Kiromic BioPharma, Inc. (Nasdaq: KRBP), an immuno-oncology
target discovery and gene-editing company, with a proprietary
artificial intelligence neural network platform (Diamond AI) to
develop novel oncology therapeutics, has announced the completion
and certification of its GMP facility in Houston, Texas:
- GMP facility construction is complete and certified to meet all
FDA required regulatory guidelines.
- GMP facility is ready to support our upcoming first in-human,
off-the-shelf, allogenic CAR-T trial. The CAR-T ovarian cancer
trials will have these targets: chPD1 Gamma-Delta and
anti-ISOMSLN.
- Gamma-Delta-T cell (GDT cell) GMP manufacturing test batch
optimization and qualification studies are proceeding as
scheduled.
"The in-house capability to manufacture allogenic, off-the-shelf
CAR products removes a layer of complexity in the workflow, which
we believe will greatly enhance our ability to move swiftly through
our CAR-T trials," says Dr. Maurizio Chiriva-Internati, PhD, CEO of
Kiromic BioPharma.
"The key features of the facility have been completed, clearing
the path for the production of our off-the-shelf Gamma-Delta-T
cells, a novel approach to CAR-T cell therapy, which will be
evaluated in the upcoming clinical trials," says David Aguilar,
PhD, Head of CMC Manufacturing of Kiromic BioPharma.
"Thanks to the hard work of our scientists, contractor
engineers, suppliers, and the third party certifiers, our Houston
Facility is completing the final steps needed for launching the
next-generation of allogenic, off-the-shelf CAR-T," says Mr. Tony
Tontat, CFO, COO of Kiromic BioPharma.
(chPD1: Chimeric PD1; ISOMSLN: Iso-mesothelin; CAR: Chimeric
Antigen Receptors)
About Allogenic Gamma-Delta-T cells
GDT cells are a small fraction of blood lymphocytes, but they
are the predominant T cell type in epithelia, where they patrol the
barrier between the body and the outside world, with their potent
multi-anti-pathogen abilities. Compared with alpha-beta-T cells
(ABT), currently used in CAR therapies, GDT cells are more
efficient in killing tumor cells and more resistant to mechanisms
by which solid tumors escape from the immune system.
Furthermore, unlike ABT cells, GDT cells manufacturing does not
require the patient’s blood, but can be produced using the blood of
healthy donors, a process called allogenic cell transfer. This is
possible because, while ABT cells from another individual will
attack a patient’s normal organs, GDT cells will only target the
tumor target for which they were engineered, leaving non-tumoral
cells untouched.
The workflow of CAR-T therapy is as follows:
- The GDT cells are grown and purified from the blood of healthy
individuals.
- The GDT cells are expanded with a proprietary process.
- The GDT cells are then genetically modified to target tumor
antigens discovered by Kiromic’s Diamond AI technology, resulting
in the next generation of CAR-T cell therapy for solid
malignancies.
About Kiromic
Kiromic BioPharma, Inc. is an immuno-oncology biopharmaceutical
company focused on discovering, developing, and commercializing
novel immuno-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 essentially 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’s headquarters are located in Houston, TX adjacent to
the world’s largest medical center and the MD Anderson Cancer
Center.
For more information, please visit Kiromic’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
intentions, projections, assessments, or expectations regarding
items such as the following:
- our goals and strategies
- research, development, and regulatory activities
- FDA authorization timeline for clinical trial initiation
- clinical trial enrollment or participation by clinical
sites
- facility manufacturing capabilities for clinical trial
support
- expectations related to gamma delta CAR therapy
- performance and success of clinical trials
- 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
- relevant government policies and regulations relating to our
industry.
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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
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amended, and elsewhere in this press release. If one or more of
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version on businesswire.com: https://www.businesswire.com/news/home/20210119006187/en/
Tony Tontat Chief Financial Officer (844) 539 -
2873 ttontat@kiromic.com
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