• Enrollment in the Expansion Phase Expected to Commence in September
• Deltacel Safety Confirmed at Day 30 in Trial’s Fifth Patient; Efficacy Results on this Patient Expected in August

HOUSTON / Jul 18, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) announces plans to advance the Deltacel-01 Phase 1 clinical trial to the Expansion Phase following a positive assessment from the Deltacel-01 Safety Monitoring Committee (SMC). The SMC convened on July 16^th and reviewed safety and efficacy data collected to-date in Deltacel-01, confirming favorable results and optimal dose.

The Deltacel-01 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.

This trial consists of two parts: Part 1 is designed to identify the optimal dose of Deltacel™. Following approval by the SMC, Part 2 (the Expansion Phase) will then further assess the therapy’s effectiveness at the optimal dose identified in Part 1. Kiromic plans to begin enrolling patients in the Expansion Phase in September, expanding the size of the trial by nine patients.

“We are pleased the SMC’s review and assessment affirmed the positive Deltacel results. Identifying the optimal dose based on encouraging safety and efficacy data is a significant milestone as it establishes a roadmap for Part 2, allowing us to focus on assessing Deltacel’s effectiveness and further validate our innovative gamma delta approach,” said Pietro Bersani, CEO of Kiromic BioPharma.

Additionally, the fifth patient in Deltacel-01 completed their 30-day visit, with a favorable safety profile and no dose-limiting toxicities reported. Kiromic expects to report early efficacy data from this patient’s two-month follow-up in August.

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.

About Kiromic BioPharma

Kiromic BioPharma, Inc. is a clinical-stage, fully integrated biotherapeutics company using its proprietary DIAMOND^® artificial intelligence (AI) 2.0 target discovery engine to develop and commercialize cell therapies focusing on immuno-oncology. Kiromic is developing a multi-indication allogeneic cell therapy platform that exploits the natural potency of Gamma Delta T-cells to target solid tumors. Kiromic’s DIAMOND^® AI is where data science meets target identification to dramatically compress the years and hundreds of millions of dollars required to develop a live drug. The Company maintains offices in Houston, Texas. To learn more, visit www.kiromic.com and connect with us on Twitter and LinkedIn.

Forward-Looking Statements

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