American Journal of Transplantation study positions GraftAssure as potentially essential in managing immunosuppression treatment in kidney transplant patients with certain cancersGraftAssure used to help avoid overtreatment and preserve patient’s immune systemAs transplant care evolves to include novel therapies, the need for ongoing molecular diagnostic monitoring should continue to grow NASHVILLE, Tenn., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (Nasdaq: IMDX), (iMDx), today an ...

KYV-101 IIT data demonstrate promising clinical activity, including robust CAR T penetration into the central nervous system (CNS) and improved expanded disability status scale scores (EDSS) KYV-101 continues to demonstrate a tolerable safety profile, consistent with observations from the first 100 patients treated with KYV-1011 Encouraging early data of KYV-101 in multiple sclerosis highlights broader potential within neuroimmunology autoimmune diseases EMERYVILLE, Calif., Sept. 24, 2025 (GLOBE NEWSWIRE) - ...

Summary of Cullinan Therapeutics Conference Call Company Overview - **Company**: Cullinan Therapeutics (NasdaqGS:CGEM) - **Focus**: Development of best-in-class molecules for oncology and autoimmune diseases, with a portfolio centered around high-priority programs including CLN-978 for autoimmune diseases and zipalertinib for oncology [2][4] Key Programs and Developments - **Lead Program**: CLN-978, a CD19 x CD3 bispecific T cell engager, is currently in phase 1 clinical studies for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjogren's disease, with initial clinical data expected in the first half of 2026 [3][4] - **Oncology Program**: Zipalertinib TKI for EGFR exon 20 non-small cell lung cancer is planned for regulatory filing by the end of 2025 [4] Clinical Data and Study Design - **SLE and RA Studies**: Initial clinical data for SLE and RA has been shifted to the first half of 2026, with ongoing patient enrollment in global sites [3][25] - **Study Design**: The SLE study includes a modified single ascending dose study to identify a deeply B cell depleting dose while maintaining a therapeutic index [14][15] - **Eligibility Criteria Update**: Adjustments made to broaden patient eligibility, allowing those who have only received small molecule immune suppressants to participate [20][22] Therapeutic Benefits and Differentiation - **T Cell Engagers**: The potential for T cell engagers to provide therapeutic benefits without ongoing immune suppression is highlighted, with a focus on achieving durable responses [6][10] - **Differentiation of CLN-978**: High affinity binding to CD19 and a favorable cytokine window are key differentiators from other CD19 T cell engagers [8][9] Evidence and Market Potential - **RA Evidence**: Previous studies indicate that T cell engagers can provide clinical benefits through B cell depletion in RA, supporting the rationale for further development [28][30] - **Sjogren's Disease**: While evidence for T cell engagers in Sjogren's is limited, the disease's B cell-centric nature suggests potential therapeutic benefits from B cell-targeting therapies [32][33] Financial Position - **Cash Reserves**: As of the end of Q2, the company reported over $500 million in cash reserves, providing a runway into 2028 [39][41] Regulatory Pathway - **Collaboration with Genrex Bio**: Ongoing studies in China are expected to facilitate regulatory ambitions outside of China, with data generation in autoimmune disease patients aiding in the development of Cullinan's own studies [36][38] Conclusion - Cullinan Therapeutics is positioned to advance its innovative therapies in both oncology and autoimmune diseases, with a strong financial foundation and promising clinical programs aimed at addressing significant unmet medical needs in these areas [41]

Summary of Artiva Biotherapeutics Conference Call Company Overview - **Company**: Artiva Biotherapeutics - **Founded**: 2019 - **Focus**: NK cell therapies, specifically non-genetically modified NK cells combined with monoclonal antibodies for enhanced B cell killing [2][3] Core Points and Arguments NK Cell Therapy Advantages - **Non-Genetically Modified NK Cells**: Artiva's NK cells are sourced from umbilical cord units, allowing for the production of thousands of vials with a billion cryopreserved NK cells each, with a shelf life of 3-4 years [2] - **Safety Profile**: NK cells are reported to have a safer profile compared to T cell modalities, reducing the risk of cytokine release syndrome [3][10] - **Efficacy**: The combination of NK cells with monoclonal antibodies enhances the potency of B cell killing, which has been demonstrated in clinical trials [6][7] Current Trials and Indications - **Autoimmunity Trials**: Artiva is currently running trials in the autoimmunity space, exploring various indications [4] - **CYFLU Regimen**: The use of cyclophosphamide (CY) and fludarabine (FLU) is intended to enhance NK cell survival and reduce B cell burden, with low doses deemed safe [10][12][13] Competitive Landscape - **Efficacy vs. Safety**: Artiva aims to demonstrate that their allo-NK therapy can achieve high efficacy while maintaining a favorable safety profile, making it suitable for community administration [6][7][19] - **Comparison with Other Therapies**: The company acknowledges the need to show superiority over existing therapies, including rituximab and other B cell depleting modalities [37][38] Enrollment and Data Generation - **Enrollment Update**: Over a dozen patients have been enrolled across more than a dozen sites, with a focus on generating robust safety and efficacy data [26][30] - **Data Sharing Plans**: Artiva plans to share pooled data on B cell depletion and safety by year-end, with a focus on demonstrating the therapy's effectiveness compared to standard care [30][32] Future Directions - **Lead Indication Announcement**: The company intends to announce its lead indication by year-end, aiming to differentiate itself in the competitive landscape [31][32] - **Pivotal Trials**: Artiva is optimistic about moving towards pivotal trials based on the data generated from ongoing studies [46] Other Important Content - **Prophylactic Measures**: The use of prophylactic antibiotics, antivirals, and antifungals is discussed to mitigate infection risks associated with lymphodepletion [19][22] - **Community Setting Compatibility**: The therapy is designed to be manageable in a community setting, allowing for outpatient treatment and reducing the need for hospitalization [23][24] - **Immune Reset Concept**: The concept of immune reset is introduced, where deep B cell depletion leads to a more naive phenotype of reconstituted B cells, potentially reducing autoantibodies [34][35] This summary encapsulates the key points discussed during the conference call, highlighting Artiva Biotherapeutics' innovative approach to NK cell therapies and its strategic positioning within the competitive landscape of autoimmune treatments.