Kiromic BioPharma Adds Virginia Oncology Associates, PC as the Second Clinical Trial Site in the Ongoing Phase 1 Deltacel-01 Trial
01 Marzo 2024 - 2:08PM
Business Wire
Third Patient Enrolled in Deltacel-01 Completes
Treatment
Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the
“Company”) announces that Virginia Oncology Associates, PC
(Norfolk, Virginia) has been activated as the second clinical trial
site in the Phase 1 Deltacel-01 trial evaluating Deltacel™
(KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta
T-cell (GDT) therapy, in patients with non-small cell lung cancer
(NSCLC).
“Virginia Oncology Associates is known for its excellence in
oncology-focused research and patient care, and we are delighted to
add them as the second Deltacel-01 clinical trial site. With
encouraging preliminary results from the first patient in
Deltacel-01, we are proud to expand trial access to more sites with
the goal of enhancing enrollment efficiency and data quality,” said
Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.
The site initiation process at Virginia Oncology Associates has
been completed and patient enrollment is expected to begin in
April, following receipt of preliminary results from the first
three-patient cohort in Deltacel-01. Dr. Gary Simmons, D.O., MSHA,
will serve as the principal investigator at this site, and brings
to Deltacel-01 extensive experience in clinical studies focused on
oncology and on CAR T-cell therapies.
Kiromic also announces that the third patient in Deltacel-01
completed treatment at the Beverly Hills Cancer Center on February
21. Kiromic expects to announce initial safety and tolerability
data, as well as preliminary efficacy results, from this patient
and from the trial’s second patient 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 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 Virginia Oncology Associates
Virginia Oncology Associates is an oncology and hematology
practice of physicians specializing in diagnosing and treating
cancer and blood disorders. With locations spanning the southeast
region of Virginia and Northeastern North Carolina, it extends
multiple services and treatments to patients, including medical
oncology, radiation oncology, gynecologic oncology, hematology,
diagnostics, clinical research, stem cell transplantation, genetic
counseling, and psychosocial oncology.
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, 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/20240301490403/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
Grafico Azioni Kiromic BioPharma (NASDAQ:KRBP)
Storico
Da Dic 2024 a Gen 2025
Grafico Azioni Kiromic BioPharma (NASDAQ:KRBP)
Storico
Da Gen 2024 a Gen 2025