Follow-up Scans Show Continued Stable Disease
in First Patient Cohort
Company to Apply for FDA Fast Track
Designation
Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the
“Company”) announces consistent favorable safety, tolerability,
and efficacy from follow-up visits of the first cohort of three
patients 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). All three patients in the first cohort are being treated
at the Beverly Hills Cancer Center (BHCC).
Two months after completing treatment, Patients 2 and 3
continued to show stable disease. Imaging scans from Patient 2 also
showed no brain metastases, confirming findings from that patient’s
six-week follow-up visit.
Four months after completing treatment, the first patient
continues to show stable disease compared with the two-month
post-treatment scans, which showed a primary tumor size reduction
of 6.6%. The four-month follow-up for the second and third patients
on trial is scheduled for June.
A summary of all findings reported to date for the first cohort
can be found in the table below.
In addition, the fourth patient in Deltacel-01 completed
treatment on April 18 at BHCC. Kiromic expects to report
preliminary safety, tolerability, and early efficacy results from
this patient in May.
Based on encouraging preliminary results from the first patient
cohort, Kiromic intends to apply for Fast Track Designation (FTD)
from the U.S. Food and Drug Administration (FDA) by the end of the
second quarter. FTD offers several benefits and expedited review of
drugs targeting a serious condition and fulfilling an unmet medical
need, including NSCLC. FTD also facilitates more frequent
communication with the FDA, enabling sponsors to receive timely
feedback and guidance throughout the drug-development process.
Additionally, FTD may qualify Deltacel for Accelerated Approval and
Priority Review, potentially reducing the time required to bring
the drug to market.
"We are highly encouraged by the initial outcomes from the first
three patients in our Deltacel-01 Phase 1 clinical trial.
Consistency in safety, tolerability, and disease stability is of
paramount importance at this stage of testing, and the data thus
far bolster our confidence in Deltacel's potential as a
transformative treatment," stated Pietro Bersani, Chief Executive
Officer of Kiromic BioPharma. "The findings are especially
promising considering the robustness of response in the absence of
brain metastasis, and the notable reduction in tumor size for the
second and the first patient, respectively.
"These early results establish the foundation of our planned FDA
application for Fast Track Designation. Achieving this designation
could significantly accelerate the process to bring Deltacel to
patients versus traditional timelines. We also have the potential
to apply for Breakthrough Therapy Designation, enabling more
guidance due to demonstrating a substantial improvement over
current standard of care. We look forward to sharing more updates,
including the results from additional patients, as Deltacel-01
progresses."
Patient
Safety
Six Weeks
Post-treatment
Two Months
Post-treatment
Four Months
Post-treatment
1
No dose-limiting toxicities
Stable disease
Tumor size reduction of 6.6%
Stable disease compared with two-month
follow-up
2
No dose-limiting toxicities
Stable disease
Complete resolution of brain lesions
Stable disease
Confirmed clean brain scan
No new brain lesions
Expected in June 2024
3
No dose-limiting toxicities
Stable disease
Stable disease
Expected in June 2024
"We are very pleased with the initial safety and efficacy
results seen in the first cohort of patients treated with Deltacel
as part of the Phase 1 clinical trial at our cancer center. The
consistency we have observed so far in disease control and lack of
dose limiting toxicities is encouraging," said Dr. Afshin Eli
Gabayan, Medical Oncologist, Medical Director and Principal
Investigator at BHCC. "As one of the pioneers of immuno-oncology
clinical research, we strive to help advance promising treatments
like Deltacel, through our expertise and partnerships with leaders
in cellular therapy innovation. Seeing signs of early response and
tolerability gives hope for patients facing late-stage cancer. We
will continue supporting efforts to better understand and
potentially transform outcomes for lung cancer patients."
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 the 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/20240424199583/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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