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Genmab Announces Updated Results from Phase 2 EPCORE® NHL-6 Study Evaluating Epcoritamab Monotherapy in the Outpatient Setting in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
Globenewswire· 2025-09-03 12:30
Core Insights - Genmab A/S announced updated results from the Phase 2 EPCORE NHL-6 trial evaluating the investigational epcoritamab for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in an outpatient setting [2][4] - The trial demonstrated the feasibility of outpatient treatment, with 92% of patients receiving the first full dose in this setting, and showed consistent safety and efficacy profiles compared to previous studies [3][4] Study Results - A total of 88 patients received the first full dose (48 mg) of epcoritamab, with 81 patients (92%) treated as outpatients [3] - The overall response rate (ORR) was 64.3% and the complete response (CR) rate was 47.6% in patients who had received one prior line of systemic therapy [4] - In patients treated after two or more lines of therapy, the ORR was 60.0% and the CR rate was 38.0% [4] Safety Profile - Cytokine release syndrome (CRS) occurred in 40.2% of patients during the trial, primarily low grade (Grade 1-2), with a median resolution time of two days [3] - Immune cell-associated neurotoxicity syndrome (ICANS) was observed in 7.6% of patients, also primarily low grade, resolving within a median of three days [3] Industry Context - DLBCL is the most common type of non-Hodgkin lymphoma, accounting for approximately 25-30% of all NHL cases, with around 25,000 new cases diagnosed annually in the U.S. [7][8] - The EPCORE NHL-6 trial results are significant as they suggest a shift towards outpatient treatment options for DLBCL patients, potentially increasing access to therapies [4]
Genmab to Participate in a Fireside Chat at the 46th Goldman Sachs Annual Global Healthcare Conference
Globenewswire· 2025-05-27 13:55
Company Overview - Genmab A/S is an international biotechnology company focused on improving patient lives through innovative antibody therapeutics [2][3] - Established in 1999 and headquartered in Copenhagen, Denmark, Genmab has a global presence across North America, Europe, and Asia Pacific [3] Product Pipeline and Vision - Genmab has developed a proprietary pipeline that includes bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators, and effector function-enhanced antibodies [2] - The company's vision by 2030 is to transform the lives of patients with cancer and other serious diseases through its "knock-your-socks-off" (KYSO) antibody medicines [2] Upcoming Events - Genmab's Chief Financial Officer, Anthony Pagano, will participate in a fireside chat at the 46th Goldman Sachs Annual Global Healthcare Conference on June 9, 2025 [1]
Genmab to Present New and Updated Results from its Robust Epcoritamab (EPKINLY®) Development Program at the 2025 European Hematology Association (EHA) Congress
Globenewswire· 2025-05-14 14:15
Core Insights - Genmab is presenting 14 abstracts on epcoritamab at the 30th European Hematology Association Congress, showcasing its development across various patient populations and treatment settings [1][4] - Epcoritamab is a T-cell engaging bispecific antibody designed for treating diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) [6][7] Development Program - The abstracts include data from Phase 1/2 trials evaluating epcoritamab in combination with other therapies for relapsed/refractory DLBCL and previously untreated DLBCL [2][4] - Key trials include EPCORE NHL-2 and NHL-5, focusing on combinations with rituximab and polatuzumab vedotin [2][5] Presentation Details - Oral presentations will occur on June 15, 2025, featuring significant findings from the EPCORE NHL-2 and NHL-5 trials [5] - Additional results from NHL-1 and NHL-3 trials will be presented as posters, highlighting three years of follow-up data [2][5] Regulatory Status - Epcoritamab has received regulatory approval in specific lymphoma indications in the U.S., Japan, and the EU, and is co-developed with AbbVie [7][10] - The companies are pursuing further international regulatory approvals for additional indications [7] Future Directions - Genmab and AbbVie are conducting five ongoing Phase 3 trials to evaluate epcoritamab's efficacy as a monotherapy and in combination therapies across various hematologic malignancies [8][9] - The companies aim to establish epcoritamab as a core therapy for B-cell malignancies [4][8]
ProMIS Neurosciences Announces First Quarter 2025 Financial Results
Globenewswire· 2025-05-12 11:30
Core Insights - ProMIS Neurosciences Inc. is advancing its lead clinical program PMN310 for Alzheimer's disease, with significant progress in patient enrollment for the PRECISE-AD trial, which is expected to yield interim results in the first half of 2026 and topline results by the end of 2026 [1][2][4] Alzheimer's Disease Program (PMN310) - PMN310 is a humanized IgG1 antibody targeting toxic amyloid-beta oligomers, which are believed to drive Alzheimer's disease [3] - The PRECISE-AD trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of PMN310, with a planned enrollment of approximately 128 patients across 22 sites in the U.S. [3] - The trial aims to assess the incidence of ARIA (Amyloid-related imaging abnormalities) and other biomarkers, with a primary focus on safety [3][4] - The interim analysis in 2026 will provide early insights into PMN310's potential clinical benefits and tolerability [2][4] Financial Highlights - As of March 31, 2025, ProMIS reported cash and cash equivalents of $8.4 million, down from $13.3 million at the end of 2024 [12] - Research and development expenses increased to $5.5 million in Q1 2025, compared to $2.1 million in Q1 2024, primarily due to costs associated with the PMN310 Phase 1b clinical trial [12] - The net loss for Q1 2025 was $7.3 million, compared to a net loss of $3.6 million in the same period of 2024 [12][18] Other Programs - ProMIS is also advancing its Aβ vaccine program (PMN311) and has initiated a program targeting toxic misfolded TDP-43 for amyotrophic lateral sclerosis (PMN267) [4][5] - The company presented preclinical data at major conferences, highlighting the potential of its vaccine candidates to selectively target toxic oligomers and misfolded proteins associated with neurodegenerative diseases [7][8]
