Biomica Presents Positive Clinical Data Update from Ongoing Phase 1 Trial of Microbiome-Based Therapeutic, BMC128, for Refractory RCC, NSCLC & Melanoma
Biomica , a subsidiary of Evogene, released promising preliminary data from a Phase 1 trial of BMC128, a microbiome-based immuno-oncology candidate, in combination with nivolumab. This trial involves patients with refractory NSCLC, melanoma, or RCC. Key findings include an exceptional safety profile with no major safety events, 72% of refractory cases showing positive clinical signals, and 64% of patients demonstrating stable disease. Additionally, 55% of patients showed sustained clinical benefits beyond 16 weeks, with some exceeding 80 weeks. The data will be presented at the 2024 ASCO annual meeting.
- Promising preliminary data from Phase 1 trial of BMC128.
- Exceptional safety profile with no major safety events.
- 72% of refractory cases exhibited positive clinical signals.
- 64% of patients' disease stopped progressing, showing stable disease.
- 55% of patients showed sustained clinical benefits for over 16 weeks, some exceeding 80 weeks.
- 100% of RCC patients and 60% of NSCLC patients demonstrated positive outcomes.
- Results are preliminary and require further validation.
- Study involved only 11 patients, a small sample size.
- The trial is still ongoing, and full efficacy data are not yet available.
The preliminary Phase 1 results for BMC128 combined with nivolumab show an encouraging safety profile and some signs of potential efficacy in treating refractory cancers. For retail investors, it's important to note that while the data is promising, it is still early in the clinical trial process. Phase 1 trials primarily assess safety rather than definitive efficacy and results can change as trials progress. The favorable safety profile observed so far is a positive indicator, as adverse events can often halt development. The early clinical responses, where 72% of refractory cases showed positive signals and 64% exhibited stable disease, suggest potential efficacy. However, these outcomes need further validation in larger and more controlled Phase 2 and Phase 3 trials. Investors should be cautiously optimistic but understand that significant hurdles remain before BMC128 can be considered for approval and market entry.
The insights from the trial reveal promising trends in using microbiome-based therapies for refractory cancers, a challenging area in oncology. The combination of BMC128 and nivolumab has shown a partial response in one patient and a noteworthy stability in disease progression for others, particularly in RCC and NSCLC. This could potentially expand the arsenal of therapies for patients who have exhausted other options. The observation that 55% of patients had sustained clinical benefits lasting over 16 weeks, with one patient exceeding 80 weeks, is particularly significant as it indicates durability of response—a key factor in cancer treatment efficacy. However, these findings are preliminary and broader trials are needed to confirm these benefits and understand any long-term impacts and side effects that may arise over extended use.
Biomica’s announcement could be viewed positively within the market, considering the innovative approach of using microbiome-based therapeutics. The data suggests a potential breakthrough in cancer treatment, which could drive investor interest. However, retail investors should be aware that early-stage biotech stocks can be highly volatile. Success in Phase 1 does not guarantee success in subsequent phases and the path to regulatory approval can be long and fraught with challenges. The involvement of a well-known institution like the ASCO annual meeting does lend credibility and visibility to Biomica’s efforts. Investors should monitor further updates, particularly as the trial progresses to later stages, which will provide a clearer picture of BMC128's potential impact and commercial viability.
Preliminary Phase 1 results show promising trends for BMC128 in combination with nivolumab in refractory cancer patients. Data will be showcased at the 2024 American Society of Clinical Oncology (ASCO) annual meeting.
REHOVOT,
All trial participants, 11 patients, had experienced disease progression in prior immunotherapy treatment before joining the trial. These preliminary findings represent some of the initial positive evidence emerging from the burgeoning field of clinical research on cancer therapies leveraging gut microbiota. While these results are preliminary and subject to further validation, they suggest potential benefits for patients facing advanced stages of these malignancies.
ASCO 2024 Presentation Details:
Title: Preliminary results from a First-in-Human (FIH), open-label Phase 1 study with BMC128, a rationally designed live bacterial consortium, in combination with nivolumab.
Session Type: Poster Session
Abstract Number: 8631
Date and Time: June 3, 2024, 1:30 PM – 4:30 PM (CDT)
Key observations from the study include:
- Safety Profile: As of the data cutoff date, the safety profile of BMC128 has been exceptional, with no major safety events potentially associated with BMC128 reported during the course of BMC128 monotherapy or combination treatment, indicating a favorable safety profile for the investigational therapy.
- 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. - Response Rates: As of the data cutoff date, one patient demonstrated partial response (PR) 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 (SD) and sustained benefits beyond the first imaging assessment, suggesting additional important potential clinical benefit. - 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. - Cross-Cancer Effectiveness:
100% of RCC patients and60% of NSCLC patients in the study demonstrated positive clinical outcomes, indicating potential efficacy across different cancer types.
With these encouraging early results, it is important to note that the study remains ongoing. Further data will become available and analyzed through the next few months to gain a deeper understanding of the therapeutic potential of BMC128 in combination with nivolumab in cancer treatment.
