Kiromic BioPharma Announces FDA Authorization of IND to Initiate Phase 1 Clinical Trial Evaluating Deltacel in Non-Small Cell Lung Cancer
01 May 2023 - 10:08PM
Business Wire
Company Expects Beginning of First in Human
Trial Activation in Second Quarter of 2023
Deltacel is Being Developed to Treat Solid
Malignancies, Which Comprise 90% of All Cancers
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, today announces that the U.S. Food and Drug
Administration (FDA) has authorized the Company’s Investigational
New Drug (IND) application to initiate a Phase 1 clinical trial to
evaluate Deltacel (KB-GDT-01) for patients with non-small cell lung
cancer (NSCLC).
Deltacel is the Company’s allogeneic, non-engineered,
off-the-shelf Gamma Delta T-cell (GDT) therapy. Notably, Deltacel
does not require the use of any viral vector as many other cell
therapies do, which, among other advantages, allows for reduced
manufacturing costs. Kiromic is seeking to address a significant
unmet need by applying cell therapy to treat solid malignancies,
which comprise 90% of all cancers, including NSCLC. Lung cancer is
by far the leading cause of cancer death in the US, accounting for
about 1 in 5 of all cancer deaths. Each year, more people die of
lung cancer than of colon, breast, and prostate cancers
combined.
“Receiving the authorization from the FDA to administer Deltacel
to patients enables us to advance our GDT therapy candidate into
the clinic. As a potentially well tolerated and effective
treatment, we look forward to the opportunity for Deltacel to have
a meaningful impact on the hundreds of thousands of patients with
non-small cell lung cancer and with other solid cancers,” stated
Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. “We
are in the process of activating clinical trial sites, and we look
forward to providing updates on our progress.”
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 develop and
commercialize cell therapies focusing 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, 2022, 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/20230501005246/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 Feb 2024 to Mar 2024
Kiromic BioPharma (NASDAQ:KRBP)
Historical Stock Chart
From Mar 2023 to Mar 2024