Kiromic Announces Expansion of In-House Cell therapy cGMP Manufacturing Facility and the Appointment of Industry Veteran Ignacio Nez as Chief…

By daniellenierenberg

HOUSTON--(BUSINESS WIRE)-- Kiromic BioPharma, Inc. (Nasdaq: KRBP)

Expansion of in-house cGMP manufacturing facility to provide support to the Company's clinical trials. Therapeutic doses expected to be ready for first in-human dosing in 3Q-2021.

Mr. Ignacio Nez, a 20-year industry veteran in global operations and manufacturing, is joining the Kiromic team to take the company to the next level and to scale up cGMP manufacturing capabilities internally.

Kiromic is an immuno-oncology company using Artificial Intelligence (AI) to identify critical markers in solid tumors to develop Allogeneic CAR-T cell therapy.

Kiromics CAR-T technology addresses critical efficacy and safety issues by developing switches to control T-cell activity reducing cell exhaustion and cytokine release syndrome among others.

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Expansion of in-house cGMP manufacturing facility

In support of the upcoming INDs, Kiromic is expanding its HQ in Houston, TX. To their current cGMP, R&D labs, vivarium and offices, Kiromic is adding an adjacent space where more cGMP clean rooms, QC, QA and regulatory, offices and ultra-cold storage will have place.

This new expansion will add up to a total of approximately 30,000 square feet and will enable supporting Kiromic significant growth as the company approaches the clinical phase.

Appointment of Chief Operating and Manufacturing Officer

Mr. Ignacio Nez MSCHE, MBB has been appointed as Chief Operating Officer and Manufacturing Officer.

Mr. Nez will play a key role in expanding the scale up of Kiromics operations, including manufacturing, taking the company from pre-IND status to the clinical phase and eventually to commercial phase.

Mr. Nez has over 20 years of global experience in corporate functions including manufacturing, research, operational excellence and strategy. He has held senior leadership positions in companies including General Electric, Johnson & Johnson and Novartis. Most recently, he was the Executive Director of Manufacturing at the Gene Therapy Program of the University of Pennsylvania.

Before that, he was the Head of Manufacturing Strategy and Operations Excellence at Novartis, where he was charged with transforming manufacturing operations in support of the ramp up of Kymriah, the first FDA-approved CAR-T cell therapy, which was developed at the University of Pennsylvania.

Mr. Nez holds an MSC in Chemical Engineering from the University of Granada.

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

Kiromic believes it has the key to resolve the current challenges in cell therapy and I believe we will become the reference and lead the industry going forward.

Cell Therapy Manufacturing: Autologous (patient) vs. Allogeneic (healthy donor)

The table below outlines the current cell therapy manufacturing challenges which Kiromic allogeneic cell manufacturing expects to resolve and which Mr. Nez will advance.

CAR-T technology challenges

AutologousCAR-T

KiromicAllogeneic

CAR-T

Safety

CRS

(cytokine release syndrome)

CRES

(T-cell related encephalopathy syndrome)

Efficacy

++++ (*)

Indication

BloodCancers

SolidTumors

T-cell overstimulation

T-cell exhaustion

Tumor immune suppressive microenvironment

Tumor specific antigens (shedding)

CD19

multipletargets

Manufacturing

Patients variation & manufacturing success

Lead time(autologous vs. off-the-shelf)

17-30 days

None

Cost of Manufacturing (per patient)

++++

Application

Order of treatment application

3rd Line

TBD

Treatment Setting

24 Daysin-patient

24 hoursin-patient (**)

(*) based upon Kiromic's pre-clinical projections, AACR posters (**) as filed in IND to the FDA (May 2021).

COMO of Kiromic, Mr. Ignacio Nez stated:

"I am impressed by Kiromics end-to-end approach to cell therapy as I believe they address almost every known issue in current cell therapies.

Expanded Kiromic in-house manufacturing capabilities are capital efficient and are optimized to deliver the capacity projections, making manufacturing a competitive advantage and not a challenge for the company.

I believe that this technology is meant to change the cell and gene therapy landscape, reshaping the future approach to cancer treatment.

I am humbled to join the team at this critical juncture."

CMO of Kiromic, Scott Dahlbeck, MD, PharmD stated:

Kiromic is pleased to obtain the clinical manufacturing expertise of Mr. Nez, whose expertise and biopharmaceutical background I believe will serve to capitalize on the cellular therapy production capabilities of Kiromic, leading to a new era in immuno-oncology treatments for solid tumors."

CSIO of Kiromic, Mr. Gianluca Rotino stated:

"I believe all of our cell therapy manufacturing is novel and resolves key industry challenges.

It is my opinion, that our manufacturing technology will be very much sought after by pharma companies and cell therapy industry players.

Our cell therapy IPs portfolio is very strong.

This manufacturing expansion and bringing Mr. Nunez to Kiromic are strategically important milestones that makes us ready to face the challenges of the clinical trials and puts us on the path of commercial viability of our novel therapy."

CFO of Kiromic, Mr. Tony Tontat stated:

"Capital efficiency is what we strove to deliver with our investments as we were building out our cGMP facility.

We are happy to receive this additional validation of capital efficiency from an industry veteran like Mr. Nez."

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

Marketed andtraditional CAR-T

Kiromic KB-PD1

Malignancies(Cancer Type)

Hematologic

Solid Tumors

Live Cell Origin

Autologous

Live Cells from