GENE ONLINE|News &
Opinion
Blog

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

by Judy Ya-Hsuan Lin
Share To

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

References
  1. https://www.prnewswire.com/news-releases/genome–company-receives-fda-ind-clearance-for-gen-001-its-first-anti-cancer-microbiome-therapeutic-301043307.html

 

©www.geneonline.com All rights reserved. Collaborate with us: service@geneonlineasia.com
Related Post
Australia’s Biggest Week in Life Sciences For Biotechnology Advancement
2023-11-01
Global Expansion between Europe and India of Novel anti-PD-1 mAb Serplulimab
2023-10-31
Daiichi Sankyo Advances Care Standards with Groundbreaking Cancer Treatment
2023-10-20
LATEST
GeneOnline’s Weekly News Highlights: Nov 20-Nov 24
2023-11-27
SK Bioscience and Hilleman Laboratories Join Forces for Ebola Vaccine Development
2023-11-23
BeiGene to Expand Oncology Pipeline Through ENSEM Therapeutics Partnership
2023-11-23
Advancing the Frontiers of Cell and Gene Therapy – An Interview with Dr. Shin Kawamata
2023-11-21
Astellas and Pfizer’s Drug Receives FDA Approval as Treatment for High-Risk Prostate Cancer Recurrence
2023-11-21
GeneOnline’s Weekly News Highlights: Nov 13-Nov 17
2023-11-20
Singapore’s NUS Medicine Launches Centre for Sustainable Medicine
2023-11-20
EVENT
2023-11-30
2023 Healthcare+ EXPO・Taiwan
Taipei , Taiwan
Scroll to Top