Core Insights - IMUNON, Inc. is making significant progress towards a potential breakthrough in ovarian cancer treatment with its immunotherapy candidate IMNN-001, as evidenced by advancements in the Phase 3 OVATION 3 Study and promising data from the MRD study [1][2][3] Group 1: Clinical Progress - The Phase 3 OVATION 3 Study is evaluating IMNN-001 in combination with standard chemotherapy for newly diagnosed advanced ovarian cancer, with strong enrollment interest from the medical community [2] - IMNN-001 demonstrated a 13-month extension in median overall survival (OS) in the Phase 2 OVATION 2 Study, with a hazard ratio of 0.70, and patients receiving PARP inhibitors showed a median OS not yet reached after over 31 months of follow-up [2] - The ongoing MRD study shows lower MRD positivity rates and higher complete response scores with IMNN-001 compared to the control arm, indicating its potential effectiveness [4] Group 2: Mechanism of Action - IMNN-001 induces IL-12 production in macrophages, enhancing T cell cytotoxic functions and remodeling the tumor microenvironment to activate both innate and adaptive immune systems [7][8] - The treatment leads to a more inflamed tumor microenvironment, effectively converting "cold" tumors to "hot" tumors, which is crucial for immunotherapy effectiveness [7] Group 3: Financial and Strategic Position - The company maintained financial discipline in 2025, with an estimated $30 million budget for the OVATION 3 trial, focusing on the HRD+ subgroup [9] - Cost reductions from cGMP-compliant manufacturing may lead to high gross margins upon potential FDA approval, reflecting growing confidence from institutional investors [9] Group 4: Future Outlook - IMUNON is poised for key milestones in 2026, including continued enrollment in OVATION 3 and potential early stopping for BLA filing in the HRD+ population [10] - The company anticipates additional data presentations and progress on business development initiatives, with Fast Track and Orphan Drug designations in place [10]

Tiziana reports excellent safety profile with intranasal foralumab after 37.4 patient-years cumulative exposureFDA denial of Sanofi’s tolebrutinib for nrSPMS shows need for safe therapy BOSTON, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana”), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces the submission of its seventh annual Development Safety Update Report (DSUR) to the U.S. Food an ...

NEW YORK, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, today announces it has entered into a $6 million securities purchase agreement with investor, David E. Lazar, for the purchase of non-voting convertible preferred stock of the Company. Mr. Lazar has been appointed Indaptus’ Co-Chief Executive Officer and Chairman of the Board. Jef ...

STAFFORD, Texas, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that its Board of Directors has extended the lock-up of the shares owned by the Company's directors, officers, and existing pre-IPO investors to September 30, 2026 which is approxi ...

BRIACELL THERAPEUTICS CORP. (Exact name of registrant as specified in its charter) British Columbia 2834 47-1099599 As filed with the U.S. Securities and Exchange Commission on December 23, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 (State or other jurisdiction of incorporation or organization) (Primary standard industrial classification code number) (I.R.S. employer identification numbe ...

Key Takeaways BD partners with Penn Institute to study 1,000 people, analyzing over 30 immune cell functions in whole blood.The study uses the BD FACSDiscover A8 and Rhapsody systems to decode complex single-cell immune data.The collaboration strengthens BD's focus on advanced flow cytometry and immune profiling research.Becton, Dickinson and Company (BDX) , popularly known as BD, recently announced a collaboration with the Institute for Immunology and Immune Health (I3H) at the University of Pennsylvania t ...

Core Viewpoint - Greenwich LifeSciences, Inc. is advancing its Phase III clinical trial, FLAMINGO-01, for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with updates on clinical, financing, and partnering strategies [1][2]. Clinical Strategy - The FLAMINGO-01 clinical strategy is evolving to reduce risk and enhance marketing approval chances, supported by financing strategies and cost reduction activities [2] - Approximately 140 sites are currently enrolling patients, with plans to activate an additional 10 sites in 2026 and expand to more EU countries [2] - The study has shifted from principal investigator interest to patient-driven interest, with wait lists forming at certain sites [2] - Discussions are ongoing with clinical sites in the UK and Canada for potential study participation, pending regulatory approvals [2] Financing Strategy - The company is utilizing an At-The-Market (ATM) financing strategy to manage its burn rate, which was approximately $7 million annually in 2023 and 2024 [2] - The burn rate for the first three quarters of 2025 remains around $7 million, indicating a gradual increase but not substantial due to cost-saving initiatives [2] - The upfront costs of clinical expenses are expected to decrease after the initial six months of vaccinations, as booster shots will be administered every six months [2] Partnering Strategy - The company is actively attending partnering conferences to explore collaborations with larger pharmaceutical companies in the breast cancer drug market [2] - Patent filings for GLSI-100 are expected to strengthen its patent portfolio, enhancing its market position [2] FLAMINGO-01 Data Monitoring - The Data Safety Monitoring Board (DSMB) has recommended continuing the FLAMINGO-01 study without modifications, indicating confidence in the current trial design [3] - The Steering Committee has endorsed planned modifications to the study, pending regulatory approval [3] Open Label Phase III Data - Over 1,000 patients have been screened, with a current screening rate of approximately 600 patients per year [4] - The non-HLA-A*02 arm is fully enrolled with 250 patients, significantly increasing the treated patient data compared to the Phase IIb trial [4] - The Primary Immunization Series (PIS) consists of six initial injections followed by five booster injections every six months to maintain immune response [4] Preliminary Analysis - Preliminary analysis shows an approximately 80% reduction in recurrence rates in the non-HLA-A*02 arm after completing the PIS, aligning with Phase IIb trial results [7] - The immune response and safety profile in the non-HLA-A*02 patients are trending similarly to the HLA-A*02 arms of FLAMINGO-01 [7] About GLSI-100 - GLSI-100 is designed for HER2 positive breast cancer patients who have undergone surgery, with the trial led by Baylor College of Medicine and plans to expand to 150 sites globally [9] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [9]

