Manufacturing - Marker Therapeutics, Inc.

Marker’s unique manufacturing process selectively expands a range of naturally occurring, often extremely rare tumor-specific T cells present in patients’ blood that are able to recognize unique epitopes of up to five different tumor-associated antigens. The result is a robust mixture of T cells that can target a broad repertoire of cancer cells within a single tumor, with the benefit of bypassing expensive, time-consuming, and complex genetic modification. Additionally, the innovative G-Rex® cell culture platform further reduces the cost and complexity of manufacturing by providing a simple and scalable solution to individualized cell culture.

A typical patient dose consists of approximately 4,000 unique anti-tumor T cell types, which when reintroduced into the patient, are able to kill heterogeneous tumor targets more effectively than single-antigen specific approaches. This reduces the likelihood of tumor “escape” and increases the durability of a patient’s response to therapy.

Manufacturing Diagram

MArker Therapeutics Manufacturing

MultiTAA-Specific T Cell Immunotherapy

1

Blood is drawn from a patient in the same manner as a blood donation in an outpatient setting, without the need for a lengthy and potentially painful apheresis procedure.

2

Marker isolates and cultures the immune cells with a proprietary blend of tumor-associated antigens, cytokines and antigen presenting cells. Marker is able to isolate, activate and expand any T cell specific for any segment of each antigen it targets in the unique genetic background of every patient.

3

Once cell manufacturing is complete, the product is tested for identity, sterility, and safety before it is released for infusion into a patient.

4

After the final patient product is released, the cells are frozen and transported to the site where the cells will be administered.

5

The cells are infused into the patient in an outpatient setting. Due to the relatively small cell dose volumes and outstanding safety profile of Marker’s therapies, cells can be infused within minutes instead of hours at an outpatient center without the need for hospitalization and overnight monitoring.