Initial Tolerability and Safety Data
from First Patient Expected by Year-End, with Preliminary Efficacy
Results by End of January 2024
Kiromic BioPharma, Inc. (OTCQB: 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 that the first patient has initiated
treatment at the Beverly Hills Cancer Center (BHCC) in the
Company’s Deltacel-01 clinical trial. This Phase 1 study is
evaluating Deltacel™ for the treatment of stage 4 metastatic
non-small cell lung cancer (NSCLC).
Initial tolerability and safety data from this first patient is
expected to be available by year-end. Additionally, Kiromic expects
to report preliminary efficacy results from the first patient by
the end of January 2024.
The Company expects that the Deltacel-01 clinical trial will
start enrolling patients at two additional clinical sites in early
2024.
“We are extremely proud to initiate this first-in-human trial of
Deltacel when we stated we would,” said Pietro Bersani, Chief
Executive Officer of Kiromic. “Non-small cell lung cancer
represents a significant unmet medical need, and a leading cause of
death in the U.S. We look forward to enrolling additional patients
to advance the clinical development of Deltacel for the treatment
of solid tumors, starting with NSCLC.”
"Beverly Hills Cancer Center is pleased to announce the dosing
of the first patient in our Deltacel-01 study," said Dr. Afshin Eli
Gabayan, Medical Oncologist, Medical Director, and Principal
Investigator at Beverly Hills Cancer Center. "We are excited about
the potential of this novel Gamma Delta T-cell therapy combined
with low dose radiation for our patients with lung cancer who have
few treatment options left. We look forward to evaluating long term
safety and efficacy outcomes as the study progresses."
Dr. Arash Gabayan, Radiation Oncologist at Beverly Hills Cancer
Center and the sub-investigator who administered the low dose
radiation treatments, commented: "The first course of combination
of Deltacel and low dose radiation was successfully delivered to
this first patient. Our clinical research team will continue
monitoring this patient closely as we seek to understand how this
innovative and exciting dual approach may impact the immune
response against the cancer cells. We are hopeful that this
investigational treatment approach can make a meaningful difference
for lung cancer patients."
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 study is to evaluate
safety, while secondary ones 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 non–small cell lung cancer. An allogeneic product
consisting of unmodified, donor-derived gamma delta T cells,
Deltacel is Kiromic BioPharma’s leading candidate in its GDT
platform. Deltacel is designed to exploit the natural potency of
GDT cells to target solid cancers, with an initial focus on NSCLC,
the most prevalent type of lung cancer and representing about 80%
to 85% of 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 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.
About Beverly Hills Cancer Center
As a private, academic, community-based cancer center, 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 composed 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 on: www.BHCancerCenter.com.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20231214862515/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 Gabayan, MBA
Chief Strategy Officer SN@bhcancercenter.com 310-432-8925
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