Prof. Gal Markel, Director of the Davidoff Cancer Center, Rabin Medical Center and Biomica's Scientific Advisory Board member, said: "The positive trends emerging from the ongoing Phase 1 trial of BMC128, particularly in combination with nivolumab, underscore the transformative potential of microbiome-based therapeutics in oncology. These findings bring hope to patients contending with refractory RCC, NSCLC, and melanoma, envisioning a future where innovative treatments like BMC128 could provide meaningful solutions to longstanding challenges in cancer care. Additionally, the observed cross-cancer effectiveness hints at BMC128's broad applicability across different cancer types, further solidifying its significance in the field of oncology. The demonstrated safety profile thus far, alongside the encouraging clinical benefits including response rate and notable durability, accentuates the potential efficacy of BMC128 in addressing the unmet needs of patients grappling with these malignancies. These initial results mark a significant advancement, reflecting our steadfast commitment to pioneering innovative solutions that address critical unmet needs in oncology."
Dr. Elran Haber, Biomica CEO, stated, "The preliminary results from this Phase 1 study show positive evidence of BMC128's superior safety profile and potential efficacy when combined with anti-PD1 checkpoint inhibitor immunotherapy. This suggests potential benefits for patients with refractory NSCLC, melanoma, or RCC who have not responded to, or developed resistance to previous immunotherapy treatments. We believe BMC128 has the promise to be a potential therapy for patients fighting cancer, and we look forward to continuing to evaluate BMC128's beneficial activity in subsequent phases of clinical development. Furthermore, these results underscore the strength of Biomica's computational platform for microbiome drug discovery, developed with Evogene, validating our approach to innovative therapeutic solutions."
Additional information about the trial, can be found at: https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT05354102).
About ASCO:
Founded in 1964, the American Society of Clinical Oncology, Inc. (ASCO®) is committed to the principle that knowledge conquers cancer. Together with the Association for Clinical Oncology, ASCO represents nearly 45,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of high quality, equitable patient care, ASCO works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. The ASCO Annual Meeting is a unique and unparalleled opportunity to connect with one of the largest, most diverse audiences in global cancer care as well as global cancer experts and professionals, to discover the latest innovations in cancer research and education.
About BMC128:
BMC128 is a rationally-designed microbial consortium identified and selected through a detailed functional microbiome analysis using PRISM, a proprietary high-resolution microbiome analysis platform powered by Evogene's MicroBoost AI platform.
Developed as a Live Bacterial Product (LBP), BMC128 is an LBP consortium comprised of four unique bacterial strains, natural inhabitants of the human intestinal tract, that harbour specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity through multiple biological processes.
Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host's microbial community with individually selected, cultured bacteria.
About Biomica Ltd.:
Biomica is a clinical stage biopharmaceutical company developing innovative microbiome-based therapeutics utilizing PRISM system, a proprietary computational platform powered by Evogene's MicroBoost AI tech-engine. licensed from Evogene. Biomica aims to identify and characterize disease-related microbiome entities and to develop novel therapeutics based on these understandings. The company is focused on the development of therapies for antibiotic resistant bacteria, immuno-oncology, and microbiome-related gastrointestinal (GI) disorders. Biomica is a subsidiary of Evogene Ltd. (Nasdaq: EVGN) (TASE: EVGN).
For more information, please visit www.biomicamed.com.
About Evogene Ltd.:
Evogene (Nasdaq: EVGN, TASE: EVGN) is a computational biology company aiming to revolutionize the development of life-science-based products by utilizing cutting-edge technologies to increase the probability of success while reducing development time and cost. Evogene established three unique tech-engines - MicroBoost AI, ChemPass AI, and GeneRator AI – leveraging Big Data and Artificial Intelligence and incorporating deep multidisciplinary understanding in life sciences. Each tech-engine is focused on the discovery and development of products based on one of the following core components: microbes (MicroBoost AI), small molecules (ChemPass AI), and genetic elements (GeneRator AI).
Evogene uses its tech-engines to develop products through subsidiaries and strategic partnerships. Evogene's subsidiaries currently utilize the tech-engines to develop human microbiome-based therapeutics by Biomica, ag-biologicals by Lavie Bio, ag-chemicals by AgPlenus, medical cannabis products by Canonic and castor varieties, for the biofuel and other industries, by Casterra.
For more information, please visit www.evogene.com.
Forward-Looking Statements:
This press release contains "forward-looking statements" relating to future events. These statements may be identified by words such as "will", "may", "could", "expects", "intends", "anticipates", "plans", "believes", "scheduled", "estimates", "demonstrates", or words of similar meaning. For example, Evogene and Biomica are using forward-looking statements in this press release when they discuss the safety and potential efficacy of BMC128 and its potential benefits for patients with refractory NSCLC, melanoma, or RCC who have not responded to or developed resistance to previous immunotherapy treatments. Such statements are based on current expectations, estimates, projections and assumptions, describe opinions about future events, and involve certain risks and uncertainties which are difficult to predict and are not guarantees of future performance. Therefore, actual future results, performance or achievements of Evogene and its subsidiaries may differ materially from what is expressed or implied by such forward-looking statements due to a variety of factors, many of which are beyond the control of Evogene and its subsidiaries, including, without limitation, the current war between Israel Hamas and Hezbollah and any worsening of the situation in
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Evogene Investor Relations Contact:
Rachel Pomerantz Gerber
Head of Investor Relations at Evogene
rachel.pomerantz@evogene.com
Tel: +972-8-9311901
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