Kiromic BioPharma Announces FDA Feedback from Type B Pre-IND Meeting Confirms Deltacel Development Strategy
October 06 2022 - 8:08AM
Business Wire
Company Reiterates Deltacel is Next Clinical
Trial Candidate, with Projected Clinical Trial Launch Expected in
Q1 2023
Company is Streamlining Operations to
Execute Deltacel-Aligned Development Strategy
Kiromic BioPharma, Inc. (NASDAQ: KRBP)
(“Kiromic” or the “Company”), a clinical-stage fully-integrated
biotherapeutics company using its proprietary DIAMOND® artificial
intelligence and data mining platform to develop cell and gene
therapies with a focus on immuno-oncology, announces it received
validating written feedback on October 4, 2022 from the FDA
pursuant to its Type B Pre-IND meeting request regarding its
Deltacel™ development strategy.
The purpose of the Pre-IND meeting request was to seek alignment
with and to obtain FDA guidance on Kiromic’s proposed development
strategy about the chemistry, manufacturing, and controls (CMC),
nonclinical studies, and clinical study plan for Deltacel™/KB-GDT
for treating subjects with Non-Small Cell Lung Cancer (NSCLC).
Kiromic will leverage this FDA Pre-IND written confirmatory
feedback and recommendations into a robust IND submission package
for a projected clinical trial launch in Q1 2023.
“We are delighted to receive this very productive feedback about
Deltacel™/KB-GDT from the FDA, confirming our development strategy
for this therapeutic candidate,” stated Pietro Bersani, Chief
Executive Officer of Kiromic. “It was a strategic decision to focus
on metastatic stage 4 lung cancer as our first indication in
addressing solid malignancies, and we are very heartened to be
continuing to fulfill our mission to address solid malignancies,
which represent more than 90% of all cancers.”
Further reiterating Management’s focus on executing the
Deltacel-aligned development strategy, the Company has streamlined
its operations and aligned key resources to advance its Deltacel™
product candidate while maintaining its other product candidates
Procel™ and Isocel™. As part of that aligned strategy and following
a thorough evaluation to maximize operational efficiencies,
Kiromic’s management made the difficult yet necessary decision to
eliminate 20 positions or approximately 29% of its workforce. The
Company believes these key actions and overall strategy align with
financing options it is actively pursuing.
“Deltacel™ is our most advanced therapeutic candidate, and its
use of allogeneic, non-viral, non-engineered off-the-shelf Gamma
Delta T-cells (GDT) is a next-generation solution for patients. As
such, this prioritization also mitigates supply-chain challenges
associated with a virus-based approach. We believe these advantages
will allow us to efficiently establish the platform’s safety and
tolerability and build upon Deltacel™’s previously demonstrated
preclinical efficacy across multiple indications. With the FDA
guidance in hand, we believe we’ve further strengthened our case to
align operations with Deltacel™ and deliver value sooner to our
shareholders,” commented Bersani.
About Kiromic BioPharma
Kiromic BioPharma, Inc. is a clinical-stage, fully integrated
biotherapeutics company using its proprietary DIAMOND® artificial
intelligence (AI) 2.0 platform to discover and develop cell and
gene therapies with a therapeutic focus on immuno-oncology and
other diseases. Kiromic is developing a multi-indication allogeneic
cell therapy platform that exploits the natural potency of Gamma
Delta T-cells to target solid cancers. From its heritage as a
cancer vaccine development company, Kiromic is focused on
discovering, developing, and commercializing novel immuno-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 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 current and anticipated IND
applications including statements regarding the scope of and timing
for submission of an IND application; the Deltacel™ product
platform; the timing for submitting and activating Kiromic’s IND
applications and clinical trials; Kiromic’s ability to achieve its
objectives; the timing for the initiation and successful completion
of Kiromic’s clinical trials of its product candidates; the
potential of Kiromic’s product candidates. 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,
2021, 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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version on businesswire.com: https://www.businesswire.com/news/home/20221006005406/en/
Kiromic BioPharma Linda Phelan Dyson, MPH Global Head,
Corporate Communications ldyson@kiromic.com M: 281-468-7683
LHA Investor Relations Tirth T. Patel tpatel@lhai.com
212-201-6614
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