Kiromic BioPharma Announces Company Will Directly Submit Amended IND for Procel™ to the FDA in Second Half of 2022
May 11 2022 - 6:58AM
Business Wire
Company Provides Regulatory Update on Progress
to Address Previously Outlined Chemistry, Manufacturing, and
Control (CMC) Issues Related to Clinical Hold on Investigational
New Drug Applications (INDs)
A Type A FDA Meeting Will Not Be Pursued
Company Announces Ongoing Progress Towards the
Implementation by the Beginning of the Third Quarter of 2022 of a
Current Good Manufacturing Practice (cGMP) Mammalian Master Cell
Bank (mMCB), a Key Component to Manufacture a GMP-Grade Retroviral
Vector for Gamma Delta T (GDT) Cell Engineering
Kiromic BioPharma, Inc. (NASDAQ: KRBP) (“Kiromic” or the
“Company”), a clinical-stage fully integrated biotherapeutics
company using its proprietary DIAMOND® artificial intelligence (AI)
and data mining platform to discover and develop cell and gene
therapies with a therapeutic focus on immuno-oncology, today
announces the Company will submit an amended Investigational New
Drug Application (IND) for its first oncology cell therapy
candidate Procel™ directly to the FDA in the second half of
2022.
Over the course of the last ten months, the Company has
developed a solid plan to address the previously outlined
chemistry, manufacturing, and control (CMC) issues cited in the
FDA’s July 2021 letter regarding the clinical hold on the Company’s
INDs. Based on the unanimous advice from independent regulatory
experts, the Company has determined that it is not necessary to
proceed with the previously contemplated Type A meeting with the
FDA to further address the CMC issues and instead will move forward
with a submission of an amended IND for Procel™ directly to the FDA
during the second half of this year.
The Company also announces ongoing progress toward the
implementation of a current good manufacturing practice (cGMP)
mammalian master cell bank (mMCB), which will provide a GMP-grade
retroviral vector for gamma delta T (GDT) cell engineering. A cGMP
mammalian master cell bank is a significant step forward in the
Company’s clinical pathway and would address a key issue identified
by the FDA in the clinical hold letter.
“We are very pleased to share these significant regulatory
updates, reflecting the progress we have been making as a Company.
In addition, progress toward establishing the master cell bank will
enable us to create the GMP-grade retroviral vector for gamma delta
cell engineering - a cornerstone of our clinical program” stated
Pietro Bersani, Kiromic BioPharma’s Chief Executive Officer. “These
achievements demonstrate our team’s execution efforts toward our
goal of beginning the activation of the clinical trial for our
first oncology cell therapy candidate Procel™ by the end of the
fourth quarter of 2022.”
About Kiromic BioPharma
Kiromic BioPharma, Inc. is a clinical-stage, fully integrated
biotherapeutics company using its proprietary DIAMOND® artificial
intelligence (AI) 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 ALEXIS, a
multi-indication allogeneic CAR-T 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 billions of drug development
dollars required to develop a cell therapy. The Company maintains
offices in Houston, Texas. To learn more, visit www.kiromic.com and
connect with us on Twitter and LinkedIn.
Note Regarding 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 ability to achieve its objectives;
the ability of the Kiromic to address any issues related to its
clinical trials including the FDAs comments and concerns; Kiromic’s
fulfillment of regulatory obligations related to our clinical
development programs, including implementation of cGMP platforms;
Kiromic’s regulatory approach, including statements about plans to
file any IND amendments or seek a Type A meeting with the FDA;
implementation or expansion of Kiromic’s manufacturing
capabilities, including statements related to the mammalian master
cell bank; the benefits from developing a mammalian master cell
bank; 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/20220511005431/en/
Linda Phelan Dyson, MPH Global Head, Corporate Communications
ldyson@kiromic.com M: 281-468-7683
Kiromic BioPharma (NASDAQ:KRBP)
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