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, Israel, May 23, 2024
/PRNewswire/ -- Biomica Ltd., a clinical-stage
biopharmaceutical company developing innovative microbiome-based
therapeutics and a subsidiary of Evogene Ltd. (Nasdaq: EVGN)
(TASE: EVGN), today announced encouraging initial findings from an
ongoing Phase 1 clinical trial. In the study, Biomica is
investigating the safety and tolerability of its microbiome-based
immuno-oncology candidate, BMC128, in combination with nivolumab,
an anti-PD1 immune checkpoint inhibitor, in patients with non-small
cell lung cancer (NSCLC), melanoma, or renal cell carcinoma
(RCC).
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 and 60%
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 Israel such as
further mobilizations or escalation in the northern border of
Israel and those risk factors
contained in Evogene's reports filed with applicable securities
authorities. Evogene and its subsidiaries disclaim any obligation
or commitment to update these forward-looking statements to reflect
future events or developments or changes in expectations,
estimates, projections, and assumptions.
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Logo: https://mma.prnewswire.com/media/1947468/Evogene_Logo.jpg
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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SOURCE Biomica Ltd.