Core Insights - Immutep Limited is focusing on changing the treatment paradigm for first-line non-small cell lung cancer (1L NSCLC) through innovative immunotherapy approaches [1][5]. Clinical Trial Results - The INSIGHT-003 trial demonstrated strong objective response rates (ORR) and disease control rates (DCR) for the combination of eftilagimod alfa (efti) with KEYTRUDA (pembrolizumab) and chemotherapy in patients with advanced or metastatic non-squamous 1L NSCLC [2][5]. - The ORR for patients with low and no PD-L1 expression (TPS <50%) reached 61.7%, significantly higher than the historical control of 40.8% [3][5]. - The combination therapy showed high ORR and DCR across all PD-L1 expression levels, with specific rates of 54.5% (no PD-L1), 68.0% (low PD-L1), and 75.0% (high PD-L1) [4]. Safety and Efficacy - The combination of efti with KEYTRUDA and chemotherapy has a favorable safety profile and has shown promising clinical responses, particularly in patients with low or absent PD-L1 expression [3][5]. - Efti is expected to set a new standard of care for 1L NSCLC patients, supported by data from multiple clinical trials, including the pivotal TACTI-004 Phase III trial [5][8]. Future Developments - The TACTI-004 Phase III trial is a global study enrolling approximately 756 patients with advanced/metastatic 1L NSCLC, evaluating the same immunotherapy/chemotherapy combination used in INSIGHT-003 [5][6]. - Efti is under evaluation for various solid tumors, including head and neck squamous cell carcinoma and breast cancer, and has received Fast Track designation from the FDA for first-line treatments [8]. Company Overview - Immutep is a late-stage biotechnology company specializing in novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in Lymphocyte Activation Gene-3 (LAG-3) [9].

Full Dose Expansion Data for Solnerstotug in PD-(L)1 Resistant Tumors October 20, 2025 Presenters: Dr. Kyriakos Papadopoulos Co-Director of Clinical Research START, San Antonio Principal Investigator for Ph1 trial of Solnerstotug John Celebi Chief Executive Officer Ron Weitzman Chief Medical Officer Disclaimer This presentation has been prepared by Sensei Biotherapeutics, Inc. (the "Company," "we," "us") and is made for informational purposes only. The information set forth herein does not purport to be com ...

Core Insights - BriaCell Therapeutics Corp. announces positive clinical biomarker data from its ongoing pivotal Phase 3 study of Bria-IMT combined with an immune checkpoint inhibitor for metastatic breast cancer, presented 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 + CPI, Treatment of Physician's Choice, or Bria-IMT monotherapy, with pooled data available from 113 patients who had a median of 6 prior treatment lines [3] - The study continues to evaluate safety and progression-free survival (PFS) among all patients, with no treatment-related discontinuations reported due to adverse events [5][11] Biomarker Findings - Neutrophil to Lymphocyte Ratio (NLR) is identified as a potential biomarker, showing significantly higher PFS in patients with NLR between 0.7 and 2.3 (4.5 months) compared to those with NLR < 0.7 or > 2.3 (2.5 months) [4] - Similar encouraging trends in biomarkers from the Phase 2 study are observed in the ongoing Phase 3 study [11] Future Prospects - Interim data analysis will occur once 144 patient events (deaths) are recorded, focusing on overall survival as the primary endpoint, with positive results potentially leading to full approval and marketing authorization for Bria-IMT in metastatic breast cancer [7]

Core Insights - Medicenna Therapeutics Corp. is a clinical-stage immunotherapy company focused on developing Superkines for cancer and autoimmune diseases, participating in several upcoming conferences to showcase its innovative therapies and engage with the investment community [1][5]. Upcoming Conference Participation - Medicenna will participate in the Planet MicroCap Showcase in Toronto in 2025, BIO-Europe 2025 in Vienna, and the Oppenheimer Miami Oncology Summit [2][3][4]. - The BIO-Europe event is one of the largest life sciences partnering events, providing Medicenna a platform to engage with potential partners and investors [7]. - The Oppenheimer Miami Oncology Summit will focus on oncology advancements, allowing Medicenna to discuss its immunotherapy innovations [7]. Company Overview - Medicenna is developing novel, highly selective versions of IL-2, IL-4, and IL-13 Superkines, including the long-acting IL-2 Superkine, MDNA11, which preferentially stimulates cancer-killing effector T cells and NK cells [5]. - The IL-4 Empowered Superkine, bizaxofusp, has been studied in five clinical trials with over 130 patients, including a Phase 2b trial for recurrent GBM, and has received FastTrack and Orphan Drug status from the FDA and EMA [5]. - Medicenna's early-stage BiSKITs™ and T-MASK™ programs aim to enhance the effectiveness of Superkines in treating immunologically "cold" tumors [5].

Solid Tumor Spotlight: TGFβR2xPD-1 Bi-specific Antibody and KRAS G12D Inhibitor ESMO 2025 October 19, 2025 Forward looking statements Except for the historical information set forth herein, the matters set forth in this release contain predictions, estimates and other forward-looking statements, including any discussion of the potential and opportunities presented by INCA33890 and INCB161734 and plans for further development of the same. These forward-looking statements are based on Incyte's current expecta ...

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]

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]