European GMO-Free Regions Conference

In an “Inception Impact Assessment” published on the 24th September, the European Commission informs the public and interested parties about its intention to prepare new legislation that would waive the standard risk assessment and labelling requirements for genetically modified organisms on “plants obtained by targeted mutagenesis and cisgenesis”. With these new terms the Commission describes results of the new genetic engineering technologies CRISPR/Cas and other “gene editing” techniques which effect either the single or multiple alteration of short DNA strands or the transfer of strands which already exist in an organisms DNA, but may not be activated or located in a different context. Cisgenesis describes genetic engineering that does not introduce new DNA from another organism (transgenesis) but alters and “rewrites” existing DNA.

The Commission invites the public to comment on its plan, goals and assumptions before October 22nd.

Europe is currently faced with a situation in which hundreds of patents on seeds might be granted in the near future. The patents on ‘New Genetic Engineering’ (e.g. CRISPR/Cas) are also an increasing threat to breeders who want to avoid genetic engineering. No Patents on Seeds! is, therefore, holding a protest against these developments at the European Patent Office (EPO) in Munich today, where they will hand over 38 empty beer bottles. Each empty bottle will contain a flag of one of the 38 contracting states of the EPO represented in the Administrative Council meeting.

The FDA has sent shockwaves through the off-the-shelf CAR-T space, slapping a clinical hold on all of Allogene Therapeutics’ AlloCAR T clinical trials in response to an abnormality that could theoretically cause cancer.

At this stage, there are a lot of unknowns, and the range of possible outcomes run from a short delay to Allogene’s programs right up to a more intractable problem for the entire off-the-shelf cell therapy space. Analysts at Jefferies expect the clinical hold to be resolved, albeit after many months of work, but at this stage it is impossible to rule out other scenarios.