[ad_1]
The FDA sent shockwaves through the standard CAR-T space, putting a clinical hold on all Allogene Therapeutics AlloCAR T clinical trials in response to an abnormality that could theoretically cause cancer.
At this point, there are many unknowns, and the range of possible outcomes ranges from a short delay for Allogene programs to a more intractable problem for the entire standard cell therapy space. Jefferies analysts expect the clinical suspension to be resolved, albeit after several months of work, but at this point it is impossible to rule out other scenarios.
Here’s what we know: A patient with heavily pretreated lymphoma underwent reduction in all blood cell lines after receiving an infusion of Allogene’s anti-CD19 CAR-T candidate ALLO-501A. Analysis of the biopsy found anti-CD19 CAR-T cells with a chromosomal abnormality.
Allogene reported the anomaly to the FDA, which prompted the agency to suspend all AlloCAR T biotech clinical trials. The scale of the FDA’s response reflects the potential for chromosomal abnormalities to cause cancer.
RELATED: Patient Death Darkens Phase 1 Data for Allogene’s CAR-T Myeloma
Beyond that, there is more guesswork than fact at this point. A fundamental unresolved question is how the cells came to present the anomaly. Cells may have acquired the chromosomal change in the process of gene editing or when they have grown rapidly.
Depending on the root cause, the TALEN editing technology used by Allogene or any therapy that alters a specific part of the chromosome could run into problems, potentially causing a setback for biotechnology or the wider space of standard T cell therapy. Likewise, the impact may be limited to delay and the adoption of additional precautions at Allogene. Jefferies analysts are optimistic.
“Ultimately, we believe the suspension will be lifted after our estimate of ‘several months’ review and review of the manufacturing, release testing, risk of underlying genetic changes, and risk of transformation. , and other confounding factors with the patient. We are thinking of short term delay and impact on actions – but the risk / benefit ratio is still high for patients and a clinical trial should be allowed to go ahead – and stocks should rebound, ”the analysts wrote in an investor note.
Allogene’s stock fell more than 30% in response to the news, from over $ 24 to less than $ 17. The fallout from the hold also affected other businesses. Shares of Cellectis, the biotechnology behind TALEN gene-editing technology, fell 17% and CRISPR shares suffered declines, indicating the potentially significant implications of the news. In contrast, shares of Autolus Therapeutics rose 7% as investors reassessed its autologous CAR-T’s in light of its standard rival’s problems.
[ad_2]
Source link