AI just found a new cancer treatment method that has never been discovered beforeA novel cancer discovery from an LLMDoomers in shamblesprinz (@deredleritt3r):Just to recap:We found out today that an LLM that fits on a high-end consumer GPU, when trained on specific biological data, can discover a novel method to make cancer tumors more responsive to immunotherapy.Confirmed novel discovery (not present in existing literature). ...

Core Insights - Regeneron Pharmaceuticals announced new data from the Phase 3 C-POST trial for Libtayo (cemiplimab), focusing on a patient-centric every 6-week dosing regimen for high-risk cutaneous squamous cell carcinoma (CSCC) [1][2] Group 1: Clinical Data and Trial Results - The C-POST trial data will be presented at the ESMO 2025 Meeting, highlighting the efficacy and safety of Libtayo as an adjuvant treatment for CSCC [1][2] - Patients in the trial initially received 350 mg of Libtayo every 3 weeks for 12 weeks, with most switching to every 6-week dosing thereafter, while the safety profile remained consistent with previous findings [2] Group 2: Regulatory and Approval Status - The new data supports the FDA approval of Libtayo as the first immunotherapy for adjuvant treatment of adult patients with high-risk CSCC following surgery and radiation [2] Group 3: Company Overview and Pipeline - Regeneron is focused on developing therapies for over 30 types of solid tumors and blood cancers, with nearly half of its pipeline dedicated to oncology assets [6][26] - Libtayo is a fully human monoclonal antibody targeting the PD-1 immune checkpoint, approved in over 30 countries for various indications, including advanced CSCC and non-small cell lung cancer [8][9]

, /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys") and SpayVac for Wildlife, Inc. are pleased to announce that results from a collaborative research project conducted in the Bavarian Forest National Park in Germany have recently been published in the European Journal of Wildlife Research. A single-dose of its immunocontraceptive vaccine SpayVacâ"¢ vaccine ("SpayVac") significantly reduced fertility to 11% in vaccinated deer compared to a fertility rate of 86% in ...

Core Insights - Immutep Limited has received positive feedback from the FDA regarding the completion of Project Optimus and has agreed on 30mg as the optimal biological dose for eftilagimod alfa (efti) [1][2] Company Overview - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, particularly leveraging Lymphocyte Activation Gene-3 (LAG-3) [5] Clinical Development - The agreement on efti's optimal biological dosing is strategically important for ongoing and future clinical development, including the TACTI-004 (KEYNOTE-F91) Phase III trial, which evaluates efti in combination with KEYTRUDA and chemotherapy for advanced or metastatic non-small cell lung cancer [2][4] - The TACTI-004 trial is currently in the process of opening clinical sites in the United States [7] Efti Overview - Efti is a novel immunotherapy that activates antigen-presenting cells via the MHC Class II pathway, engaging both the adaptive and innate immune systems to initiate a broad anti-cancer immune response [3] - Efti is being evaluated for various solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, soft tissue sarcoma, and breast cancer, and has received Fast Track designation from the FDA for first-line treatments in HNSCC and NSCLC [4]

Core Insights - BriaCell Therapeutics Corp. is presenting positive clinical biomarker data from its pivotal Phase 3 study of Bria-IMT combined with an immune checkpoint inhibitor in metastatic breast cancer at the ESMO Congress 2025 [1][2] Study Details - The Phase 3 study involves randomizing patients in a 1:1:1 ratio to receive Bria-IMT plus CPI, Physician's Choice, or Bria-IMT monotherapy [2] - As of the abstract submission, data from 68 evaluable patients, with a median of 6 prior lines of treatment (ranging from 2 to 13), has been collected [2] Clinical Efficacy - Significant improvement in progression-free survival (PFS) was observed in biomarker-positive subgroups who developed an immune response to Bria-IMT, with a p-value of 0.0002 [3][9] - Positive delayed-type hypersensitivity (DTH) was significantly associated with longer PFS in a blinded analysis of current Phase 3 patients [9] Tolerability Profile - Bria-IMT was well tolerated, with no treatment-related discontinuations due to adverse events (AEs) [3] - The most common AEs reported were fatigue (22.8%), anemia (22.8%), and nausea (21.5%) [3] Future Analysis - Interim data will be analyzed once 144 patient events (deaths) occur, focusing on overall survival (OS) as the primary endpoint [5] - Positive results could lead to full approval and marketing authorization for Bria-IMT in metastatic breast cancer patients [5] Regulatory Status - The Bria-IMT combination regimen has received FDA Fast Track designation, indicating its potential significance in treating metastatic breast cancer [5]

