Kiromic BioPharma Updates Deltacel-01 Trial

Kiromic BioPharma, Inc. has shared follow-up results for the second, third, and fourth patients in its Deltacel-01 Phase 1 clinical trial. This study is testing Deltacel™ (KB-GDT-01), an allogeneic Gamma Delta T-cell (GDT) therapy, in stage 4 metastatic non-small cell lung cancer (NSCLC) patients who have not responded to standard treatments.

The third and fourth patients exhibited stable disease at their four-month and two-month follow-up visits, respectively. Both are in good health and showed no dose-limiting toxicities. These patients are being treated at the Beverly Hills Cancer Center (BHCC).

Meanwhile, the second patient, also treated at BHCC, previously had stable disease and showed a complete response in their brain metastasis. At their four-month follow-up, stable disease in previously treated sites and a clean brain MRI were confirmed, though a new sub-cutaneous metastasis was detected via CT and PET scans. This patient is generally well and tolerated the initial treatment. Consequently, the FDA and Institutional Review Board (IRB) approved a single-use, single-patient protocol, allowing this patient to start a new treatment course with low-dose radiation and gamma-delta T cells under a single patient IND.

Kiromic BioPharma's CEO, Pietro Bersani, expressed optimism that the latest targeted treatment with Deltacel will control the second patient’s new lesion, which may have originated from an undetected micro-metastasis during the first treatment. Bersani suggested that this new protocol might be extended to all patients undergoing Deltacel treatment to manage new or progressing tumor lesions effectively.

Kiromic has also submitted a request for Fast Track designation for Deltacel to the FDA. This designation is intended to expedite the development and review of drugs that treat serious conditions and meet unmet medical needs.

Bersani commented positively on the Deltacel-01 trial results, highlighting the potential of Deltacel to provide significant clinical benefits. This optimism was reflected in the recent open-market purchases of Kiromic's common stock by several directors and executive officers.

Additionally, the company is moving forward with a single-use, single-patient protocol for Deltacel, reinforcing its dedication to advancing innovative therapies that address unique clinical needs, including the potential for retreatment. Bersani also expressed enthusiasm for the expedited development of Deltacel through the Fast Track designation.

The fifth patient in the trial has completed their 30-day safety visit at BHCC without any toxicities reported, and the enrollment of the sixth patient is anticipated in July.

The Deltacel-01 trial, officially 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), aims to assess the safety of Deltacel™. Secondary objectives include evaluating objective response, progression-free survival, overall survival, time to progression, time to treatment response, and disease control rates.

Deltacel™ (KB-GDT-01) is an investigational therapy in Kiromic’s GDT platform, targeting solid cancers with a clinical focus on NSCLC. Initial data from preclinical studies showed Deltacel™'s favorable safety and efficacy when combined with low-dose radiation.

The Beverly Hills Cancer Center, a private academic and community-based institution, offers state-of-the-art cancer treatments and leading clinical trials, drawing patients worldwide. Their multidisciplinary medical team provides exceptional patient care and support services, including a robust clinical research team.

Kiromic BioPharma, Inc., based in Houston, Texas, is a clinical-stage biotherapeutics company developing cell therapies focused on immuno-oncology using its proprietary DIAMOND® AI target discovery engine. The company’s platform aims to develop multi-indication allogeneic cell therapies leveraging the natural potency of Gamma Delta T-cells to target solid tumors.