바이오스펙테이터

by Joungmin Cho

Genome & Company is moving with speed into clinical trials of Microbiome Immuno-oncology Agent, the first pipeline in the United States of America. Genome & Company established the mode of action (MOA), which has been regarded as an important milestone of the new drug development of microbiome, and is preparing for the clinical trial through the production of specimens of clinical trial and scheduled Pre-IND meetings with the FDA.

Genome & Company is reinforcing the research and development of Immuno-oncology antibody, as well as microbiome. In particular, research and development is in progress to discover new targets of ‘Immune Checkpoint Inhibitor’, specialized for patients of ‘anti-PD1 non-indicative/unreactive’. The company has joined with the double antibody developing company, ABL Bio Inc., for the development of the new ‘Immune Checkpoint Inhibitor’.

Bae Ji-soo, the president of Genome & Company, said, “… in 2019, significant progress is expected in the fields of immuno-oncology agent (microbiome, antibody), cosmetics, and health & functional foods…”, “… we are willing to accomplish business objectives this year, for the transfer and listing on KOSDAQ in 2020...”.

Genome & Company has been focusing on the development of a microbiome therapeutic agent that is capable of maximizing the immune function, and enhancement of the efficacy thereof through co-administration with immuno-oncology agent since its foundation. The company unearthed new candidates for new drugs through comparison of specimens of microbiome collected from groups differentiated into reactive- and unreactive groups to anticancer agent, and groups of patients and normal persons.

Genome & Company has been carrying out research based on the multi-omics mechanism, and identified the anticancer mechanism of candidate material for anticancer agent through research on the genome, transcriptome, metabolome, and lipodome of selected bacterial strain.

Genome & Company is currently preparing for the IND request for phase-1 clinical trial to be appointed in September this year. A researcher of the company stated, “… currently, the design of clinical trial of phase-1b and phase 2 is in progress. It is estimated to comprise 100–150 patients, and the pre-IND meeting with the FDA is scheduled to be held within this month...”.

Genome & Company expanded its business into the new area of developing immuno-oncology antibody. The company has targeted the development of specialized immune checkpoint inhibitor for patients unreactive to PD-1 targeted anticancer agent, or for patients for whom the manifestation of PG-1 has been disabled.

President Bae stated, “… many biopharmaceutical companies have started to develop bio-drugs mostly targeted at PD-1 and PD-L1, along with the emergence of immuno-oncology agent. We are targeting the unmet needs of unreactive or patients who are disabled from using existing targets …”. He continued, “… there are two ways for the development of new drugs or technologies. The first one is led by the advancement of development, followed by an assessment on the needs thereof, whereas the second one is led by an assessment of unmet needs, followed by the development of technologies. Genome & Company belongs to the second category. We are thoroughly based on the assessment of unmet needs…”.

The company selected targets of prioritized development for new drugs through the screening and analysis of many protein ligands. Among them, two candidates for new drugs have been selected, and are being jointly developed with ABL Bio Inc., which specializes in new double antibody drugs.

Above all, the patent applications have been filed for the targeted usage and substance of the drugs among the development targets. The company stated, “… there are currently candidate materials for new drugs, of which the results are being obtained from the experiments of pre-clinical phase that are being conducted to identify the effects from animal models, which are in progress…”

Genome & Company is expanding its product domain from microbiome to antibody. President Bae explained, “… the CTO of the company, the joint representative Park Han-soo, is a specialist in oncology and genomics, while Dr. Yun Gyeong-wan, the CSO, as well as being the head of the research laboratory of the company, is also a specialist in tumor immunology. Together with new drugs based on microbiome modules, anticancer strategies are being developed by Genome & Company, which has established the business objectives of developing immuno-anticancer agent by multilateral immuno-control through development based on new antibody drugs…”.

Besides the development of new drugs that are needed for long breathing, Genome & Company are developing and commercializing, as cash cows, cosmetics and functional foods based on the microbiome. Two pipelines for atopy and pimples are currently being developed, whereas the functional foods are targeted at obesity.

The company expects that, “… the early commercialization of the two products of cosmetics that have been identified with efficacy, and the functional foods, will contribute to the company as cash cows.”

President Bae Ji-soo stated, “… the products from pipelines derived through R&D will start to show tangible accomplishments through the Phase-1 Clinical Trials of microbiome-based new drugs. clinical researches in microbiome-based cosmetics and commercialization, as well as the derivation of antibody for immuno-anticancer agent, and the conducting of experiments of pre-clinical trials …”