BD FACSDiscoverâ"¢ A8 Cell Analyzer to Enable Investigation of 30+ Cellular Characteristics to Capture Key Biological Insights and Support Planned 1,000-Person Immune Profiling Study FRANKLIN LAKES, N.J., Dec. 18, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced a strategic collaboration with the Institute for Immunology and Immune Health (I3H) at the University of Pennsylvania, to advance research in deep human immune profilin ...

Core Viewpoint - BioVaxys Technology Corp. announced positive results from a phase 1 clinical study of maveropepimut-S (MVP-S) combined with neoadjuvant hormone therapy for women with hormone receptor positive HER2 negative (HR+HER2-) stage II-III breast cancer, indicating a promising treatment avenue in this patient population [1][7]. Clinical Study Results - The clinical study showed that MVP-S in combination with letrozole generated a strong immune response in participants with HR+HER2- stage II-III breast cancer [2]. - All three patients in the study experienced at least a 50% decrease in Ki67 levels, a marker for cancer cell proliferation, from a median of 24% before treatment to a median of 6% after treatment [6]. Market Potential - The global market for HER2-negative breast cancer was valued at $14.4 billion in 2024 and is projected to reach $21.5 billion by 2030, with HR+/HER2- tumors representing approximately 57.77% of the total revenue share in 2024 [3]. Technology Platform - BioVaxys' DPX platform is a novel liposome-based delivery system designed to create long-lasting, targeted immune responses without releasing active ingredients at the injection site, enhancing the efficiency of immune cell programming [4]. Future Plans - BioVaxys plans to further evaluate the systemic immunity of MVP-S and conduct expanded profiling of biopsy samples compared to post-treatment surgical samples, aiming to pursue a phase II study to modify the tumor immune environment in high-risk HR+ breast cancer [7].

Core Insights - Immutep Limited reports significant operational progress in the TACTI-004 Phase III trial for eftilagimod alfa (efti) in combination with KEYTRUDA and chemotherapy for advanced non-small cell lung cancer [1][5] Group 1: Trial Progress - The TACTI-004 trial has enrolled 289 patients, which is over 38% of the targeted 756 patients, with recruitment continuing at a strong pace [2][8] - More than 120 clinical sites have been activated across 27 countries, all of which have received full regulatory approvals [2][8] - The first clinical site in the United States has received regulatory clearance following the FDA's Project Optimus initiative [3] Group 2: Future Milestones - The trial has already enrolled the necessary 170 patients for a futility analysis, which is expected to be conducted in the first quarter of CY2026 [4] - Completion of patient enrollment is anticipated in the third quarter of CY2026 [4] Group 3: Efti Overview - Efti is a first-in-class MHC Class II agonist that activates antigen-presenting cells to initiate a broad anti-cancer immune response [7] - 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 [8][9] Group 4: Company Background - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in LAG-3 therapeutics [10]

Core Insights - BioVaxys Technology Corp. has appointed Dr. Marianne Stanford as Scientific Advisor, bringing extensive experience in vaccine development and immunotherapy [1][4] - Dr. Stanford previously led the R&D at IMV Inc., where she developed the DPX™ vaccine portfolio, demonstrating enhanced efficacy in cancer models through innovative combinations [1][2] - The company focuses on novel immunotherapies using the DPX platform, targeting cancers and infectious diseases, with ongoing clinical trials for multiple products [4] Company Overview - BioVaxys Technology Corp. is a clinical-stage biopharmaceutical company based in British Columbia, Canada, dedicated to developing immunotherapies for various diseases [4] - The DPX platform is designed to generate specific and robust immune responses, with a clinical pipeline that includes MVP-S for advanced cancers and other immunotherapies [4] Dr. Stanford's Background - Dr. Stanford holds a PhD in Microbiology and Immunology and has a strong background in viral immunotherapy and oncology, enhancing her role at BioVaxys [3] - Her previous role as Chief Scientific Officer at Mara Renewables Corp. involved the commercialization of bio-based nutrition products, showcasing her leadership in scientific research [2]

STAFFORD, Texas, Dec. 15, 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 GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced an approximately 80% recurrence rate reduction in the open label non-HLA-A*02 arm of FLAMINGO-01. A preliminary analysis of recurrence rates by two methods to estimate the reduction in recurrence rate s ...

Registration No. 333-[____] UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GEOVAX LABS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 87-0455038 (I.R.S. Employer Identification Number) 1955 Lake Park Drive, Suite 300, Smyrna, Georgia 30080, (678) 384-7220 (Address, includin ...

