Core Insights - TG4050 demonstrates strong potential as an individualized cancer immunotherapy, showing 100% two-year disease-free survival in patients with operable head and neck cancers [3][5][8] Clinical Trial Results - The Phase I/II trial of TG4050 involved patients with HPV-negative head and neck squamous cell carcinoma (HNSCC), where one-third of patients typically experience recurrence within two years post-surgery [3] - Half of the participants received TG4050 immediately after primary adjuvant treatment, while the other half received it at the time of disease recurrence [4][16] - The trial results indicate that TG4050 can prevent cancer relapses when used as monotherapy in high-risk, resected, locally advanced HPV-negative HNSCC patients [5] Immunogenicity and T-cell Responses - TG4050 induced neoantigen-specific T-cell responses in 73% of evaluable patients, with these responses being durable for up to one year post-treatment [6][7] - The vaccine was well-tolerated, showing no unexpected safety signals, reinforcing its potential for further development [5][8] Publication and Transparency - The results of the Phase I trial have been published on medRxiv, emphasizing the company's commitment to transparency and scientific rigor [2][8] - The findings are currently under evaluation for publication in a peer-reviewed journal [2] Future Developments - TG4050 is undergoing further evaluation in a randomized Phase I/II clinical trial (NCT04183166), with first immunogenicity data from the Phase II part expected in the second half of 2026 [7][16]

撰文丨王聪 编辑丨王多鱼 排版丨水成文 三级淋巴结构 （TLS） 通过高效呈递肿瘤抗原并迅速激活效应免疫细胞来增强抗肿瘤免疫。近期的研究阐明了 TLS 所驱动的抗肿瘤免疫反应及其在癌症免疫治 疗中的关键预后价值。这些发现促使我们利用肿瘤突变负荷的免疫原性作用来探索下一代癌症免疫疗法。然而，许多实体瘤缺乏可检测到的肿瘤浸润淋巴细胞 区，尤其是在对免疫治疗无响应的癌症中。 缺乏肿瘤浸润淋巴细胞表明肿瘤微环境免疫原性低，并导致预后不良。因此，关键的挑战在于明确驱动 TLS 形成的机制，并开发诱导 TLS 的策略，以用于抗肿 瘤免疫疗法。 2026 年 1 月 8 日，中山大学孙逸仙纪念医院 林天歆 教授、 陈长昊 教授作为共同通讯作 者 （ 陈长昊 、 安明杰 、 郑汉豪 、 庞明睿 、 李元龙 为共同第一作 者 ） 在 Cancer Cell 期刊 发表了题为： B cells disrupt tertiary lymphoid structure formation and suppress anti-tumor immunity 的研究论文。 该研究揭示了 B 细胞 破坏 三级淋巴结构 （TLS） 形成并抑制 ...

Vancouver, British Columbia--(Newsfile Corp. - January 8, 2026) - BioVaxys Technology Corp. (CSE: BIOV) (FSE: 5LB0) (OTCQB: BVAXF) ("BioVaxys" or the "Company"), a clinical stage biotechnology company focused on developing advanced treatments in oncology, infectious disease, allergy, and other immune diseases based on its DPX™ antigen delivery and immune-educating technology platform, is pleased to announce highly promising results from a two-arm phase 1 clinical study of the safety and immunogenicity of b ...

Fiscal Full Year 2025 Financial Highlights About Citius Oncology, Inc. Launched LYMPHIRâ"¢ (denileukin diftitox-cxdl), a novel IL2 receptor-directed immunotherapy, in the U.S. in December 2025 for the treatment of adult patients with relapsed or refractory Stage I–III cutaneous Tcell lymphoma (CTCL) after at least one prior systemic therapy; Executed service agreements with the three leading U.S. pharmaceutical wholesalers to distribute LYMPHIR to healthcare organizations, including major medical centers an ...

Subsidiary, Citius Oncology, launches cancer immunotherapy, LYMPHIRâ"¢, in the U.S. in December 2025 CRANFORD, N.J., Dec. 23, 2025 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal year ended September 30, 2025. "2025 was a pivotal year for Citius as we successfully launched LYMPHIR f ...

LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced the publication of clinical results from the ovarian cancer cohort of its Phase 1b C- 800-01 trial evaluating botensilimab plus balstilimab (BOT+BAL) in The Journal for ImmunoTherapy of Cancer (JITC). These results offer a meaningful signal of clinical activity for women with platinum-refractory ovarian cancer...Botensilimab's unique immune activation profile translated into clinically sign ...

