Kiromic BioPharma Reports Patient 4 in Deltacel-01 Clinical Trial Reaches 10-Month Progression-Free Survival

Rhea-AI Summary

Kiromic BioPharma (OTCQB: KRBP) has reported positive results from its Deltacel-01 Phase 1 clinical trial, evaluating Deltacel™ (KB-GDT-01), an allogeneic, off-the-shelf, Gamma Delta T-cell therapy. The fourth patient, treated for stage 4 metastatic or locally-advanced non-small cell lung cancer (NSCLC), has shown a partial response with a 10-month progression-free survival (PFS).

The patient demonstrated a partial response (30% or greater decrease in tumor size) at the eight-month follow-up and continued without disease progression through the 10-month follow-up visit in January 2025. Two additional subjects are currently being screened and are scheduled to begin treatment at Texas Oncology in Tyler, Texas, in late February and early March.

Positive

• Patient 4 achieved partial response (>30% tumor size reduction)
• 10-month progression-free survival demonstrated in Patient 4
• Two new patients scheduled to begin treatment

Negative

• data from only one patient reported
• Still in early Phase 1 trial stage

HOUSTON--(BUSINESS WIRE)-- Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports continued favorable efficacy results from the 10-month follow-up visit for the fourth patient enrolled in its Deltacel-01 Phase 1 clinical trial and provides an enrollment update. 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.

The fourth patient in Deltacel-01 demonstrated a partial response (defined as a 30% or greater decrease in the size of the tumor) at the eight-month follow-up visit and continued without any evidence of disease progression as of the 10-month follow-up visit, thereby extending progression-free survival (PFS) to 10 months.

“We are very pleased that as of January 2025 Patient 4 had no evidence of disease progression since the partial response registered in November 2024, with a PFS of 10 months reinforcing our view that Deltacel may offer a transformative treatment option for people with advanced solid tumors,” said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. “Our team remains committed to advancing the Deltacel-01 clinical program, and we look forward to building upon these encouraging results as we expand the trial to additional participants.”

Additionally, Kiromic reports that two subjects are undergoing screening and are scheduled to start treatment at Texas Oncology in Tyler, Texas, in late February and early March, 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 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.

About Texas Oncology

With more than 530 physicians and 280 locations, Texas Oncology is an independent private practice that sees more than 71,000 new cancer patients each year. Founded in 1986, Texas Oncology provides comprehensive, multidisciplinary care and includes Texas Center for Proton Therapy, Texas Breast Specialists, Texas Colon & Rectal Specialists, Texas Oncology Surgical Specialists, Texas Urology Specialists and Texas Infusion and Imaging Center. Texas Oncology’s robust community-based clinical trials and research program have contributed to the development of more than 100 FDA-approved cancer therapies. Learn more at www.TexasOncology.com.

About the Beverly Hills Cancer Center

As a private, academic, community-based cancer center, the Beverly Hills Cancer Center not only provides the latest state-of-the-art cancer treatments all under one roof, but also provides leading clinical trials and research, attracting patients globally. By providing access to groundbreaking clinical trials, the Beverly Hills Cancer Center offers patients the opportunity to participate in the most advanced cancer treatments currently in development in the world. Beverly Hills Cancer Center is comprised of an internationally recognized multidisciplinary medical team consisting of medical oncologists, radiation oncologists, radiologists, hematologists and internists who provide exceptional patient care and support services including a robust and highly efficient team of clinical research professionals. More information is available at www.BHCancerCenter.com.

About Kiromic BioPharma

Kiromic BioPharma, Inc. is a clinical-stage, fully integrated biotherapeutics company developing a multi-indication allogeneic cell therapy platform that exploits the natural potency of Gamma Delta T-cells to target solid tumors. Kiromic is using its proprietary DIAMOND^® artificial intelligence (AI) 2.0 platform to discover novel targets for immuno-oncology. 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. 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, 2024, 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/20250218269453/en/

Alliance Advisors IR

Tirth T. Patel

tpatel@allianceadvisors.com

212-201-6614

Beverly Hills Cancer Center

Sharon Neman, MBA

Chief Strategy Officer

SN@bhcancercenter.com

310-432-8925

Source: Kiromic BioPharma, Inc.

FAQ

What results did KRBP report for Patient 4 in the Deltacel-01 trial?

Patient 4 showed a partial response (>30% tumor reduction) and achieved 10-month progression-free survival as of January 2025.

How many new patients are scheduled to join KRBP's Deltacel-01 trial?

Two new subjects are scheduled to start treatment at Texas Oncology in Tyler, Texas, in late February and early March.

What type of cancer is KRBP's Deltacel therapy targeting in the Phase 1 trial?

Deltacel is targeting stage 4 metastatic or locally-advanced non-small cell lung cancer (NSCLC) that has failed to respond to standard therapies.

What is the significance of the 10-month PFS in KRBP's Deltacel trial?

The 10-month progression-free survival indicates that Patient 4's cancer has not progressed since showing initial partial response, suggesting potential efficacy of the treatment.