Kiromic Biopharma, Inc. (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 planned resubmission of two
investigational new drug (IND) applications with the U.S. Food and
Drug Administration (FDA).
The revised INDs will be for first in-human dosing of our
Off-the-Shelf, Allogenic Gamma-Delta T cell therapy for metastatic
and progressive locally advanced solid malignancies.
The revised INDs have protocols which retain approximately 80%
of the original INDs. The differences between the INDs are detailed
below:
Revised INDs
Original INDs
Enrollment
Open enrollment, multiple solid
tumors
Single enrollment 1 solid tumor
(ovarian)
Administration
Only IV
Either IV or IP
Chimeric T cell therapies
Separate INDs for 2 chimeric T
cell therapies IND-1: chPD1 (solid tumors, IV)
IND-2: Iso-Mesothelin (solid
tumors, IV)
Separate INDs for varying routes
of administration IND-1: chPD1 (ovarian, IV)
IND-2: chPD1 (ovarian, IP)
IND-3: Iso-Mesothelin (ovarian IV
& IP)
BENEFITS
Shorten the time required to
reach full enrollment
Expanded potential future
indications
** IV = Intravenous, IP = Intraperitoneal
Timelines for the planned two INDs:
-- 2Q-2021, Expected timeline for planned two IND
resubmissions
-- 30 days, Expected review and return by the FDA post IND
submissions
-- 3Q-2021, Expected timeline of first-in-human dosing
-- 4Q-2021, Expected timeline of first-in-human safety and
efficacy data from the trial
Since filing the original INDs in December 2020, the Company has
had many discussions with the FDA, and numerous consults with
scientific board and clinical advisors regarding the changes listed
above. These changes shown above were made to ensure the optimal
chances for success for the planned clinical trials.
Open-Enrollment and Impact on Timing
"We believe the changes in the two revised IND’s are very
positive for Kiromic. The open enrollment will add breast,
prostate, colorectal, and lung to our existing ovarian cancer. It
is expected that the change to an open enrollment will decrease the
time to reach full enrollment," says Dr. Maurizio
Chiriva-Internati, CEO of Kiromic.
Single Mode of Administration (IV)
"One of the most strategic modifications was the move to a
single route of administration. The new INDs will have only IV
administration versus previous INDs having IV and IP. IV
administration reflects the dominant and preferred mode of
administration for cancer therapies in the clinic today whereby
intracavitary infusions are considered more invasive. The feedbacks
from the clinical sites on the new IV administration and open
enrollment have been very well received," commented Dr. Scott
Dahlbeck, Chief Medical Officer of Kiromic.
** IV = Intravenous, IP = Intraperitoneal
Market Expansion with Multiple Solid Tumors
"Ovarian cancer is already a significant indication by itself.
However, having multiple solid tumors that are eligible in our new
open enrollment protocol, including cancers such as breast,
prostate, colorectal, and lung for example, will only increase the
potential applications of our Off-the-Shelf, Allogenic Gamma-Delta
T cell therapies," says Mr. Gianluca Rotino, Chief of Strategy and
Innovation of Kiromic.
GMP Facility Readiness
"Kiromic continues to prepare itself for the upcoming first
in-human trials by making sure that its GMP manufacturing facility
is ready, staffed, and fully equipped. Despite COVID and the recent
ice-storms which made national news, Kiromic is still running daily
batch testing and validations of our Off-the-Shelf, Allogenic
Gamma-Delta T cell manufacturing in full preparation for the
upcoming trial," says Mr. Tony Tontat, CFO and COO of Kiromic.
Upcoming Events
-- Kiromic CEO interview on Bloomberg TV Europe (March 2021)
-- Kiromic CEO, CFO presentation at Benzinga Small Cap
Conference (Mar 25th, 2021)
-- Kiromic Abstracts highlighting our AI Neoantigen discovery
engine, and our Off-the-Shelf, Allogenic Gamma-Delta T cell
manufacturing at AACR 2021 conference (April 9-14, 2021).
www.aacr.org
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;
- expected changes in our revenue, costs or expenditures;
- growth of and competition trends in our industry;
- our expectations regarding demand for, and market acceptance
of, our products;
- our expectations regarding our relationships with investors,
institutional funding partners and other parties we collaborate
with;
- fluctuations in general economic and business conditions in the
markets in which we operate; including those fluctuations caused by
COVID-19; and
- relevant government policies and regulations relating to our
industry.
In some cases, you can identify forward-looking statements by
terms such as "may," "could," "will," "should," "would," "expect,"
"plan," "intend," "anticipate," "believe," "estimate," "predict,"
"potential," "project" or "continue" or the negative of these terms
or other comparable terminology. These statements are only
predictions. You should not place undue reliance on forward-looking
statements because they involve known and unknown risks,
uncertainties and other factors, which are, in some cases, beyond
our control and which could materially affect results. Factors that
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
Securities and Exchange Commission (SEC) on May 11, 2020, as
amended, and elsewhere in this press release. If one or more of
these risks or uncertainties occur, or if our underlying
assumptions prove to be incorrect, actual events or results may
vary significantly from those implied or projected by the
forward-looking statements. No forward-looking statement is a
guarantee of future performance.
The forward-looking statements made in this press release relate
only to events or information as of the date on which the
statements are made in this press release. Except as expressly
required by the federal securities laws, there is no undertaking to
publicly update or revise any forward-looking statements, whether
as a result of new information, future events, changed
circumstances or any other reason. You are advised, however, to
review any further disclosures we make on related subjects in our
Forms 10-Q, 8-K and other reports filed with the SEC.
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version on businesswire.com: https://www.businesswire.com/news/home/20210309006043/en/
Tony Tontat Chief Financial Officer (844) 539 -
2873 ttontat@kiromic.com
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