Core Insights - Fapon Biopharma has published pioneering research on FP008, a novel bifunctional fusion protein designed to enhance cancer immunotherapy by reactivating exhausted T cells within tumors [1][2] Group 1: Product Development - FP008 is a first-in-class fusion protein combining anti-PD-1 and engineered IL-10M, aimed at overcoming limitations in current cancer therapies [1] - The engineered IL-10M shows a significant reduction in toxicity compared to traditional IL-10, enabling targeted delivery to PD-1-positive exhausted CD8 T cells [2] - FP008 has demonstrated robust anti-tumor activity in multiple mouse tumor models, including those resistant to anti-PD-1 therapy, by reversing T cell exhaustion [3] Group 2: Safety and Efficacy - Comprehensive GLP toxicology studies in cynomolgus monkeys indicate a favorable safety profile for FP008 at doses up to 10 mg/kg, with no significant hematological adverse events [4] - The innovative "cis-delivery" mechanism of FP008 mitigates systemic toxicity while potentially enhancing anti-tumor immune responses [2] Group 3: Regulatory Progress - FP008 has cleared Investigational New Drug (IND) applications with both the U.S. FDA and China NMPA, with a Phase I clinical trial currently ongoing [5] - The readout from the Phase I clinical trial is expected later this year, marking a significant step in the development of therapies for patients with advanced solid tumors [5] Group 4: Company Overview - Fapon Biopharma specializes in developing biologics for cancer treatment and other diseases with unmet medical needs, utilizing advanced drug discovery platforms [6] - The company is committed to delivering safer, more efficacious, and accessible biologics through innovative research and development [6]

HOLON, Israel, Dec. 17, 2025 /PRNewswire/ -- Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN) a clinical- stage cancer immunotherapy company and a pioneer in predictive computational target discovery powered by AI/ML, today announced that it has agreed with AstraZeneca to monetize a portion of Compugen's rilvegostomig future royalties. Compugen has amended the exclusive license agreement with AstraZeneca, previously entered into in March 2018, to strengthen Compugen's balance sheet and advance its innovative and d ...

Core Viewpoint - OS Therapies Inc. has made significant progress in discussions with the FDA regarding the Phase 2b clinical trial of its lead product candidate, OST-HER2, for the treatment of recurrent pulmonary metastatic osteosarcoma, with plans to submit a Biologics Licensing Application (BLA) by the end of January 2026 [1][2][7]. Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, leading in listeria-based cancer immunotherapies [4]. - OST-HER2 is an innovative immunotherapy that utilizes a bioengineered form of Listeria monocytogenes to elicit a strong immune response against cancer cells expressing HER2 [2][4]. FDA Meeting Highlights - The FDA confirmed that data from single-arm studies in ultra-rare pediatric cancer osteosarcoma could support a BLA under the Accelerated Approval Program [7][8]. - The FDA suggested a confirmatory study design that includes additional osteosarcoma disease settings, such as the prevention of recurrence following primary tumor resection [7][8]. - The FDA indicated that the use of canine data to support the correlation between immune biomarker activation and clinical benefit will depend on the chosen biomarkers and their clinical validation [7][8]. Upcoming Milestones - The company expects to complete the immune activation biomarker analysis soon, with data to be released during the JP Morgan Healthcare Conference in January 2026 [2][3]. - Following the BLA submission, the company plans to hold additional meetings with the FDA to review biomarker data and confirmatory study design [2][3][7].

Core Insights - TuHURA Biosciences is advancing its Phase 3 program of IFx-2.0 as an adjunctive therapy with Keytruda® for advanced Merkel cell carcinoma, with enrollment completion targeted for Q4-2026 [1][13] - The company raised $15.6 million in a recent equity financing transaction, providing a cash runway to achieve key milestones across its development programs [1][2] - A mini KOL symposium highlighted the potential of targeting VISTA in acute myeloid leukemia (AML) and the combination with menin inhibitors for NPM1 mutated relapsed/refractory AML [1][3] Company Developments - The Phase 3 trial of IFx-2.0 has been initiated, marking a significant step in the company's strategy to address resistance to cancer immunotherapy [2][13] - The merger with Kineta has added a Phase 2 ready VISTA inhibiting antibody to the company's pipeline, enhancing its therapeutic offerings [2][14] - Preliminary data from the IFx-2.0 basket trial and insights on inhibiting Delta Opioid Receptor (DOR) are expected to be presented at scientific conferences in 2026 [3] Clinical Insights - VISTA is identified as the only checkpoint significantly upregulated in AML, particularly in high-risk subtypes, contributing to low response rates in patients treated with menin inhibitors [11] - The combination of TBS-2025 (VISTA inhibiting antibody) with menin inhibitors shows promise in improving survival outcomes in murine models of AML [11] - Key opinion leaders expressed enthusiasm for the potential of TBS-2025 in combination therapies for high-risk AML and patients unfit for intensive treatments [3][11]