Disease Stabilization and Tumor Size Reduction Seen in Fourth Patient Treated in Trial for Kiromic’s NSCLC T-cell Therapy Deltacel

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Imaging scans also showed disease stabilization, with no new sites of metastatic disease observed.

The fourth 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 experienced disease stabilization and tumor size reduction.1

Imaging scans conducted at 6 weeks after the initiation of treatment in the study for the patient, who is receiving treatment at Beverly Hills Cancer Center (BHCC), showed disease stabilization, with no new sites of metastatic disease observed. Furthermore, a reduction in tumor size of 8.5% was recorded. Kiromic also noted that the patient no longer required prescription pain medication. The company characterized the safety and tolerability profile of Delta-cel as “favorable” in this patient.

“The fourth patient in Deltacel-01 suffered from metastatic squamous cell carcinoma. They were enrolled in this trial after failing chemotherapy, antibody-based immunotherapy and standard radiotherapy,” Afshin Eli Gabayan, MD, a medical oncologist and the medical director and principal investigator at BHCC, said in a statement.1 “The 6-week follow-up visit revealed stable disease, no new lesions and an 8.5% reduction in tumor size compared with pre-treatment measurements. In addition, while at the time of study enrollment this patient was taking a medication for cancer pain, it was not necessary any longer after receiving Deltacel, indicating a quality-of-life improvement.”

The patient was the first to be treated in the trial’s second cohort. Deltacel is nonengineered 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.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.

“These encouraging clinical findings represent a strong start to the second cohort in our Deltacel-01 trial,” Pietro Bersani, CPA, the chief executive officer of Kiromic, added to the statement.1 “We are particularly encouraged by the reduction in size of the tumor observed in this patient, and by the significant improvement in quality of life as evidenced by the reduction in cancer-related pain. Our team remains committed to advancing Deltacel-01 and we look forward to reporting preliminary results from the remainder of the 3-patient second cohort in June.”

In February 2024, Kiromic reported results from the 2-month follow-up PET/CT scan for the first patient treated in Deltacel-01, on which a 6.6% reduction in tumor size was observed.2 In a more recent April 2024 update, the company reported that the second and third patients to have been enrolled in the trial were continuing to show stable disease at 2 months after completing the treatment.3 Safety, tolerability, and efficacy were deemed consistent for all 3 patients in the study’s first cohort.

As of now, all 4 patients in Deltacel-01 have received the treatment at BHCC, but Kiromic plans to treat patients at additional sites in the future. In March 2024, the company announced that Virginia Oncology Associates, PC, located in Norfolk, VA, had been activated as the second trial site for Deltacel-01. More recently, on May 20, 2024, Kiromic announced that another trial site for Deltacel-01, University of Pittsburgh School of Medicine, had been activated.4 At the time, the company stated that enrollment of the fifth participant was expected before the end of May and that enrollment of the sixth participant was anticipated to take place in June.

REFERENCES
1. Kiromic Biopharma reports favorable results at six weeks from fourth patient in Deltacel-01 clinical trial. News release. Kiromic BioPharma, Inc. May 29, 2024. Accessed May 31, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-reports-favorable-results-six-weeks-fourth
2. 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
3. KiromicBiopharma reports consistent favorable safety, tolerability, and efficacy in deltacel-01 clinical trial first three patients. News release. Kiromic BioPharma, Inc. April 24, 2024. Accessed May 31, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-reports-consistent-favorable-safety
4. Kiromic Biopharma adds UPMC as fourth Deltacel-01 clinical trial site. News release. Kiromic BioPharma, Inc. May 20, 2024. Accessed May 31, 2024. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-adds-upmc-fourth-deltacel-01-clinical-trial
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