Kiromic BioPharma Reports Favorable Deltacel™ Preclinical Pharmacology Results
01 March 2023 - 12:08AM
Business Wire
Favorable Safety Results are Last Component
Needed to Complete the Nonclinical Module of the Company’s IND
Application
IND Submission and Activation of Clinical Trial
Process on Track for the First Quarter and Second Quarter of this
Year, Respectively
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 therapies with a focus on
immune-oncology, announces favorable safety results from the
histopathology evaluation of a preclinical study of the
pharmacology of KB-GDT-01 (trademark: Deltacel™) administered alone
and in combination with a non-biological anti-tumor therapy in
mice.
The histopathology report, authored by a certified veterinary
pathologist, revealed no adverse microscopic findings related to
the administration of Deltacel™ alone or as part of the combination
treatment.
“We’re pleased to receive a clean pharmacology profile with no
adverse findings and are encouraged by the preclinical results
to-date in support of our planned IND submission. This
histopathology report includes results from more than 500
histological sections from multiple organs of mice treated with
Deltacel™, with the combination treatment of Deltacel™ and a
non-biological anti-tumor therapy, or mice left untreated. This
study completes the necessary dataset for authoring the
Pharmacology Report of the Efficacy Study, which is an essential
component of the nonclinical module of our IND application,” stated
Leonardo Mirandola, Ph.D., Chief Scientific Officer of Kiromic
BioPharma.
“These findings are in line with what we observed in a study
evaluating Deltacel™ monotherapy at a dose more than 7 times higher
than the maximum dose planned for the Deltacel™ clinical trial, and
they confirm that Deltacel™ was well tolerated in mice, even when
given as part of a combination therapy that further boosted its
potency,” continued Dr. Mirandola. “Kiromic plans to submit the
Deltacel™ IND application to the U.S. FDA in this first quarter,
and if accepted, plans to begin the activation of the clinical
trial process in the second quarter of 2023. The planned clinical
study will evaluate Deltacel™ in combination with a non-biological
anti-tumor therapy for the treatment of non-small cell lung
cancer.”
About Kiromic BioPharma
Kiromic BioPharma, Inc. is a clinical-stage, fully integrated
biotherapeutics company using its proprietary DIAMOND® artificial
intelligence (AI) 2.0 target discovery engine to detect, develop,
and commercialize cell therapies with a therapeutic focus on
immuno-oncology. Kiromic is developing a multi-indication
allogeneic cell therapy platform that exploits the natural potency
of Gamma Delta T-cells to target solid cancers. Kiromic’s DIAMOND®
AI 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 ability to achieve its objectives
and Kiromic’s financing strategy and availability of funds. 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 other 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/20230228005440/en/
Kiromic BioPharma Linda Phelan Dyson, MPH Global Head,
Corporate Communications ldyson@kiromic.com 281-468-7683
LHA Investor Relations Tirth T. Patel tpatel@lhai.com
212-201-6614
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