Kiromic BioPharma Reports 20% Tumor Size Reduction at Eight Months in First Patient Enrolled in Deltacel-01

Rhea-AI Summary

Kiromic BioPharma (OTCQB: KRBP) has reported favorable eight-month follow-up results from the first patient in its Deltacel-01 Phase 1 clinical trial. The 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 standard therapies.

Key findings include:

• 20% tumor size reduction at eight months post-treatment
• No new tumor lesions detected
• Eight-month progression-free survival
• Improvement from 13% reduction at six months post-treatment

The patient is being treated at the Beverly Hills Cancer Center. Kiromic expects to report additional follow-up results from the fourth and fifth patients in August.

Positive

• 20% tumor size reduction in first patient at eight months post-treatment
• No new tumor lesions detected, indicating eight-month progression-free survival
• Improvement from 13% tumor reduction at six months to 20% at eight months

Negative

• None.

HOUSTON--(BUSINESS WIRE)-- Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”), reports favorable eight-month follow-up results from the first patient enrolled in its Deltacel-01 Phase 1 clinical trial. 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 non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.

Scans taken eight months post-treatment showed the patient’s tumor size had decreased by 20% compared with the pre-treatment size and no new tumor lesions were detected, which indicate an eight-month progression-free survival. This follows a 13% reduction detected at six months post-treatment, showing a continued favorable progression. This patient is being treated at the Beverly Hills Cancer Center (BHCC).

“We are pleased to announce continued excellent clinical results from our Deltacel-01 trial, with the first patient enrolled demonstrating not only stable disease and continuing to do well, but also a 20% reduction in tumor size at the eight-month post-treatment evaluation. This result is a promising indication of the potential for our novel GDT therapy. We remain dedicated to advancing innovative cancer treatments and are encouraged by the progress we are making toward providing new options for patients,” said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.

Kiromic expects to report additional follow-up results from the fourth and fifth patients in the study 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

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/20240801334301/en/

LHA Investor Relations

Tirth T. Patel

tpatel@lhai.com

212-201-6614

Source: Kiromic BioPharma, Inc.

FAQ

What are the latest results from Kiromic BioPharma's Deltacel-01 Phase 1 clinical trial for KRBP stock?

Kiromic BioPharma (KRBP) reported a 20% tumor size reduction in the first patient at eight months post-treatment, with no new tumor lesions detected, indicating an eight-month progression-free survival in their Deltacel-01 Phase 1 clinical trial for stage 4 metastatic non-small cell lung cancer.

How has the tumor size changed in the first patient of Kiromic BioPharma's Deltacel-01 trial for KRBP?

The first patient in Kiromic BioPharma's Deltacel-01 trial showed a 20% tumor size reduction at eight months post-treatment, improving from a 13% reduction observed at six months post-treatment.

When will Kiromic BioPharma (KRBP) report additional results from the Deltacel-01 trial?

Kiromic BioPharma (KRBP) expects to report additional follow-up results from the fourth and fifth patients in the Deltacel-01 study in August.

What type of cancer is Kiromic BioPharma's Deltacel-01 trial targeting for KRBP stock?

Kiromic BioPharma's Deltacel-01 trial is targeting stage 4 metastatic non-small cell lung cancer (NSCLC) in patients who have failed to respond to standard therapies.