Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 104

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 104
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 molecule therapeutics and biologics to direct robust tumor elimination.

The Increasing Prominence of CAR-T Technology

Immunotherapy is a treatment
that harnesses the components and mechanics of the immune system to address diseases and disorders. Cellular immunotherapy is a form of
immunotherapy that focuses on modulating or enhancing the activity of different immune cells. One of the more prominent and promising
therapeutic uses of T-cells to emerge has been CAR-T cell technology.

CAR-T therapy recognizes
specific antigens that are present on the surface of tumor cells and destroys them. The concept of CAR-T builds upon the normal biology
of CTLs, whereby naturally occurring receptors serve to activate these cells when a foreign pathogen or cancerous cell is detected. Conventional
CAR-T cell therapy involves the genetic manipulation of a patient’s T cells to enable these modified cells to express a receptor
designed to bind to a specific surface antigen. To engineer these cells, a fraction of a patient’s T cells are collected from their
blood, and a viral vector containing the genetic instructions for the CAR is used to insert those genes into the genome of the T cell
through a process known as transduction. Contained in a single viral vector are the genes encoding for each component of the CAR. Typical
CAR-T cells include the following components:

●Antigen recognition domain. At one end of the CAR is a binding domain that is specific to a targeted
antigen. This domain is exposed to the outside of the engineered lymphocyte, where it can recognize the target antigen or antigens. The
extracellular target binding domain of CAR-T therapies currently approved by the FDA typically use a single-chain variable fragment (“scFv”),
consisting of the heavy-chain and light-chain variable regions of an antibody.

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●Extracellular hinge domain. The hinge domain is a small structural component which extends from
the outer cell membrane to the antigen recognition domain and provides conformational flexibility to facilitate optimal binding of the
antigen recognition domain to the targeted antigen on the surface of the cancer cell.

●Transmembrane domain. This middle portion of the CAR links the antigen recognition domain to the
activating elements inside the cell. The transmembrane domain anchors the CAR in the lymphocyte’s membrane, bridging the extracellular
hinge and antigen recognition domains with the intracellular signaling domain and provides critical stability to the CAR. In addition,
the transmembrane domain may also interact with other transmembrane proteins that enhance CAR