Kiromic BioPharma Activates the University of Arizona Cancer Center as the Fifth Clinical Trial Site in the Ongoing Phase 1 Deltacel-01 Trial

Rhea-AI Summary

Kiromic BioPharma (OTCQB: KRBP) has activated the University of Arizona Cancer Center (UACC) as the fifth clinical trial site for its ongoing Phase 1 Deltacel-01 trial. The trial 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) who have failed to respond to standard therapies.

UACC is one of 57 NCI-Designated Comprehensive Cancer Centers in the U.S. Dr. Ricklie Ann Julian, Assistant Professor of Medicine at UACC, will serve as Principal Investigator at the site. The site initiation visit has been completed, and patient enrollment is expected to begin in the coming weeks.

Positive

• Expansion of clinical trial to fifth site, potentially accelerating patient enrollment
• Collaboration with a prestigious NCI-Designated Comprehensive Cancer Center
• Progress in the development of innovative cancer therapy for advanced NSCLC patients

Negative

• None.

HOUSTON--(BUSINESS WIRE)-- Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) announces that the University of Arizona Cancer Center (UACC) has been activated as the fifth clinical trial site in the Deltacel-01 Phase 1 trial 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) who have failed to respond to standard therapies.

The UACC is one of the 57 NCI-Designated Comprehensive Cancer Centers in the U.S. Dr. Ricklie Ann Julian, Assistant Professor of Medicine at UACC, will serve as Principal Investigator at the site.

“We are delighted to partner with UACC, expanding our Deltacel-01 clinical trial to a fifth site. We believe we are well-positioned to enroll the next cohort of patients, and we are optimistic that we will continue to register encouraging results in the expansion phase of the study. The UACC has earned a reputation as a premier research institution actively engaged in clinical trials and delivering the highest-quality care to those with cancer. We look forward to working with their team,” stated Pietro Bersani, CEO of Kiromic BioPharma.

The site initiation visit at UACC has been completed and patient enrollment is expected to begin in the coming weeks.

About the University of Arizona Cancer Center

The University of Arizona Cancer Center (UACC) is the only NCI-Designated Comprehensive Cancer Center headquartered in Arizona and is one of only 57 such centers in the U.S. With more than a dozen research and education offices throughout the state, the center’s mission is to alleviate the burden of cancer in Arizona, particularly in underserved populations including Hispanics and Native Americans.

UACC is a regional resource and national model for overcoming cancer risks, improving treatments through transdisciplinary discoveries, training talented scientists and providers, and engaging communities though a shared determination to discover, innovate and improve health equity. The center has Banner – University Medicine as its clinical affiliate in Tucson, and it operates local outpatient clinics. Founded by Sydney Salmon, a physician who served from 1976 until 1999, UACC received its first NCI Cancer Center Support Grant in 1978 and was designated a comprehensive cancer center in 1990.

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

This press release contains forward-looking statements that involve substantial risks and uncertainties. Kiromic makes such forward-looking statements pursuant to the safe harbor provisions of the United States Private Securities Litigation Reform Act, Section 21E of the Securities Exchange Act of 1934, as amended, and other federal securities laws. All statements other than statements of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as: “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements regarding: Kiromic’s ability to achieve its objectives and Kiromic’s financing strategy and availability of funds. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in our Annual Report on Form 10-K for the year ended December 31, 2023, and as detailed from time to time in our other SEC filings. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. Such forward-looking statements relate only to events as of the date of this press release. We undertake no obligation to update any forward-looking statements except to the extent required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240919466768/en/

LHA Investor Relations

Tirth T. Patel

tpatel@lhai.com

212-201-6614

Source: Kiromic BioPharma, Inc.

FAQ

What is the purpose of Kiromic BioPharma's Deltacel-01 Phase 1 trial?

The Deltacel-01 Phase 1 trial is evaluating Deltacel™ (KB-GDT-01), an allogeneic, off-the-shelf, Gamma Delta T-cell therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.

How many clinical trial sites are now active for Kiromic BioPharma's (KRBP) Deltacel-01 trial?

With the activation of the University of Arizona Cancer Center, there are now five active clinical trial sites for Kiromic BioPharma's Deltacel-01 trial.

Who is the Principal Investigator for the Deltacel-01 trial at the University of Arizona Cancer Center?

Dr. Ricklie Ann Julian, Assistant Professor of Medicine at the University of Arizona Cancer Center, will serve as Principal Investigator at the site.

When is patient enrollment expected to begin at the new Kiromic BioPharma (KRBP) trial site?

Patient enrollment at the University of Arizona Cancer Center is expected to begin in the coming weeks, following the completion of the site initiation visit.