Kiromic BioPharma Reports Favorable Early Efficacy Results from First Patient in Deltacel-01 Phase 1 Clinical Trial in Non-Small Cell Lung Cancer

Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports favorable early efficacy results from the first patient enrolled in the Phase 1 Deltacel-01 clinical trial with Deltacel for treating stage 4 metastatic non-small cell lung cancer (NSCLC).

Favorable preliminary evidence demonstrates Deltacel’s efficacy in controlling the growth of NSCLC. Deltacel continues to be well-tolerated, further confirming the early safety assessment reported on January 5^th. The first patient was enrolled at the Beverly Hills Cancer Center (BHCC) and was confirmed to suffer from an actively progressing disease three days prior to beginning treatment. The CT scan performed six weeks later confirmed stabilization of the disease, indicating a preliminary progression-free survival of one and one-half months. Kiromic plans to provide updates as more data becomes available from follow-up monitoring activities and as additional subjects are enrolled in the study.

“We are delighted to share these best-case scenario, preliminary efficacy results following recently announced favorable safety and tolerability data in this patient. It is a significant clinical milestone in a deadly cancer that counts more than 2 million new diagnoses globally each year and is almost three times as deadly as breast and ovarian cancers,” said Pietro Bersani, Chief Executive Officer of Kiromic. “Our initial results with Deltacel offer a glimpse of hope and are a testament to our dedication to improving patient outcomes with this challenging disease. We look forward to sharing more detailed data as our trial progresses and remain committed to the rigorous investigation of Deltacel's potential in treating NSCLC.”

“The first patient treated in the Deltacel-01 study continues to do well. We remain hopeful regarding the treatment outcome with subsequent patients and look forward to working with Kiromic to advance enrollment in this study,” said Afshin Eli Gabayan, M.D., Medical Oncologist, Medical Director, and Principal Investigator at Beverly Hills Cancer Center.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled “Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer” (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the study is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.