All Press Releases for October 09, 2020

[Pangyo Technovalley, Innovation hub in ASIA] Genome & Company Develops New Drug Development Pipeline and Platform

- Applied domestic patent for oral microbiome treatment candidate GEN-001 - Succeeded in attracting new investment in pre-IPO worth KRW 20 billion from KDB



in August, Genome & Company made an equity investment in Scioto Biosciences, a microbiome new drug research and development company in the US.

    LOS ANGELES, CA, October 09, 2020 /24-7PressRelease/ -- Microbiome is a compound word of "microbe" and "biome." It refers to microorganisms living in our body and their genetic information, and it has recently gained special attention in pharmaceutical and biohealth areas. Microbiome, also referred to as the Second Genome, is a field that can be widely used for research on new drug development and treatment of incurable diseases as it can help analyze the relationship between the principle of the generation of beneficial bacteria and harmful bacteria and diseases. In Korea, there is an increasing number of pharmaceutical and biohealth-related companies that use microbiome to contribute to human health. Genome & Company in Pangyo Techno Valley is one of the leaders in the microbiome trend in Korea.

Genome & Company is a bio-venture company established in 2015, developing next-generation innovative new drugs in the field of immune anticancer drugs such as microbiome, new target immune checkpoint inhibitors, and fusion proteins to overcome unmet medical demands of cancer patients. The company is the first Korean microbiome research and development company to collaborate in a clinical trial of concomitant use and supply contract of Merck and Pfizer's immune anticancer drug Avelumab (product name: Bavencio) and its own immune anticancer microbiome treatment (GEN-001) in December last year. In April of this year, the US Food and Drug Administration (FDA) approved the clinical trial plan (IND), and the clinical trial of concomitant use is in progress. Along with this. in December last year, it signed an MOU with LG Chem for the exclusive development and commercialization rights for GEN-001 in Korea and the East Asian region.

GEN-001, an immunological anticancer drug candidate, which is the main pipeline of the microbiome immune anticancer drug development company Genome & Company is a candidate substance for oral microbiome treatment and is a substance that has immune activity. It is used as an anticancer drug for combination therapy with an immune checkpoint inhibitor. GEN-001 is a single strain of bacteria isolated from healthy volunteers, and it was found out that it activates dendritic cell, macrophage, and T cell responses in the preclinical trial. In the preclinical stage, GEN-001 has secured optimal safety, and in particular, when administered in combination with an immune checkpoint inhibitor (ICI), it showed a synergistic effect that significantly inhibits cancer growth in models that are responsive to existing immune checkpoint inhibitors and models that do not respond.

GEN-001 was recently patented in Korea, and with this patent decision, Genome & Company received the exclusive rights for anti-cancer monotherapy and chemotherapy/immunotherapy, and combination anti-cancer therapy with GEN-001 regardless of cancer type in addition to the strain on main pipeline GEN-001. R&D representative Park Han-soo at Genome & Company said, "It is of great significance not only for the anti-cancer microbiome itself, but also for obtaining a patent decision for single or combined administration regardless of cancer type. We are going to accelerate the approval and clinical procedure to become a company that can give hope to cancer patients through the development of anticancer drugs."

In addition, in August, Genome & Company made an equity investment in Scioto Biosciences, a microbiome new drug research and development company in the US, and laid a bridgehead for expanding the microbiome new drug development business. Through this investment, Genome & Company has become one of the largest shareholders of Scioto Biosciences. The two companies agreed for multilateral cooperation for research on new microbiome new drug candidates based on Scioto Biosciences's unique Activated Bacterial Therapeutics (ABT) platform technology, including clinical development of SB-121, a new drug candidate with autism as the main indication.

Consisting of the board of directors and the advisory group including the Chief Scientific Officer (CSO) from a multinational pharmaceutical company Eli Lily & Co., Scioto Bioscience is focusing on the development of new microbiome drugs for the treatment of brain diseases and bowel diseases, and it has ABT platform technology exclusive new drug development and commercialization rights based on the collaborative research with Nationwide Children's Hospital located in Ohio, US.

On July 15, Genome & Company passed the technical evaluation for the technology privileged listing, and now is going for listing on the KOSDAQ. CEO Bae Ji-soo of Genome & Company said, "We have confirmed the excellence of new drug development technology through this technology evaluation. As soon as we see the technology evaluation, we plan to go ahead with listing in KOSDAQ right away." Genome

Genome & Company is a bio-venture company established in 2015, developing next-generation innovative new drugs in the field of immune anticancer drugs such as microbiome, new target immune checkpoint inhibitors, and fusion proteins to overcome unmet medical demands of cancer patients. The company is the first Korean microbiome research and development company to collaborate in a clinical trial of concomitant use and supply contract of Merck and Pfizer's immune anticancer drug Avelumab (product name: Bavencio) and its own immune anticancer microbiome treatment (GEN-001) in December last year. In April of this year, the US Food and Drug Administration (FDA) approved the clinical trial plan (IND), and the clinical trial of concomitant use is in progress. Along with this. in December last year, it signed an MOU with LG Chem for the exclusive development and commercialization rights for GEN-001 in Korea and the East Asian region.

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