BMC128 / Evogene - LARVOL DELTA

Preliminary results from a FIH, open-label phase 1 study with BMC128, a rationally designed live bacterial consortium, in combination with nivolumab. (ASCO 2024) - P1 | "BMC128 has demonstrated an excellent safety profile and preliminary beneficial clinical effect. A phase 2 study to investigate the efficacy of BMC128 is planned to be initiated in late 2024."

Clinical • Combination therapy • P1 data • Breast Cancer • Clear Cell Renal Cell Carcinoma • Cutaneous Melanoma • Genito-urinary Cancer • Lung Adenocarcinoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • CD4 • CD8 • EGFR

Biomica Presents Positive Clinical Data Update from Ongoing Phase 1 Trial of Microbiome-Based Therapeutic, BMC128, for Refractory RCC, NSCLC & Melanoma (PRNewswire) - P1 | N=11 | NCT05354102 | Sponsor: Biomica Ltd. | "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....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....100% of RCC patients and 60% of NSCLC patients in the study demonstrated positive clinical outcomes, indicating potential efficacy across different cancer types."

P1 data • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Biomica to Present at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting (PRNewswire) - "Biomica...announced that it will present preliminary data from its Phase 1 study of BMC128, in combination with immune checkpoint inhibitor (ICI) immunotherapy, in refractory patients with either non-small cell lung cancer (NSCLC), melanoma or renal cell carcinoma (RCC), who previously progressed on immunotherapy, at the American Society of Clinical Oncology (ASCO) Annual Meeting. The conference will take place at McCormick Place in Chicago, Illinois, and will also be available virtually from May 31 to June 4, 2024."

P1 data • Melanoma • Non Small Cell Lung Cancer • Renal Cell Carcinoma

BMC128-001: A First-in-human (FIH) Combination Treatment Study With a Single Dose Level of BMC128 (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Biomica Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Clear Cell Renal Cell Carcinoma • Cutaneous Melanoma • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Biomica Successfully Completes Phase I Trial Enrollment for Microbiome-Based Immuno-Oncology Drug (PRNewswire) - "Biomica Ltd...announced that the final patient has been enrolled in its Phase I clinical trial....Biomica remains on track with preliminary results, and the first data point readout is expected in H1 2024."

Enrollment closed • P1 data • Genito-urinary Cancer • Kidney Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor

Biomica Opens Second Site to Advance Its Immuno-Oncology Drug Trials at Davidoff Center (PRNewswire) - "Biomica Ltd...has announced the opening of a second site at The Davidoff Cancer Center for its ongoing Phase I clinical trial of its immuno-oncology drug candidate, BMC128. The trial aims to assess the safety and tolerability of BMC128 in combination with immune checkpoint inhibitor (ICI) immunotherapy, Bristol Myers Squibb's Opdivo^®, for the treatment of refractory patients with non-small cell lung cancer (NSCLC), melanoma, or renal cell carcinoma (RCC)."

Trial status • Genito-urinary Cancer • Kidney Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor

BMC128-001: A First-in-human (FIH) Combination Treatment Study With a Single Dose Level of BMC128 (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Biomica Ltd. | Trial completion date: May 2023 ➔ Nov 2025 | Trial primary completion date: Feb 2023 ➔ Apr 2024

Combination therapy • Trial completion date • Trial primary completion date • Clear Cell Renal Cell Carcinoma • Cutaneous Melanoma • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Biomica Announces Closing of $20 Million Financing Round led by Shanghai Healthcare Capital (PRNewswire) - "Biomica Ltd...announced that it has closed a financing round of $20 million....The $20 million investment enables Biomica to forge ahead with developing its pipeline of microbiome-based therapeutics. Biomica plans to use the proceeds to complete its current BMC128 phase 1 immuno-oncology study and advance to phase 2 clinical trial; scale up and complete GMP production of BMC333 in preparation for a phase 1 clinical trial for the treatment of inflammatory bowel disease (IBD); as well as advance additional programs."

Financing • Genito-urinary Cancer • Immunology • Inflammatory Bowel Disease • Kidney Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Thoracic Cancer • Ulcerative Colitis • Urothelial Cancer

Biomica VP R&D to Present at the Pharmabiotics 2023 Conference on March 21, 2023 (PRNewswire) - "Biomica Ltd...announced that its VP R&D, Dr. Shiri Meshner, will be presenting at the Pharmabiotics 2023 Conference, 'The Future of Microbiome-based Medicines', taking place in Lyon, France from March 21-22, 2023....BMC128 is currently being tested in a 12 patient Phase 1 open label study (ClinicalTrials.gov Identifier: NCT05354102) to primarily evaluate its safety and tolerability in combination with anti-PD-1 (Opdivo) in patients with either non-small cell lung cancer (NSCLC), melanoma or renal cell carcinoma (RCC)"

Clinical • Genito-urinary Cancer • Kidney Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Urothelial Cancer

Biomica Raises $20 Million in a Financing Round to Advance its Pipeline of Microbiome-based Therapeutics (PRNewswire) - "Biomica Ltd...announced the signing of a definitive agreement for a $20 million financing round, to be led by Shanghai Healthcare Capital (SHC). The financing is subject to customary closing conditions, including clearance by Chinese regulatory authorities...The financing round will enable Biomica to forge ahead, developing its pipeline of microbiome-based therapeutics. Biomica plans to use the proceeds to complete its current BMC128 phase 1 immuno-oncology study and advance to phase 2 clinical trial..."

