On January 21, 2025 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported favorable efficacy results from the 12-month follow-up visit for the first patient and the two-month follow-up visit for the seventh patient enrolled in its Deltacel-01 Phase 1 clinical trial, and provides an enrollment update (Press release, Kiromic, JAN 21, 2025, View Source [SID1234649792]). 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 or locally-advanced non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.

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At the 12-month post-treatment follow-up visit, the first patient in Deltacel-01 had a 33.33% reduction in tumor volume compared with their pre-treatment tumor size, thereby achieving a partial response. This marks the second patient in the Deltacel-01 study with a partial response after our fourth patient. Additionally, the seventh patient had a 9.5% reduction in tumor size at their two-month follow-up visit. Both patients are being treated at the Beverly Hills Cancer Center (BHCC).

"The sustained, positive results we are seeing with the Deltacel-01 clinical trial are highly encouraging. Having a second patient achieve partial response with the first patient’s remarkable 33% tumor shrinkage at the 12-month follow-up highlights the therapeutic potential of our gamma-delta T cell therapy. The early response observed in the seventh patient further supports our confidence in this platform. We are expanding trial enrollment to expose more patients to the potential benefit of Deltacel while bolstering our clinical dataset," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.

"The remarkable 33% tumor reduction seen in the first and fourth patient at our center along with the encouraging 9.5% reduction in the seventh patient, are truly exciting results from the Deltacel-01 clinical trial. These data, coupled with the patients’ reports of improved energy and better quality of life, reinforce the potential of Kiromic’s gamma delta T-cell therapy to deliver meaningful clinical benefit for patients with advanced lung cancer who have exhausted other treatment options," said Dr. Afshin Eli Gabayan, Medical Oncologist, Medical Director, and Principal Investigator at BHCC. "As a leading cancer center focused on providing access to the most innovative therapies, we are proud to partner with Kiromic and look forward to continuing to enroll patients and generate additional evidence supporting Deltacel’s promise as a transformative new treatment option."

The Eighth Patient Completes Treatment

The eighth patient successfully completed the Deltacel-01 treatment regimen and is tolerating therapy well. Initial efficacy results for this patient are expected in late February 2025. This patient was enrolled at the Clinical Research Advisors Koreatown, a satellite location of BHCC.

Kiromic also announces that the ninth patient in Deltacel-01 started treatment at Virginia Oncology Associates (Norfolk, VA). Additionally, the company expects to enroll the 10th and 11th patients into the trial by the end of January.

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 advanced NSCLC receive three intravenous infusions of Deltacel with six courses of low-dose, localized radiation over a 31-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.