Kiromic BioPharma (“the Company”) (NASDAQ: KRBP), a
target discovery and gene-editing company utilizing artificial
intelligence and its proprietary neural network platform with a
therapeutic focus on immuno-oncology, announced today the
submission of two investigational new drug (IND) applications with
the U.S. Food and Drug Administration (FDA) for the initiation
of:
--- Phase 1 clinical trial of an intravenously (IV) administered
allogenic CAR-T for epithelial ovarian carcinoma (EOC) and
malignant pleural mesothelioma (MPM) and
--- Phase 1 clinical trial of an intrapleural/intraperitoneal
(IP) administered allogenic CAR-T for EOC and MPM.
Kiromic’s proprietary PD1 Gamma-delta CAR (PD1-GDT CAR) T cell
therapy is a novel method for “off-the-shelf” allogeneic CAR T
cells derived from healthy donors. We believe our proprietary
gamma-delta T cell manufacturing and distribution will offer
significant advantages over competitive manufacturing
technologies.
The initial dose escalation component of each CAR-T trial is
projected to enroll approximately 12 patients over 4 months at two
sites.
The first in-human dosing is targeted for 1Q-2021.
"It's an exciting time to see our technology go into the clinic.
This is the culmination of +25 years of research and development
which has spanned the globe with international contributions and
scientific collaborations from the sharpest minds of our time. Our
gamma-delta T-cells are designed to offer clinicians a treatment
option with:
-- higher efficacy,
-- higher safety (reducing graft vs. host risks), and
-- lower manufacturing and distribution costs vs. cellular
therapy technologies of the past," says Dr. Maurizio
Chiriva-Internati, PhD, CEO of Kiromic.
"This first in-human off-the-shelf allogenic gamma-delta chPD1
CAR-T cell therapy trial will mark a major milestone, not only for
Kiromic, but also for clinicians who have been frustrated with the
lack of CAR T cell treatment options for solid malignancies, since
current CAR T cell therapies are only approved for hematologic
malignancies, with all of the drawbacks of autologous based
platforms,” commented Dr. Scott Dahlbeck, MD, Chief Medical Officer
of Kiromic.
"The cGMP suite consists of 5 clean rooms which will be used to
manufacture the Company’s off-the-shelf allogeneic therapies during
clinical trials. The Company is fully ready for this IND filing and
has the clinical manufacturing capability to supply its clinical
trials," commented Mr. Tony Tontat, CFO, COO of Kiromic.
"Kiromic’s proprietary PD1 Gamma-delta CAR (PD1-GDT CAR) T cell
therapy is a novel method for “off-the-shelf” allogeneic CART T
Cells derived from healthy donors. As we continue to grow our
targets and our clinical programs, our IP portfolio is continually
being fortified in all major geographies, and we look forward to
updating our investors in upcoming presentations and filings,"
commented Mr. Gianluca Rotino, Chief of Strategy and Innovations of
Kiromic.
About Epithelial Ovarian Carcinoma
Ovarian tumors grow rapidly and metastasize early with a very
aggressive disease course, either through direct extension from the
ovarian/fallopian tumor to neighboring organs (bladder/colon), or
by detaching from the primary tumor, and then spreading and
adhering to intraperitoneal organs.
Epithelial ovarian carcinoma represents the vast majority of
ovarian cancers and the most common histologic subtype is high
grade serous epithelial ovarian carcinoma. Unlike most other
cancers, ovarian carcinoma rarely disseminates through the
vasculature, although pelvic and/or para-aortic lymph nodes can be
involved. When ovarian cancer spreads to the mesothelium of the
organs within the peritoneal cavity, it can result in encasement of
these organs with significant pain and eventual obstruction of the
stomach, large, and small intestines.
Despite advances in surgical techniques and intensive
combination chemotherapy approaches, the survival rate
substantially decreases after ovarian cancer has metastasized to
pelvic organs (such as the uterus, fallopian tubes, bladder, and
rectum), metastasized across the pelvic cavity to the abdominal
organs and tissue (such as the omentum, small intestine, and
retroperitoneal lymph nodes), or metastasized beyond the peritoneal
cavity to distant parenchymal organs such as the liver and
lung.
The ovarian cancer tumor microenvironment (TME) within the
peritoneal cavity is a key element in the support of ovarian cancer
growth, and only by addressing the TME, along with the ovarian
cancer tumor cell itself, will significant advances be
achieved.
Since ovarian cancer 5 year survival statistics have improved
only slightly over the last few decades, innovative approaches such
as Kiromic’s administration of a PD1-GDT CAR, which is designed to
address the TME of EOC, are desperately needed.
About Malignant Pleural Mesothelioma
Patients with a diagnosis of mesothelioma are generally
considered to be incurable, and typically present late, with
multiple signs and symptoms such as shortness of breath, chest
pain, cough, hemoptysis, dysphagia, weight loss, fatigue, night
sweats, and face/arm swelling which often precludes surgical
options. Chemotherapy and radiation therapy are also options but
are often only palliative, with or without an attempted surgical
resection.
If the patient is one of the few considered to be a surgical
candidate, the surgical objective will be to obtain a maximal
cellular reduction (MCR), followed by chemotherapy +/- radiation
therapy. Yet even with an MCR and adjuvant therapies, the vast
majority of patients still experience a recurrence, most of which
are local, and when the tumors do recur, second line treatments are
essentially palliative.
Hence, the majority of patients suffering from this disease need
innovative and novel treatment options, as most patients will
ultimately die of their disease with a poor remaining quality of
life due to symptoms such as severe shortness of breath and chest
pain, due to hardening of the pleura associated with the inevitable
disease progression. Innovative approaches such as Kiromic’s
administration of a PD1-GDT CAR, which is designed to address the
tumor microenvironment (TME) of MPM are urgently needed.
About Kiromic
Kiromic BioPharma, Inc. is a preclinical stage biopharmaceutical
company which is focused on discovering, developing, and
commercializing novel immune-oncology applications through its
robust product pipeline. The pipeline development is leveraged
through the Company’s proprietary target discovery engine called
"DIAMOND." Kiromic's DIAMOND is big data science meeting target
identification, dramatically compressing man-years and billions of
drug development dollars to develop a live drug. The Company
maintains offices in Houston, Texas.
For more information, please visit the company’s website at
www.kiromic.com.
Forward-Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. We make such
forward-looking statements pursuant to the safe harbor provisions
of the U.S. 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. These statements
relate to future events or to our future financial performance and
involve known and unknown risks, uncertainties and other factors
that may cause our actual results, levels of activity, performance
or achievements to be materially different from any future results,
levels of activity, performance or achievements expressed or
implied by these forward-looking statements. Forward-looking
statements include, but are not limited to, statements about:
- our goals and strategies;
- our future business development, financial condition and
results of operations;
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- growth of and competition trends in our industry;
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of, our products;
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markets in which we operate; including those fluctuations caused by
COVID-19; and
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may cause actual results to differ materially from current
expectations include, among other things, those listed under the
heading "Risk Factors" included in our Registration Statement on
Form S-1 (file no. 333-238153) , originally filed with the
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amended, and elsewhere in this press release. If one or more of
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version on businesswire.com: https://www.businesswire.com/news/home/20201217005901/en/
Tony Tontat Chief Financial Officer (844) 539 -
2873 ttontat@kiromic.com
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