Core Points - IMUNON, Inc. is a clinical-stage biotechnology company focused on DNA-mediated immunotherapy, currently in Phase 3 development [1][4] - The company will present at the Zacks SCR Life Sciences Virtual Investor Forum on June 12, 2025, at 11:30 a.m. ET [1] - IMUNON's lead clinical program, IMNN-001, is a DNA-based immunotherapy targeting advanced ovarian cancer, having completed multiple clinical trials including a Phase 2 trial [5] Company Overview - IMUNON is developing innovative treatments that utilize the body's natural mechanisms to generate effective responses against various diseases, differentiating from conventional therapies [4] - The company is advancing its non-viral DNA technology through two main modalities: TheraPlas for gene-based delivery of cytokines and PlaCCine for gene delivery of viral antigens [4] Clinical Programs - IMNN-001 instructs the body to produce cancer-fighting molecules at the tumor site, specifically interleukin-12 and interferon gamma [5] - The company has also completed dosing in a first-in-human study of its COVID-19 booster vaccine, IMNN-101 [5] - IMUNON aims to leverage its technologies to address difficult-to-treat conditions, either directly or through partnerships [5]

Core Insights - Innovent Biologics has received a second Breakthrough Therapy Designation (BTD) from China's NMPA for IBI363, a bispecific antibody fusion protein targeting squamous non-small cell lung cancer (sqNSCLC) [1][3] - IBI363 has also received Fast Track Designations (FTDs) from the U.S. FDA for sqNSCLC and melanoma, highlighting its potential in treating immunotherapy-resistant cancers [1][8] - The drug aims to address unmet clinical needs in patients who have progressed after anti-PD-(L)1 immunotherapy and platinum-based chemotherapy [1][4] Company Overview - Innovent Biologics is a leading biopharmaceutical company founded in 2011, focusing on developing high-quality medicines for various diseases, including oncology and autoimmune disorders [9] - The company has launched 15 products and has multiple assets in various stages of clinical trials, including 3 new drug applications under regulatory review [9] - Innovent collaborates with over 30 global healthcare companies, enhancing its research and development capabilities [9] Clinical Development - IBI363 has shown promising results in Phase 1 clinical studies, demonstrating manageable safety and encouraging efficacy in immunotherapy-resistant patients [2][6] - The drug's dual mechanism of action combines PD-1 blockade and IL-2-driven T-cell expansion, potentially reshaping the tumor microenvironment [3][5] - Innovent is accelerating global development for IBI363, with ongoing clinical studies in China, the U.S., and Australia targeting various tumor types [7]

HCW Biologics earned upfront payment and will recognize revenue of $7.0 million in Q2 2025MIRAMAR, Fla., June 04, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or “HCW Biologics”), (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, and WY Biotech Co., Ltd., a China-based company specializing in the early-stage development of recombi ...

Core Viewpoint - Elicio Therapeutics has secured a $10 million senior secured promissory note to extend its operational runway into Q1 2026, supporting its clinical development initiatives, particularly the AMPLIFY-7P Phase 2 interim analysis expected in Q3 2025 [2][4]. Financial Summary - The company received gross proceeds of $10 million from the Note Financing, which bears an interest rate of up to 12.5% and matures on June 3, 2028 [3]. - The financing includes a 24-month interest-only period, with interest accrued during the first 12 months payable in a lump sum starting from the thirteenth month [3]. Product Development - Elicio's lead product candidate, ELI-002, targets mKRAS-driven tumors, which account for approximately 25% of all solid tumors [4][5]. - ELI-002 is currently being studied in a randomized clinical trial for mKRAS-positive pancreatic cancer and has shown promising Phase 1 data, including a 16.3-month median recurrence-free survival and a 28.9-month median overall survival [4][6]. Technology Platform - Elicio's proprietary Amphiphile (AMP) platform is designed to enhance the education and activation of cancer-specific T cells, aiming for durable cancer immunosurveillance [4][7]. - The AMP technology allows for targeted delivery of immunotherapeutics to lymph nodes, potentially leading to superior clinical outcomes compared to conventional therapies [7][8]. Future Plans - The company plans to explore combination regimens for ELI-002 in treating pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer, leveraging robust interest from clinical investigators [4]. - Elicio intends to expand ELI-002 to other indications, including mKRAS-positive lung cancer, and is developing additional off-the-shelf therapeutic cancer vaccine candidates [4][6].

