Yield10 Bioscience Obtains Positive Response from USDA-APHIS on Regulatory Status of its CRISPR Genome-Edited C3007 Trait in ...
April 27 2020 - 8:30AM
Yield10 Bioscience, Inc. (Nasdaq:YTEN), an agricultural bioscience
company, today announced that it has obtained a positive response
from USDA-APHIS’s Biotechnology Regulatory Services (BRS) for its
CRISPR genome-edited C3007 trait in Camelina sativa plant lines
designed to increase oil content. Yield10’s submission along with
the USDA-APHIS BRS response is posted on the USDA’s website.
In January 2020, Yield10 submitted an “Am I Regulated?” letter
to the BRS, requesting confirmation of the regulatory status for
Camelina plant lines containing the Company’s novel, CRISPR
genome-edited C3007 trait. The positive USDA-APHIS response came in
the form of a published letter indicating that the plant lines do
not meet the definition of a regulated article under 7 CFR Part
340.
This clarification of the regulatory status under USDA-APHIS
guidelines accelerates the path for Yield10 to conduct field trials
of the CRISPR genome-edited C3007 plants in the United States in
the 2020 growing season. The plant lines may still be subject to
regulation by the U.S. Environmental Protection Agency (“EPA”) or
the U.S. Food and Drug Administration (“FDA”).
“Receiving a positive response from USDA-APHIS for our
CRISPR genome-edited C3007 lines is a critical milestone within our
development program and facilitates the transition of lines with
this trait to field testing this year,” said Dr. Kristi Snell,
Ph.D., Chief Science Officer of Yield10 Bioscience. “Initial
studies with C3007 have demonstrated potential for increased oil
content, and the next step of testing this trait under field
conditions will help us to characterize its performance and role in
boosting oil content in Camelina and other oilseed crops.”
The ability to increase oil content in specialty oilseed crops
like Camelina has the potential to make a significant impact in the
supply of omega fatty acid containing oils, to human nutrition and
aquaculture feed markets. Further, the continued analysis of C3007
and its role as a key regulator of oil content in Camelina may also
enable this trait to be used to increase production of edible oils
in other major oilseed crops such as soybean and canola.
“Once again, we appreciate both the speed and the transparency
in which USDA-APHIS reviewed our letter and the data we provided,
which has enabled us to plan our first field trials with this trait
in 2020,” said Dr. Oliver Peoples, Chief Executive Officer of
Yield10 Bioscience. “It is this sound, science-based regulatory
framework that we believe is so important to the successful
development and commercialization of new technologies for
agriculture to increase crop performance, as well as other efforts
to address sustainable global food security.”
Yield10 licensed C3007 from the University of Missouri (“MU”) in
2018. The protein encoded by C3007, also known as BADC, is a novel
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 successfully used
CRISPR to inactivate a number of the C3007 gene copies in Camelina
and have seen clear evidence of increased oil content in some lines
in laboratory studies. The use of CRISPR to deploy the trait may
enable an expedited timeline for development and commercialization
within the U.S. market.
The CRISPR genome-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 for human consumption or 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.
About Yield10 Bioscience
Yield10 Bioscience, Inc. is an agricultural bioscience company
developing crop innovations to improve crop yields and enhance
sustainable global food security. The Company utilizes its
proprietary “GRAIN” (Gene Ranking Artificial Intelligence Network)
gene discovery platform to identify gene targets to improve yield
performance and value in major commercial food and feed crops.
Yield10 uses its Camelina oilseed platform to rapidly evaluate and
field test new trait leads enabling the translation of promising
new traits into the major commercial crops. As a path toward
commercialization, Yield10 is pursuing a partnering approach with
agricultural companies to drive new traits into development in
crops such as canola, soybean and corn. The Company is also
developing Camelina as a platform crop for producing nutritional
oils and specialty products such as PHA biomaterials for use in
water treatment applications. Yield10 is headquartered in Woburn,
MA and has an Oilseeds Center of Excellence in Saskatoon,
Canada.
For more information about the company, please
visit www.yield10bio.com, or follow the Company
on Twitter, Facebook and LinkedIn.
(YTEN-G)
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 conduct
field testing of C3007 in Camelina plant lines in 2020, the
possibility that testing this trait under field conditions will
help us to characterize the performance of the trait and its role
in boosting oil content in Camelina and other oilseed crops, the
ability of C3007 to increase oil content in Camelina and other
oilseed crops, the potential to make a significant impact in the
supply of omega fatty acid containing oils to human nutrition and
aquaculture feed markets, the potential for the trait to be used to
increase production of edible oils in other major oilseed crops
such as soybean and canola, the potential for an expedited timeline
for development and commercialization within the U.S. market, the
possibility for the trait to deliver economic value in other areas,
and the possibility of translating promising new traits into the
major commercial 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. Yield10 assumes no obligation to update any
forward-looking information contained in this press release or with
respect to the matters described herein.
Contacts: Yield10 Bioscience: Lynne
H. Brum, (617) 682-4693, LBrum@yield10bio.com
Investor Relations Contact: Bret Shapiro, (561)
479-8566, brets@coreir.com Managing Director, CORE IR
Media Inquiries: Eric Fischgrund, eric@fischtankpr.com
FischTank Marketing and PR
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