AbCellera Biologics (ABCL) 2025 Conference Transcript
2025-05-05 13:30
Summary of AbCellera Biologics (ABCL) 2025 Conference Call Company Overview - **Company**: AbCellera Biologics (ABCL) - **Location**: Vancouver, Canada - **Focus**: Therapeutic antibody development - **Public Listing**: Nasdaq since 2020, initial share price at $20, currently trading around $2.5 [4][3] Key Points and Arguments 1. **Biotech Industry Context**: The biotech sector is experiencing significant challenges, with many companies facing volatile market conditions. AbCellera considers itself fortunate compared to others in the industry [4][5]. 2. **Leadership**: The company is led by Carl Hansen, a visionary CEO, who emphasizes the importance of drug development and its impact on human life [5][6]. 3. **Historical Perspective**: The company draws parallels between current biotech advancements and historical moments in physics, suggesting that the industry is at a pivotal point for innovation [7][8][9]. 4. **Drug Development Challenges**: Drug development is described as a Herculean task, with high costs, lengthy timelines, and low success rates. Only a small number of companies have successfully developed sustainable drug pipelines [11][12]. 5. **Company Aspirations**: AbCellera aims to be among the few companies that can develop and sustain a successful drug pipeline, particularly in the Canadian biotech landscape, which lacks major pharmaceutical companies [13][14]. 6. **Therapeutic Focus**: The company is focused on developing therapeutic antibodies, having completed over 100 programs for partners, with 16 molecules reaching phase one clinical trials [15][17]. 7. **COVID-19 Contributions**: AbCellera's COVID-19 antibodies treated over 2.5 million patients, saving numerous lives and hospitalizations [18]. 8. **Pipeline Development**: The company is transitioning to wholly owning its drug candidates, with significant investments in infrastructure, including a GMP manufacturing facility expected to be operational for clinical batches in 2026 [19][20][21]. 9. **Financial Position**: AbCellera has approximately $650 million in cash and $200 million in committed capital from government sources, providing a strong financial foundation for drug development [21]. 10. **Target Selection Criteria**: The company employs a rigorous framework for selecting drug targets, focusing on validated biology, commercial opportunity, differentiation, and clear clinical development plans [22][23]. 11. **Upcoming Clinical Trials**: Two molecules, ABCL-635 and ABCL-575, are set to enter clinical trials, with the first target being disclosed during the earnings call [24][25][26]. 12. **Market Potential**: The total addressable market for ABCL-635 is estimated to exceed $2 billion, indicating potential blockbuster status [27]. 13. **Differentiation Strategy**: For ABCL-575, differentiation is expected based on half-life and dosing frequency compared to competitors [28][29]. Additional Important Content - **Strategic Partnerships**: The company maintains strategic partnerships with major pharmaceutical firms, which have not been negatively impacted by its focus on internal programs [37][39]. - **T Cell Engagement**: AbCellera is developing a portfolio for T cell engagement, which has attracted interest from partners like AbbVie [38]. - **Manufacturing Plans**: The company plans to manufacture its own antibodies, particularly those it has discovered, rather than operating strictly as a contract manufacturer [42]. This summary encapsulates the key insights and strategic directions discussed during the conference call, highlighting AbCellera's position within the biotech industry and its future plans for drug development.
Genmab Announces Net Sales of DARZALEX® (daratumumab) for First Quarter of 2025
Globenewswire· 2025-04-15 10:22
Company Announcement - Genmab A/S reported worldwide net trade sales of DARZALEX (daratumumab) totaling USD 3,237 million in Q1 2025, with USD 1,829 million from the U.S. and USD 1,409 million from the rest of the world [1][5] - Genmab receives royalties on the worldwide net sales of DARZALEX, which includes both intravenous and subcutaneous products, under an exclusive license agreement with Johnson & Johnson [1][5] About Genmab - Genmab is an international biotechnology company focused on developing innovative antibody therapeutics to improve patient lives, with a vision to transform cancer treatment by 2030 [2] - The company has a proprietary pipeline that includes bispecific T-cell engagers, antibody-drug conjugates, and next-generation immune checkpoint modulators [2] Company Background - Established in 1999, Genmab is headquartered in Copenhagen, Denmark, and has a presence in North America, Europe, and Asia Pacific [3]