Allogene Therapeutics is discontinuing two of its Phase II trials investigating its ‘off-the-shelf’ cell therapy in advanced large B-cell lymphoma (LBCL) patients, with the company instead focusing on using it as a first-line consolidation therapy.
The CAR-T specialist has already initiated start-up activities for a trial investigating cema-cel’s new focus area, according to a 4 January press release.
While its focus shifts towards the frontline treatment, the company’s Phase II trials investigating cema-cel in patients with advanced LBCL will be deprioritised.
As part of the pivot, Allogene also said it will be cutting 22% of its workforce, as per Reuters’ report on 5 January. Allogene had 361 employees as of February 2023.
The upcoming ALPHA3 trial will enrol around 230 patients who still have cancer cells in their body after R-CHOP, a combo of chemotherapy, steroids and cancer drugs. Although six cycles of R-CHOP are effective, around 30% of patients will relapse.
Allogene said it intends for anti-CD19 therapy cema-cel, formerly known as ALLO-501A, to become the ‘seventh cycle’ of treatment. The trial’s primary endpoint is event-free survival.
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To help with identifying patients whose cancer remains following treatment, Allogene has partnered with Foresight Diagnostics to develop a minimal residual test (MRD), as per a 4 January announcement.
The MRD in-vitro diagnostic characterises the number of cancer cells that remain in the patient after treatment using circulating tumour DNA (ctDNA) analysis.
The US-based cancer diagnostics company Foresight has a liquid biopsy testing platform for MRD measurement. The technology forms the basis for what will be used in the ALPHA3 trial. Foresight’s investigational PhasED-Seq ctDNA-MRD platform will identify LBCL patients with MRD after first-line consolidation treatment.
Allogene’s co-founder and CEO David Chang said an ultra-sensitive ctDNA-based biomarker is crucial to identify patients that still have a small amount of cancer cells, and for whom cancer will likely recur.
Chang added that the combination of a rapid, blood-base test and Allogene’s ‘off-the-shelf’ therapy will broaden patient access by making enrolment available in places where infrastructure to administer autologous therapies does not exist.
Allogene received rights to 16 pre-clinical chimeric antigen receptor (CAR)-T cell therapy assets from Pfizer, which it in turn had licensed from Cellectis. Allogene was formed with $300m in Series A financing with a contribution from Pfizer, which holds a 25% stake in the company.