Kiromic to Resubmit Two Expanded INDs to the FDA for Its Allogenic, Off-the-Shelf Gamma-Delta T cell Therapies for Multiple Solid Tumors

Rhea-AI Summary

Kiromic Biopharma, Inc. (Nasdaq: KRBP) announced a planned resubmission of two investigational new drug (IND) applications to the FDA for its Allogenic Gamma-Delta T cell therapy targeting various solid tumors. Retaining 80% of the original protocols, the revised INDs aim for open enrollment, allowing broader eligibility across multiple cancers, enhancing potential market reach. Key changes include exclusively intravenous administration, streamlining procedures. The company expects IND resubmissions in 2Q 2021, with first-in-human dosing anticipated in 3Q 2021 and safety data by 4Q 2021.

Positive

• Open enrollment across multiple solid tumors, including breast and prostate cancer, enhances market potential.
• Move to single intravenous administration streamlines the process, reflecting industry preferences.
• The revised IND protocols maintain 80% of the original, ensuring a strong foundation for the trials.
• Expected timeline for IND resubmissions is in 2Q 2021, with first-in-human dosing targeted for 3Q 2021.

Negative

• None.

Kiromic Biopharma, Inc. (Nasdaq: KRBP), a target discovery and gene-editing company utilizing artificial intelligence and its proprietary neural network platform with a therapeutic focus on immuno-oncology, announced today the planned resubmission of two investigational new drug (IND) applications with the U.S. Food and Drug Administration (FDA).

The revised INDs will be for first in-human dosing of our Off-the-Shelf, Allogenic Gamma-Delta T cell therapy for metastatic and progressive locally advanced solid malignancies.

The revised INDs have protocols which retain approximately 80% of the original INDs. The differences between the INDs are detailed below:

			Revised INDs			Original INDs
Enrollment			Open enrollment, multiple solid tumors			Single enrollment 1 solid tumor (ovarian)
Administration			Only IV			Either IV or IP
Chimeric T cell therapies			Separate INDs for 2 chimeric T cell therapies IND-1: chPD1 (solid tumors, IV) IND-2: Iso-Mesothelin (solid tumors, IV)			Separate INDs for varying routes of administration IND-1: chPD1 (ovarian, IV) IND-2: chPD1 (ovarian, IP) IND-3: Iso-Mesothelin (ovarian IV & IP)
BENEFITS			Shorten the time required to reach full enrollment Expanded potential future indications

** IV = Intravenous, IP = Intraperitoneal

Timelines for the planned two INDs:

-- 2Q-2021, Expected timeline for planned two IND resubmissions

-- 30 days, Expected review and return by the FDA post IND submissions

-- 3Q-2021, Expected timeline of first-in-human dosing

-- 4Q-2021, Expected timeline of first-in-human safety and efficacy data from the trial

Since filing the original INDs in December 2020, the Company has had many discussions with the FDA, and numerous consults with scientific board and clinical advisors regarding the changes listed above. These changes shown above were made to ensure the optimal chances for success for the planned clinical trials.

Open-Enrollment and Impact on Timing

"We believe the changes in the two revised IND’s are very positive for Kiromic. The open enrollment will add breast, prostate, colorectal, and lung to our existing ovarian cancer. It is expected that the change to an open enrollment will decrease the time to reach full enrollment," says Dr. Maurizio Chiriva-Internati, CEO of Kiromic.

Single Mode of Administration (IV)

"One of the most strategic modifications was the move to a single route of administration. The new INDs will have only IV administration versus previous INDs having IV and IP. IV administration reflects the dominant and preferred mode of administration for cancer therapies in the clinic today whereby intracavitary infusions are considered more invasive. The feedbacks from the clinical sites on the new IV administration and open enrollment have been very well received," commented Dr. Scott Dahlbeck, Chief Medical Officer of Kiromic.