Financing • Genito-urinary Cancer • Kidney Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor

BMC128: A rationally designed live bacterial consortium for the potentiation of immune checkpoint therapy in solid tumors. (ASCO 2022) - "The primary objective is to investigate the safety and tolerability of BMC128 in combination with Nivolumab. Enrollment is intended to start in Feb, 2022."

Breast Cancer • Clear Cell Renal Cell Carcinoma • Cutaneous Melanoma • Genito-urinary Cancer • Immune Modulation • Inflammation • Lung Adenocarcinoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CD4 • CD8 • EGFR

BMC128-001: A First-in-human (FIH) Combination Treatment Study With a Single Dose Level of BMC128 (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Biomica Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Clear Cell Renal Cell Carcinoma • Cutaneous Melanoma • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Biomica Announces First Patient Dosed in its Phase I Study of its Microbiome-Based Immuno-Oncology Drug (PRNewswire) - "Biomica Ltd...and a subsidiary of Evogene Ltd...announced that the first patient was dosed in its Phase I clinical trial that is designed primarily to evaluate the safety and tolerability of Biomica's microbiome-based immuno-oncology drug candidate, BMC128, in combination with immune checkpoint inhibitor (ICI) immunotherapy, in patients with either non-small cell lung cancer (NSCLC), melanoma or renal cell carcinoma (RCC). Bristol Myers Squibb's Opdivo® is the immune checkpoint inhibitor in the trial."

Trial status • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma

Biomica Announces Successful Enrollment of First Patient in its Phase I Study of Microbiome-Based Immuno-Oncology Drug (PRNewswire) - "Biomica Ltd...announced the successful enrollment of the first patient in its first Proof-of-Concept (POC) Phase I clinical trial. The trial is designed primarily to evaluate the safety and tolerability of Biomica's microbiome-based immuno-oncology drug candidate, BMC128, in combination with immune checkpoint inhibitor (ICI) immunotherapy (an anti PD-1 agent), in patients with either non-small cell lung cancer, melanoma or renal cell carcinoma. Bristol Myers Squibb's Opdivo® is the immune checkpoint inhibitor in the trial."

Trial status • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor

A First-in-human (FIH) Combination Treatment Study With a Single Dose Level of BMC128 (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Biomica Ltd.

Combination therapy • New P1 trial • Clear Cell Renal Cell Carcinoma • Cutaneous Melanoma • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Biomica Announces Clearance for First-in-Human Phase I Study of BMC-128 in Combination with Bristol Myers Squibb’s Anti-PD-1 Opdivo (PRNewswire) - "Biomica Ltd...and a subsidiary of Evogene Ltd...announced that the Israeli Ministry of Health (MoH) cleared the company to proceed with its Proof-of-Concept (POC), Phase I clinical trial of Biomica's drug candidate BMC-128 in patients with Non-Small Cell Lung Cancer (NSCLC), Melanoma or Renal Cell Carcinoma (RCC), in combination with immune checkpoint inhibitor (ICI) immunotherapy (an anti-PD-1 agent)."

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma

Biomica & Rambam Health Care Campus Sign Agreement for Clinical Trial of Biomica's Microbiome-Based Immuno-Oncology Drug (PRNewswire) - "Biomica Ltd....and Rambam Health Care Campus today announced the signing of a clinical trial agreement (CTA) for initiating a first in-human proof-of-concept (POC) for BMC128, Biomica's drug candidate....The study is titled, 'A Phase 1, Open-Label Study to Evaluate the Safety and Tolerability of BMC128 in Combination with anti-PD-1 in Patients with Non-small Cell Lung Cancer (NSCLC), Melanoma or Renal Cell Carcinoma (RCC).'...The initiation of this study is pending approval by the Israeli Ministry of Health (MoH)."

Licensing / partnership • New P1 trial • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Evogene Reports Second Quarter 2021 Financial Results (PRNewswire) - "Impressive pre-clinical data released for its microbiome therapeutic candidate BMC128 in immuno-oncology. BMC128, in combination with Immune Checkpoint Inhibitors (ICI), in a breast cancer mouse model, demonstrated pronounced anti-tumor activity as manifested in an increase of almost 50% in Objective Response Rate, in comparison to ICI alone....2nd half of the year: Expect to initiate its first-in-human proof-of-concept clinical trial in its immuno-oncology program."

New trial • Preclinical • Oncology • Solid Tumor

Biomica Announces Positive Pre-Clinical Results, Demonstrating Efficacy of BMC128 in Melanoma (PRNewswire) - “Biomica…announced additional positive pre-clinical…In these studies, Biomica tested BMC128, which consists of four live bacterial strains, in a mouse model of melanoma…These positive pre-clinical results indicate the potential of BMC128 to become best-in-class in the treatment of solid cancer tumors, and help validate Biomica's computational-based drug design approach…The group treated with only anti-PD1 showed no response (ORR = 0%) as measured by the Response Evaluation Criteria in Solid Tumors (RECIST), while the group treated with a combination of BMC128 and anti-PD1 demonstrated a total of 13% response (ORR = 13%). The %TGI was increased by 100% in the BMC128 and anti-PD1 combination treated group compared to the group treated by anti-PD1 alone…the first-in-human proof-of-concept clinical trial expected later this year.”

Clinical • Preclinical • Melanoma • Oncology • Skin Cancer • Solid Tumor