France- and US-based ag biotech company Micropep is closer to commercializing its peptide-based biofungicide Promisin after making regulatory submissions in the United States and the European Union this week.
The submissions come on the heels of Promisin submissions in Paraguay and Brazil, and send “an important signal to external stakeholders,” says Micropep VP of regulatory Dr. Kevin Leiner.
“It’s a really strong proof point for the capabilities of Micropep and for the ability of our Krisalix discovery platform to advance interesting product candidates and de-risk them to the point where we can get them on the market and provide a valuable tool to the farmer.”
Promisin is the first product to come out of Krisalix, the company’s AI-based discovery platform platform, which uses computational biology, AI, and formulation science to discover the best micro-peptide sequences for crop protection.
According to Leiner, regulatory submissions for the product also mark the company’s shift from a research and discovery entity to one truly readying itself for launch in commercial markets.
Fighting fungicide resistance with peptides
Promisin relies on a novel biological mode of action to fight fungal diseases in crops, and is designed to complement existing fungicide tools rather than replace them outright, says Leiner. It is particularly useful in managing fungicide resistance, which has steadily risen since the 1970s.
The bulk of conventional fungicides are site-specific, meaning they target one single metabolic pathway. A single genetic mutation in that pathway, such as one amino acid in the protein, can reduce a fungus’s sensitivity to a chemical and render it ineffective.
Promisin is in a class of peptides that acts by disrupting cell membranes rather than binding to a specific target, says Leiner. Because of that, “It would be very difficult for an organism to evolve resistance to Promisin peptides.”
This class of peptides also complements existing pest management strategies, he adds. Promisin mixes well with other solutions in the tank, allowing farmers to hit targets with multiple modes of action, which also addresses and lessen the chance of resistance developing.
“[For] what is lost against a conventional fungicide. Promisin can come in and and essentially clean up the resistant strains.”
Outside of resistance management, Promisin has already shown strong efficacy in hundreds of field trials around the world over multiple years, says Leiner, who adds that there is a “highly favorable safety and sustainability profile” in play too.
“We don’t see significant concern with non-target organisms. From a human and environmental safety perspective, it’s fantastic. From a sustainability perspective, we’re not worried about persistence in the environment, the way you may be with some small molecule conventional pesticides. We’re not worried about residues or having to establish tolerances or maximum residue limits.”
Towards commercialization
Leiner joined Micropep a few years ago, when it was essentially a discovery and research company “with an almost academic feel.”
“These regulatory submissions really are the the milestone where we can say, okay, this development stage for the initial crops is now complete. Now we start our pre-commercial phase.”
Soybeans are a key export in Paraguay and Brazil, and Micropep will focus on that and other row crops for those markets. In particular, it is targeting Phakopsora pachyrhizi (Asian soybean rust), Corynespora cassiicola (Target Spot), and Cercospora kikuchii (Leaf Blight).
Row crops will also be a focus area in the US along with grapevines and potatoes. In Europe, which produces significantly fewer soybeans, Micropep will work mostly in grapevines and potatoes.
Last year saw Micropep appoint new CEO Georg Goeres, who previously ran the biologicals unit of Indigo Ag and will lead Micropep’s efforts to commercialization.
Regulatory evaluations and approvals for Promisin will vary in terms of timeline based on the region. Brazil, for example, has a notably faster approval timeline than the European Union—around 18 months versus a few years, respectively.
In the meantime, Micropep will “prepare the ground” for product launches, says Leiner. “We will make sure the supply chain is established, distribution relationships are established, and that way, when we have the market authorizations in each country, we’ll be ready to hit the ground running.”
The company will continue to work on fungicides but will also look for new peptides that could work as herbicides and insecticides.
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