Core Insights - Precigen, Inc. announced long-term follow-up data showing durable responses to PAPZIMEOS (zopapogene imadenovec-drba) for adults with recurrent respiratory papillomatosis (RRP), presented at the AAO-HNSF 2025 Annual Meeting [1][3] - PAPZIMEOS is the first and only FDA-approved therapy for RRP, granted full approval in August 2025 [1][7] Efficacy and Safety - The pivotal study for PAPZIMEOS met primary safety and efficacy endpoints, with 51% of patients achieving complete response, requiring no surgeries in the 12 months post-treatment [2][5] - Long-term follow-up data indicated that 83% of complete responders maintained their response with a median follow-up of 36 months, and no new safety events were observed [5][6] Impact on Patients and Healthcare System - Durable responses from PAPZIMEOS lead to fewer surgical procedures, reducing complications and long-term healthcare burdens [3] - The percentage of patients experiencing a reduction in surgeries compared to the year prior to treatment was 86% in Year 1, 91% in Year 2, and 95% in Year 3 [5][6] Background on RRP - RRP is a rare disease caused by chronic HPV 6 or HPV 11 infection, leading to severe complications and requiring repeated surgeries, which can significantly impact patients' quality of life [4] - Approximately 27,000 adult RRP patients are estimated to be in the US, highlighting the unmet medical need for effective treatments [4]

Core Insights - Immutep Limited is advancing its TACTI-004 Phase III trial for eftilagimod alfa (efti) in combination with KEYTRUDA and chemotherapy for advanced non-small cell lung cancer (NSCLC) [1][4] Company Updates - The TACTI-004 trial has enrolled over 170 patients, surpassing the required number for a futility analysis [2][8] - There are now over 100 active clinical trial sites across 24 countries, indicating strong recruitment momentum [2][8] - The futility analysis is scheduled for the first quarter of CY2026, to be conducted by an independent data monitoring committee [3][8] Product Information - Efti is a first-in-class MHC Class II agonist that activates antigen-presenting cells to enhance anti-cancer immune responses [10][11] - The trial aims to enroll approximately 756 patients, focusing on those with advanced or metastatic NSCLC without specific genomic aberrations [7][9] Market Context - Lung cancer is the leading cause of cancer-related deaths, with an expected increase to approximately 3 million cases globally by 2030 [5] - NSCLC accounts for about 80-85% of lung cancer diagnoses, highlighting a significant unmet need for effective treatment options [5]

Core Insights - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial FLAMINGO-01 to Austria, which is aimed at evaluating GLSI-100, an immunotherapy for preventing breast cancer recurrences [1][2] Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy targeting breast cancer recurrences in patients post-surgery [6] - The company has initiated the FLAMINGO-01 trial, which is designed to assess the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients [4][6] Clinical Trial Details - FLAMINGO-01 is a Phase III trial that includes sites in the US and Europe, with plans to expand to 150 sites globally [4] - The trial will randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types [4] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [4] Market Context - In Austria, breast cancer is the most common cancer among women, accounting for about 28% of all female cancers, with 6,070 new cases diagnosed in 2022 [3] - Breast cancer was the leading cause of cancer-related deaths in women in Austria, with 1,789 deaths reported in 2022 [3] Collaboration and Expansion - The company is collaborating with principal investigators at Ordensklinikum Linz in Upper Austria, with plans to activate this site within the year and explore additional sites in Vienna and Salzburg [4]

Approval based on pivotal Phase 3 C-POST trial showing Libtayo significantly reduced the risk of disease recurrence or death by 68% compared to placebo (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001), the primary endpoint of the trial Libtayo is the current standard of care in advanced CSCC; approval has the potential to change the treatment paradigm for patients in an earlier setting TARRYTOWN, N.Y., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today ...

Core Insights - Roche's immunotherapy drug Tecentriq has received FDA approval for label expansion, allowing its use in combination with Jazz Pharmaceuticals' Zepzelca for maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC) [1][2][9] Group 1: FDA Approval and Clinical Impact - The FDA approved Tecentriq and Tecentriq Hybreza in combination with Zepzelca for adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy [2][9] - This approval represents the first and only combination therapy for first-line maintenance treatment of ES-SCLC [3] - The IMforte study demonstrated that the combination therapy reduced the risk of disease progression or death by 46% and the risk of death by 27% compared to Tecentriq alone, with median overall survival of 13.2 months versus 10.6 months [6][9] Group 2: Market Performance and Sales - Roche's shares have increased by 32.5% year to date, outperforming the industry growth of 10.7% [5] - Tecentriq sales reached CHF 1.7 billion in the first half of 2025, contributing to the overall growth in Roche's Pharmaceuticals Division, which saw a 10% increase in sales to CHF 24 billion [10][11] Group 3: Strategic Acquisitions and Pipeline Developments - Roche announced the acquisition of clinical-stage biopharmaceutical company 89bio, Inc. for $3.5 billion, aimed at enhancing its portfolio in cardiovascular, renal, and metabolic diseases [12] - The acquisition will incorporate 89bio's pegozafermin, currently in late-stage development for metabolic dysfunction-associated steatohepatitis [13] Group 4: Challenges and Setbacks - Despite strong performance in key areas, Roche faces pipeline setbacks, including the failure of the phase III ARNASA study for astegolimab in chronic obstructive pulmonary disease [14] - The performance of Roche's Diagnostics division has also been disappointing [15]