Aktis Oncology Reports First-in-Human Clinical Imaging and Dosimetry Data for AKY-2519 Demonstrating Robust Tumor Uptake and Limited Normal Tissue Exposures in Patients with B7-H3 Expressing Tumors
View original at globenewswire.comAktis Oncology Reports First-in-Human Clinical Imaging and Dosimetry Data for AKY-2519 Demonstrating Robust Tumor Uptake and Limited Normal Tissue Exposures in Patients with B7-H3 Expressing Tumors Data to be presented across two posters at the 2026 American Society of Clinical Oncology (ASCO) Annual MeetingCombined re…
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Preliminary data from the AKY-1189 (Nectin-4 targeting) Phase 1b trial is expected in Q1 2027.
60% confidenceAdministration of AKY-2519 was generally well tolerated with no adverse events or infusion-related reactions reported with either [68Ga]Ga-AKY-2519 or [177Lu]Lu-AKY-2519 in the mCRPC assessment.
60% confidenceAKY-2519 offers a potentially differentiated therapeutic option for patients with B7-H3 expressing tumors, including mCRPC, lung cancer, and colorectal cancer.
60% confidenceB7-H3 is highly expressed in mCRPC, lung, colorectal and various other solid tumor types with limited expression in normal tissues; high expression is associated with poor prognosis and lack of response to certain therapies.
60% confidenceAKY-2519 demonstrated robust tumor uptake and retention in tumors for at least 6 days after administration in mCRPC patients.
60% confidenceAKY-2519 has the potential to expand targeted radiopharmaceuticals to broader patient populations, and low predicted salivary gland dose suggests a unique profile as a B7-H3-targeted agent for mCRPC versus PSMA-targeting agents.
60% confidencePreliminary data from the AKY-2519 mCRPC Phase 1b trial (PLUVICTO-naïve and PLUVICTO-experienced) is anticipated in 2027.
60% confidenceAdministration of [68Ga]Ga-AKY-2519 was generally well tolerated with no adverse events or infusion-related reactions in the 18-patient solid tumor imaging assessment.
60% confidenceCombined predicted absorbed doses in tumors and normal tissues suggest a wide therapeutic index and a favorable profile for AKY-2519 compared to approved radiopharmaceuticals.
60% confidenceTumor uptake distribution of [68Ga]Ga-AKY-2519 is comparable to [68Ga]Ga-PSMA-11 at the standard 60-minute time point, with AKY-2519 uptake continuing to increase over time.
60% confidenceAktis expects to initiate a second Phase 1b trial of AKY-2519 in various B7-H3 expressing tumor types in the second half of 2026.
60% confidence