Clinical Program

Phase 1a:

Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy (NCT03353402).

Fecal Microbiota Transplantation (FMT) in metastatic melanoma patients who failed immunotherapy. FMT donors were metastatic melanoma patients who achieved a durable complete response to immunotherapy. FMT recipients were treatment refractory metastatic melanoma patients.

Results: Twelve evaluable patients received the combination of FMT and reintroduction of anti PD1 therapy. Of these patients one demonstrated complete response and two demonstrated partial response as measured by Immune Response Evaluation Criteria in Solid Tumors (iRECIST). In parallel, a profound decrease in the percentage of viable tumor cells was recorded in these three patients. Overall, treatment was tolerable, and the combination treatment has planted hope that turning non responders to responders is possible.

 

The preliminary results were presented at oral presentations at the 2019 American Association for Cancer Research and at the 2019 annual meeting of the Infectious Disease Society of America. Final results were published in Science Magazine.

Figure I: % Change in tumor size compared basline. E. N. Baruch et al., Science 10.1126/science.abb5920 (2020).

Phase Ib:

Evaluate Safety and Efficacy of FMT and Nivolumab in Subjects with Metastatic Melanoma or NSCLC (NCT04521075).

Our phase Ib study is designed to confirm, extend and validate the previously observed results while using predictive elements such as donor-recipient matching, based on the data gathered in our previous study. During the study we will evaluate the safety and efficacy of FMT in combination with Nivolumab for patients with treatment-refractory or inoperable melanoma or Non-small-cell lung carcinoma (NSCLC).  

This study has more donors than the previous trial. An interim analysis will be conducted following the completion of recruitment of 15 patients then move on to treat 41 patients. The study is estimated to end in September 2021.

Alteration of Microbiome

Alteration of Immune Response

Clinical
Response

Alteration of Immune Response

Alteration of Immune Response

Clinical
Response

Our Results - Summary

#
Age
Gender
BRAF
Previous Lines
Baseline Staging
Baseline LDH
Sum Of Diameter > 100mm
Donor #
Best Response (iRECIST) (1)
1
66
F
V600E
4
M1d
High
Yes
1
Progressive disease
2
70
M
WT
4
M1b
High
Yes
2
Progressive disease
3
78
M
WT
1
M1a
Normal
No
1
Complete Response
4
69
F
WT
1
M1a
Normal
Yes
2
Progressive disease
5
66
M
WT
1
M1a
Normal
No
1
Partial Response
6
33
M
V600E
9
M1d
Normal
Yes
2
Stable disease
7
66
M
V600E
2
M1c
High
Yes
1
Partial Response
8
65
M
WT
1
M1c
Normal
No
2
Progressive disease
9
35
F
WT
3
M1c
High
Yes
1
Progressive disease
10
62
M
WT
2
M1c
High
No
1
Progressive disease
11
19
M
WT
2
M1a
Normal
No
1
Progressive disease