Kiromic BioPharma Adds UPMC as Fourth Deltacel-01 Clinical Trial Site

Rhea-AI Summary

Kiromic BioPharma has announced that UPMC in Pittsburgh, PA, is now the fourth clinical trial site for their Deltacel-01 Phase 1 trial. This trial evaluates 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). Dr. Jason J. Luke, a leading expert in immuno-oncology, will serve as the principal investigator at UPMC. Preliminary safety and tolerability data from the fourth patient in Deltacel-01 are favorable, with early efficacy data expected by the end of May. The company plans to enroll the fifth and sixth patients in May and June, respectively, and activate one more trial site later this quarter.

Positive

• UPMC, a world-renowned healthcare system, added as the fourth clinical trial site.
• Dr. Jason J. Luke, a leading immuno-oncology expert, appointed as principal investigator at UPMC.
• Favorable preliminary safety and tolerability data from the fourth patient in Deltacel-01 trial.
• Early efficacy data expected by end of May.
• Plans to enroll the fifth and sixth patients in May and June.
• Expansion to one more clinical trial site expected later this quarter.

Negative

• No concrete efficacy data reported yet, only preliminary safety data.
• Potential delays if early efficacy data or further patient enrollments are not favorable.
• Dependence on the successful activation of additional trial sites for broader patient enrollment.

HOUSTON--(BUSINESS WIRE)-- Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) announces that UPMC in Pittsburgh, Pennsylvania has been activated as the fourth 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).

UPMC is a world-renowned healthcare system that employs some of the nation’s top clinicians and medical researchers. UPMC Hillman Cancer Center is Western Pennsylvania’s only National Cancer Institute-designated Comprehensive Cancer Center.

The lead principal investigator for Deltacel-01, Jason J. Luke, MD, FACP, will also serve as principal investigator at the UPMC site. Dr. Luke is Associate Professor of Medicine at the University of Pittsburgh and UPMC Hillman Cancer Center, where he is Associate Director for Clinical Research and Director of the Immunotherapy and Drug Development Center.

“We’re delighted to have Dr. Jason Luke and UPMC participating in the conduct of research of our potentially transformative therapy. Dr. Luke is one of the world’s foremost investigators in immuno-oncology, having led clinical trials of immunotherapies across many cancer types. His expertise in early phase drug development for solid tumors has played a critical role in shaping our trial, and we are optimistic Deltacel will demonstrate continued favorable outcomes in this deadly disease as we expand treatment to patients across more sites. We expect to activate one more clinical trial site later this quarter and to begin enrolling patients at UPMC this summer,” said Pietro Bersani, Chief Executive Officer of Kiromic.

Kiromic also announces favorable preliminary safety and tolerability data from the fourth patient in Deltacel-01, with early efficacy data on this patient expected by the end of May. The fifth and sixth patients are expected to be enrolled later in May and June, respectively.

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 UPMC

UPMC is a world-renowned, nonprofit health care provider and insurer committed to delivering exceptional, people-centered care and community services. Headquartered in Pittsburgh and affiliated with the University of Pittsburgh Schools of the Health Sciences, UPMC is shaping the future of health through clinical and technological innovation, research, and education. Dedicated to advancing the well-being of our diverse communities, we provide more than $1 billion every year in community benefits, more than any other health system in Pennsylvania. Our 100,000 employees — including more than 5,000 physicians — care for patients across 40 hospitals and 800 doctors’ offices and outpatient sites in Pennsylvania, New York, and Maryland, as well as overseas. UPMC Insurance Services covers more than 4 million members with a focus on providing the highest-quality care at the most affordable price. To learn more, visit UPMC.com.

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/20240520744653/en/

LHA Investor Relations

Tirth T. Patel

tpatel@lhai.com

212-201-6614

Source: Kiromic BioPharma, Inc.

FAQ

What is the new clinical trial site added by Kiromic BioPharma for Deltacel-01?

UPMC in Pittsburgh, PA, is the fourth clinical trial site for the Deltacel-01 Phase 1 trial by Kiromic BioPharma.

Who is the principal investigator for the Deltacel-01 trial at UPMC?

Dr. Jason J. Luke, Associate Professor of Medicine at the University of Pittsburgh and UPMC Hillman Cancer Center, is the principal investigator.

What type of therapy is being tested in the Deltacel-01 trial?

Deltacel™ (KB-GDT-01), an allogeneic, off-the-shelf, Gamma Delta T-cell therapy, is being tested in the Deltacel-01 trial.

What is the focus of the Deltacel-01 Phase 1 trial?

The Deltacel-01 Phase 1 trial focuses on evaluating Deltacel™ therapy in patients with stage 4 metastatic non-small cell lung cancer (NSCLC).

When can we expect early efficacy data from the Deltacel-01 trial?

Early efficacy data from the fourth patient in the Deltacel-01 trial are expected by the end of May.