Core Viewpoint - Innovent Biologics has presented promising clinical data for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, at the 2025 ASCO conference, demonstrating its potential efficacy in treating advanced non-small cell lung cancer (NSCLC) and other tumor types [1][2][11]. Group 1: Clinical Data and Efficacy - IBI363 has shown a manageable safety profile and encouraging efficacy in patients with immunotherapy-resistant squamous NSCLC and wild-type lung adenocarcinoma, with trends indicating long-term survival benefits [1][4][11]. - In a Phase 1 study, IBI363 monotherapy was administered to 136 NSCLC patients, with a focus on those with squamous cell carcinoma and EGFR wild-type adenocarcinoma [3][6]. - The confirmed overall response rate (ORR) for squamous NSCLC patients receiving IBI363 at different dosages was reported as 25.9% and 36.7%, with disease control rates (DCR) of 66.7% and 90.0% respectively [5][6]. Group 2: Long-term Survival Benefits - IBI363 demonstrated potential long-term survival benefits, with median overall survival (OS) of 15.3 months for the 1/1.5 mg/kg dose group and not reached for the 3 mg/kg group, alongside a 12-month OS rate of 70.9% [5][6][10]. - Among patients with PD-L1 TPS<1%, the ORR was 30.0% for the lower dose and 46.2% for the higher dose, indicating IBI363's effectiveness in low PD-L1 expression populations [7]. Group 3: Future Development Plans - Innovent plans to initiate a Phase 3 registration clinical study for IBI363 in locally advanced or metastatic squamous NSCLC patients who have failed prior treatments [11]. - The company has received Breakthrough Therapy Designation (BTD) from China CDE and Fast Track Designation (FTD) from the US FDA for IBI363 in treating squamous NSCLC [11][17]. Group 4: Company Overview - Innovent Biologics is a leading biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, with 15 products launched and multiple assets in clinical trials [18]. - The company collaborates with over 30 global healthcare companies to advance its innovative therapies [18].

Châtillon, France, June 03, 2025 DBV Technologies announces the filing of an addendum to the 2024 Universal Registration Document DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company (the “Company”), today announced today the filing of an addendum to the 2024 Universal Registration Document (the “Addendum”) with the French market authority, “Autorité des Marchés Financiers” (“AMF”). This Addendum provides an update to the Board of Dir ...

Core Insights - Johnson & Johnson announced long-term follow-up data from the CARTITUDE-1 study, showing that 33% of patients with relapsed or refractory multiple myeloma treated with CARVYKTI® achieved progression-free survival of five years or more with a single infusion [1][3][4] - The CARTITUDE-4 analysis demonstrated significant overall survival and progression-free survival benefits across various patient subgroups, including those with standard and high-risk cytogenetics [1][5] Group 1: CARTITUDE-1 Study Findings - In the CARTITUDE-1 study, 32 out of 97 patients (33%) achieved progression-free survival for at least five years after receiving CARVYKTI® [1][3] - The median overall survival for patients in the study was reported at 60.7 months, indicating a durable response to the treatment [3] - Among the patients who remained progression-free, the majority had undergone a median of six prior lines of therapy, with 90.6% being triple-class refractory [3][7] Group 2: Safety Profile - The safety profile of CARVYKTI® in the CARTITUDE-1 study remained consistent with previous findings, with no new safety signals identified [4] - Two new cases of second primary malignancies were reported, but no new cases of Parkinsonism or cranial nerve palsies were observed [4] - The incidence of cytokine release syndrome (CRS) was noted in 84% of patients, with 4% experiencing Grade 3 or higher CRS [21] Group 3: CARTITUDE-4 Study Insights - The CARTITUDE-4 study, presented at the ASCO Annual Meeting, showed that CARVYKTI® improved progression-free survival and overall survival compared to standard care in various patient subgroups [5][9] - The study included patients with relapsed and lenalidomide-refractory multiple myeloma who had received one to three prior lines of therapy [9] Group 4: Future Directions - Johnson & Johnson is focusing on shifting treatment strategies from managing progression to aiming for a cure in multiple myeloma [6] - Upcoming presentations at the European Hematology Association (EHA) 2025 Congress will further discuss the findings from the CARTITUDE studies [6]

