Kiromic BioPharma is making significant progress in the Deltacel-01 clinical trial for the treatment of non-small cell lung cancer (NSCLC). The safety monitoring committee (SMC) has recommended moving forward with the dose expansion phase of the trial after analyzing safety data from the first 2 cohorts. This phase is expected to include around 9 new patients and is set to begin screening patients by the end of September.
The CEO of Kiromic BioPharma, Pietro Bersani, expressed excitement about the approval to advance to the expansion phase, anticipating increased patient enrollment and the opportunity to evaluate Deltacel’s impact on patient outcomes. Additionally, the company has activated the University of Arizona Cancer Center as the fifth trial site, further expanding the reach of the study.
Recent findings from the trial have shown promising results, with an average progression-free survival (PFS) of 4.8 months for patients in long-term follow-up. One patient even achieved a 20% reduction in tumor size at 8 months posttreatment, with no new lesions observed. Deltacel, a nonengineered therapy, utilizes gamma delta T-cells to target solid cancers without the need for viral vectors in the manufacturing process.
In August 2024, Deltacel received fast track designation from the FDA for metastatic NSCLC in patients who have progressed on multiple lines of standard therapy. This designation aims to improve progression-free survival and overall survival for these patients.
Overall, Kiromic BioPharma’s advancements in the Deltacel-01 trial show promise in addressing the critical unmet needs in the treatment of solid tumors, particularly in NSCLC. The company’s commitment to innovation and collaboration with leading research institutions like the University of Arizona Cancer Center positions them well for continued success in the development of novel cancer therapies.