Genome and Company, a leading global microbiome anti-cancer drug development company, signed a second clinical trial collaboration and supply agreement (CTCSA) with Merck KGaA, Darmstadt, Germany and Pfizer Inc. with the aim of developing the world's first immuno-oncology microbiome therapeutic. The collaboration follows in just a year after signing the first agreement with Merck KGaA, Darmstadt, Germany and Pfizer in December 2019 to conduct the first combination clinical trial of avelumab (BAVENCIO®) and GEN-001 (NCT04601402, "Study 101").
The objective of the clinical trial ("Study 201") under this newly entered CTCSA is to investigate the efficacy and safety of the combination of GEN-001 and avelumab for gastric and gastroesophageal junction adenocarcinoma that continue to be difficult to treat. This trial will be conducted simultaneously at six or more hospital and medical center sites in the Republic of Korea.
With this clinical trial, Genome and Company will proceed with Phase 2a to assess the efficacy and safety of the combination of GEN-001 and avelumab using the defined recommended phase 2 dose (RP2D) of GEN-001 in combination with avelumab. Merck KGaA, Darmstadt, Germany and Pfizer will supply avelumab for use in the new company-led clinical trial, Study 201. The extended clinical collaboration between Genome and Company and Merck KGaA, Darmstadt, Germany and Pfizer marks the first time that two consecutive clinical development collaborations have been executed between combination partners for immuno-oncology microbiome treatment.
Genome and Company is developing GEN-001 through an efficient clinical development roadmap in cooperation with experts. The company is leading clinical trials in systematic approaches to immediately advance to phase 2 upon the completion of a phase 1 study. Also, the company has achieved IND clearance by the US FDA and MFDS in the Republic of Korea for a variety of patient demographics as well as cancer types.
Dr. Jisoo Pae, CEO of Genome and Company, said, "This second CTCSA with Merck KGaA, Darmstadt, Germany and Pfizer is the achievement of our outstanding R&D capabilities and the effective clinical collaboration that is established through the ongoing Study 101. We would be able to reach the oncology leadership position using immuno-oncology microbiome treatment especially in the Asian market through the additional clinical trial."
Under the terms of these agreements, Genome and Company will be the sponsor of the studies, and Merck KGaA, Darmstadt, Germany and Pfizer will supply avelumab for both Study 101 and Study 201. Both parties will have access to the clinical data.
About Genome & Company
Since its establishment in 2015, Genome & Company develops next waves of innovative drugs including anti-cancer microbiome therapeutics and novel target immune checkpoint inhibitors. With the acquisition of Scioto Biosciences, a US biotech, in August this year, the company has expanded its global microbiome pipeline into brain diseases and continues to pioneer the market in order to transform into a global microbiome healthcare group capable of research, development and production.
About GEN-001
GEN-001 is an oral microbiome therapeutic candidate developed to have immune modulating activities, resulting in potential partnership with immune checkpoint inhibitors. GEN-001 consists a single-strain bacteria (Lactococcus lactis) isolated from gut of healthy human volunteers that has been shown to activate dendritic cells, macrophages and T cell response. In preclinical studies, GEN-001 has shown optimal safety margin and synergistic effects in combination with immune checkpoint inhibitors by enhancing the effect of suppressing the growth of both immune checkpoint inhibitor sensitive and resistant tumor models. A Phase 1/1b clinical trial is currently in progress in the US and Korea.
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