The Dutch regulatory authority CTGB has recommended EU-wide approval of Biotalys’ crop protection solution, Evoca. CEO Kevin Helash tells Food Ingredients First that this milestone “validates” the potential of the company’s Agrobody technology platform for developing novel biocontrol solutions for growers.

CTGB has extensive expertise in evaluating biocontrols, such as Biotalys’ Evoca — a novel protein-based biofungicide that helps control the fungal diseases botrytis (grey mold) and powdery mildew in fruits and vegetables.

This comes after the CTGB approved large-scale greenhouse trials of Evoca and allowed the harvested fruits and vegetables to be sold for human consumption last September.

“The European market for fungicides is estimated at around US$2.5 billion, significantly larger than the US market, which is around US$1 billion. So it’s crucial that we capitalize on the market opportunity in Europe,” Helash notes.

“In the US, the Environmental Protection Agency (EPA) is currently reviewing our dossier, and we have learned from the California regulator that it has completed its own in-depth review, paving the way for swift approval at the state level pending the EPA’s approval of the product at the federal level.”

Targeting fungal growth

Biotalys is primed to transform the crop protection industry, says Helash. The company harnesses "nature’s own defense mechanisms" to create antibody-based biocontrol products using the power of proteins to disrupt the lifecycle, reproduction or metabolic processes of pests and/or pathogens.

Its product Evoca is the “first protein-based fungicide” in the industry, he adds. “It intervenes at a critical stage — binding to the immature cell wall of the fungus and halting further growth and maturation.”

“It’s an ideal rotation partner for growers in their spray programs. If approved, Evoca will pave the way for Evoca NG, which is expected to be the first commercial product out of the Biotalys’ pipeline.”

The biofungicide has performed “strongly” in trials across various regions, climates, soil types, production types, pathogen pressure and crops.

Replacing conventional pesticides

Biotalys’ protein-based biocontrol solutions aim to provide alternatives to conventional chemical pesticides for a more sustainable and safer food supply, notes the company.

They are based on the company’s novel Agrobody technology platform, which develops safe, effective solutions for key crop pests and diseases — from soil to plate.

“Our technology platform is built upon the knowledge gained over the past 30 years in using antibodies to combat diseases. We are the first company using this knowledge to develop innovative, protein-based crop protection products that are highly effective and that safeguard the health of both our food and our environment,” underscores Helash.

“Our products are by nature biodegradable. They have no adverse impact on soil and biodiversity, do not accumulate in groundwater and are designed to be applied as conveniently as any conventional pesticide.”

Additionally, the Agrobody biocontrols can be easily introduced in farmers’ integrated pest management programs, leaving no chemical residues on crops, he adds.

ongoing regulatory and financial hurdles

The crop protection industry currently faces a number of challenges, such as the “decreasing efficacy” of existing products due to resistance development and “growing regulatory pressure” to keep the existing active ingredients on the market “despite many being restricted or banned altogether,” flags Helash.

These hurdles signal the need for continuous innovation in the industry, “to stay ahead of nature.”

But Helash believes innovations too, are deterred by various factors. These include the “high cost and time to develop new synthetic crop protection products (8+ years and >US$300million); lengthy regulatory approval processes, now extending up to four years in the US and Europe.”

Start-ups seeking funding also face a “challenging financial landscape” to develop products, which can take eight to ten years to reach commercialization, he adds.

Meanwhile, rising resistance against existing products is also a major roadblock in developing biologicals that aim to control fungi and harmful insects while maintaining the “same efficacy, predictability, and cost as conventional products.”

Balancing scalability with cost

Another significant challenge Helash points out is achieving cost-effective “scalable manufacturing.”

“We all know that while chemical production is very efficient, it poses risks for the environment. The production of biologicals, on the other hand, is much more sustainable since we are working with nature, but we are not there yet in terms of scalability.”

“Biotalys is confident that the industry will overcome scalability issues so we will be able to create new modes of action at competitive prices. Its products, for example, are produced through fermentation, a process also used in various applications like the production of certain food ingredients or vegan cheese.”

The company is working with key industry players to drive down production costs and increase scale so that it can offer growers sufficient volume at market prices.

Additionally, it uses a “targeted approach” to product development, ensuring that its products inhibit the growth or survival of target pests or diseases at highly specific sites within its cells, shares Helash.

“Our Agrobody technology platform operates at the molecular level of the target species. Ultimately, we are working toward combining different modes of action into one product.”

Next steps

The CTGB will now send its draft report to the Dutch Institute for Health and Environment (RIVM) for input on classification, labeling, and packaging, marking the closure of the first phase of Evoca’s regulatory review in Europe.

“While the review process is lengthy and there’s a lot of work still to be done, earning the support of the regulator in one of the largest exporting countries of fruits and vegetables worldwide is a sign of confidence in our technology,” says Helash.

While Biotalys is currently developing biofungicides and bio-insecticides mainly for fruits and vegetables, it aims to expand into a wider range of crops as “production costs decrease further.”

“By 2040, we want to have launched more than ten new biocontrols in the US and Europe, and potentially in other regions such as Latin America.”

“In addition to pre-harvest applications, we are also exploring options for our products in the post-harvest segment to protect produce during storage and transportation before it reaches the customer,” he concludes.