Kiromic BioPharma Advances Deltacel-01 Into Expansion Phase Following Safety Monitoring Committee’s Unanimous Recommendation
September 19 2024 - 8:00AM
Business Wire
Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the
“Company”) announced today that the Deltacel-01 Safety
Monitoring Committee (SMC) has unanimously voted in favor of
proceeding with the expansion phase of the Deltacel-01 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.
This recommendation by the SMC follows a favorable review of
safety data from the first two cohorts, including recent results
from the 40-day follow-up visit of the sixth patient in
Deltacel-01, which demonstrated a positive safety and tolerability
profile with no dose-limiting toxicities (DLTs) observed.
As part of the expansion phase of Deltacel-01, Kiromic will
enroll approximately nine patients. Screening for new participants
is expected to commence later this month. The expansion phase, or
Part 2 of Deltacel-01, will further assess the effectiveness of
Deltacel treatment.
“We are delighted to receive unanimous SMC approval to move
forward with the expansion phase of the Deltacel-01 trial,” said
Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. “As
we enter this next phase with more activated clinical sites, we
expect a solid cadence of patient enrollment. We are optimistic
about the potential to further evaluate Deltacel’s impact on
patient outcomes and address critical unmet needs in solid
tumors.”
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 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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LHA Investor Relations Tirth T. Patel tpatel@lhai.com
212-201-6614
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