Kiromic BioPharma Reports Favorable Results at Six Weeks from Fourth Patient in Deltacel-01 Clinical Trial
May 29 2024 - 8:00AM
Business Wire
Scans of this first patient in the second
cohort show 8.5% reduction in tumor size
Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the
“Company”) reports favorable safety and tolerability, and early
efficacy in the fourth patient enrolled 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) who have failed to respond to
standard therapies.
Preliminary results of this first patient in the second cohort
obtained six weeks after beginning treatment show a favorable
safety and tolerability profile, while imaging shows promising
early efficacy for the Deltacel™ treatment. Scans showed disease
stabilization, no new sites of metastatic disease and an 8.5%
reduction in the tumor size. Additionally, this patient experienced
quality-of-life benefits from Deltacel treatment including stopping
their previous need for prescription pain medication. This patient
is being treated at the Beverly Hills Cancer Center (BHCC).
“The fourth patient in Deltacel-01 suffered from metastatic
squamous cell carcinoma. They were enrolled in this trial after
failing chemotherapy, antibody-based immunotherapy and standard
radiotherapy. The six-week follow-up visit revealed stable disease,
no new lesions and an 8.5% reduction in tumor size compared with
pre-treatment measurements. In addition, while at the time of study
enrollment this patient was taking a medication for cancer pain, it
was not necessary any longer after receiving Deltacel, indicating a
quality-of-life improvement,” said Afshin Eli Gabayan, M.D.,
Medical Oncologist, Medical Director and Principal Investigator at
BHCC.
“These encouraging clinical findings represent a strong start to
the second cohort in our Deltacel-01 trial. We are particularly
encouraged by the reduction in size of the tumor observed in this
patient, and by the significant improvement in quality of life as
evidenced by the reduction in cancer-related pain. Our team remains
committed to advancing Deltacel-01 and we look forward to reporting
preliminary results from the remainder of the three-patient second
cohort in June,” said Pietro Bersani, Chief Executive Officer of
Kiromic BioPharma.
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/20240529675813/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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