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Kiromic Announces FDA IND Submission First-In-Human, AI derived Off-The-Shelf IsoMesothelin Gamma Delta CAR T-cell Therapy, 30 Days Before the End of the Second Quarter

HOUSTON–()–Kiromic Biopharma, Inc. (Nasdaq: KRBP), an immuno-oncology target discovery and gene-editing company with a proprietary artificial intelligence neural network platform (Diamond AI) that is used to develop novel oncology therapeutics, today announced the submission of a novel Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial that has the potential to be a universal CAR T-Cell therapy for any solid malignancy that expresses the biomarker Iso-mesothelin, with higher efficacy, higher safety, as well as lower manufacturing and distribution costs.

The title of the clinical trial is: ALEXIS-ISO-1: A Phase 1, Open-label, Dose Escalation Study of KB-ISM, Allogeneic Gamma Delta T-cells Expressing a Chimeric Antigenic Receptor (CAR) Against the Isoform 2 of Mesothelin in Subjects with Metastatic or Progressive Locally Advanced Solid Malignancies.

The FDA feedback is expected within 30 days from IND submission.

Key features of the IND:

Product Name

KB-ISM

Product Type

CAR-T live cell therapy

Cancer Type

All solid tumors that express IsoMesothelin

Targeting

Isoform 2 of Mesothelin (AI algorithm predicted targets)

Patient Type

Patients with solid tumor positive for ISM

No. of Patients

30

Dosing

Dose escalation

Duration of Trial

18 months

First-in-human

3Q 2021 pending FDA authorization

First data from Trial

4Q 2021

How Our KB-ISM Live Cell Therapy CAR-T Improves CAR-T Market:

 

Marketed and traditional CAR-T

Kiromic KB-ISM

Malignancies

(Cancer Type)

Hematologic

Solid Tumors

Live Cell Origin

Autologous

 

Live Cells from pre-treatment patients

Allogenic

 

Live Cells from healthy donors

Live Cell Cloning

(Manufacturing)

Single batch

Single dose

Single batch

Multi dose

 

(aka. Off-The-Shelf)

Mass Manufacturing

on-demand

a single patient

— Will be manufactured like a traditional drug

— Kiromic proprietary manufacturing

— Kiromic proprietary cryopreservation processing techniques

This submission follows by one week the company’s prior submission of the IND for a phase 1 trial of the Gamma Delta chimeric PD1 Switch Receptor.

Both clinical trials support Kiromic’s clinical strategy of developing a “universal” off-the-shelf cell therapy against solid tumors.

This Submission was made 30 days ahead of the schedule previously announced on March 9, 2021.

This IND represents a Key Milestone of the program, which brings to the clinic the first target derived from the Kiromic’s AI and Bioinformatics target prediction platform.

Kiromic now expects that it will be able to deliver a first in human patient dosing by the end of the third quarter of 2021 Kiromic, an organization that is driven to achieve scientific breakthroughs, dedicated significant resources to the IND submission in an effort to achieve the optimal clinical trial design on the fastest possible timeline.

IQVIA (https://www.iqvia.com/) will be managing our clinical trial sites as the CRO (Clinical Research Organization). Leading global sites are lining up to be the first to dose our KB-ISM live cell therapies for solid tumors expressing IsoMesothelin.

IQVIA is an industry driver in data technology and advanced analytics, designed to produce and develop optimal clinical trial outcomes.

Site announcements are expected within the next few weeks.

Since Kiromic BioPharma’s Isoform 2 Mesothelin (KB-ISM) is off-the-shelf, it can be pre-manufactured like a typical drug, even though it is a living cellular therapy. This industry leading innovation is due to Kiromic’s proprietary manufacturing and cryopreservation processing techniques.

Kiromic is optimistic that any cancer cell that expresses the Isoform 2 Mesothelin marker will effectively activate and accelerate the ability of KB-ISM to traffic through the tumor microenvironment (TME), which thus far has proven to be an imposing barrier to effective T cell treatments in solid cancers.

