Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 106

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 106
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 Yescarta and sold by Gilead under the tradename
Tecartus, was approved in 2020. Lisocabtagene matraleucel, sold by Bristol Myers Squibb under the brand name Breyanzi, received FDA approval
in February 2021 with Bristol Myers Squibb also receiving approval for idecabtagene vicleucel, sold under the tradename Abecma, in March
of that year. Most recently, Janssen Biotech received FDA approval for ciltacabtagene autoleucel, brand name Carvykti, to treat adult
patients with relapsed or refractory multiple myeloma and which targets the BCMA protein expressed on cancer cells rather than CD19, the
target of the other approved CAR-T cell therapies. Each of these therapies is an autologous therapy and is made from T cells first collected
from the patient, which are then genetically modified and administered back to the same patient. Sales of CAR-T cell therapies are anticipated
to grow rapidly over the next several years and are expected to exceed $10 billion by 2030. CAR-constructs incorporating alternate immune
effector cell types, including NK cells and macrophages, are in earlier stages of clinical development and have only recently entered
clinical trials. To date, no CAR-based therapies that employ NK cells or macrophages have received FDA approval. There are at present
no FDA approved CAR T cell products for AML.

5

The Limitations of Current CAR-T Technology

Much of the excitement of
cellular therapy surrounds the curative potential of adoptive transfer of genetically engineered T cells. Adoptively transferred T cells
proliferate upon their engagement with target antigens and represent a form of therapy that can be appropriately characterized as living
and expanding. Efficient targeted killing and tumor elimination may be achieved in a short period of time. However, multiple barriers
limit the efficacy of conventional CAR-T cell therapy. A high rate of side effects often accompany treatment with currently approved products,
especially in those patients with high tumor burdens. In addition, partial responses occur, often associated with immune escape of the
tumor from the CAR or the display by the T cells of an exhaustion phenotype. Moreover, while engineered CAR-T cells have shown remarkable
potential in the treatment of hematological cancers, they have not demonstrated equivalent efficacy in the treatment of solid tumors.
Curative cell therapies for solid tumors currently do not exist and the importance of this limitation is