Manufacturing process essential for bispecific cell therapies


The process of manufacturing a new type of chimeric antigen receptor (CAR) T cell therapy is intrinsic to the quality of the product. This is according to the CSO of a company that saw promising results at an early stage of a phase I trial of bispecific CAR-T.

“We believe that our manufacturing process is important for the results seen in patients,” says Jim Johnston, PhD, CSO / COO of ImmPACT-Bio, who recently reported signs of long-term remission in a small study of patients with non- B cell Hodgkin lymphoma.

The company announced that six out of seven patients had ongoing complete remission after a median follow-up of nine months.

According to Johnston, a key part of the manufacturing process of ImmPACT is enriching the T cells of patients who are more like stem cells and therefore are less likely to burn out.

This is especially important, he explains, because patients have often undergone multiple rounds of chemotherapy, which has left their T cells in poor condition.

“It’s really important that we are careful in the manufacturing process and that as much as possible the T cells are functional,” he says. “There are a number of reports that [poor functionality of] The T cells in the product correlate with less optimal patient outcomes. The manufacturing process is therefore important.

The company is working on a bispecific CAR-T, which recognizes two antigens, CD19 and CD20, both expressed on the surface of B lymphoma cells.

Most current CAR-T therapies target a single antigen, such as CD19.

“About 50% of patients treated with CAR-T CD19 therapy do not have long-term remission, sometimes due to loss of antigen and this technology also attempts to address this problem, improving the percentage of patients who achieve a long lifespan. complete remission by targeting more than one antigen, ”continues Johnston, who is the former CSO of Kalthera, a University of California Los Angeles (UCLA) spin-off company that he founded with Yvonne Chen, PhD.

Kalthera recently announced its merger with ImmPACT with the goal of advancing its bispecific CAR-T therapy towards commercialization.

“We are building a company capable of performing a Phase II clinical study,” says Johnston. “The merged company brings together a world-class team and invests in a manufacturing facility to make it happen. “


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