First Patient Treated in Trial for NSCLC T-cell Therapy Deltacel Shows Evidence of Tumor Reduction

The first patient with non–small cell lung cancer (NSCLC) who was treated with Kiromic BioPharma’s KB-GDT-01 (Deltacel), an investigational allogeneic gamma delta T-cell (GDT) therapy, in the phase 1/2 Deltacel-01 clinical trial (NCT06069570) has shown evidence of tumor reduction.¹

At the 2-month follow-up PET/CT scan, the patient showed a 6.6% reduction in tumor size. Furthermore, no new metastasis was observed and the tumor lesion’s metabolism had decreased by 20%. Previously, at the 6 week follow-up time point, the patient had shown stable disease, with a preliminary progression-free survival of 1.5 months. In terms of safety, Kiromic previously reported in January 2024 that the patient, who was treated in December 2023, had experienced no adverse events at 23 days posttreatment.²

“We are proud and excited to report these highly promising early results showing tumor reduction in a patient population that has few treatment options available,” Pietro Bersani, CPA, the chief executive officer of Kiromic, said in a statement.¹ “When considering that the first patient enrolled in Deltacel-01 suffered from an actively progressing disease immediately prior to therapy, this is a remarkable finding. We look forward to advancing our trial and to treating additional patients.”

Beyond this first patient, 2 additional patients have now been treated in Deltacel-01. The second patient in this trial received the second infusion of Deltacel, which is administered in 2 infusions, as of February 14, 2024. Kiromic noted at the time that initial efficacy results from this patient are anticipated before the end of Q1 2024. The third patient in the study received the second infusion of the therapy on February 21, 2024.³ All 3 of these patients were treated at Beverly Hills Cancer Center (BHCC). Although, the company expects to begin enrolling patients at 2 other trial sites during the first half of 2024.¹ On March 1, 2024, Kiromic announced that Virginia Oncology Associates, PC, located in Norfolk, VA, had been activated as a trial site for Deltacel-01 and that the initiation of patient enrollment for this site is anticipated in April.³

“The preliminary data from our first patient offers promising insights into the effectiveness of gamma delta T-cell therapy when used alongside low-dose radiation for this condition,” Afshin Eli Gabayan, MD, a medical oncologist and the medical director and principal investigator at BHCC, added to the statement.¹ “We are encouraged by the preliminary data on the first patient and are optimistic about the outcomes of the subsequent patients in the study. We continue to evaluate safety and efficacy outcomes as this study progresses, and are pleased to have enrolled two additional patients in the Deltacel-01 study.”

The investigational new drug application for the Deltacel-01 trial was originally cleared by the FDA in May 2023.⁴ Deltacel is non-engineered and based on a platform that aims to utilize the natural characteristics of GDTs in the targeting of solid cancers; as such, viral vectors are not required in the manufacturing process. Deltacel has demonstrated favorable safety and efficacy when combined with low-dose radiation in 2 preclinical studies.² In the Deltacel-01 trial, which is enrolling patients with stage 4 metastatic NSCLC, patients receive Deltacel in 2 separate intravenous infusions alongside 4 courses of low-dose, localized radiation during a 10-day timeframe.¹

REFERENCES
1. Results from first patient in Kiromic Biopharma’s Deltacel-01 clinical trial indicate tumor reduction at two months. News release. Kiromic BioPharma, Inc. February 14, 2024. Accessed March 18, 2024. https://ir.kiromic.com/news-releases/news-release-details/results-first-patient-kiromic-biopharmas-deltacel-01-clinical
2. Kiromic Biopharma reports favorable early safety and tolerability data from first patient enrolled in the phase 1 Deltacel-01 clinical trial. News release. Kiromic Biopharma. January 5, 2024. Accessed March 18, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-reports-favorable-early-safety-and
3. Kiromic Biopharma adds Virginia Oncology Associates, PC as the second clinical trial site in the ongoing phase 1 Deltacel-01 trial. News release. Kiromic BioPharma, Inc. March 1, 2024. Accessed March 18, 2024.https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-adds-virginia-oncology-associates-pc-second
4. Kiromic Biopharma announces FDA authorization of IND to initiate phase 1 clinical trial evaluating Deltacel in non-small cell lung cancer. News release. Kiromic BioPharma, Inc. May 1, 2023. Accessed March 18, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-announces-fda-authorization-ind-initiate-phase