Kiromic BioPharma to Advance Deltacel-01 Clinical Trial to Part 2, Expansion Phase

Rhea-AI Summary

Kiromic BioPharma (OTCQB: KRBP) is advancing its Deltacel-01 Phase 1 clinical trial to the Expansion Phase following a positive assessment from the Safety Monitoring Committee. The trial evaluates Deltacel™, an allogeneic, off-the-shelf, Gamma Delta T-cell therapy for stage 4 metastatic non-small cell lung cancer patients who have failed standard therapies. The company plans to begin enrolling patients in the Expansion Phase in September, adding nine more patients to the trial.

The fifth patient in Deltacel-01 completed their 30-day visit with a favorable safety profile and no dose-limiting toxicities. Kiromic expects to report early efficacy data from this patient's two-month follow-up in August. The trial's progress marks a significant milestone in validating Kiromic's innovative gamma delta approach to cancer treatment.

Positive

• Deltacel-01 trial advancing to Expansion Phase after positive Safety Monitoring Committee assessment
• Favorable safety profile observed in fifth patient at 30-day visit with no dose-limiting toxicities
• Optimal dose for Deltacel™ identified, establishing roadmap for Part 2 of the trial
• Expansion Phase enrollment planned to begin in September, increasing trial size by nine patients

Negative

• None.

Enrollment in the Expansion Phase Expected to Commence in September

Deltacel Safety Confirmed at Day 30 in Trial’s Fifth Patient; Efficacy Results on this Patient Expected in August

HOUSTON--(BUSINESS WIRE)-- Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) announces plans to advance the Deltacel-01 Phase 1 clinical trial to the Expansion Phase following a positive assessment from the Deltacel-01 Safety Monitoring Committee (SMC). The SMC convened on July 16^th and reviewed safety and efficacy data collected to-date in Deltacel-01, confirming favorable results and optimal dose.

The Deltacel-01 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.

This trial consists of two parts: Part 1 is designed to identify the optimal dose of Deltacel™. Following approval by the SMC, Part 2 (the Expansion Phase) will then further assess the therapy’s effectiveness at the optimal dose identified in Part 1. Kiromic plans to begin enrolling patients in the Expansion Phase in September, expanding the size of the trial by nine patients.

“We are pleased the SMC’s review and assessment affirmed the positive Deltacel results. Identifying the optimal dose based on encouraging safety and efficacy data is a significant milestone as it establishes a roadmap for Part 2, allowing us to focus on assessing Deltacel’s effectiveness and further validate our innovative gamma delta approach,” said Pietro Bersani, CEO of Kiromic BioPharma.

Additionally, the fifth patient in Deltacel-01 completed their 30-day visit, with a favorable safety profile and no dose-limiting toxicities reported. Kiromic expects to report early efficacy data from this patient’s two-month follow-up 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/20240718683694/en/

LHA Investor Relations

Tirth T. Patel

tpatel@lhai.com

212-201-6614

Source: Kiromic BioPharma, Inc.

FAQ

What is the current status of Kiromic BioPharma's (KRBP) Deltacel-01 clinical trial?

Kiromic BioPharma's Deltacel-01 Phase 1 clinical trial is advancing to the Expansion Phase (Part 2) following a positive assessment from the Safety Monitoring Committee. The company plans to begin enrolling additional patients in September.

What type of cancer is Kiromic's Deltacel™ (KRBP) therapy targeting?

Deltacel™ is being evaluated for the treatment of stage 4 metastatic non-small cell lung cancer (NSCLC) in patients who have failed to respond to standard therapies.

When does Kiromic BioPharma (KRBP) expect to report early efficacy data for the fifth patient in the Deltacel-01 trial?

Kiromic BioPharma expects to report early efficacy data from the fifth patient's two-month follow-up in August 2023.

How many additional patients will be enrolled in the Expansion Phase of Kiromic's (KRBP) Deltacel-01 trial?

Kiromic plans to expand the size of the Deltacel-01 trial by enrolling nine additional patients in the Expansion Phase.