Kiromic BioPharma Reports Consistent Favorable Safety, Tolerability, and Efficacy in Deltacel-01 Clinical Trial First Three Patients

Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) announces consistent favorable safety, tolerability, and efficacy from follow-up visits of the first cohort of three patients 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). All three patients in the first cohort are being treated at the Beverly Hills Cancer Center (BHCC).

Two months after completing treatment, Patients 2 and 3 continued to show stable disease. Imaging scans from Patient 2 also showed no brain metastases, confirming findings from that patient’s six-week follow-up visit.

Four months after completing treatment, the first patient continues to show stable disease compared with the two-month post-treatment scans, which showed a primary tumor size reduction of 6.6%. The four-month follow-up for the second and third patients on trial is scheduled for June.

A summary of all findings reported to date for the first cohort can be found in the table below.

In addition, the fourth patient in Deltacel-01 completed treatment on April 18 at BHCC. Kiromic expects to report preliminary safety, tolerability, and early efficacy results from this patient in May.

Based on encouraging preliminary results from the first patient cohort, Kiromic intends to apply for Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) by the end of the second quarter. FTD offers several benefits and expedited review of drugs targeting a serious condition and fulfilling an unmet medical need, including NSCLC. FTD also facilitates more frequent communication with the FDA, enabling sponsors to receive timely feedback and guidance throughout the drug-development process. Additionally, FTD may qualify Deltacel for Accelerated Approval and Priority Review, potentially reducing the time required to bring the drug to market.

"We are highly encouraged by the initial outcomes from the first three patients in our Deltacel-01 Phase 1 clinical trial. Consistency in safety, tolerability, and disease stability is of paramount importance at this stage of testing, and the data thus far bolster our confidence in Deltacel's potential as a transformative treatment," stated Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "The findings are especially promising considering the robustness of response in the absence of brain metastasis, and the notable reduction in tumor size for the second and the first patient, respectively.