CERo Therapeutics, Inc. Completes IND-Enabling Activities Following Successful Manufacturing Runs for Lead Compound CER-1236
June 13 2024 - 8:15AM
CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) (“CERo”), an
innovative immunotherapy company seeking to advance the next
generation of engineered T cell therapeutics that employ phagocytic
mechanisms, announced it successfully executed pre-IND
manufacturing activities for its lead therapeutic, CER-1236. The
completion of multiple manufacturing runs is required to meet
safety and efficacy standards for drug administration in clinical
trials, and this was the final required technical activity for the
Company prior to completing its Investigational New Drug
Application (IND) package. The Company anticipates sending the IND
submission to the U.S. Food and Drug Administration (FDA) in order
to receive clearance to begin human trials (Phase1) with CER-1236
in the near term.
CERo Chairman and CEO Brian G. Atwood comments, “This is an
important milestone for CERo, paving the way for us to complete our
IND package for review by the FDA, which is the final step prior to
beginning clinical trials in humans. We are grateful for the hard
work from our entire team as we reach this important milestone and
look forward to providing updates soon regarding the outcome of the
filing.”
About CERo Therapeutics, Inc.
CERo is an innovative immunotherapy company advancing the
development of next generation engineered T cell therapeutics for
the treatment of cancer. Its proprietary approach to T cell
engineering, which enables it to integrate certain desirable
characteristics of both innate and adaptive immunity into a single
therapeutic construct, is designed to engage the body’s full immune
repertoire to achieve optimized cancer therapy. This novel cellular
immunotherapy platform is expected to redirect patient-derived T
cells to eliminate tumors by building in engulfment pathways that
employ phagocytic mechanisms to destroy cancer cells, creating what
CERo refers to as Chimeric Engulfment Receptor T cells (“CER-T”).
CERo believes the differentiated activity of CER-T cells will
afford them greater therapeutic application than currently approved
chimeric antigen receptor (“CAR-T”) cell therapy, as the use of
CER-T may potentially span both hematological malignancies and
solid tumors. CERo anticipates initiating clinical trials for its
lead product candidate, CER-1236, in 2024 for hematological
malignancies.
Forward-Looking Statements
This communication contains statements that are forward-looking
and as such are not historical facts. This includes, without
limitation, statements regarding the financial position, business
strategy and the plans and objectives of management for future
operations of CERo. These statements constitute projections,
forecasts and forward-looking statements, and are not guarantees of
performance. Such statements can be identified by the fact that
they do not relate strictly to historical or current facts. When
used in this communication, words such as “anticipate,” “believe,”
“continue,” “could,” “estimate,” “expect,” “intend,” “may,”
“might,” “plan,” “possible,” “potential,” “predict,” “project,”
“should,” “strive,” “would” and similar expressions may identify
forward-looking statements, but the absence of these words does not
mean that a statement is not forward-looking. When CERo discusses
its strategies or plans, it is making projections, forecasts or
forward-looking statements. Such statements are based on the
beliefs of, as well as assumptions made by and information
currently available to, CERo’s management.
Actual results could differ from those implied by the
forward-looking statements in this communication. Certain risks
that could cause actual results to differ are set forth in CERo’s
filings with the Securities and Exchange Commission, including its
Annual Report on Form 10-K, filed on April 2, 2024, and the
documents incorporated by reference therein. The risks described in
CERo’s filings with the Securities and Exchange Commission are not
exhaustive. New risk factors emerge from time to time, and it is
not possible to predict all such risk factors, nor can CERo assess
the impact of all such risk factors on its business, or the extent
to which any factor or combination of factors may cause actual
results to differ materially from those contained in any
forward-looking statements. Forward-looking statements are not
guarantees of performance. You should not put undue reliance on
these statements, which speak only as of the date hereof. All
forward-looking statements made by CERo or persons acting on its
behalf are expressly qualified in their entirety by the foregoing
cautionary statements. CERo undertakes no obligation to update or
revise publicly any forward-looking statements, whether as a result
of new information, future events or otherwise, except as required
by law.
Contact:Brian AtwoodChief Executive
Officerbatwood@cero.bio
Investors:CORE IRinvestors@cero.bio
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