Obe-cel

Developing a transformational treatment for adult Acute Lymphoblastic Leukemia

The novel fast off rate CAR in obe-cel drives T cell activity and long-term persistence in the absence of severe immunotoxicity

Adult Acute Lymphoblastic Leukemia

Adult B-ALL (acute lymphoblastic leukemia) is an aggressive type of leukemia characterised by the presence of too many B lymphocytes in the bone marrow and peripheral blood. Without treatment adult ALL usually progresses very rapidly. Prognosis for patients based on current treatments is very poor. 

Combination chemotherapy enables 90% of adult patients to enter complete remission, but only 30-40% of these patients will achieve long term remission. The median overall survival is < 1 year in r/r adult ALL.

The only redirected T cell therapies for adult patients are blinatumomab and brexucabtagene autoleucel. These therapies are highly active, but achieving long term remissions remains challenging. Patients are generally more fragile with co-morbidities, yet CAR T toxicities in this setting have been notable with high incidences of severe CRS and cases of fatal neurotoxicity.

A significant unmet need remains for adult ALL patients. A successful therapy requires high level of activity and sustained persistence paired with good tolerability.

Adult ALL is a significant unmet medical need

8,400 patients*

New cases of adult ALL diagnosed every year in the US and EU

 

3,000 patients* 

Estimated addressable adult ALL patients in relapsed refractory setting

 

*SEER and EUCAN estimates (respectively) for US and EU

Median OS <1 year

Median overall survival <1 year for relapsed refractory adult ALL

Obe-cel in adult ALL

The Phase 2 pivotal FELIX study of obe-cell in adult ALL met its primary endpoint at an interim analysis with an overall response rate (ORR) of 70%. Additional data were presented at ASCO and EHA in June 2023, with longer term follow up data and subgroup analysis data expected at ASH in late 2023, as well as at medical conferences in H1 2024. A BLA submission to the US FDA is planned by the end of 2023. In this indication, obe-cel has been granted orphan drug designation by the FDA, PRIME designation by EMA and ILAP designation by the MHRA.

Data from the FELIX Phase 1b and ALLCAR19 Phase 1 studies in relapsed / refractory adult ALL patients shows a high levels of complete responses across both studies in the absence of high grade (≥Grade 3) cytokine release syndrome (CRS) and with low rates of immune effector cell-associated neurotoxicity syndrome (ICANS). 

In the ALLCAR19 study where longer term follow up data is available, we continue to observe sustained responses with obe-cel without the requirement for subsequent therapy. The event free survival, a measure of long term efficacy, is 46% at 24 months, with some patients approaching up to 42 months of durability. These data support the curative potential of obe-cel as a standalone therapy in r/r adult ALL patients.

Latest Obe-cel Abstracts and Publications

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Nature Medicine
July 06 2023

Transcriptional signatures associated with persisting CD19 CAR-T cells in children with leukemia

Molecular Therapy
March 21 2023

Dual targeting of CD19 and CD22 against B-ALL using a novel high-sensitivity aCD22 CAR

AMERICAN SOCIETY OF HEMATOLOGY ANNUAL MEETING
December 12 2022

Dual Antigen Targeting with Co-Transduced CD19/22 CAR T Cells May Prevent Antigen-Negative Relapse after CAR T Cell Therapy for Relapsed/Refractory ALL (AUTO1/22)