Yield10 Bioscience Obtains Confirmation of Nonregulated Status from USDA-APHIS for its Genome-edited Camelina Line

WOBURN, Mass., Sept. 05, 2017 (GLOBE NEWSWIRE) -- Yield10 Bioscience, Inc. (NASDAQ:YTEN) announced today that it has received a positive response from USDA-APHIS’s Biotechnology Regulatory Services (BRS) confirming that its genome-edited Camelina sativa plant line developed using CRISPR genome editing technology for increased oil content does not meet the definition of a regulated article under 7 CFR Part 340 biotechnology regulations. In June 2017, Yield10 submitted its first “Am I Regulated?” letter to the BRS, which requested confirmation of the regulatory status for the novel plant line with an edit in the gene for the C3008 trait. The Company’s submission along with the APHIS BRS response is posted on the USDA’s web site.

“Obtaining nonregulated status from USDA-APHIS for our genome-edited Camelina designed for enhanced oil content represents an important milestone for our team,” commented Kristi Snell, Ph.D., Chief Science Officer of Yield10 Bioscience. “This designation highlights the versatile options we have for developing commercial crops with novel gene traits discovered in our T3 Technology platform. We have the option of using either genome editing as is the case with C3008 in Camelina, or strategies based on genetic modifications made utilizing only plant DNA, to develop our traits in key crops with the potential to be deemed nonregulated.” 

“This timely decision by USDA-APHIS provides us with confidence that we have established a robust internal process for developing nonregulated plant lines incorporating novel crop yield traits,” commented Oliver Peoples, Chief Executive Officer of Yield10 Bioscience. “The opportunity for Yield10 and our future collaborators is that we believe that we can significantly reduce the timeline and expense for developing novel yield traits in key crops such as canola, soybean and corn.”

Yield10 Bioscience and Metabolix Oilseeds, Inc., a wholly owned Canadian subsidiary of Yield10 Bioscience, developed the genome-edited Camelina line. Researchers used the CRISPR genome editing tool to inactivate an enzyme designed to increase seed oil content in Camelina, a trait Yield10 has designated as C3008. There are three copies of this gene in the Camelina genome and complete editing of all copies was achieved. This trait may have further applications when used in combination with other traits that the Company is developing that are expected to increase seed oil content, including C3007. Yield10 Bioscience has research underway aimed at using genome editing and other approaches based on utilizing plant DNA exclusively to increase seed yield and oil content in Camelina, canola and soybean crops.  

The APHIS BRS determination will allow Yield10 Bioscience to conduct field testing of its genome-edited Camelina outside of the Part 340 regulations for genetically engineered organisms.  APHIS also noted in its response letter that there is “no reason to believe that the intended genotype of this genome-edited Camelina line would increase the weediness of Camelina.” However, the Company will still be required to follow any EPA or FDA regulations that may be applicable to the modified plant line.  

About Yield10 Bioscience  

Yield10 Bioscience, Inc. is focused on developing new technologies to achieve step-change improvements in crop yield to enhance global food security. Yield10 has an extensive track record of innovation based around optimizing the flow of carbon in living systems.  Yield10 is leveraging its technology platforms and unique knowledge base to design precise alterations to gene activity and the flow of carbon in plants to produce higher yields with lower inputs of land, water or fertilizer. Yield10 is advancing several yield traits it has developed in crops such as Camelina, canola, soybean and corn. Yield10 is headquartered in Woburn, MA and has an Oilseeds center of excellence, Metabolix Oilseeds, Inc. in Saskatoon, Canada. 

For more information about the Company, please visit www.yield10bio.com.


Safe Harbor for Forward-Looking Statements

This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical, including, without limitation, statements regarding the Company's ability to achieve a nonregulated status from USDA-APHIS for future genome-edited crops and the possibility of using genome editing technology or technology approaches using plant DNA exclusively to rapidly deploy desirable, novel traits into commercial agricultural crops, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including the risks and uncertainties detailed in Yield10 Bioscience's filings with the Securities and Exchange Commission and the evolving landscape of intellectual property rights in the CRISPR area. Yield10 assumes no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein.


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