Promising Results from Kiromic's Deltacel-01 Trial: Safety, Tolerability, and Efficacy in Patient Three

April 2, 2024 — Kiromic BioPharma, Inc. has announced early indications of tumor stabilization in a patient enrolled in the Deltacel-01 Phase 1 clinical trial. The trial is assessing the safety and tolerability of Deltacel™ (KB-GDT-01), an allogeneic, off-the-shelf Gamma Delta T-cell (GDT) therapy for patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have not responded to standard treatments.
Preliminary imaging from the patient, conducted six weeks post-treatment initiation, revealed a favorable safety profile and potential early efficacy of Deltacel™ therapy. Notably, the patient exhibited disease stabilization across all tumor sites without the emergence of new metastatic sites. The treatment is being administered at the Beverly Hills Cancer Center (BHCC).
The Deltacel-01 Safety Monitoring Committee (SMC) has reviewed the preliminary data from the first three patients and recommended maintaining the initial cell dose level for subsequent patient cohorts. This decision was based on the observed safety, tolerability, and signs of anti-tumor activity.
Pietro Bersani, CEO of Kiromic BioPharma, expressed optimism regarding the early findings from the Deltacel-01 trial, which support the advancement of Deltacel™ as a potential therapeutic option. He highlighted the commitment to further testing Deltacel™ and the decision to not escalate the cell dose level as a strategic move that could shorten the trial's duration and benefit patients.
The open-label Phase 1 Deltacel-01 trial involves two intravenous infusions of Deltacel™ combined with low-dose, localized radiation over a 10-day period. The primary objective is to evaluate the safety of the treatment, with secondary measurements including response rates and survival outcomes.
Deltacel™ is an investigational GDT therapy currently in Phase 1 for stage 4 metastatic NSCLC. It is designed to target solid cancers, with an initial focus on NSCLC, which accounts for a significant proportion of all lung cancer cases. Preclinical studies have demonstrated Deltacel™’s safety and efficacy when combined with low-dose radiation.
Kiromic BioPharma is a clinical-stage biotherapeutics company utilizing its proprietary DIAMOND® AI 2.0 target discovery engine to develop cell therapies for immuno-oncology. The company is focused on creating a multi-indication allogeneic cell therapy platform targeting solid tumors using Gamma Delta T-cells.

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