Cellectis submits IND to US FDA for ‘off-the-shelf’ UCART22
The French biotech submitted the investigational new drug (IND) application to the US Food and Drug Administration (FDA) earlier this month, and if approved, will instigate a Phase I clinical trial in Q3 2018.
UCART22 is an allogeneic, gene-edited T-cell candidate designed to treat B-cell acute lymphoblastic leukemia (B-ALL) in adult patients.
Unlike autologous therapies, which use a patient’s own engineered T-cells, this “off-the-shelf” investigational therapy uses engineered cells from a healthy donor for use in multiple patients.
Cellectis’ first allogeneic off-the-shelf CAR-T investigational therapy – UCART19 – is still in clinical development.
“In its design, UCART22 is quite similar to UCART19, that only by the target recognized by the CAR – CD22 in lieu of CD19,” a spokesperson explained.
“The UCART22 cells infused in patients are meant to recognise CD22-bearing tumour cells, expand and destroy the tumour mass in the body, leading to remission of the patient,” she added.
But anti-CD19 therapy trials have shown that ALL-patients may lose the CD19 antigen from their tumour cells, hence the need for a second target – CD22, we were told.
Cellectis has selected MD Anderson in Houston, Texas, to conduct clinical trials and CELLforCURE to manufacture its product candidates.
