Kiromic BioPharma Reports Favorable Ongoing Clinical Results From Fourth and Sixth Patients Enrolled in Deltacel-01

Rhea-AI Summary

Kiromic BioPharma (OTCQB: KRBP) reports favorable ongoing clinical results from its Deltacel-01 Phase 1 trial, evaluating Deltacel™ (KB-GDT-01) in stage 4 metastatic non-small cell lung cancer (NSCLC) patients. Key highlights:

• Patient 4: Maintained stable disease with a 5.3% tumor size reduction at 6-month follow-up
• Patient 6: Demonstrated stable disease with no new lesions at 2-month follow-up
• Median progression-free survival (PFS) increased to 6 months
• Median follow-up duration for all patients is 7.7 months

These results support Deltacel's potential to delay disease progression in advanced lung cancer patients and validate the therapeutic potential of gamma-delta T cells in advanced cancer treatment.

Positive

• Patient 4 showed a 5.3% reduction in tumor size at 6-month follow-up
• Patient 6 demonstrated stable disease with no new lesions at 2-month follow-up
• Median progression-free survival (PFS) increased to 6 months
• Median follow-up duration for all patients is 7.7 months
• Consistent disease stabilization observed across enrolled patients

Negative

• None.

HOUSTON--(BUSINESS WIRE)-- Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports favorable ongoing efficacy results from follow-up visits for Patient 4 and Patient 6 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.

At the six-month follow-up visit, Patient 4 maintained stable disease with a 5.3% reduction in tumor size compared to the pre-treatment size. At the two-month follow-up visit, Patient 6 demonstrated stable disease with no new lesions detected and no signs of disease progression. Both of these patients are being treated at the Beverly Hills Cancer Center.

As a result of these updates, the median progression-free survival (PFS) across the trial has now increased to 6 months, highlighting the potential of Deltacel-01 to delay disease progression in advanced lung cancer patients. The median follow-up duration for all patients in the trial is now 7.7 months.

“We are encouraged by the consistency in disease stabilization seen across the patients enrolled in this study as well as the emerging signs of tumor reduction, which further support the potential clinical benefits of Deltacel,” said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. “These latest results continue to validate the therapeutic potential of gamma-delta T cells and their ability to provide meaningful outcomes for patients with advanced cancer.”

“The follow-up results we are seeing in the Deltacel-01 trial are encouraging, especially for patients with limited treatment options. The stabilization of disease, combined with early signs of tumor reduction in some cases, speaks to the potential of this therapy to make an impact in the treatment of advanced solid tumors. We are hopeful that continued follow-up will support the promising outcomes we’ve seen to date,” added Afshin Eli Gabayan, M.D., Medical Oncologist, Medical Director and Deltacel-01 Principal Investigator at the Beverly Hills Cancer Center.

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 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 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.

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LHA Investor Relations

Tirth T. Patel

tpatel@lhai.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 are the latest results from Kiromic BioPharma's (KRBP) Deltacel-01 Phase 1 trial?

Kiromic BioPharma reported favorable ongoing clinical results from Patient 4 and Patient 6 in the Deltacel-01 Phase 1 trial. Patient 4 maintained stable disease with a 5.3% tumor size reduction at 6-month follow-up, while Patient 6 demonstrated stable disease with no new lesions at 2-month follow-up. The median progression-free survival (PFS) has increased to 6 months.

What is the target patient population for Kiromic BioPharma's (KRBP) Deltacel-01 trial?

The Deltacel-01 trial is evaluating Deltacel™ (KB-GDT-01) in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.

What is the median follow-up duration for patients in Kiromic BioPharma's (KRBP) Deltacel-01 trial?

The median follow-up duration for all patients in the Deltacel-01 trial is now 7.7 months.

How does Kiromic BioPharma's (KRBP) Deltacel™ therapy work?

Deltacel™ (KB-GDT-01) is an allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy. It utilizes gamma-delta T cells to potentially provide meaningful outcomes for patients with advanced cancer by delaying disease progression and stabilizing tumors.