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Artiva Biotherapeutics (ARTV) 2025 Conference Transcript
2025-06-04 14:20
Summary of Ativa Biotherapeutics Conference Call Company Overview - **Company**: Ativa Biotherapeutics - **Industry**: Biotech, specifically focusing on cell therapies for autoimmune diseases and oncology Key Points and Arguments Oncology Programs - Ativa Biotherapeutics was founded as a spin-off from GC Cell, focusing on a scalable process for generating NK cells [3] - The company has conducted two oncology trials: one for Non-Hodgkin Lymphoma (NHL) using RNK cells with Rituximab, and another for Hodgkin's lymphoma with Affimed using a CD30 targeted biologic [4] - The lead asset, AlloNK, is a non-genetically modified NK cell that combines with targeted therapies, showing enhanced efficacy and a safer profile compared to other cell therapies [5] Autoimmune Programs - Initial data for the autoimmune program (L1K) has been postponed to the first half of 2026 to ensure more interpretable results [6] - The decision to delay was influenced by the need for a larger patient pool to derive meaningful efficacy signals, as patient heterogeneity can skew results [8] - Ativa plans to present data sets by year-end that will pool across indications, focusing on safety and translational markers [9] Patient Selection and Trial Management - Patient selection is crucial; younger patients with less organ damage tend to respond better to therapies [11] - The company acknowledges that real-world patients often have more severe disease than those in academic studies, leading to a need for stricter inclusion criteria over time [15] - The goal is to identify patients with significant disease activity who can benefit from inflammation resolution [15] Efficacy Benchmarks - Evidence of B cell depletion is necessary but not sufficient for efficacy; safety profiles are also critical [17] - Efficacy benchmarks will vary by indication, with comparisons to the best available therapies [20] - For lupus nephritis, efficacy will be benchmarked against obinutuzumab, while for rheumatoid arthritis (RA), comparisons will be made against patients refractory to multiple therapies [21] Clinical Trial Enrollment - Ativa has learned that expanding beyond CAR T centers to non-CAR T centers can enhance patient enrollment due to a favorable safety profile [23] - The company emphasizes the importance of having multiple trial sites to ensure adequate patient recruitment [25] Community Settings - The company is conducting investigator-initiated trials in community settings, which have shown promise in managing patients as outpatients [27] Dosing and Lymphodepletion - The dosing schedule for L1K aims to achieve deeper B cell depletion by administering monoclonal antibodies alongside NK cells [28] - Lymphodepletion is viewed as manageable and not a major limitation, with ongoing education about its short-term effects [32] Regulatory Path - Ativa is closely monitoring FDA conversations regarding regulatory pathways for autoimmune therapies, noting that smaller indications may have more flexibility for accelerated approval [40] - The company anticipates that larger indications will require more robust data to demonstrate safety and efficacy compared to standard care [41] Additional Important Insights - The company is exploring various monoclonal antibodies for combination therapies, starting with those already approved to minimize regulatory friction [36] - There is ongoing speculation about the efficacy of different B cell targets (CD19 vs. CD20) in various indications, with plans to announce further developments [39] This summary encapsulates the key discussions and insights from the Ativa Biotherapeutics conference call, highlighting the company's strategic focus on both oncology and autoimmune therapies, as well as its approach to clinical trials and regulatory considerations.
Artiva Biotherapeutics to Participate in the 24th Annual Needham Virtual Healthcare Conference
Globenewswireยท 2025-03-31 20:05
Core Viewpoint - Artiva Biotherapeutics, Inc. is set to present at the 24th Annual Needham Virtual Healthcare Conference on April 7, 2025, highlighting its focus on developing cell therapies for autoimmune diseases and cancers [1][2]. Company Overview - Artiva Biotherapeutics is a clinical-stage biotechnology company founded in 2019, specializing in cell therapies for autoimmune diseases and cancers [3]. - The company's lead program, AlloNK, is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved NK cell therapy candidate aimed at enhancing the efficacy of monoclonal antibodies for B-cell depletion [3]. - AlloNK is currently undergoing clinical trials for systemic lupus erythematosus and is involved in an investigator-initiated basket trial for multiple autoimmune indications [3]. - Artiva's pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers [3]. - The company has exclusive worldwide rights (excluding Asia, Australia, and New Zealand) to GC Cell's NK cell manufacturing technology and programs, following a strategic partnership [3]. Event Participation - Members of the Artiva management team will engage in investor meetings during the conference, and a live webcast of the presentation will be available for the public [2]. - A replay of the webcast will be accessible for 90 days post-event [2]. Contact Information - For investor inquiries, Neha Krishnamohan can be contacted at ir@artivabio.com, and for media inquiries, Jessica Yingling, Ph.D., can be reached at jessica@litldog.com or +1.858.344.8091 [6].