Yield10 Bioscience submits "Am I Regulated?" letter to USDA-APHIS BRS for CRISPR genome-edited C3007 in camelina to pave the way for U.S. field tests

Yield10 Bioscience, Inc. (Nasdaq:YTEN), an agricultural bioscience company that uses its “Trait Factory” to develop high value seed traits for the agriculture and food industries, today announced that it has submitted an "Am I Regulated?" letter to USDA-APHIS's Biotechnology Regulatory Services (BRS) to confirm that the use of CRISPR genome-edited trait C3007 in Camelina sativa plant lines for increased oil content does not meet the definition of a regulated article under 7 CFR Part 340 regulations. Once regulatory status of the plants is confirmed, Yield10 plans to conduct field tests of CRISPR genome-edited Camelina plants in the United States.

“We have applied considerable effort and resources into the discovery and early development of a portfolio of novel traits with the potential to increase oil content in oilseed crops,” said Dr. Kristi Snell, Ph.D., Chief Science Officer of Yield10 Bioscience. “The creation of a CRISPR genome-edited version of C3007 in Camelina and its progression toward field testing represents an important milestone in our development program. Initial studies with C3007 have been promising and we look forward to testing the trait under field conditions to evaluate the impact this unique trait may have on boosting oil content.”

“Yield10 is transitioning from a company that is developing innovative technologies designed to address global food security through discoveries related to crop yield, into a company that is also developing crop-based products and assets that our peers in the industry deem of high commercial interest,” said Dr. Oliver Peoples, Chief Executive Officer of Yield10 Bioscience. “We believe there is considerable potential for C3007 and, more broadly, technologies that enhance oil biosynthesis which would provide an economic boost to the production of food, energy and livestock feeds.”

Yield10 licensed C3007 from the University of Missouri (“MU”) in mid-2018. The protein encoded by C3007, also known as BADC, is a novel, negative regulator of the enzyme acetyl-CoA carboxylase (ACCase), the key enzyme for producing fatty acids for oil biosynthesis. In pilot studies conducted by MU researchers, reducing activity of the protein encoded by C3007 resulted in significantly increased oil content in seeds. Yield10 researchers have now successfully used CRISPR to reduce the activity of C3007 in Camelina and have seen clear evidence of increased oil content in some lines in laboratory studies. The use of CRISPR may enable an expedited timeline for development and commercialization within the U.S. market based on obtaining confirmation that USDA-APHIS does not consider the lines to be regulated pursuant to 7 CFR part 340. The lines may still be subject to regulation by EPA or FDA.

The CRISPR edited C3007 trait could deliver significant economic value by changing the value equation for the commercialization of identity preserved, specialty oilseed crops where the key value-driver is oil content with improved nutritional profiles or oils, modified for aquaculture feed or industrial markets. These traits may also be used to increase production of edible oils in major oilseed crops such as soybean and canola.