD. (“Vaxil” or the “Company”) (TSX VENTURE: VXL), is pleased to announce that the Company intends to complete a non-brokered private placement on a commercially reasonable efforts basis (the "Offering") of up to 2,456,140 units ("Units") of the Company at a price of $0.1425 per Unit to raise gross proceeds of up to $350,000. Each Unit will consist of one common share of the Company ("Sha ...

Core Insights - PDS Biotechnology Corporation is seeking an expedited approval pathway from the FDA for its immunotherapy PDS0101 targeting HPV16-positive head and neck cancer, projected to be the most prevalent type of head and neck cancer in the US by the mid-2030s [1][2] Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on innovative cancer treatments, particularly through its lead program PDS0101, which is being developed in combination with standard immune checkpoint inhibitors [4] Clinical Trials - The VERSATILE-002 trial has shown promising results, reporting a median overall survival (mOS) of 39.3 months and a median progression-free survival (PFS) of 6.3 months, leading to a proposed amendment in the ongoing VERSATILE-003 trial to include PFS as an earlier primary endpoint [1][2][3] - The VERSATILE-002 trial is an open-label, multi-center Phase 2 study evaluating the safety and efficacy of PDS0101 in combination with pembrolizumab for patients with unresectable, recurrent, or metastatic HPV16-positive head and neck cancer [3] Regulatory Strategy - The company plans to meet with the FDA to discuss changes to the current trial protocol, aiming to shorten the trial duration by making PFS an earlier primary endpoint, which could facilitate an accelerated approval submission [1][2]

Core Insights - Immutep Limited is advancing its clinical trials for eftilagimod alfa (efti) in oncology and autoimmune diseases, with significant progress reported in multiple trials [2][3][31] Oncology Development Programs - The TACTI-004 (KEYNOTE-F91) Phase III trial for advanced non-small cell lung cancer (NSCLC) is ongoing, with over 100 clinical sites activated across 24 countries, aiming to enroll approximately 756 patients [3][4] - The trial has successfully enrolled and randomized over 170 patients, surpassing the number required for a futility analysis, which is expected to be completed in Q1 CY2026 [6] - Positive feedback from the FDA has been received regarding the late-stage clinical development of efti for head and neck cancer patients with low PD-L1 expression [9][11] - The INSIGHT-003 Phase I trial is also evaluating efti in combination with KEYTRUDA® and chemotherapy for non-squamous NSCLC, with data presented at ESMO 2025 [7][8] Soft Tissue Sarcoma and Breast Cancer Trials - The EFTISARC-NEO Phase II trial for soft tissue sarcoma has met its primary endpoint, showing significant tumor hyalinization compared to historical data [16] - The AIPAC-003 trial for metastatic breast cancer has enrolled 71 patients, with ongoing follow-up and data analysis expected to be reported at the San Antonio Breast Cancer Symposium in December 2025 [17][19] Financial Position - As of September 30, 2025, Immutep reported a strong cash position of approximately A$109.85 million, consisting of A$83.41 million in cash and cash equivalents and A$26.44 million in term deposits [27] - The net cash used in R&D activities during Q1 FY26 was A$15.83 million, reflecting increased clinical trial activities [28] Intellectual Property Developments - Immutep was granted four new patents during the quarter, enhancing its intellectual property portfolio related to LAG-3 and its therapeutic applications [24]

From @WSJopinion: If Marty Makary and Vinay Prasad really want to prove they’re not impeding life-saving treatments, they’ll approve Replimune’s RP1 immunotherapy for metastatic melanoma, which the agency rejected this summer https://t.co/cDT7st0w6w ...

Core Points - Corvus Pharmaceuticals, Inc. will host a conference call and webcast on November 4, 2025, at 4:30 pm ET to provide a business update and report third quarter 2025 financial results [1] - The conference call can be accessed via a toll-free number or through a link for instant access, with a replay available for 90 days on the company's website [2] - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on ITK inhibition for immunotherapy targeting various cancers and immune diseases, with its lead product candidate being soquelitinib [3]

Regeneron Corporate Presentation O C T O B E R 2 0 2 5 This non-promotional presentation contains investigational data as well as forward-looking statements; actual results may vary materially. Note regarding forward-looking statements and non-GAAP financial measures This presentation includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may ...

