Kiromic BioPharma Submits Investigational New Drug Application for Phase 1 Trial with Deltacel for Non-Small Cell Lung Cancer
April 03 2023 - 8:08AM
Business Wire
Deltacel is Being Developed as an Allogeneic,
Non-Viral, Non-Engineered Off-the-Shelf Gamma Delta T-Cell
Therapy
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
immuno-oncology, announces the submission of an Investigational New
Drug (IND) application to the U.S. Food and Drug Administration
(FDA) for a Phase 1 clinical trial to evaluate KB-GDT-01, or
Deltacel, in combination with an anti-tumor therapy for the
treatment of non-small cell lung cancer (NSCLC).
Deltacel is the Company’s allogeneic, non-viral, non-engineered
off-the-shelf Gamma Delta T-cell (GDT) therapy. The Company is
seeking to address the significant unmet need of applying cell
therapy to treat solid malignancies, which comprise 90% of all
cancers, including NSCLC.
“Submitting this IND brings us one step closer to beginning
human clinical testing with this incredible science and providing a
promising treatment option to the tens of thousands of patients
living with non-small cell lung cancer. While this is the second
most common type of cancer, lung cancer is the leading cause of
cancer deaths in the United States, accounting for about 1 in 5 of
all cancer deaths,” stated Pietro Bersani, Chief Executive Officer
of Kiromic BioPharma. “This milestone, achieved on March 31, 2023,
is a tremendous accomplishment by our team, and we look forward to
initiating clinical testing upon IND acceptance by the FDA.”
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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230403005088/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
Kiromic BioPharma (NASDAQ:KRBP)
Historical Stock Chart
From Oct 2024 to Nov 2024
Kiromic BioPharma (NASDAQ:KRBP)
Historical Stock Chart
From Nov 2023 to Nov 2024