Lavie Bio reports advancement in its bio-fungicide program for fruit rots

Lavie Bio Ltd., a leading ag-biologicals company focusing on improving food quality and agricultural productivity and sustainability through the introduction of microbiome-based products, and a subsidiary of Evogene Ltd. (NASDAQ: EVGN, TASE: EVGN), on Tuesday announced advancement to the pre-commercialization development stage^[1] in its bio-fungicide program targeting fruit rot diseases. Today’s announcement follows the completion of three consecutive years of vineyard trials, including promising 2021 results, conducted in Europe and the U.S., for two of its leading bio-fungicide product candidates, LAV.311 and LAV.312. Lavie Bio has prioritized LAV311 as its lead candidate for final development and submission of a regulatory dossier, expected to be filed with the federal U.S. Environmental Protection Agency (EPA) and California EPA during 2022.

The annual expenditure on chemical fungicide crop protection was estimated at approximately $18.7 billion in 2019^[2], out of which the annual global expense of fruit rot control usually exceeds $1 billion^[3]. Increasing disease resistance to existing chemicals and sustainability concerns may encourage the use of biological products^[4], which could be integrated into the farmer’s existing IPM (Integrated Pest Management)^[4]. The target market for Lavie Bio’s fruit rot bio-fungicide is expected to be in the greater U.S. market and California in particular, targeting a variety of fruits, and may include grapes, tomatoes and berries.

Lavie Bio conducted these vineyard trials in a variety of geographies in Europe and the U.S., with different grapes varieties, agro-practices and several product formulations and applications. The results indicate that LAV.311 and LAV.312 provided better efficacy and consistency than the commercial biological benchmark control and in some cases may even be comparable to commonly used benchmark chemical solutions. The positive results achieved provide the required empirical foundation for the continued development of both product candidates, and Lavie Bio has prioritized LAV.311 to enter the regulatory process.

Looking forward, pre-commercial activities are expected to include LAV.311 undergoing additional optimization of product formulation and additional trials via third parties towards preparation of a regulatory dossier to be filed to the federal U.S. EPA and California EPA during 2022. Given the regulatory process and seasonality of fruit, Lavie Bio aims to launch its first bio-fungicide product for controlling fruit rots for use in fruit in 2024.

This program has been supported by the Israeli Innovation Authority (IIA) for the last 4 years. This support was instrumental in allowing Lavie Bio to utilize its technology and apply it in this target market.

Dr. Michael Ionesco, Vice President Research of Lavie Bio, stated: “I am very happy with the results we received from our 2021 vineyard trials. LAV.311 and LAV.312 are optimized formulations of live microbial strains, developed though the utilization of Lavie Bio’s BDD (Biology Driven Design) platform, powered by Evogene’s MicroBoost AI engine. With the results now achieved, Lavie Bio will continue optimization of LAV.311’s formulation in parallel to trials for the regulatory process.”

Mr. Ofer Haviv, Active Chairman of Lavie Bio and President & CEO of Evogene, stated: “I am excited to see the progress achieved in Lavie Bio’s bio-fungicide program. Bio-fungicides could provide a valuable opportunity for implementing sustainable practices in valuable fruit and vegetable categories. Advancement to the pre-commercial stage in this program represents the very beginning of the robust pipeline Lavie Bio is developing.”

^[1] For more information about the development process of ag-biological products, please see the section titled “Market Segments – Agriculture – Lavie Bio Ltd. – Product Development Programs – Product Development Cycle” under “Item B. Business Overview” in Evogene Ltd.’s Annual Report on Form 20-F for the year ended December 31, 2020.

^[2] https://www.marketsandmarkets.com/Market-Reports/fungicides-356.html

^[3] Dean, R., et al. (2012). The top 10 fungal pathogens in molecular plant pathology. Molecular Plant Pathology 13:414-430 (https://academic.oup.com/fqs/article/2/3/111/5057759)

^[4] https://lgpress.clemson.edu/publication/biological-control-strategies-in-integrated-pest-management-ipm-programs/, https://ec.europa.eu/research/bioeconomy/pdf/20150429_1_ki0213360enc_web_en.pdf