Company: EVGN
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001178913-25-001092
Chunk: 88

Company: Evogene Ltd.
Filing Date: 2025-03-27
Form: 20-F
Item: Item 4
Chunk 88
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, was presented at the American Society of Clinical Oncology Annual Meeting on June 3, 2024.
 
Key observations from the study include:
 

•                          Safety Profile: as of the data cutoff date, the safety profile of BMC128 has been positive,                       
    with no major safety events potentially associated with BMC128 reported during the course of BMC128 monotherapy or combination treatment,
                                     indicating a favourable safety profile for the investigational therapy.                                 
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•                         Clinical Responses: as of the data cutoff date, among the patients included in the study,                       
    72% of refractory cases exhibited positive clinical signals, indicating a potential efficacy for the BMC128 and nivolumab combination.
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•                               Response Rates: as of the data cutoff date, one patient demonstrated partial response                             
         upon imaging and RECIST v1.1 assessment and remains actively responding to treatment. Additionally, 64% of patients’ disease stopped     
    progressing following the combination treatment, and they displayed stable disease and sustained benefits beyond the first imaging assessment,
                                             suggesting additional important potential clinical benefit.                                          
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•                Durability of Response: as of the data cutoff date, 55% of patients showed sustained             
    clinical benefit, with notable durations of response of over 16 weeks and with one patient exceeding 80 weeks.
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•          Cross-Cancer Effectiveness: 100% of RCC patients and 60% of NSCLC patients in the study       
    demonstrated positive clinical outcomes, indicating potential efficacy across different cancer types.
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GI Disorders
 
In the IBD program, BMC333 is an optimized consortium, which consists of four bacterial strains derived from Biomica’s BMC321 and BMC322 (rationally-designed consortia that were identified using Biomica’s computational analysis and predictive capabilities designed with specific emphasis on the anti-inflammatory activity of these strains and their potential as novel therapeutic modality for IBD). During 2024, Biomica continued scale-up development of BMC333. During 2025, Biomica plans to continue with the scale-up development in preparation for GMP clinical batch production of BMC333 pending sufficient funding.
 
In the IBS program, Biomica utilizes proprietary data from several clinical trials conducted in the U.S. to develop a novel microbiome-based drug candidates, BMC426/7. On May 18, 2024, Biomica presented its results from pre-clinical studies in its IBS program at the Digestive Disease Week 2024 Annual Meeting