On December 12, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported favorable ongoing efficacy results from the eight-month follow-up visit for the fourth patient enrolled in its Deltacel-01 Phase 1 clinical trial, and provides additional updates on the first and seventh patients (Press release, Kiromic, DEC 12, 2024, View Source [SID1234649077]). This trial is evaluating Deltacel (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.
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8-Month Follow-Up for Patient #4: Partial Response with Tumor Reduction of 32%
Preliminary results from the eight-month follow-up visit for the fourth patient enrolled in Deltacel-01 revealed an approximately 32% decrease in tumor volume compared with the pre-treatment size. This patient continues to experience clinical benefit without adverse events.
11-Month Follow-Up for Patient #1: Stable Disease Maintained
The first patient enrolled in the Deltacel-01 trial has maintained stable disease with no evidence of disease progression or new sites of malignancy. Kiromic last reported that in this patient, the tumor size was reduced by approximately 27% compared with the pre-treatment size, and no new sites of disease were identified. As a result, the PFS has reached 11 months with no reported adverse events. This patient’s final follow-up visit is scheduled for the end of December.
Patient #7 Completes Treatment
The seventh patient successfully completed the Deltacel-01 treatment regimen and is tolerating therapy well. Initial efficacy results for this patient are expected in early January 2025.
Patient #8 Enrolled
The eighth patient in the Deltacel-01 clinical study was enrolled this week at the Clinical Research Advisors Koreatown, a satellite location of the Beverly Hills Cancer Center (BHCC).
"The magnitude of the tumor reduction observed in Patient #4 is significant and highly encouraging. We look forward to reporting results from the first and seventh patients in January, and expect to enroll additional patients through the beginning of 2025," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.
"The remarkable 32% tumor reduction seen in the fourth patient treated with Deltacel is truly exciting and holds great promise for improving outcomes for patients with advanced lung cancer. As a leading cancer center focused on delivering the most innovative and effective therapies, we are proud to partner with Kiromic on this important clinical trial. The early safety and tolerability data, coupled with these signs of robust antitumor activity, suggest Deltacel’s promise as a transformative new treatment option. We look forward to continued enrollment and results that could change the standard of care for these patients who have exhausted other options," said Dr. Afshin Eli Gabayan, Medical Oncologist, Medical Director, and Principal Investigator at Beverly Hills Cancer Center. "At the Beverly Hills Cancer Center, our mission is to provide our patients with access to the most advanced and cutting-edge cancer treatments available. By working with visionary companies like Kiromic, we are able to offer our patients the opportunity to participate in groundbreaking clinical trials that have the potential to transform cancer care. We look forward to continuing to support the Deltacel-01 trial and reporting on the progress of the additional patients enrolled at our center. Together, we are making important strides in the fight against this devastating disease."
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 Deltacel-01 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.
About Deltacel
Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of all lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.