americanpharmaceuticalreviewAugust 02, 2021
Marker Therapeutics, Inc., a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, announced that the Company's new cGMP manufacturing facility in Houston, TX, located near the George Bush Intercontinental Airport, is fully operational. The facility will manufacture Marker's MultiTAA-specific T cell products for the Company's Phase 2 acute myeloid leukemia (AML) trial as well as future hematological and solid tumor trials, in addition to producing the potential commercial supply of any approved products.
"We are excited to open Marker's new in-house cGMP manufacturing facility and potentially bring our therapies to the affected patient communities," said Anthony H. Kim, Chief Financial Officer of Marker Therapeutics. "Cell therapy manufacturing is a complex science and is a competitive advantage for Marker. Building our own cGMP manufacturing facility was a strategic goal for Marker to ensure broad access to our therapies while reducing overall manufacturing costs."
The Company employed modular processes to build its cGMP manufacturing facility at its 48,500 square foot location. Currently, about a third of the square footage is being utilized and is dedicated to support the Company's Phase 2 AML trial, which is expected to enroll 160 patients. Additional clean rooms may be added using the cost-effective and scalable modular processes for the manufacturing of other MultiTAA-specific T cell products in future clinical trials.
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