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Kiromic Announces FDA IND Submission Forty-Five Days before the end of the Second Quarter: First-In-Human, Off-The-Shelf Chimeric PD1 Switch Receptor – Gamma Delta T-cell Therapy

HOUSTON–()–Kiromic Biopharma, Inc. (Nasdaq: KRBP)

Today, Kiromic announces 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 T-Cell therapy for any solid malignancy that expresses the biomarker PD-L1, with higher efficacy, higher safety, as well as lower manufacturing and distribution costs.

The clinical trial title: ALEXIS-PRO-1: A Phase 1, Open-label, Dose Escalation Study of KB-PD1, an Allogeneic Gamma Delta T-Cell Expressing a Chimeric PD1 Switch Receptor, in Subjects with PD‑L1 Positive Metastatic or Progressive Locally Advanced Solid Malignancies.

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

Kiromic’s preclinical studies show rapid and complete tumor elimination with no toxicity as per results presented at the American Association Cancer Research 2021 poster LB148.

Unlike in the case of autologous CAR-T cell therapy products, which are derived from pretreated cancer patients, Kiromic’s proprietary PD1 Gamma-delta switch receptor therapy is derived from healthy donors.

Key features of the IND:

Product Name

KB-PD1

Product Type

Chimeric PD1 T-Cell live cell therapy

Cancer Type

All solid tumors

Targeting

Chimeric PD-L1

Patient Type

Patients with solid tumor positive for PD‑L1

Projected No. of Patients

30

Dosing

Dose escalation

Primary Completion of Trial

18 months

First-in-human dosing

3Q 2021 pending FDA authorization

First data from Trial

4Q 2021

How Our KB-PD1 Live T-Cell Therapy Improves CAR-T Market:

 

Marketed and traditional CAR-T

Kiromic KB-PD1

Malignancies

(Cancer Type)

Hematologic

Solid Tumors

Live Cell Origin

Autologous

Live Cells from pre-treatment patients

Allogeneic

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

Kiromic was able to respect the expectations and meet the timeline 45 days before the end of the second quarter. Kiromic now expects that it will be able to deliver a first in human patient dosing by the end of Q3 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.

Historically, checkpoint inhibitors have been successful in solid malignancies, but KB-PD1 takes it one step further by not just blocking the PD1/PD-L1 interaction (“cutting the brakes”) like a checkpoint inhibitor does, but rather, KB-PD1 rewires the brake into an accelerator.

In this way, Kiromic is optimistic that any cancer cell that expresses the PD-L1 marker will effectively activate and accelerate the ability of KB-PD1 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.

IQVIA (CRO, Clinical Research Organization)

https://www.iqvia.com/

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

IQVIA will be managing our clinical trail sites CRO (Clinical Research Organization).

Leading global sites are lining up to be the first to dose our KB-PD1 live cell therapies for solid tumors.

Site announcements are coming within weeks.

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

“I’m thrilled to see our technology go into the clinic, and it was due to the dedication of our team, and our strong preclinical results which helped propel Kiromic to be able to file this IND submission to the FDA on May 14, 2021,” stated Dr. Maurizio Chiriva-Internati, DBSc, PhDs, CEO of Kiromic.

“Our people and vendors have been working tirelessly. They are excited and ready to launch the first-in-human dosing by 3Q 2021 pending FDA authorization.

Our KB-PD1 will be the first in the world to deliver this T-cell therapy to solid tumors with key features demanded by the T-cell therapy market. We aim to deliver KB-PD1 which will have:

— Higher efficacy

— Higher safety

— Lower manufacturing costs

— Lower distribution costs.”

CFO of Kiromic, Mr. Tony Tontat

“This IND filing is an awaited news for the markets and will open up advantageous financing options to the company as we look to extend cash runway into 2022.”

CSIO of Kiromic, Mr. Gianluca Rotino

“This IND filing is supported by strong IP portfolio including new IP in areas such as:

— Gene editing

— Live cell harvesting

— Live cell expansion (manufacturing clones from small batches)

— Live cell logistics (manufacturing, tissue preservation, and transfers)

As we continue to grow our DIAMOND derived targets and our related clinical programs, our IP portfolio is continually being fortified in all major geographies, and we look forward to updating our investors in upcoming presentations and filings.

This is a key milestone, not only for Kiromic, positioning Kiromic as a pioneer in T-Cell therapy for solid tumors, but also for immunotherapy in general.

With the support of Kiromic’s innovations in AI, the clinical trial R&D process will now be faster bringing cellular therapies to patients with more expediency than previously achievable.”

CMO of Kiromic, Dr. Scott Dalhbeck

“Patients and clinicians alike have been waiting for a T-Cell therapy which could deliver a safe, effective, and lower cost solution for solid tumors. We are on the brink of making this vision a reality when we dose the first solid tumor patients.”

About Metastatic Solid Malignancies

The ALEXIS-PRO-1 clinical trial will enroll patients with metastatic or progressive locally advanced solid malignancies that express the PD-L1 marker on their tumor.

These late-stage patients typically have a survival of only a few months, and so effective treatments that are non-toxic and rapidly effective, are desperately needed.

Since most solid malignancies express PD-L1, the dose escalation phase of the trial will be open to a wide range of tumor types such as prostate, breast, pancreas, lung, colon, renal, bladder, ovarian, and others.

Once the optimal biologic dose (OBD) has been determined, the OBD will then be given to an expanded number of patients for the most promising indications.

Since Kiromic’s preclinical animal studies have shown a fast and brisk anti-tumor response, expectations are high that this product will be able to achieve what has thus far proven to be elusive with late-stage cancer patients – a significant and long-lasting improvement in the quality and quantity of life.

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 MDAnderson 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.

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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