Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 159

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 159
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7,
are axicabtagene ciloleucel, sold by Gilead Sciences under the brand name Yescarta, and tisagenlecleucel, sold by Novartis under the
brand name Kymriah. A third CAR-T cell therapy, brexucabtagene autoleucel, which is comparable to 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.

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