On March 19, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported early efficacy results showing primary lung tumor stabilization and the complete disappearance of brain metastases in the second patient in the Company’s Deltacel-01 Phase 1 clinical trial (Press release, Kiromic, MAR 19, 2024, View Source [SID1234641267]). Deltacel-01 is evaluating Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC).

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Preliminary results obtained six weeks from the beginning of treatment show Deltacel’s efficacy in controlling tumor growth, as well as favorable safety and tolerability. Stable disease status was confirmed by CT scan. An MRI scan of the patient’s brain performed before treatment began noted new onset metastatic disease, which completely resolved on repeat MRI imaging performed six weeks from the beginning of treatment. This patient is being treated at the Beverly Hills Cancer Center (BHCC).

"These six-week results in the second patient enrolled in Deltacel-01 are extremely promising. Along with preliminary results from the first patient we previously reported, they strengthen the candidacy of Deltacel as a potential treatment for patients with advanced disease. The complete eradication of this patient’s preexisting brain metastases supports a growing body of evidence for the benefit of our therapy and could also support Deltacel-01 crossing the blood-brain barrier," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.

"These preliminary results, especially the CT and MRI scan findings and the absence of dose-limiting toxicities, underscore the promise of Deltacel as a potentially efficacious therapy. We are cautiously optimistic given we have achieved a stable disease status for this patient. This aligns with our center’s commitment to bringing pioneering care for patients with few or no available treatment options," commented Afshin Eli Gabayan, M.D., Medical Oncologist, Medical Director, and Principal Investigator at BHCC.

Kiromic expects to announce initial safety, tolerability, and preliminary efficacy results from the third patient enrolled in Deltacel-01 by the end of March.

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 the Deltacel-01 trial 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.