Korean Firm, Asia’s First to Get FDA Clearance for Testing Anti-Cancer Microbiome Therapeutic

by Judy Ya-Hsuan Lin
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By Judy Ya-Hsuan Lin

Genome & Company, a clinical-stage biotech headquartered in South Korea, announces a key milestone for its first anti-cancer microbiome therapeutic, GEN-001. On April 20th this year, the company received FDA Investigational New Drug (IND) clearance to further research into the efficacy and safety of its drug in combination with the previously developed anti-PD-L1 drug, Bavencio (avelumab) to treat cancers. Launched in 2015, Genome & Company focuses on developing innovative therapeutics in immune-oncology with specialization in immune checkpoint inhibitors and fusion proteins. The FDA clearance will further reinforce its status in the microbiome and immune-oncology industry, according to CTO officer, Dr. Hansoo Park, and CEO, Dr. Jisoo Pae.


The GEN-001, Avelumab Combo

Earlier this year, the firm signed a collaboration with Merck KGa, Darmstadt, Germany, and Pfizer Inc. to conduct clinical trials with the GEN-001 and avelumab combination. Avelumab is an FDA approved monoclonal antibody therapy for pediatric patients with metastatic Merkel cell carcinoma (mMCC) that is currently evaluated in several trials for treating other cancers. Last May, the drug was approved in combination with Axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). The therapy is available in 50 countries with low restrictions on treatment guidelines. The phase 1/1b clinical trial that tests the combination of the two drugs will be conducted in the US, and potentially, the first patient will be enrolled within this year.

Both GEN-001 and avelumab aim to treat cancers, but their targets vary. GEN-001, an oral microbiome therapeutic candidate, is compatible with immune checkpoint inhibitors because of its immune-modulating activities. GEN-001 can be found as a single strain bacterium in the human gut and is responsible for activating dendritic cells, T cell response, and macrophages.


Safety of Combination Therapy

When administered as a combination therapy, GEN-001 was found to reduce the growth of both immune checkpoint inhibitor sensitive and resistant tumors. Most importantly, it shows an optimal safety margin in preclinical studies. Avelumab is known to cause several adverse effects, namely fatigue, musculoskeletal pain, nausea, diarrhea, or peripheral edema among others. Previously, its combination with axitinib did not show any signs of reduction. Nevertheless, the GEN-001 combination with avelumab would be anticipated to perform better because of the promise it showed in safety evaluations thus far.

Related Article: Bavencio Meets Primary Endpoint in Bladder Cancer Trial



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