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CEO of Kiromic, Dr. Maurizio Chiriva-Internati, DBSc, PhDs stated:

“Kiromic’s Off-The-Shelf (OTS) CAR Gamma Delta T-Cell (GDT) is a unique product, and I am very excited to present this IND to the FDA.

This technology is meant to potentially change the Cell and Gene Therapy landscape, helping to address the major issues on manufacturing, safety, cost and most importantly, time.

A Bioinformatics approach in the Cell Therapy & Gene Therapy field is disruptive and will help to screen and design specific binder (monoclonal Antibodies) with more specificity and avidity creating better and more robust therapy with less side effects.

Kiromic is in a unique position because its bioinformatic engine combines CancerDiff, a data-mining tool for the identification of tumor-preferred isoforms, with Diamond, an AI-driven immunogenic peptide identification system.

This combination allows Kiromic to identify targetable sections of a tumor isoform (peptides) that are a unique signature of cancer cells.

The advantage of Kiromic’s system is two-fold: 1) it saves time and money because it allows the prioritization of tumor-selective targets, and 2) it maximizes the likelihood of identifying targets that are safe by increasing the targeting specificity.

I am proud of our Translational and CMC teams that were capable of creating a feeder free expansion system with a purity of over 99% GDT, and it is very exciting that we can cryopreserve these cells in long term storage so that they are available on demand for shipment and ready to inject around the world.

I believe that our science will reshape and revolutionize the approach to Immune Oncology treatment in the years to come.”

CFO of Kiromic, Mr. Tony Tontat stated:

“With this IsoMesothelin IND filing, Kiromic shows its commitment to invest in the latest AI technologies and then bring these AI predicted biomarkers into the clinic.

Going forth, we will look to announce our further investments in AI and how these investments in AI will keep the company in front of competitors in our space who are working without AI.”

CSIO of Kiromic, Mr. Gianluca Rotino stated:

“This IND filing confirms the solidity of our IP portfolio, and highlights the results obtained by our Bioinformatics department and the application of our AI platform.

In combination with the ALEXIS-PRO-1 clinical trial, it represents the second element of the development of our clinical strategy, which will allow us at the end of the dose escalation phase of this trial, to select the best indication for the expansion phase that we project will ultimately lead to a BLA.”

CMO of Kiromic, Dr. Scott Dahlbeck stated:

“I am looking forward to testing this novel AI discovered biomarker in metastatic cancer patients that desperately need safe and effective treatment options. This unique target was unearthed by our dedicated team of bioinformatic specialists, and if this clinical trial can validate the ability of Kiromic’s AI system to quickly discover dynamic targets, then it will meet one of the greatest needs in immunotherapy today, that of a lack of effective targets that can be used in immunotherapy treatments.”

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About Kiromic

Kiromic BioPharma, Inc. (Nasdaq: KRBP) is a target discovery and gene-editing company utilizing a state-of-the-art artificial intelligence (AI) platform focused on unleashing the power of the patient’s own immune system to fight cancer.

Kiromic’s pipeline development is leveraged through the Company’s proprietary target discovery Artificial Intelligence engine called “DIAMOND.” Kiromic’s DIAMOND is big data science meeting target identification, dramatically compressing the man-years and the millions of drug development dollars needed to develop a live drug.

The Company maintains its HQ offices in the world’s largest medical center in Houston, Texas adjacent to MD Anderson Cancer Center and the Baylor College of Medicine Where Kiromic has ongoing collaboration with these Institutions.

Kiromic’s scientific achievements related to this endeavor can be seen in the six poster nominations awarded by the prestigious AACR at its annual meeting in April, 2021 (https://ir.kiromic.com/news-releases/news-release-details/kiromic-announces-6-posters-presented-american-association).

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

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Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our company’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Company’s annual report on Form 10-K for the most recently completed fiscal year and subsequent reports filed after the date of the annual report with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and our company undertakes no duty to update such information except as required under applicable law.

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