Genome & Company announces first patient dosed in Phase 1/1b study of GEN-001, an immuno-oncology microbiome therapeutic, in combination with avelumab

The first microbiome oncology therapeutic candidate developed by an Asia-based biotech successfully initiates phase 1/1b clinical trial in the US,six months after its IND went into effect.

The first patient enrolled and treated at OHSU (Oregon Health & Science University Knight Cancer Institute

"We will continue to strive for optimal results as part of the global leading group of anti-cancer microbiome therapeutics."

SEOUL,South Korea,Oct. 27,2020 -- Genome & Company (KONEX: 314130),a global pioneer company of microbiome therapeutics,initiated clinical trials of GEN-001,an anti-cancer microbiome therapeutic(NCT04601402).

GEN-001 is an oral microbiome therapeutic candidate of Genome & Company. In this clinical trial,it will be administered to cancer patients by combining an immune checkpoint inhibitor for the first time among Asian microbiome development companies.

The phase 1 study aims to determine the RP2D (recommended Phase 2 dose) of GEN-001 in combination with BAVENCIO® (avelumab). Avelumab is an anti-PD-L1 checkpoint inhibitor co-developed and co-commercialized by Merck KGaA,Darmstadt,Germany and Pfizer Inc. In the phase 1b study,the safety and preliminary efficacy of the combination therapy at the RP2D of GEN-001 in combination with BAVENCIO® for patients with specific solid tumors will be investigated.

A total of three clinical sites including OHSU Knight Cancer Institute located in Portland,Oregon will complete the dose escalation cohort within the first half of 2021. The OHSU Knight Cancer Institute is a globally renowned cancer center and one of the 51 National Cancer Institute (NCI) designated Comprehensive Cancer Centers in the U.S. Amid harsh conditions due to COVID-19,close collaboration among OHSU,contract research organization and Genome & Company enabled this clinical trial to initiate only after six months since its FDA IND clearance.

"We are pleased to offer our patients access to a new clinical trial of the drug GEN-001 in combination with avelumab," said Shivaani Kummar,M.D.,head of the division of hematology and medical oncology in the OHSU School of Medicine,and co-director of the OHSU Knight Cancer Institute Center for Experimental Therapeutics. "Our goal is to learn more about whether this combination therapy will be effective in overcoming acquired resistance to anti-PD-(L)1 therapy in patients with advanced solid tumors whose disease has progressed on prior anti-PD-(L)1 therapy."

Dr. Jisoo Pae,CEO of Genome & Company stated,"The study outcome of GEN001-101 is expected to demonstrate preliminary efficacy of GEN-001 in various cancers. We hope to see clinically meaningful results fairly soon that would allow us to continue to progress GEN-001 through clinical trials,with the potential to eventually become an alternative therapeutic option in the immuno-oncology market."

In December 2019,Genome & Companyinked a Clinical Trial Collaboration and Supply Agreement with Merck KGaA,Germany and Pfizer to evaluate the safety,tolerability,biological and clinical activities of GEN-001 therapy in combination with avelumab,a human anti-PD-L1 therapy,in multiple cancer indications. Under the terms of this agreement,Genome & Company will be the sponsor of the study,and Merck KGaA,Germary and Pfizer will supply avelumab for the phase 1/1b clinical trial.

BAVENCIO® is a trademark of Merck KGaA,Germany.

Avelumab Approved Indications

Avelumab (BAVENCIO®) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Avelumab in combination with axitinib is approved in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US,the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO®) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases],colitis,endocrinopathies,nephritis,and other immune-mediated adverse reactions as a single agent or in combination with axitinib [which can be severe and have included fatal cases]),infusion-related reactions,hepatotoxicity in combination with axitinib,major adverse cardiovascular events (MACE) in combination with axitinib [which can be severe and have included fatal cases],and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO® monotherapy include fatigue,musculoskeletal pain,diarrhea,nausea,infusion-related reaction peripheral edema,decreased appetite,urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO® in combination with axitinib include diarrhea,fatigue,hypertension,mucositis,palmar-plantar erythrodysesthesia,dysphonia,hypothyroidism,rash,hepatotoxicity,cough,dyspnea,abdominal pain and headache. Grade 3-4 hematology laboratory value abnormalities reported in at least 10% of patients with Merkel cell carcinoma treated with BAVENCIO® monotherapy include lymphopenia; in patients receiving BAVENCIO® in combination with axitinib,grade 3-4 clinical chemistry abnormalities include blood triglyceride increased and lipase increased.

For full US Prescribing Information and Medication Guide for BAVENCIO®,please see http://www.BAVENCIO.com.

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. For more information,please refer to our website http://www.genomecom.co.kr.

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