Kiromic BioPharma Reports Favorable Safety, Tolerability, and Early Efficacy from Third Patient in Deltacel-01 Clinical Trial

Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports early efficacy results showing tumor stabilization in the third patient enrolled in the Company’s Deltacel-01 Phase 1 clinical trial. Deltacel-01 is evaluating Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.

Preliminary imaging results for this last patient in the first cohort, obtained six weeks after beginning treatment, show a favorable safety and tolerability profile, and promising early efficacy for the Deltacel treatment. While this patient presented with active disease at the time of enrollment, PET/CT, diagnostic CT and MRI scans showed disease stabilization at all tumor sites with no new sites of metastatic disease. This patient is being treated at the Beverly Hills Cancer Center (BHCC).

Additionally, the Deltacel-01 Safety Monitoring Committee (SMC) convened to analyze all preliminary patient data received to date and to determine the next phase of the trial. After reviewing safety and efficacy findings from the first cohort of three patients, the SMC recommended not to escalate the cell dose level and instead to treat the next cohort of patients at the initial dose level. This unanimous recommendation was based on encouraging preliminary data supporting Deltacel safety and tolerability, and evidence of anti-tumor activity.

“Early findings from the first three patients enrolled in Deltacel-01 – especially the consistent favorable safety profile and signs of efficacy – reinforce our commitment to advancing Deltacel as a potential off-the-shelf, Gamma Delta T-cell therapy. We are particularly pleased to observe a growing body of evidence that Deltacel could be a significant step forward in treating cancer. Our team is inspired by these results and remains dedicated to further testing the therapeutic potential of Deltacel, as confirmed by SMC’s recommendation not to increase the Deltacel dose level. Achieving a therapeutic effect with the initial dose level will benefit patients, while not having to test additional dose levels will shorten the overall length of the Phase 1 clinical trial,” said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.