Follow-up Findings Show Stable Disease
FDA and IRB Approve IND for a Single-Use,
Single-Patient Treatment with Deltacel
Fast Track Designation Request Submitted to
FDA
Complete Enrollment in Trial’s Second Cohort
Expected in July
Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the
“Company”) reports follow-up results from the second, third and
fourth patients enrolled in its 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.
The third and fourth patients showed stable disease at their
four- and two-month follow-up visits, respectively. Both patients
are doing well, and neither showed any dose-limiting toxicities.
Patients three and four are being treated at the Beverly Hills
Cancer Center (BHCC).
The second patient, also being treated at the BHCC, previously
had stable disease and showed a complete response in their brain
metastasis. At the four-month follow-up visit, while stable disease
of previously treated sites and a clean brain MRI were confirmed, a
new site of disease, a sub-cutaneous metastasis, was detected by CT
and PET scans. This patient is in generally good condition and
tolerated their initial treatment well. As such, the Institutional
Review Board (IRB) and the U.S. Food and Drug Administration (FDA)
approved a single-use, single-patient protocol, and on June 19, the
patient started a new course of treatment with low-dose radiation
and gamma-delta T cells under a single patient IND.
“We are optimistic the latest targeted treatment with Deltacel
will control the second patient’s new lesion, which is suspected to
have originated from a micro-metastasis not detected and therefore
not targeted with radiation during the first course of treatment.
This new protocol might be applied to all patients who received or
will receive the Deltacel treatment and could be instrumental in
controlling any new tumor lesions or progressing lesions,” said
Pietro Bersani, CEO of Kiromic BioPharma.
Kiromic BioPharma also reports submitting a request for Fast
Track designation for Deltacel to the FDA. Fast Track designation
facilitates and expedites the development and review of drugs that
treat serious conditions and address unmet medical needs. For
further information on Fast Track designation, please visit the
FDA’s website.
“We continue to be encouraged by the favorable results of the
Deltacel-01 trial, which reinforce our confidence in the potential
of Deltacel to provide meaningful clinical benefits to patients in
need. This confidence underscores the recent open-market purchases
of common stock by several Kiromic directors and executive
officers, as reported on Form 4 filings,” noted Mr. Bersani.
“Proceeding with a single-use, single-patient protocol of
Deltacel supports our commitment to advancing innovative therapies
that address unmet clinical needs in unique ways, which include the
possibility for retreatment,” he added. “We are also excited about
the potential of expediting Deltacel clinical development through
Fast Track designation.”
The fifth patient in the trial completed their 30-day safety
visit at the BHCC with no toxicities reported, and the sixth
patient is expected to be enrolled in July.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240620761147/en/
LHA Investor Relations Tirth T. Patel tpatel@lhai.com
212-201-6614
Kiromic BioPharma (NASDAQ:KRBP)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
Kiromic BioPharma (NASDAQ:KRBP)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024
