Early Efficacy Results Show Primary Lung Tumor Stabilization and Complete Disappearance of Brain Metastases in Second Patient in Kiromic BioPharma’s Deltacel-01 Clinical Trial
19 Marzo 2024 - 1:08PM
Business Wire
Favorable Safety and Tolerability also
Observed
Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the
“Company”) reports early efficacy results showing primary lung
tumor stabilization and the complete disappearance of brain
metastases in the second patient in the Company’s Deltacel-01 Phase
1 clinical trial. Deltacel-01 is 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).
Preliminary results obtained six weeks from the beginning of
treatment show Deltacel’s efficacy in controlling tumor growth, as
well as favorable safety and tolerability. Stable disease status
was confirmed by CT scan. An MRI scan of the patient’s brain
performed before treatment began noted new onset metastatic
disease, which completely resolved on repeat MRI imaging performed
six weeks from the beginning of treatment. This patient is being
treated at the Beverly Hills Cancer Center (BHCC).
“These six-week results in the second patient enrolled in
Deltacel-01 are extremely promising. Along with preliminary results
from the first patient we previously reported, they strengthen the
candidacy of Deltacel as a potential treatment for patients with
advanced disease. The complete eradication of this patient’s
preexisting brain metastases supports a growing body of evidence
for the benefit of our therapy and could also support Deltacel-01
crossing the blood-brain barrier,” said Pietro Bersani, Chief
Executive Officer of Kiromic BioPharma.
"These preliminary results, especially the CT and MRI scan
findings and the absence of dose-limiting toxicities, underscore
the promise of Deltacel as a potentially efficacious therapy. We
are cautiously optimistic given we have achieved a stable disease
status for this patient. This aligns with our center’s commitment
to bringing pioneering care for patients with few or no available
treatment options," commented Afshin Eli Gabayan, M.D., Medical
Oncologist, Medical Director, and Principal Investigator at
BHCC.
Kiromic expects to announce initial safety, tolerability, and
preliminary efficacy results from the third patient enrolled in
Deltacel-01 by the end of March.
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 Beverly Hills Cancer Center
As a private, academic, community-based cancer center, the
Beverly Hills Cancer Center not only provides the latest
state-of-the-art cancer treatments all under one roof, but also
provides leading clinical trials and research, attracting patients
globally. By providing access to groundbreaking clinical trials,
the Beverly Hills Cancer Center offers patients the opportunity to
participate in the most advanced cancer treatments currently in
development in the world. Beverly Hills Cancer Center is comprised
of an internationally recognized multidisciplinary medical team
consisting of medical oncologists, radiation oncologists,
radiologists, hematologists and internists who provide exceptional
patient care and support services including a robust and highly
efficient team of clinical research professionals. More information
is available at www.BHCancerCenter.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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version on businesswire.com: https://www.businesswire.com/news/home/20240319287248/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
Beverly Hills Cancer Center Sharon Neman Chief Strategy
Officer SN@BHCancerCenter.com 310-432-8925
Grafico Azioni Kiromic BioPharma (NASDAQ:KRBP)
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