Core Insights - The FDA's recent approval of the first bispecific antibody combination for second-line blood cancer treatment signifies a major shift from traditional chemotherapy, with engineered cell therapies and bispecific antibodies achieving response rates over 90% in relapsed and refractory hematologic malignancies [1][2] Company Developments - GT Biopharma, Inc. is advancing its Phase 1 clinical trial of GTB-3650 to Cohort 4, with patients receiving a dose of 10 µg/kg/day, focusing on relapsed or refractory blood cancers expressing CD33, particularly acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) [3][4][6] - The therapy utilizes the patient's natural killer cells to target cancer cells, with treatment structured in two-week cycles followed by rest intervals, continuing for up to four months based on patient response [5][6] - The current dose in Cohort 4 is seen as a threshold for potential clinical efficacy, supported by positive immunological biomarker trends and no dose-limiting toxicities reported across previous cohorts [6][7] - GT Biopharma is also developing GTB-5550, targeting B7H3 in various solid tumors, with regulatory submission for human trials expected in late December 2025 or January 2026 [8][9] Market Trends - The CAR-T cell therapy market is projected to grow from $3.87 billion in 2024 to $13.25 billion by 2030, driven by its efficacy in treating relapsed and refractory patient populations [2]

Core Insights - SAB Biotherapeutics, Inc. has initiated dosing of the first patient in the Phase 2b SAFEGUARD clinical trial for SAB-142, a treatment aimed at delaying the progression of type 1 diabetes (T1D) [1][2] Company Overview - SAB Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing human anti-thymocyte immunoglobulin (hATG) for T1D and other autoimmune diseases [1][5] - The company's lead candidate, SAB-142, is designed as a disease-modifying immunotherapeutic approach to treat stage 3 T1D [4][5] Clinical Trial Details - The SAFEGUARD trial is a double-arm, multi-center Phase 2b study assessing the safety, efficacy, and tolerability of SAB-142 in patients with stage 3 new onset T1D [3] - The trial consists of two parts: Part A is a dose-ranging study in adults, while Part B is a randomized double-blind, placebo-controlled study [3] - Patients will receive two SAB-142 infusions six months apart, with all participants eligible for a 12-month long-term extension study upon completion [3] Treatment Mechanism - SAB-142 is a multi-specific, fully human anti-thymocyte globulin that targets immune cells involved in the destruction of pancreatic beta cells, potentially preserving insulin-producing cells [4] - The treatment aims to modulate "bad acting" T-lymphocytes, such as cytotoxic T-cells, to prevent them from attacking beta cells [4] Future Outlook - The company is focused on rapid enrollment for the SAFEGUARD trial, with multiple sites activated globally, including in the U.S., Australia, and New Zealand [2][6] - SAB Biotherapeutics plans to share Phase 2b data in the second half of 2027 [6]

Core Insights - BriaCell Therapeutics Corp.'s Phase 3 Bria-IMT™ clinical trial in metastatic breast cancer has been highlighted in Nature Medicine's Year In Review as a significant trial to watch in 2026 [1][8] Group 1: Clinical Trial Details - The BRIA-ABC trial aims to evaluate the effectiveness of Bria-IMT, a new cell-based immunotherapy, in improving outcomes for patients with metastatic breast cancer who have undergone multiple prior treatments [2][3] - The trial is inclusive, allowing participation from individuals with all breast cancer subtypes, including those with brain metastases and extensive prior treatments [2] - BriaCell has screened over 230 patients and enrolled more than 160 patients to date, with interim data analysis planned once 144 patient events occur [4] Group 2: Regulatory and Market Implications - Positive results from the Phase 3 study could lead to full approval and marketing authorization of Bria-IMT for metastatic breast cancer patients [4] - The Bria-IMT combination regimen has received FDA Fast Track designation, which may expedite its development and review process [4]