Kiromic BioPharma Reports Favorable Results at Six Weeks from Fourth Patient in Deltacel-01 Clinical Trial

Rhea-AI Summary

Kiromic BioPharma (OTCQB: KRBP) reported favorable six-week results from the fourth patient in its Deltacel-01 Phase 1 clinical trial. This trial evaluates the allogeneic, off-the-shelf Gamma Delta T-cell (GDT) therapy, Deltacel™ (KB-GDT-01), in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who didn't respond to standard treatments. Preliminary results show an 8.5% reduction in tumor size and no new metastatic disease sites, indicating promising early efficacy. The patient also experienced improved quality of life, including discontinuation of prescription pain medications. CEO Pietro Bersani expressed optimism about these initial findings and the upcoming results from the remaining patients in the second cohort, expected in June.

Positive

• 8.5% reduction in tumor size.
• No new metastatic disease sites.
• Improved quality of life for patient, including discontinuation of pain medication.
• Favorable safety and tolerability observed.
• Early efficacy signals in an advanced, treatment-resistant cancer patient.

Negative

• Results based on only one patient in the second cohort.
• Full data from the second cohort pending.
• to preliminary findings; long-term efficacy and safety not yet established.

Scans of this first patient in the second cohort show 8.5% reduction in tumor size

HOUSTON--(BUSINESS WIRE)-- Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports favorable safety and tolerability, and early efficacy in the fourth patient enrolled in the Company’s Deltacel-01 Phase 1 clinical trial. Deltacel-01 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.

Preliminary results of this first patient in the second cohort obtained six weeks after beginning treatment show a favorable safety and tolerability profile, while imaging shows promising early efficacy for the Deltacel^™ treatment. Scans showed disease stabilization, no new sites of metastatic disease and an 8.5% reduction in the tumor size. Additionally, this patient experienced quality-of-life benefits from Deltacel treatment including stopping their previous need for prescription pain medication. This patient is being treated at the Beverly Hills Cancer Center (BHCC).

“The fourth patient in Deltacel-01 suffered from metastatic squamous cell carcinoma. They were enrolled in this trial after failing chemotherapy, antibody-based immunotherapy and standard radiotherapy. The six-week follow-up visit revealed stable disease, no new lesions and an 8.5% reduction in tumor size compared with pre-treatment measurements. In addition, while at the time of study enrollment this patient was taking a medication for cancer pain, it was not necessary any longer after receiving Deltacel, indicating a quality-of-life improvement,” said Afshin Eli Gabayan, M.D., Medical Oncologist, Medical Director and Principal Investigator at BHCC.

“These encouraging clinical findings represent a strong start to the second cohort in our Deltacel-01 trial. We are particularly encouraged by the reduction in size of the tumor observed in this patient, and by the significant improvement in quality of life as evidenced by the reduction in cancer-related pain. Our team remains committed to advancing Deltacel-01 and we look forward to reporting preliminary results from the remainder of the three-patient second cohort in June,” said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.

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 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

Chief Strategy Officer

SN@BHCancerCenter.com

310-432-8925

Source: Kiromic BioPharma, Inc.

FAQ

What are the results from the Deltacel-01 trial involving KRBP?

Preliminary six-week results show an 8.5% reduction in tumor size and no new metastatic disease sites in the fourth patient, indicating promising early efficacy and improved quality of life.

How does the Deltacel-01 treatment impact patients with stage 4 NSCLC?

The treatment showed an 8.5% reduction in tumor size, stabilization of the disease, and improved quality of life, including stopping the need for pain medication.

What is the significance of the Deltacel-01 trial's initial findings?

The initial findings are promising for the Deltacel-01 trial, showing favorable safety, tolerability, and early efficacy in a patient with advanced stage 4 NSCLC.

What is the next step in the Deltacel-01 clinical trial for KRBP?

Kiromic BioPharma plans to report preliminary results from the remaining patients in the second cohort of the Deltacel-01 trial in June.