FDA okays Allogene to resume cell therapy trials

USA – The Food and Drug Administration has cleared Allogene Therapeutics to resume testing its cancer cell therapies after determining the company’s technology wasn’t to blame for a “chromosomal abnormality” observed in a patient who received one of the treatments.

The company announced in October that the US Food and Drug Administration had ordered the suspension of all five of its AlloCAR T clinical trials in order to investigate a “chromosomal abnormality” discovered in a patient treated with ALLO-501A.

The chromosomal abnormality was discovered only after the patient developed side effects that necessitated a bone marrow biopsy.

According to Allogene, the agency agreed with the findings of its investigation, which determined that the abnormality was unrelated to the gene editing used in the treatment and did not cause any health problems.

As a result, Allogene will work to restart the studies that had been halted as soon as possible — all tests of experimental drugs for several blood cancers.

Allogene’s CAR-T candidates are engineered with lentivirus and TALEN nucleases, which can cause insertion, deletion, or chromosomal translocation, according to the company.

The approval is critical for Allogene, whose stock had plummeted to all-time lows after the FDA halted its clinical trials in October.

It’s also a boon for the field of allogeneic, or “off the shelf,” cellular cancer treatments, which are meant to be more convenient alternatives to the personalized CAR-T therapies that are currently being used to treat a variety of blood cancers.

Allogene is the most advanced, with far-reaching implications for other developers of off-the-shelf treatments, many of which involve gene editing.

Allogene is working on treatments for lymphoma, leukemia, multiple myeloma, and certain solid tumors. They are made up of donor cells that have been genetically modified to seek out and destroy cancerous cells that express a specific protein.

A gene editing technology known as TALEN is also used to modify the cells so that they do not trigger a potentially harmful immune response.

These types of treatments have the potential to broaden the reach of CAR-T therapies, which are made from patient cells and, while highly effective, have been hampered by logistical challenges in producing and delivering them.

Allogene now plans to begin what is expected to be a pivotal study of ALLO-501A in the middle of the year, months later than its previous target of the end of 2021.

The company stated that it is too early to predict how the timelines for its other programs will change.

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