Positive Results from Interim Analysis of 'GEN-001' Plus avelumab (Bavencio®) Phase II Trial

Positive primary endpoint result of objective response rate (ORR) from the planned interim analysis of Phase II trial in advanced gastric/gastroesophageal junction adenocarcinoma (GC/GEJ).

Top-line data of the final analysis from Phase II to be announced in the second half of next year.

SEOUL,South Korea,May 19,2023 -- Genome & Company (CEOs: Pae,Jisoo,Park,Hansoo),a global leading microbiome therapeutics developer,announced that this phase II trial (NCT05419362) will continue without modifications to move on to the second stage,based on the positive result of the interim analysis.

Using a single-strain bacteria in combination with avelumab (Bavencio®) from Merck KGaA,Darmstadt,Germany and Pfizer Inc.,it is the first time to show positive antitumor activity per ORR in Phase II trial. The detailed results will be presented at a conference in the second half of 2023.

On the basis of these results and in accordance with the predetermined hypothesis of the interim analysis,Genome & Company highly expect that the evidence for treatment with GEN-001 plus avelumab as a 3rd line of therapy for GC/GEJ will be strongly established.

This is a Phase II study to evaluate the safety and efficacy of GEN-001 plus Avelumab as a ≥3rd line treatment for PD-L1 positive GC/GEJ patients regardless of prior immune-oncology (IO) treatment. Following enrollment of the 21st patient,a pre-planned interim analysis was conducted and results were reviewed by an independent data monitoring committee (IDMC).

As the observed ORR met the pre-determined criteria together with no safety concerns,the IDMC recommended to continue with the second stage without modifications and enroll additional 21 patients. The detailed results will be presented at an Oncology conference in the second half of 2023. The top-line data of the final analysis from Phase II are expected in the second half of next year.

Professor Jeeyun Lee,the principal investigator of clinical trials from the Hematology and Oncology Division at Samsung Medical Center,stated,"There is a strong unmet medical need to establish 3rd line of therapy for GC/GEJ patients compared with the establishing 1st and 2nd lines of therapy. Hence,the pre-planned interim result of this trial is quite interesting. We continue to enroll patients and look forward to seeing the final analysis of this trial soon."

The CEO of Genome & Company,Pae,"We attach great significance to presenting data-driven results for the first time through Phase II clinical trials on gastric cancer patients using the immuno-oncology microbiome therapeutic 'GEN-001' in combination with avelumab from Merck KGaA,Germany and Pfizer Inc." and "we intend to obtain phase II clinical data for 'GEN-001' within next year and to discuss a licensing agreement with partners or global big pharmaceutical companies."

It is also worth noting that GEN-001 is currently undergoing phase 2 clinical trial with combination therapy with MSD's pembrolizumab (Keytruda®) for patients with advanced biliary tract cancer. The first patient in will be initiated in the second half of this year. To expand treatment options for advanced biliary tract cancer with high unmet medical needs,Genome & Company recently requested approval from the Ministry of Food and Drug Safety (MFDS) in South Korea to amend the protocol.