Second Patient Completed Treatment and Third
Patient Dosed in Phase 1 Study Evaluating Deltacel™ for the
Treatment of Non-Small Cell Lung Cancer
Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the
“Company”) announces continued encouraging clinical findings
from the most recent follow-up visit of the first patient enrolled
in Deltacel-01, the Company’s Phase 1 clinical trial evaluating
Deltacel™ for the treatment of stage 4 metastatic non-small cell
lung cancer (NSCLC). After stable disease and preliminary
progression-free survival of one and a half months were reported
six weeks post-treatment, the two-month follow-up PET/CT scan
revealed that the patient’s tumor size was reduced by 6.6%, and no
new disease sites (metastasis) were detected. In addition, a 20%
decrease in the tumor lesion’s metabolism was noted.
This patient, who was treated at the Beverly Hills Cancer Center
(BHCC), continues to do well two months following treatment.
“We are proud and excited to report these highly promising early
results showing tumor reduction in a patient population that has
few treatment options available. When considering that the first
patient enrolled in Deltacel-01 suffered from an actively
progressing disease immediately prior to therapy, this is a
remarkable finding. We look forward to advancing our trial and to
treating additional patients,” said Pietro Bersani, Chief Executive
Officer of Kiromic.
Kiromic also reports that the second patient in the Deltacel-01
clinical trial has received the second and final infusion of
Deltacel. Kiromic expects to report initial tolerability and safety
data from this patient in early March, and preliminary efficacy
results by the end of the first quarter.
Additionally, Kiromic reports that the third patient has been
enrolled and is expected to complete treatment on February 21. Both
the second and third patients are being treated at BHCC. The
Deltacel-01 clinical trial is expected to start enrolling patients
at two additional clinical trial sites in the first half of the
year.
“The preliminary data from our first patient offers promising
insights into the effectiveness of Gamma Delta T-cell therapy when
used alongside low-dose radiation for this condition. We are
encouraged by the preliminary data on the first patient and are
optimistic about the outcomes of the subsequent patients in the
study. We continue to evaluate safety and efficacy outcomes as this
study progresses, and are pleased to have enrolled two additional
patients in the Deltacel-01 study,” said Afshin Eli Gabayan, M.D.,
Medical Oncologist, Medical Director and Principal Investigator at
Beverly Hills Cancer Center.
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 study 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 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/20240214056810/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
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