Kiromic BioPharma Adds UPMC as Fourth Deltacel-01 Clinical Trial Site
20 Maggio 2024 - 2:00PM
Business Wire
Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the
“Company”) announces that UPMC in Pittsburgh, Pennsylvania has
been activated as the fourth clinical trial site in the Deltacel-01
Phase 1 trial evaluating Deltacel™ (KB-GDT-01), Kiromic’s
allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in
patients with stage 4 metastatic non-small cell lung cancer
(NSCLC).
UPMC is a world-renowned healthcare system that employs some of
the nation’s top clinicians and medical researchers. UPMC Hillman
Cancer Center is Western Pennsylvania’s only National Cancer
Institute-designated Comprehensive Cancer Center.
The lead principal investigator for Deltacel-01, Jason J. Luke,
MD, FACP, will also serve as principal investigator at the UPMC
site. Dr. Luke is Associate Professor of Medicine at the University
of Pittsburgh and UPMC Hillman Cancer Center, where he is Associate
Director for Clinical Research and Director of the Immunotherapy
and Drug Development Center.
“We’re delighted to have Dr. Jason Luke and UPMC participating
in the conduct of research of our potentially transformative
therapy. Dr. Luke is one of the world’s foremost investigators in
immuno-oncology, having led clinical trials of immunotherapies
across many cancer types. His expertise in early phase drug
development for solid tumors has played a critical role in shaping
our trial, and we are optimistic Deltacel will demonstrate
continued favorable outcomes in this deadly disease as we expand
treatment to patients across more sites. We expect to activate one
more clinical trial site later this quarter and to begin enrolling
patients at UPMC this summer,” said Pietro Bersani, Chief Executive
Officer of Kiromic.
Kiromic also announces favorable preliminary safety and
tolerability data from the fourth patient in Deltacel-01, with
early efficacy data on this patient expected by the end of May. The
fifth and sixth patients are expected to be enrolled later in May
and June, respectively.
About Deltacel-01
In Kiromic’s open-label Phase 1 clinical trial, titled “Phase 1
Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell
Infusions in Combination With Low Dose Radiotherapy in Subjects
With Stage 4 Metastatic Non-Small Cell Lung Cancer” (NCT06069570),
patients with stage 4 NSCLC will receive two intravenous infusions
of Deltacel™ with four courses of low-dose, localized radiation
over a 10-day period. The primary objective of the Deltacel-01
trial is to evaluate safety, while secondary measurements include
objective response, progression-free survival, overall survival,
time to progression, time to treatment response and disease control
rates.
About Deltacel™
Deltacel™ (KB-GDT-01) is an investigational gamma delta T-cell
(GDT) therapy currently in the Deltacel-01 Phase 1 trial for the
treatment of stage 4 metastatic NSCLC. An allogeneic product
consisting of unmodified, donor-derived gamma delta T cells,
Deltacel™ is the leading candidate in Kiromic’s GDT platform.
Deltacel™ is designed to exploit the natural potency of GDT cells
to target solid cancers, with an initial clinical focus on NSCLC,
which represents about 80% to 85% of all lung cancer cases. Data
from two preclinical studies demonstrated Deltacel™’s favorable
safety and efficacy profile when it was combined with low-dose
radiation.
About UPMC
UPMC is a world-renowned, nonprofit health care provider and
insurer committed to delivering exceptional, people-centered care
and community services. Headquartered in Pittsburgh and affiliated
with the University of Pittsburgh Schools of the Health Sciences,
UPMC is shaping the future of health through clinical and
technological innovation, research, and education. Dedicated to
advancing the well-being of our diverse communities, we provide
more than $1 billion every year in community benefits, more than
any other health system in Pennsylvania. Our 100,000 employees —
including more than 5,000 physicians — care for patients across 40
hospitals and 800 doctors’ offices and outpatient sites in
Pennsylvania, New York, and Maryland, as well as overseas. UPMC
Insurance Services covers more than 4 million members with a focus
on providing the highest-quality care at the most affordable price.
To learn more, visit UPMC.com.
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 tumors. 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, 2023, 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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LHA Investor Relations Tirth T. Patel tpatel@lhai.com
212-201-6614
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