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<\/a>\nFourteen additional patients have been dosed since first clinical data were reported at the American Society of Hematology (ASH) 2025 Annual Meeting, bringing the total number of patients dosed to 18. The interim data presented at ASCO demonstrate a 100% overall response rate (ORR) and minimal residual disease (MRD)-negative bone marrow at one month post treatment in all evaluable patients.<\/p>
\nAdditional highlights of the updated data presented today:<\/p>
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- \nFirst patient treated remains in deep, ongoing MRD-negative response beyond 10 months<\/li>\n
- \nSix patients with \u2265 4 months of follow up include 4 stringent complete response (sCR) and 2 very good partial response (VGPR), all with ongoing MRD-negative bone marrows<\/li>\n
- \nRobust generation and sustained persistence of CAR-T cells in the peripheral blood and bone marrow exceeding what is typically seen with ex vivo<\/i> CAR-T therapies<\/li>\n
- \nContinued favorable safety and tolerability profiles; safety review committee has approved outpatient infusion\n
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- \n16 of 18 patients experienced cytokine release syndrome (CRS); all were Grade 1-2<\/li>\n
- \nOne Grade 1 and one Grade 3 immune effector-cell associated neurotoxicity syndrome (ICANS) event; Grade 3 event was limited to 3 days<\/li>\n
- \nNo delayed neurotoxicity observed<\/li>\n
- \nCytopenias and Grade 3-4 infections were notably limited<\/li>\n<\/ul><\/li>\n
- \nNo infusion-related reactions (IRRs) following dexamethasone premedication implementation<\/li>\n<\/ul>
\n\u201cThe clinical data presented today at ASCO strengthens our conviction that the iGPS platform has the potential to transform the treatment experience and outcomes for patients with serious hematologic malignancies,\u201d said Kevin Friedman, Ph.D., Chief Executive Officer and Founder of Kelonia. \u201cThis expanded patient cohort continues to provide clear clinical validation of KLN-1010 and our platform. Durable and deep responses were achieved without the need for preparative chemotherapy or complex CAR-T cell manufacturing that impact patient access and treatment timelines. Combined with a safety profile consistent with traditional <\/i>CAR-T therapies in multiple myeloma, we are seeing growing evidence for the potential of KLN-1010 to democratize CAR-T treatment of multiple myeloma.\u201d<\/p>
\n\u201cEarly data from Kelonia\u2019s lead in vivo<\/i> CAR-T program continues to demonstrate highly encouraging responses in additional patients, with the benefit of extended follow-up revealing a consistent pattern of strong clinical responses over time, and a continued favorable safety profile,\u201d said ASCO Presenter and inMMyCAR investigator, Professor Joy Ho, MBBS, D.Phil, Royal Prince Alfred Hospital, Sydney, Australia. \u201cThe persistent generation of CAR-T cells observed across the expanded cohort reinforces the potential of KLN-1010 to make a meaningful difference for multiple myeloma patients.\u201d<\/p>
\nEli Lilly and Company\u2019s proposed acquisition of Kelonia Therapeutics announced in April 2026 is pending transaction close.<\/p>
\nAbout KLN-1010<\/b><\/p>
\nKLN-1010, which has received Fast Track designation from the U.S. Food and Drug Administration (FDA), is an investigational in vivo<\/i> gene therapy that generates anti-BCMA CAR-T cells, targeting the BCMA protein expressed on the surface of multiple myeloma cells. Unlike traditional CAR-T treatments, KLN-1010 is administered to patients via direct infusion and is designed to generate durable CAR-T cells inside the body after a single dose, potentially eliminating the need for long wait times to receive treatment. This may overcome several limitations faced by current CAR-T approaches, including limited access to treatment and the requirement of preconditioning chemotherapy.<\/p>
\nAbout inMMyCAR<\/b><\/p>
\ninMMyCAR is a Phase 1, open-label, dose-escalation clinical trial designed to assess the safety, tolerability, pharmacology and preliminary efficacy of a single dose of KLN-1010 in up to 40 patients. The primary endpoints are incidence and severity of treatment-emergent adverse events (TEAEs), including dose limiting toxicities (DLTs), and to establish the recommended Phase 2 dose of KLN-1010. Additional information and study site information may be found on clinicaltrials.gov (NCT07075185).<\/p>
\nAbout Relapsed and Refractory Multiple Myeloma<\/b><\/p>
\nMultiple myeloma is a hematologic malignancy characterized by the proliferation of plasma cells in the bone marrow, leading to bone destruction, anemia, renal dysfunction, and immunosuppression. It is driven by complex genetic and epigenetic alterations that promote malignant cell survival and resistance to apoptosis. Relapsed and refractory multiple myeloma is characterized by clonal evolution, drug resistance, and increased disease heterogeneity, heightening the need for accessible, personalized therapeutic strategies.<\/p>
\nAbout Kelonia Therapeutics<\/b><\/p>
\nKelonia Therapeutics is a clinical-stage biotechnology company pioneering a new wave of genetic medicines using its in vivo<\/i> gene placement system (iGPS). Kelonia\u2019s elegant, cutting-edge in vivo<\/i> gene delivery technology uses an advanced lentiviral vector particle harboring envelope modification to improve in vivo<\/i> gene transfer efficiency and tropism molecules to facilitate tissue-specific delivery. Kelonia is building a pipeline of genetic medicines across a range of diseases, with the bold goal of making CAR-T cell therapies accessible to every patient in need, when and where they need them. Kelonia\u2019s lead candidate, KLN-1010, is an in vivo <\/i>anti-BCMA CAR-T therapy for multiple myeloma being evaluated in a Phase 1 clinical trial. For more information, please visit: https:\/\/www.keloniatx.com\/<\/a>.<\/p>
\nKelonia, iGPS, and inMMyCAR are trademarks of Kelonia Therapeutics, Inc.<\/p>
- \nContinued favorable safety and tolerability profiles; safety review committee has approved outpatient infusion\n