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Biotech companies issue first joint declaration on human gene editing

Companies involved in human gene editing have entered the ethical debate about the controversial technology, issuing a joint declaration that DNA must not be altered in a way that passes genetic changes on to future generations. The Alliance for Regenerative Medicine (ARM), an international group representing the cell and gene therapy sector, put out a “statement of principles” on genome editing endorsed by 13 of the most active companies in this field.

“Gene-editing technologies have not matured to the point where human trials of edited germline cells are appropriate. Many important safety, ethical, legal, and societal issues involved with this type of gene editing remain unresolved,” the Task Force stated. “Unless and until ethical and potential safety questions with respect to germline gene editing are adequately addressed, we do not support or condone germline gene editing in human clinical trials or for human implantation.”

Addressing those questions, the Task Force added, should be done by the FDA and European Medicines Agency through evolving national and regional regulatory frameworks which the panel praised as being “important to support appropriate development of these technologies and should act as the primary regulatory and enforcement mechanism.”

The Alliance statement was signed by Sangamo and 12 other developers of therapies based on gene editing, including: Audentes Therapeutics, bluebird bio, BlueRock Therapeutics (which Bayer earlier this month agreed to acquire for up to $600 million), Caribou Biosciences, Casebia Therapeutics, and CRISPR Therapeutics.

Also among the 12 were Editas Medicine, BluebirdBio, Intellia Therapeutics, LogicBio Therapeutics, Precision Biosciences, and Tmunity Therapeutics.

ARM said that 31 clinical trials for gene edited therapies are in progress around the world, 20 of which are in oncology. None is yet close to commercialisation. The US has the largest number of trials (19) followed by China (10) and the UK (6). No other country has more than two gene editing trials.

The Task Force’s full letter can be read here.




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