Kiromic BioPharma Gets Greenlight to Move to Dose Expansion in Trial for NSCLC T-cell Therapy Deltacel

Kiromic BioPharma has received a unanimous recommendation to move ahead dose expansion from the safety monitoring committee (SMC) for the phase 1/2 Deltacel-01 clinical trial (NCT06069570) evaluating KB-GDT-01 (Deltacel), an investigational allogeneic gamma delta T-cell (GDT) therapy, for the treatment of non-small cell lung cancer (NSCLC).¹

Kiromic noted that the SMC’s vote came after safety data from the trial’s first 2 cohorts were analyzed. The company specifically pointed out that the sixth patient to have received the cell therapy in the trial had recently underwent their follow-up visit for the 40 days posttreatment time point and that the findings from the visit indicated a “positive safety and tolerability profile” for the product. No dose-limiting toxicities had occurred. Kiromic anticipates that Deltacel-01's expansion portion, which is expected to include around 9 new patients, will begin screening patients before the end of September.

“We are delighted to receive unanimous SMC approval to move forward with the expansion phase of the Deltacel-01 trial,” Pietro Bersani, the chief executive officer of Kiromic BioPharma, said in a statement.¹ “As we enter this next phase with more activated clinical sites, we expect a solid cadence of patient enrollment. We are optimistic about the potential to further evaluate Deltacel’s impact on patient outcomes and address critical unmet needs in solid tumors.”

On September 19, 2024, Kiromic additionally announced that it had activated the fifth trial site for Deltacel-01: the University of Arizona Cancer Center (UACC).² The company stated that this site is expected to begin enrollment activities within the coming weeks.

“We are delighted to partner with UACC, expanding our Deltacel-01 clinical trial to a fifth site,” Bersani said in a statement at the time.² “We believe we are well-positioned to enroll the next cohort of patients, and we are optimistic that we will continue to register encouraging results in the expansion phase of the study. The UACC has earned a reputation as a premier research institution actively engaged in clinical trials and delivering the highest-quality care to those with cancer. We look forward to working with their team.”

In August 2024, Kiromic announced progression-free survival (PFS) findings from an interim data update from Deltacel-01.³ For the 5 patients in long-term follow-up who had been evaluated, the average PFS was 4.8 months (range, 2-8 months). Earlier in the month, Kiromic also announced that the first patient to have been treated in Deltacel-01 achieved a 20% reduction in tumor size on scans at 8 months posttreatment, in comparison to pretreatment observations.⁴ Furthermore, there were no new lesions observed, and it was noted that the patient had previously shown a 13% reduction in tumor size from baseline at their 6 month assessment.

Deltacel, which is nonengineered, is based on a platform that aims to utilize the natural characteristics of GDTs for targeting of solid cancers; as such, viral vectors are not required in the manufacturing process.⁵ In August 2024, the therapy, as used in combination with low dose radiotherapy, received fast track designation from the FDA for metastatic NSCLC in patients who have progressed on 2 or more lines of standard of care therapy, including platinum-based chemotherapy, immune checkpoint inhibitors, and targeted therapy to improve PFS and OS.⁶

REFERENCES
1. Kiromic Biopharma advances Deltacel-01 into expansion phase following safety monitoring committee’s unanimous recommendation. News release. September 19, 2024. Accessed September 24, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-advances-deltacel-01-expansion-phase-following
2. Kiromic Biopharma activates the University of Arizona Cancer Center as the fifth clinical trial site in the ongoing phase 1 Deltacel-01 trial. News release. September 19, 2024. Accessed September 24, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-activates-university-arizona-cancer-center
3. Kiromic Biopharma provides update on part 1 of the Deltacel-01 trial. News release. Kiromic BioPharma, Inc. August 9, 2024. Accessed September 24, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-provides-update-part-1-deltacel-01-trial
4. Kiromic BioPharma reports 20% tumor size reduction at eight months in first patient enrolled in Deltacel-01. News release. Kiromic BioPharma, Inc. August 1, 2024. Accessed September 24, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-reports-20-tumor-size-reduction-eight-months
5. Kiromic BioPharma to advance Deltacel-01 clinical trial to part 2, expansion phase. News release. Kiromic BioPharma, Inc. July 18, 2024. Accessed September 24, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-advance-deltacel-01-clinical-trial-part-2
6. Kiromic BioPharma’s Deltacel receives FDA fast track designation. News release. Kiromic BioPharma, Inc. August 9, 2024. Accessed September 24, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharmas-deltacel-receives-fda-fast-track-designation