Kiromic BioPharma Achieves Milestone with Timely Completion of Expanded cGMP Manufacturing Facility to Support Cell Therapy Oncology Pipeline
July 07 2022 - 8:18AM
Business Wire
Construction Completion is One of the
Pre-requisites to Beginning the Deltacel™ Clinical Trial Activation
Later This Year and Addresses a Key Clinical Hold Citation
Kiromic BioPharma, Inc. (NASDAQ: KRBP) (“Kiromic” or the
“Company”), a clinical-stage fully integrated biotherapeutics
company using its proprietary DIAMOND® artificial intelligence and
data mining platform to develop cell and gene therapies with a
focus on immuno-oncology, announces the timely completion of
construction on its expanded current good manufacturing practice
(cGMP) manufacturing facility in Houston. This significant
milestone was accomplished within the timeline established by the
Company, specifically June 30, 2022.
The expanded facility located at Kiromic’s headquarters is one
of the conditions required for the Company to begin the activation
of its cell therapy clinical trial for the Deltacel™ product
candidate by the end of this year. The completion also addresses a
key component in the clinical hold communication the Company
received from the U.S. Food and Drug Administration (FDA) in June
2021.
“The on-time completion of our cGMP manufacturing facility is
one of the conditions necessary to begin the activation of the
Deltacel™ clinical trial by the end of this year,” stated Pietro
Bersani, Kiromic BioPharma’s Chief Executive Officer. “The facility
supports an expanding product pipeline of cell therapies designed
to target solid tumors, furthering our commitment to delivering
lifesaving treatments to patients with cancer who have limited
therapeutic options. We believe our allogeneic, off-the-shelf
manufacturing process will result in shorter lead times and lower
costs, thereby increasing the availability of these promising
cellular therapies for oncology patients.”
The expanded 34,000-square-foot facility includes flexible
cellular therapy and viral vector suites, a dedicated cGMP
microbiology lab, a dedicated cGMP quality control (QC) lab, a
research and development laboratory, and an FDA Code of Federal
Regulations (CFR-9) compliant vivarium.
About Kiromic BioPharma
Kiromic BioPharma, Inc. is a clinical-stage, fully integrated
biotherapeutics company using its proprietary DIAMOND® artificial
intelligence (AI) 2.0 platform to discover and develop cell and
gene therapies with a therapeutic focus on immuno-oncology and
other diseases. Kiromic is in the process of developing a
multi-indication allogeneic cell therapy platform that exploits the
natural potency of Gamma Delta T-cells to target solid cancers.
From its heritage as a cancer vaccine development company, Kiromic
is 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 where data science meets target identification to
dramatically compress the years and hundreds of millions of dollars
required to develop a live drug. The Company maintains offices in
Houston, Texas. To learn more, visit www.kiromic.com and connect
with us on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. Kiromic makes such
forward-looking statements pursuant to the safe harbor provisions
of the United States 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. In some cases,
you can identify forward-looking statements by terms such as:
“will,” “potential,” “could,” “can,” “believe,” “intends,”
“continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,”
or the negative of these terms or other comparable terminology.
These forward-looking statements include, but are not limited to,
statements regarding: Kiromic’s current and anticipated IND
applications including statements regarding the scope of and timing
for submission of an IND application; the Deltacel™ product
platform; the sponsored research agreement and the data that will
be generated as a result of such collaboration; the timing for
submitting and activating Kiromic’s IND applications; the benefits
of utilizing non-genetically engineered Gamma Delta T cells as our
first in-human study; Kiromic’s ability to achieve its objectives;
and the timing for the initiation and successful completion of
Kiromic’s clinical trials of its product candidates. These
forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause actual results,
levels of activity, performance, or achievements to be materially
different from the information expressed or implied expressed or
implied by these forward-looking statements. These risks and
uncertainties include, but are not limited to, the risks and
uncertainties discussed in our Annual Report on Form 10-K for the
year ended December 31, 2021, and as detailed from time to time in
our SEC filings. You should not rely upon forward-looking
statements as predictions of future events. Although we believe
that the expectations reflected in the forward-looking statements
are reasonable, we cannot guarantee that the future results, levels
of activity, performance, or events and circumstances reflected in
the forward-looking statements will be achieved or occur. Moreover,
neither we nor any other person assumes responsibility for the
accuracy and completeness of the forward-looking statements. Such
forward-looking statements relate only to events as of the date of
this press release. We undertake no obligation to update any
forward-looking statements except to the extent required by
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20220707005261/en/
Kiromic BioPharma Linda Phelan Dyson, MPH Global Head,
Corporate Communications ldyson@kiromic.com M: 281-468-7683
LHA Investor Relations Tirth T. Patel tpatel@lhai.com
212-201-6614
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