Core Insights - The combination of pelareorep and atezolizumab achieved a 30% objective response rate (ORR) in patients with second-line or later squamous cell anal carcinoma (SCAC), significantly higher than the historical benchmark of 13.8% for the only FDA-approved treatment [1][2] - The median duration of response for this combination therapy was 15.5 months, compared to 9.5 months for the current standard of care [3] - Oncolytics Biotech plans to discuss a single-arm accelerated approval study with the FDA in Q1 2026 [1][6] Efficacy Results - Among 20 evaluable patients, six achieved a response, resulting in a 30% ORR, which is more than double the historical benchmark [2] - Two durable complete responses were observed, with one lasting over two years and another lasting 15 months; an additional patient has an ongoing response at 64 weeks [3] - The results indicate the potential for pelareorep to provide durable immunologic tumor control in gastrointestinal tumors without chemotherapy [4] Company Strategy - The SCAC cohort is part of the broader GOBLET study, which evaluates pelareorep in combination with checkpoint inhibitors and standard therapies across multiple gastrointestinal cancer indications [5] - Oncolytics intends to engage with the FDA regarding a potential single-arm study for accelerated approval in SCAC, with a possible launch in the first half of 2026 [6] - The GOBLET study includes multiple treatment groups targeting various gastrointestinal cancers, assessing both efficacy and safety [7][8] Company Background - Oncolytics Biotech is a clinical-stage biotechnology company focused on developing pelareorep, an investigational immunotherapeutic agent designed to activate immune responses against cancer [10] - The company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in various cancer types, including pancreatic and breast cancers [11]

Core Insights - AlphaTON Capital Corp and its subsidiary Cyncado Therapeutics presented new findings at the AACR-NCI-EORTC conference, demonstrating that selective adenosine A2B receptor inhibition has a direct anti-tumor effect in mesothelioma cells, reducing PD-L1 expression and modulating YAP signaling [1][2][3] Clinical Development - The new data supports the efficacy of Cyncado's selective A2B receptor antagonist TT-4, which showed better monotherapy activity than anti-PD-1 and improved tumor control when combined with anti-PD-1, leading to increased immune infiltration [2][3] - TT-4 is advancing towards first-patient dosing expected in Q1 2026, with a focus on translating these findings into clinical applications [4][10] Research Collaboration - The research was conducted in collaboration with the Italian Group for Mesothelioma and other institutions, highlighting the importance of partnerships in advancing cancer therapeutics [1][5] Mechanistic Insights - In human mesothelioma models, hypoxia-linked adenosine signaling was found to increase tumor growth and PD-L1 expression, while selective A2B receptor inhibition effectively reduced cell growth and PD-L1 protein levels [3][4] - In vivo studies demonstrated that TT-4 significantly inhibited tumor growth in immunocompetent models, further enhanced by combination therapy with anti-PD-1 [3][4] Company Overview - AlphaTON Capital is focused on building a strategic reserve of TON tokens and developing the Telegram ecosystem, providing institutional-grade exposure to the TON ecosystem while maintaining transparency as a Nasdaq-listed company [6][7] - Cyncado Therapeutics is developing small molecule adenosine receptor antagonists targeting A2A and A2B receptors to overcome immune suppression in oncology, with TT-4 being the lead program [10]

Core Insights - AlphaTON Capital Corp. has appointed Wes Levitt as Chief Financial Officer, effective immediately, to support its growth in the TON ecosystem and digital asset markets [1][2]. Company Overview - AlphaTON Capital is a specialized digital asset treasury company focused on building and managing a strategic reserve of TON tokens and developing the Telegram ecosystem [5][6]. - The company implements a comprehensive treasury strategy that includes direct token acquisition, validator operations, and strategic ecosystem investments to generate sustainable returns for shareholders [5]. Leadership and Strategy - Wes Levitt brings extensive experience in finance, investment management, and blockchain strategy, having previously served as Co-CIO at Alpha Sigma Capital Advisors and Head of Strategy at Theta Labs [2][3]. - In his new role, Levitt will oversee finance, accounting, and capital markets operations, while also supporting strategic initiatives to enhance AlphaTON's position within the TON ecosystem [4]. Business Activities - AlphaTON's activities include network validation, staking operations, and the development of Telegram-based applications, as well as potential investments in TON-based decentralized finance protocols and gaming platforms [6]. - The company is also involved in advancing therapies targeting checkpoint resistance pathways, contributing to drug development and strategic counsel for immunotherapy assets [7].