** IV = Intravenous, IP = Intraperitoneal

Market Expansion with Multiple Solid Tumors

"Ovarian cancer is already a significant indication by itself. However, having multiple solid tumors that are eligible in our new open enrollment protocol, including cancers such as breast, prostate, colorectal, and lung for example, will only increase the potential applications of our Off-the-Shelf, Allogenic Gamma-Delta T cell therapies," says Mr. Gianluca Rotino, Chief of Strategy and Innovation of Kiromic.

GMP Facility Readiness

"Kiromic continues to prepare itself for the upcoming first in-human trials by making sure that its GMP manufacturing facility is ready, staffed, and fully equipped. Despite COVID and the recent ice-storms which made national news, Kiromic is still running daily batch testing and validations of our Off-the-Shelf, Allogenic Gamma-Delta T cell manufacturing in full preparation for the upcoming trial," says Mr. Tony Tontat, CFO and COO of Kiromic.

Upcoming Events

-- Kiromic CEO interview on Bloomberg TV Europe (March 2021)

-- Kiromic CEO, CFO presentation at Benzinga Small Cap Conference (Mar 25th, 2021)

-- Kiromic Abstracts highlighting our AI Neoantigen discovery engine, and our Off-the-Shelf, Allogenic Gamma-Delta T cell manufacturing at AACR 2021 conference (April 9-14, 2021). www.aacr.org

About Kiromic

Kiromic BioPharma, Inc. is a preclinical stage biopharmaceutical company which is focused on discovering, developing, and commercializing novel immune-oncology applications through its robust product pipeline. The pipeline development is leveraged through the Company’s proprietary target discovery engine called "DIAMOND." Kiromic's DIAMOND is big data science meeting target identification, dramatically compressing man-years and billions of drug development dollars to develop a live drug. The Company maintains offices in Houston, Texas.

For more information, please visit the company’s website at www.kiromic.com.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the U.S. 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. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements include, but are not limited to, statements about:

• our goals and strategies;
• our future business development, financial condition and results of operations;
• expected changes in our revenue, costs or expenditures;
• growth of and competition trends in our industry;
• our expectations regarding demand for, and market acceptance of, our products;
• our expectations regarding our relationships with investors, institutional funding partners and other parties we collaborate with;
• fluctuations in general economic and business conditions in the markets in which we operate; including those fluctuations caused by COVID-19; and
• relevant government policies and regulations relating to our industry.

In some cases, you can identify forward-looking statements by terms such as "may," "could," "will," "should," "would," "expect," "plan," "intend," "anticipate," "believe," "estimate," "predict," "potential," "project" or "continue" or the negative of these terms or other comparable terminology. These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, which are, in some cases, beyond our control and which could materially affect results. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the heading "Risk Factors" included in our Registration Statement on Form S-1 (file no. 333-238153) , originally filed with the Securities and Exchange Commission (SEC) on May 11, 2020, as amended, and elsewhere in this press release. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance.

The forward-looking statements made in this press release relate only to events or information as of the date on which the statements are made in this press release. Except as expressly required by the federal securities laws, there is no undertaking to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances or any other reason. You are advised, however, to review any further disclosures we make on related subjects in our Forms 10-Q, 8-K and other reports filed with the SEC.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210309006043/en/

FAQ

What is Kiromic Biopharma's plan for the IND applications?

Kiromic Biopharma plans to resubmit two IND applications for its Allogenic Gamma-Delta T cell therapy to the FDA, with open enrollment for multiple solid tumors.

What is the expected timeline for Kiromic's IND resubmissions?

The expected timeline for the IND resubmissions is in 2Q 2021, with first-in-human dosing anticipated in 3Q 2021.

How do the revised INDs differ from the original ones?

The revised INDs maintain approximately 80% of the original protocols, with changes including open enrollment and exclusive intravenous administration.

What cancers are targeted in Kiromic's revised INDs?

The revised INDs target multiple solid tumors, including ovarian, breast, prostate, colorectal, and lung cancers.

What are the benefits of the changes in Kiromic's INDs?

The changes aim to shorten enrollment time and expand the potential future indications for the therapy.