Core Insights - Ivonescimab combined with chemotherapy demonstrated a 40% reduction in the risk of disease progression or death compared to Tislelizumab plus chemotherapy in the first-line treatment of patients with squamous non-small cell lung cancer (NSCLC) in the HARMONi-6 study [1][5][33] - The median progression-free survival (PFS) was 11.14 months for Ivonescimab plus chemotherapy versus 6.90 months for Tislelizumab plus chemotherapy, with a hazard ratio of 0.60 [1][5][6] - The safety profile of Ivonescimab was comparable to Tislelizumab, with similar rates of serious treatment-related adverse events (TRAEs) and discontinuation due to TRAEs [1][7][9] Study Overview - The HARMONi-6 trial was a Phase III, multi-center study conducted in China, evaluating Ivonescimab in combination with platinum-based chemotherapy against Tislelizumab plus chemotherapy in patients with advanced squamous NSCLC, regardless of PD-L1 expression [2][4][33] - The study was sponsored by Akeso, Inc., with all relevant data generated and analyzed by Akeso [2][4] Efficacy Results - Ivonescimab showed a statistically significant improvement in PFS, with a hazard ratio of 0.60 (95% CI: 0.46, 0.78; p<0.0001) [5][6] - The overall response rate (ORR) was 75.9% for Ivonescimab plus chemotherapy compared to 66.5% for Tislelizumab plus chemotherapy [6] - Duration of response (DoR) was also longer for Ivonescimab at 11.20 months versus 8.38 months for Tislelizumab [6] Safety Profile - The safety profile of Ivonescimab was manageable, with 3.4% of patients discontinuing due to TRAEs compared to 4.2% for Tislelizumab [9][11] - Serious TRAEs occurred in 32.3% of patients receiving Ivonescimab and 30.2% for Tislelizumab [11] - Grade 3 or higher immune-related adverse events were reported in 9.0% of Ivonescimab patients versus 10.2% for Tislelizumab [11] Future Studies - The HARMONi-3 global study will analyze squamous and non-squamous NSCLC cohorts separately, with enrollment completion expected in the first half of 2026 for the squamous cohort and the second half of 2026 for the non-squamous cohort [1][19][20] - An interim analysis for overall survival is planned for both cohorts upon reaching the prespecified number of events [19][20] Publication and Presentation - The results of the HARMONi-6 trial were published in The Lancet and presented at the European Society for Medical Oncology (ESMO) 2025 Congress [1][13][24]

As Filed with the Securities and Exchange Commission on October 17, 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 GEOVAX LABS, INC. (Exact name of registrant as specified in its charter) (Primary Standard Industrial Classification Code Number) Delaware 2834 87-0455038 (I.R.S. Employer Identification Number) 1900 Lake Park Drive, Suite 380, Smyrna, Georgia 30080, (678) 384-7220 (Address, incl ...

Core Insights - The interim data from the Phase 1b/2 clinical trial of ciforadenant in combination with ipilimumab and nivolumab shows feasibility and tolerability as a potential first-line therapy for metastatic renal cell cancer (RCC) [1][4][5] Group 1: Trial Overview - The trial enrolled 50 patients with newly diagnosed or recurrent stage IV clear cell RCC, with 8 in Phase 1b and 42 in Phase 2 [2][3] - Patients received ciforadenant 100 mg orally twice daily, ipilimumab 1 mg/kg every three weeks for twelve weeks, and nivolumab 3 mg/kg every three weeks [2] Group 2: Key Findings - The deep response rate was 34%, which is an improvement compared to historical data for the combination of ipilimumab and nivolumab alone [4] - The overall response rate (ORR) was 46%, including two complete responses and 21 partial responses [4] - The median progression-free survival (PFS) was reported at 11.04 months [4] Group 3: Patient Characteristics - The median age of patients in the trial was 61.5 years, with only 54% having undergone prior nephrectomy, indicating more unfavorable disease characteristics [4] - 82% of patients had a poor or intermediate prognosis according to International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria [4] Group 4: Future Directions - The company plans to continue following the 19 patients who remain on therapy to better understand the potential benefits of this treatment approach [2][5]

Core Insights - Sensei Biotherapeutics announced results from the dose expansion portion of its Phase 1/2 trial for solnerstotug, a monoclonal antibody targeting VISTA, at the ESMO Congress 2025 [1][2] Study Design and Patient Population - The Phase 1 dose expansion is a multi-center, open-label study evaluating solnerstotug as monotherapy and in combination with Libtayo, enrolling 44 patients with "hot" tumor types and 20 patients with "cold" tumor types [2] - Among the "hot tumor" patients, 41 had previously received PD-(L)1 therapy and progressed, indicating a challenging prognosis for these patients [3][4] Efficacy Results - In the higher 15 mg/kg dose cohort, the overall 6-month progression-free survival (PFS) rate was 50% among PD-(L)1 resistant patients, which is significantly higher than historical benchmarks [6][7] - Six clinical responses were observed at the 15 mg/kg dose, including five in patients with PD-(L)1 resistant tumors, while no responses were noted at the 3 mg/kg dose [5][6] Safety Profile - Solnerstotug was well tolerated, with only six mild (Grade 1) cytokine release syndrome (CRS) events reported, all manageable [8][9] - The safety profile remains consistent with prior data and compares favorably to other checkpoint inhibitor combinations [8] Future Development Plans - Sensei plans to initiate two Phase 2 studies in 2026, subject to FDA feedback and capital raising, focusing on NSCLC and Merkel Cell Carcinoma [11][12] - The first trial will be a randomized study comparing solnerstotug plus a PD-(L)1 inhibitor against chemotherapy in patients who failed anti-PD-(L)1 treatment [11] - The second trial will be a single-arm study in PD-(L)1 resistant Merkel Cell Carcinoma patients, with potential for accelerated approval [12] Unique Mechanism of Action - The combination of solnerstotug and cemiplimab may demonstrate a unique pattern of delayed, durable responses, indicating a complementary mechanism to PD-(L)1 therapies [10][9]

Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies targeting chronic inflammation and associated diseases [5] - The company's lead product candidate, HCW9302, was developed using the TOBI™ platform, and it has also created the TRBC platform for constructing immunotherapeutics [5] - The TRBC platform enables the development of multiple classes of immunotherapeutic compounds, including multi-functional immune cell stimulators and second-generation immune checkpoint inhibitors [5] Upcoming Event - HCW Biologics will participate in the 2025 Maxim Growth Summit on October 22nd to 23rd at The Hard Rock Hotel NYC, which gathers industry leaders and innovators [1] - Dr. Hing C. Wong, the CEO, will meet with institutional investors and senior analysts during the event [2] - Keynote speakers at the summit include Larry Kudlow and Christopher Ruddy, with discussions covering various sectors including biotechnology and artificial intelligence [3] Company Pipeline - The company has constructed over 50 molecules using the TRBC platform, with ongoing preclinical evaluation studies based on promising data [5] - HCW Biologics has two licensing programs for exclusive rights to some proprietary molecules [5] Maxim Group Overview - Maxim Group LLC is a full-service investment banking and wealth management firm providing a range of financial services [6] - The firm is registered with the U.S. Securities and Exchange Commission and is a member of FINRA, SIPC, and NASDAQ [6]

Core Insights - HCW Biologics Inc. will present research data on three lead drug candidates utilizing its TRBC platform technology at the 40th Annual Meeting of the Society for Immunotherapy of Cancer from November 5 to 9, 2025 [1][2] Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies targeting chronic inflammation and related diseases, aiming to improve healthspan and quality of life [3] - The company's lead product candidate, HCW9302, was developed using the legacy TOBI platform, while the new TRBC platform allows for the creation of various classes of immunotherapeutic compounds [3] TRBC Platform Details - The TRBC platform enables the development of multiple classes of immunotherapeutic compounds: - Class I: Multi-Functional Immune Cell Stimulators - Class II: Second-Generation Immune Checkpoint Inhibitors - Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers [2][3] - Over 50 molecules have been constructed using the TRBC platform, with ongoing preclinical evaluations based on promising data [3] Upcoming Presentations - The company will showcase three posters at the conference: - **Poster 1**: A novel multi-functional bispecific T-cell engager molecule for cancer therapy (Class III TRBC Compound) on November 7, 2025 [2] - **Poster 2**: A novel tetra-specific pembrolizumab-based immunotherapeutic (Class II TRBC Compound) on November 8, 2025 [2] - **Poster 3**: Enhancing immune cell expansion and checkpoint inhibitor synergy using HCW11-006 (Class I TRBC Compound) on November 8, 2025 [2]

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]

Core Insights - BioVaxys Technology Corp. and SpayVac for Wildlife, Inc. have published results demonstrating the efficacy of the SpayVac immunocontraceptive vaccine, which reduced fertility in vaccinated deer to 11% compared to 86% in control animals [1][2] - The study involved 47 free-ranging red deer and confirmed the vaccine's effectiveness across three deer species, indicating broad applicability for managing deer populations [2] - The company is pursuing regulatory approval for SpayVac, targeting feral horses and free-ranging deer populations, with significant commercial potential anticipated due to the large deer population worldwide [2] Group 1: Vaccine Efficacy - A single dose of SpayVac vaccine significantly reduced fertility rates in deer, demonstrating long-lasting effects for 3 to 5 years [2] - The vaccine's technology utilizes a liposome-based delivery platform that enhances immune response [1][2] - SpayVac has shown clinical validation in three distinct deer species, indicating its potential for widespread use [2] Group 2: Market Potential - The commercial potential for SpayVac is significant, with expectations of a healthy royalty stream from vaccine sales [2] - Overabundant deer populations can double in size every two years, leading to ecological and agricultural challenges, making non-lethal population management methods like SpayVac increasingly relevant [2] - The company is also exploring trials with other species, including feral horses and Asian elephants, to expand the market for SpayVac [3] Group 3: Company Background - BioVaxys Technology Corp. is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies [5][6] - The company is also advancing other immunotherapy products targeting various diseases, including cancer and allergies [6] - BioVaxys shares are listed on multiple exchanges, indicating a commitment to transparency and investor engagement [7]

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]