Core Insights - AC Immune SA has released interim results from the Phase 2 VacSYn trial for its anti-alpha-synuclein immunotherapy ACI-7104.056, indicating potential disease modification in early Parkinson's disease [1][2] - The results show stabilization of disease-related biomarkers, suggesting a slowing of neuronal damage and progression of Parkinson's disease [2][3] Biomarker Results - Elevated levels of neurofilament light (NfL) are associated with neuronal damage; stabilization of NfL levels indicates a potential slowing of neurodegeneration [2] - Plasma glial fibrillary acidic protein (GFAP) and dopamine transporter (DaT) SPECT imaging trends also suggest disease modification [3] Antibody Response - ACI-7104.056 demonstrated a 100% responder rate in generating antibodies against the a-syn target antigen, with serum antibody titers over 500-fold higher than the placebo group at week 76 [3][4] - Antibody responses were boosted with each immunization, and average IgG antibody levels in cerebrospinal fluid (CSF) were also over 500-fold higher than in the placebo group [4] Clinical Measures - Clinical measures of motor symptoms indicate a trend toward stabilization in the active treatment group, with no meaningful progression in the MDS-UPDRS Part III score compared to an expected increase in the placebo group [5][6] - The difference in change from baseline scores between the active treatment and placebo groups was enhanced when stratified by levodopa (L-DOPA) ON/OFF state [6] Safety and Tolerability - Interim results from weeks 50 and 76 show that ACI-7104.056 is generally safe and well-tolerated [6] - Final data from Part 1 of the VacSYn trial are anticipated in mid-2026 [6] Market Reaction - Following the announcement, AC Immune's stock price increased by 12.43%, reaching $3.14 [6]

Summary of Genmab's ASH 2025 Update Company Overview - **Company**: Genmab - **Event**: ASH 2025 update and R&D review Key Highlights 1. **Strategic Acquisitions and Growth** - Genmab proposed the acquisition of Mirus and added Pathosentomab to its portfolio, positioning for sustained growth and long-term value creation [3][4] - The integration of Mirus is a key priority for 2026, with expectations for the transaction to close in Q1 2026 [4] 2. **Pipeline Developments** - Significant progress in the development of RINA-S, with three phase three trials and two phase two potentially registrational trials ongoing [5] - Epcoritamab has shown promising results in various lymphoma settings, with 31 abstracts accepted at ASH, including seven oral presentations [9][10] 3. **Epcoritamab Data** - In the EPCORE FL-1 study, the addition of epcoritamab to R squared resulted in a 79% risk reduction in progression or death, with a hazard ratio of 0.21 [17] - Overall response rate was 95% for the combination versus 79% for R squared alone, with a complete response rate of 83% compared to 50% [18] - The study demonstrated a significant improvement in duration of response, with a hazard ratio of 0.19 [19] 4. **Regulatory Approvals** - Epcoritamab received FDA approval for the treatment of follicular lymphoma after at least one line of therapy [25] - Ongoing global regulatory submissions are expected to be positively received [25] 5. **Future Expectations** - 2026 is anticipated to be a year of important catalysts, including multiple potential registrational data sets for EPCORE, RINA-S, and beta centromere [34] - Genmab aims to advance its evolution into a global biotech leader with a diversified, fully integrated model [35] Industry Context - **Oncology Market** - The oncology community is seeing a shift towards bispecific antibodies like epcoritamab, which offer off-the-shelf solutions and are easier to administer compared to CAR-T therapies [46] - Epcoritamab's subcutaneous administration and manageable safety profile are key differentiators for adoption in community settings [37] Additional Insights - **Safety and Tolerability** - Epcoritamab's safety profile showed manageable adverse events, with no severe cytokine release syndrome reported [21][22] - Proactive management of infections is emphasized, particularly in outpatient settings [23][40] - **Comparative Efficacy** - The discussion around sequencing CAR-T and bispecific therapies indicates that bispecifics may serve as effective bridging therapies before CAR-T cell collection [44] - The potential for improved overall survival with epcoritamab in comparison to existing therapies is a focal point for future studies [51] This summary encapsulates the key points from Genmab's ASH 2025 update, highlighting the company's strategic direction, pipeline advancements, and the evolving landscape of oncology treatments.

Core Insights - BioNTech SE (BNTX) is viewed positively due to the promising prospects of its anti-CTLA4 therapy, Gotistobart, for treating squamous non-small cell lung cancer (NSCLC) [1][2] - The therapy demonstrates a 54% reduction in death risk compared to standard chemotherapy and a survival rate of 63% versus 30% with chemotherapy [1] - The oncology pipeline of BioNTech is considered undervalued, with potential for combination therapies using in-house antibody-drug conjugates [2] Company Overview - BioNTech SE is a German biotechnology firm focused on developing and commercializing innovative immunotherapies and vaccines for cancer and infectious diseases [3] - The company gained recognition for creating the first approved mRNA-based drug, the Pfizer-BioNTech COVID-19 vaccine, branded as Comirnaty [3]

Core Insights - Karolinska Development AB's portfolio company SVF Vaccines has presented promising preclinical data on its immunotherapy SVF-001, targeting hepatitis B and D, at the HepDart scientific meeting [1][3] - The new data indicates sustained antiviral activity of SVF-001, showing reductions in hepatitis D virus RNA in blood for up to six weeks post-treatment [2][4] - Karolinska Development holds a 33% ownership stake in SVF Vaccines, which also includes other vaccine candidates like SVF-002 for COVID-19 [5] Company Overview - Karolinska Development AB is a Nordic life sciences investment company focused on identifying and developing breakthrough medical innovations [6][7] - The company aims to build companies around leading scientists and experienced management teams, co-funded by international investors [7][8] - The portfolio includes eleven companies targeting innovative treatments for serious diseases, emphasizing a strong global network and proven track record in company building [8]