Core Viewpoint - TuHURA Biosciences, Inc. has secured $12.5 million in a private offering to fund its operations, including a proposed merger with Kineta, Inc. and the initiation of a Phase 3 trial for its lead product, IFx-2.0 [1][5][9] Funding Details - The private placement involves the issuance of 4.6 million shares of common stock at a price of $2.65 per share, representing a 15% discount to the closing price on June 2, 2025 [1] - Approximately $9.0 million of the total offering will be purchased in four equal tranches based on the achievement of specific milestones, with the remaining $3.5 million to be funded by December 31, 2025 [2][7] - The initial closing of the offering is anticipated on June 4, 2025, subject to customary closing conditions [2] Use of Proceeds - The net proceeds from the offering will be used to fund the merger with Kineta, initiate the Phase 3 trial for IFx-2.0, advance Kineta's VISTA-inhibiting antibody to a Phase 2 trial, and cover other working capital needs [5][9] Milestones for Funding - The funding milestones include: - Notification from the FDA that the company is no longer under a partial clinical hold for the Phase 3 trial of IFx-2.0 [7] - Initiation of the Phase 3 trial for IFx-Hu2.0 [7] - Completion of the merger with Kineta [7] Company Overview - TuHURA Biosciences, Inc. is focused on developing novel technologies to overcome resistance to cancer immunotherapy, particularly through its lead product, IFx-2.0, which is designed to enhance the efficacy of existing treatments [11][12] - The company is also advancing a bi-specific antibody drug conjugate and antibody peptide conjugate targeting immune-suppressing cells in the tumor microenvironment [14]

Core Insights - IMUNON, Inc. announced positive results from its Phase 2 OVATION 2 Study, demonstrating the efficacy of IMNN-001 in improving overall survival and progression-free survival in women with newly diagnosed advanced ovarian cancer [1][4][9] Group 1: Study Results - The Phase 2 OVATION 2 Study involved 112 participants randomized to receive IMNN-001 plus neoadjuvant and adjuvant chemotherapy versus standard of care, with a median follow-up of 31 months [2][5] - IMNN-001 treatment resulted in a median overall survival increase of 13 months (46 months vs. 33 months) and a median progression-free survival increase of 3 months (14.9 months vs. 11.9 months) compared to standard care [4][5] - The chemotherapy response score indicated a response rate of 26.1% in the IMNN-001 group versus 13.0% in the control group, highlighting a significant therapeutic effect [4] Group 2: Safety Profile - IMNN-001 exhibited a favorable safety profile with no serious immune-related adverse events reported, and the most common adverse events included abdominal pain, nausea, and vomiting [4][6] - The study showed a surgical response rate of 64.6% for the IMNN-001 treatment arm compared to 52.1% for the control arm, indicating better surgical outcomes [4] Group 3: Mechanism and Technology - IMNN-001 is based on IMUNON's proprietary TheraPlas technology, designed to induce a potent anti-cancer immune response through the local secretion of IL-12 [6][9] - The treatment is particularly effective in patients with homologous recombination deficiency (HRD+), including those with BRCA1 and BRCA2 mutations, as indicated by a hazard ratio of 0.42 [4][6] Group 4: Future Directions - The company plans to advance its pivotal Phase 3 OVATION 3 trial of IMNN-001, with initial trial sites recently initiated [3][9] - IMUNON aims to leverage its non-viral DNA technology to develop innovative treatments for various diseases, focusing on solid tumors [8][9]

Core Insights - Roche announced positive results from the Phase III IMforte study of Tecentriq in combination with lurbinectedin for extensive-stage small cell lung cancer, showing a 46% reduction in the risk of disease progression or death and a 27% reduction in the risk of death compared to Tecentriq alone [1][6]. Study Results - The IMforte study demonstrated that the combination therapy significantly extended median overall survival (OS) to 13.2 months compared to 10.6 months for Tecentriq alone, with a stratified hazard ratio (HR) of 0.73 [2][3]. - Median progression-free survival (PFS) was also improved, with 5.4 months for the combination therapy versus 2.1 months for Tecentriq alone, yielding a stratified HR of 0.54 [2][3]. Study Design - The IMforte study was a Phase III, open-label, randomized trial involving 660 patients in the induction phase and 483 patients randomized for maintenance therapy [3][4]. - Patients received four cycles of induction therapy with Tecentriq, carboplatin, and etoposide before being randomized to maintenance therapy [3]. Safety Profile - The safety profile of the combination therapy was consistent with the known safety profiles of both Tecentriq and lurbinectedin, with no new safety signals observed [1][2]. Implications for Treatment - The results from the IMforte study are considered potentially practice-changing, offering a new option for patients with extensive-stage small cell lung cancer, a group with high unmet medical needs [2][6].