Kiromic BioPharma to Advance Deltacel-01 Clinical Trial to Part 2, Expansion Phase
July 18 2024 - 8:00AM
Business Wire
Enrollment in the Expansion Phase Expected to
Commence in September
Deltacel Safety Confirmed at Day 30 in Trial’s
Fifth Patient; Efficacy Results on this Patient Expected in
August
Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the
“Company”) announces plans to advance the Deltacel-01 Phase 1
clinical trial to the Expansion Phase following a positive
assessment from the Deltacel-01 Safety Monitoring Committee (SMC).
The SMC convened on July 16th and reviewed safety and efficacy data
collected to-date in Deltacel-01, confirming favorable results and
optimal dose.
The Deltacel-01 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 trial consists of two parts: Part 1 is designed to identify
the optimal dose of Deltacel™. Following approval by the SMC, Part
2 (the Expansion Phase) will then further assess the therapy’s
effectiveness at the optimal dose identified in Part 1. Kiromic
plans to begin enrolling patients in the Expansion Phase in
September, expanding the size of the trial by nine patients.
“We are pleased the SMC’s review and assessment affirmed the
positive Deltacel results. Identifying the optimal dose based on
encouraging safety and efficacy data is a significant milestone as
it establishes a roadmap for Part 2, allowing us to focus on
assessing Deltacel’s effectiveness and further validate our
innovative gamma delta approach,” said Pietro Bersani, CEO of
Kiromic BioPharma.
Additionally, the fifth patient in Deltacel-01 completed their
30-day visit, with a favorable safety profile and no dose-limiting
toxicities reported. Kiromic expects to report early efficacy data
from this patient’s two-month follow-up in August.
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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