Kiromic BioPharma Reports Six-Month Results from First Patient Enrolled in Deltacel-01 Clinical Trial
06 Juni 2024 - 2:00PM
Business Wire
Favorable Follow-up Findings Include Stable
Disease and a 13% Decrease in Tumor Size
Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the
“Company”) reports favorable six-month follow-up results from
the first patient enrolled in the Deltacel-01 Phase 1 clinical
trial. This trial is evaluating Deltacel™ (KB-GDT-01), the
Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT)
therapy, in patients with stage 4 metastatic non-small cell lung
cancer (NSCLC) who have failed to respond to standard
therapies.
Scans taken six months post-treatment showed the patient’s tumor
size had decreased by 13% compared with the pre-treatment size, and
no new tumor lesions were detected, which translates into a
six-month progression-free survival. In addition, no dose-limiting
toxicities were reported, reinforcing the safety profile of
Deltacel observed in previous follow-up visits. This patient is
being treated at the Beverly Hills Cancer Center (BHCC).
“We are delighted to report that Patient 1 in the Deltacel-01
clinical trial has achieved six-month progress-free survival, and
that they continue to do well with no side effects. This is an
important clinical milestone that underscores the potential of
Deltacel in treating advanced cancers,” said Pietro Bersani, Chief
Executive Officer of Kiromic BioPharma. “Notably, we observed a 13%
decrease in tumor size. These results are encouraging and support
our belief in the potential of Deltacel to provide an effective new
treatment for patients with advanced cancers. We are committed to
advancing this trial and bringing hope to those with limited
treatment options.”
Kiromic continues to expect to report long-term follow-up
results for the other two subjects in the first cohort and the
first subject in the second cohort by the end of June.
Additionally, the fifth patient in Deltacel-01 began treatment
in May, is currently doing well without any signs of toxicity and
is expected to have their first efficacy assessment in July. The
sixth patient is currently undergoing pre-enrollment screening and
is projected to start treatment in mid-June.
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/20240606202467/en/
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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