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Wednesday, June 12, 2019

Synlogic, Ginkgo expand synthetic biology research pact

Synlogic has tapped Ginkgo Bioworks for a cell programming platform to support development of its pipeline of engineered microbes.
Massachusetts-based synthetic biology startup Synlogic began working with Ginkgo in 2017 to gain access to high-throughput organism screening and design capabilities. The goal was to accelerate the development of what Synlogic calls Synthetic Biotic medicines, microbes genetically engineered to counter the biology that drives diseases including hyperammonemia and forms of cancer.
Now, both parties have stepped up their commitment to the relationship. Synlogic is putting up $30 million to source synthetic biology services from Ginkgo over the next five years.
“This collaboration significantly enhances Synlogic’s Synthetic Biotic strain optimization capabilities. It enables us to advance high-quality candidate strains into development more efficiently and provides technology and resources that will fuel pipeline expansion,” Synlogic CEO Aoife Brennan said in a statement.
Ginkgo is committing cash, too, handing over $80 million to buy a stake in Synlogic at a 44% premium to its closing price prior to news of the deal. Synlogic’s share price leapt 20% in premarket trading.
The investment furthers Ginkgo’s move into biopharma. Ginkgo started out engineering microbes to produce flavors and fragrances. In 2015, Ginkgo floated the prospect of its $45 million series B round supporting a push into biopharma, but the expansion really took off last year when it opened a facility focused on the engineering of mammalian cell genomes for drug research and production.
Synlogic will use Ginkgo’s technology in a slightly different way. Its focus is on engineering microbes to directly treat disease, for example by consuming ammonia that builds up in patients whose ability to convert the toxin into urea is impaired. That is the idea behind SYNB1020, one of Synlogic’s clinical-phase candidates.
Working with Ginkgo, Synlogic thinks it can cut the time it takes to turn early preclinical leads into optimized drug candidates that are ready to join SYNB1020 in the clinic.

White House Exec Order to Streamline Reg Review for GM Farm Products

Agricultural biotech received a boost late Tuesday as President Donald Trump signed an executive order that streamlines the federal review process for products like genetically modified seeds and livestock.
The order noted the importance of biotechnology on the nation’s food supply and agricultural needs and supports a long-time goal of Trump’s support of loosening restrictions on the use of genetically-modified crops and animal products. The order points to the industry as a means of meeting food production needs, improving crop characteristics, increasing the nutritional value of crops and enhancing food safety. In order to meet those needs, the executive order noted that a streamlined review system that fosters “public confidence in biotechnology” while avoiding “undue regulatory burdens” is critical.
Ahead of the signing of the executive order, CNBC noted that the action has been seen as a way to “bolster the bottom line” of farmers who have been caught up in the trade war with China. Officials have called for a need to standardize agricultural approvals to support domestically developed goods that are typically sold overseas. CNBC said that soybean farmers are impacted by regulations that can hinder them from selling genetically modified products overseas in critical markets like China and Brazil.

The executive order lays out a number of steps to achieve these goals, including basing regulatory decisions on scientific evidence while considering the law and economic factors. The order also calls for federal regulators making decisions based on “risks associated with the product and its intended end use” and urging trade partners to “adopt science- and risk-based regulatory approaches.”
The presidential order calls for a number of federal departments, such as the Department of Agriculture, the Environmental Protection Agency and the Food and Drug Administration, to “identify relevant regulations and guidance documents within their respective jurisdictions that can be streamlined to ensure that products of agricultural biotechnology are regulated in accordance with the policy set forth” by the order.
The Associated Press reported that current U.S. regulations involving genetically engineered plants and animals vary depending on the “exact methods used to produce them.” The government has been working to clarify new policies as the technologies continue to evolve. Last year the FDA announced a new Plant and Animal Biotechnology Innovation Action Plan that was aimed at oversight of animal biotechnology products. The plans included genetically altered animals and the food and drug products derived from them.
The executive order has, so far, been met with praise from industry representatives. Jim Greenwood, president and chief executive officer of BIO (Biotechnology Innovation Organization) applauded the move and called it an “important step forward

“America is on the threshold of entering a new era of sustainable agriculture and food production, and it’s important we get this right for farmers, consumers, U.S. companies and the world as a whole. With prudent regulations, we can foster American innovation and bring to market biology-driven solutions that are improving nutrition, reducing food waste, increasing crop yield, combating debilitating crop diseases and advancing environmentally friendly farming practices,” Greenwood said in a statement.
The executive order comes days after the United States told the World Trade Organization it was planning to revise regulations on importing GMOs (genetically modified organisms), Reuters reported.

Savara’s Molgradex flunks late-stage aPAP study

Thinly traded micro cap Savara (NASDAQ:SVRA) is poised for a significant down move after announcing that its Phase 3 clinical trial, IMPALA, evaluating lead drug Molgradex in patients with autoimmune alveolar pulmonary proteinosis (aPAP) failed to sufficiently separate from placebo.
The study did not achieve the primary endpoint of a statistically significant change from baseline to week 24 in a measure of low blood oxygen called alveolar-arterial oxygen gradient (A-aDO2). Specifically, average A-aDO2improved 12.1 mmHg in the treatment group compared to 8.8 mmHg in the placebo arm (p=0.17), falling short of statistical significance.
There was a statistically valid separation from control for a secondary endpoint of a patient-reported outcomes/quality of life scale called SGRQ. Another secondary endpoint, the six-minute walk test, failed to adequately separate from control.
On a positive note, the safety profile was on par with placebo.
APAP is a rare autoimmune disorder in which a surfactant accumulates in the alveoli (tiny air sacs in the lungs) making it difficult to breathe.
The company plans to meet with the FDA and EMA in the coming months to discuss the data and a path forward.
Management will host a conference call today at 5:30 pm ET to discuss the results.
Shares will resume trading at 4:30 pm ET.
Update: Shares are down 75% after hours.

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