Kiromic BioPharma Submits Investigational New Drug Application for Phase 1 Trial with Deltacel for Non-Small Cell Lung Cancer

Rhea-AI Summary

Kiromic BioPharma (NASDAQ: KRBP) has submitted an Investigational New Drug (IND) application to the FDA for its Phase 1 clinical trial of KB-GDT-01, known as Deltacel, aimed at treating non-small cell lung cancer (NSCLC) in combination with anti-tumor therapy. Deltacel is an allogeneic, non-viral, off-the-shelf Gamma Delta T-cell therapy, targeting solid tumors that account for 90% of all cancers. This submission marks a significant advancement in the company's efforts to provide new treatment options for lung cancer patients, which is the leading cause of cancer-related deaths in the U.S.

Positive

• Submission of IND for KB-GDT-01 (Deltacel) is a significant milestone.
• Deltacel aims to address unmet needs in treating solid tumors, specifically NSCLC.
• Potential to provide a promising treatment option for a leading cause of cancer deaths.

Negative

• None.

Deltacel is Being Developed as an Allogeneic, Non-Viral, Non-Engineered Off-the-Shelf Gamma Delta T-Cell Therapy

HOUSTON--(BUSINESS WIRE)-- Kiromic BioPharma, Inc. (NASDAQ: KRBP) (“Kiromic” or the “Company”), a clinical-stage fully-integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence and data mining platform to develop cell therapies with a focus on immuno-oncology, announces the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial to evaluate KB-GDT-01, or Deltacel, in combination with an anti-tumor therapy for the treatment of non-small cell lung cancer (NSCLC).

Deltacel is the Company’s allogeneic, non-viral, non-engineered off-the-shelf Gamma Delta T-cell (GDT) therapy. The Company is seeking to address the significant unmet need of applying cell therapy to treat solid malignancies, which comprise 90% of all cancers, including NSCLC.

“Submitting this IND brings us one step closer to beginning human clinical testing with this incredible science and providing a promising treatment option to the tens of thousands of patients living with non-small cell lung cancer. While this is the second most common type of cancer, lung cancer is the leading cause of cancer deaths in the United States, accounting for about 1 in 5 of all cancer deaths,” stated Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. “This milestone, achieved on March 31, 2023, is a tremendous accomplishment by our team, and we look forward to initiating clinical testing upon IND acceptance by the FDA.”

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 detect, develop and commercialize cell therapies with a focus 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 cancers. 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, 2021, 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/20230403005088/en/

Kiromic BioPharma

Linda Phelan Dyson, MPH

Global Head, Corporate Communications

ldyson@kiromic.com

281-468-7683

LHA Investor Relations

Tirth T. Patel

tpatel@lhai.com

212-201-6614

Source: Kiromic BioPharma, Inc.

FAQ

What is the purpose of Kiromic BioPharma's IND submission for KRBP?

The IND submission is to initiate a Phase 1 clinical trial for KB-GDT-01 (Deltacel) in treating non-small cell lung cancer.

When was the IND application submitted for Deltacel?

The IND application was submitted on March 31, 2023.

What type of therapy is Deltacel developed by KRBP?

Deltacel is an allogeneic, non-viral, non-engineered off-the-shelf Gamma Delta T-cell therapy.

What significant cancer does Deltacel target?

Deltacel targets non-small cell lung cancer (NSCLC), which is a major type of lung cancer.

What impact could Deltacel have on KRBP's market position?

If successful, Deltacel could enhance KRBP's market position by addressing a significant unmet medical need in cancer therapy.