Celyad expects to treat the first patients with its autologous CAR-T therapy CYAD-01 using the updated manufacturing process by the end of September.
CYAD-01 is an autologous chimeric antigen receptor (CAR) T-cell therapy in development by Celyad for hematological malignancies and solid tumors. The immunotherapy has the ability to bind to eight different ligands that are naturally expressed by cancer cells.
In July, the firm announced regulators accepted a proposal to change the candidate’s manufacturing process to use its proprietary OptimAb platform in upcoming trials, and during Celyad’s second quarter results call David Gilham, VP of R&D, said: “We expect to treat the first patient with CYAD-01 using the OptimAb manufacturing process by the end of September.”
The OptimAb platform builds upon key characteristics of Celyad’s first two manufacturing processes for CYAD-01, building upon key characteristics of both.
“This includes an eight-day culture period, which is two days shorter than the previous antibody-based manufacturing process, the incorporation of an NKG2D blocking antibody, and the inclusion of a selective PI3 kinase inhibitor that helps us to enrich T cells with a memory-like phenotype,” Gilham said (transcript here).
“CMC amendments relating to OptimAb were recently accepted by regulators in both the United States and Belgium and are now in effect under the current IND application for CYAD-01. Looking ahead, we will be treating all future patients in our autologous relapsed/refractory AML and MDS program with an OptimAb manufactured product.
“With the recent introduction of the OptimAb manufacturing process, we are continuing to tap into our deep expertise and knowledge in cell therapy manufacturing, which is providing tremendous flexibility in our platform and the ability to produce autologous novel CAR-T cell therapies with a memory-like phenotype for increased persistence and CAR-T potency.”
Gilham told stakeholder the OptimAb platform was developed as a response to understanding the role of memory-like cells in CAR-T cell therapy, which the firm hopes will lead to increased persistence and CAR-T potency as well as reducing the cost of CYAD-01 and other CAR-T candidates.
“Cost of goods are really related to manufacturing success rates. And the reason why we work through the iterations of our manufacturing process, and particularly the moment to the mAb and Ab building on the mAb, has really been around improving our manufacturing success rate, which I think is very high, particularly for where we are and the patients we’re treating.”
He continued: “And so that, and that we will have a beneficial effect and the cost of goods in the end. So when we’re thinking about this as we go through these modifications, one of the things that are top of mind really is to ensure that we maintain that manufacturing success rate. So we’re not looking to generate cells that are particularly free not tight but then compromising in our manufacturing success, and so I think that’s an important thing to remember.”