What is known is known 1
Genome & Company Announces First Patient Enrolled in a Phase 1
1b study of GEN-001, an immuno-oncological microbiome therapeutic, was treated in combination with avelumab
Seoul, south korea, Jan. 28 / PRNewswire / -
- The first therapeutic candidate for microbiome oncology developed by an Asia-based biotech company is successfully launching a phase 1 / 1b clinical trial in the United States six months after the IND came into force.
- The first patient was admitted and treated at OHSU (Oregon Health & Science University Knight Cancer Institute)
- "We will continue to strive for optimal results as part of the world's leading group of anti-cancer microbiome therapeutics."
Genome & Company (KONEX: 314130), a pioneering global microbiome therapeutics company, initiated clinical testing of GEN-001, an anti-cancer microbiome therapeutic (NCT04601402).
GEN-001 is an oral microbiological therapy candidate from Genome & Company. In this clinical trial, it will be given to cancer patients by combining an immune control point inhibitor for the first time at Asian microbiome development companies.
The aim of the phase I study is to determine the RP2D (recommended phase 2 dose) of GEN-001 in combination with BAVENCIO® (avelumab). Avelumab is an anti-PD-L1 checkpoint inhibitor that is jointly developed and marketed by Merck KGaA, Darmstadt, Germany, and Pfizer Inc. In the phase 1b study, the safety and preliminary efficacy of the combination therapy on the RP2D of GEN-001 in combination with BAVENCIO® in patients with specific solid tumors is being investigated.
A total of three trial centers, including the OHSU Knight Cancer Institute in Portland, Oregon, will complete the dose escalation cohort in the first half of 2021. The OHSU Knight Cancer Institute is a world-renowned cancer center and one of the 51 National Cancer Institute (NCI) designated Comprehensive Cancer Centers in the United States. In difficult circumstances due to COVID-19, the close collaboration between the OHSU, the contract research organization, and Genome & Company did not allow this clinical trial to begin until six months after FDA approval.
"We are pleased to offer our patients access to a new clinical trial of the drug GEN-001 in combination with avelumab," said Dr. Shivaani Kummar, director of the Department of Hematology and Medical Oncology at OHSU Medical School and Co-Director of the OHSU Knight Cancer Institute Center for Experimental Therapeutics. "Our aim is to find out more about whether this combination therapy can help overcome an acquired resistance to anti-PD in patients with advanced solid tumors whose disease has progressed with previous anti-PD (L) 1 therapy. (L) 1 therapy will be effective. "
Dr. Jisoo Pae, CEO of Genome & Company, stated, "The study result of GEN001-101 is expected to demonstrate the preliminary efficacy of GEN-001 in a variety of cancers. We hope to have clinically meaningful results fairly soon would allow GEN-001 to advance through clinical trials with the potential to eventually become an alternative therapeutic option in the immuno-oncology market. "
In December 2019, Genome & Company entered into an agreement with Merck KGaA, Darmstadt, Germany, and Pfizer to collaborate and deliver clinical trials to investigate the safety, tolerability, and biological and clinical activities of GEN-001 therapy in combination with avelumab , a human anti-PD-L1 therapy, in various cancer indications. Under this contract, Genome & Company will sponsor the trial, and Merck KGaA, Darmstadt, Germany and Pfizer will supply avelumab for the phase 1 / 1b clinical trial.
BAVENCIO® is a trademark of Merck KGaA, Darmstadt, Germany.
Avelumab Approved Indications
Avelumab (BAVENCIO®) is indicated in the United States for the maintenance treatment of patients with locally advanced or metastatic urothelial cancer (UC) who have not progressed to first-line chemotherapy with platinum-based chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or after platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-based 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 United States, the FDA granted accelerated approval for BAVENCIO for the treatment of adult and pediatric patients 12 years of age and older with metastatic Merkel cell carcinoma (MCC). This indication is accelerated approval based on the tumor response rate and duration of response. Further approval may depend on the verification and description of the clinical benefit in confirmatory studies.
Avelumab Important safety information from US FDA-approved label
The warnings and precautions for avelumab (BAVENCIO®) include immune-related side effects (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis and other immune-related side effects, taken alone or in combination with axitinib [which can be serious and included fatal cases ]), infusion-related reactions, hepatotoxicity in combination with axitinib, Serious Cardiovascular Events (MACE) in combination with axitinib [which can be serious and have been fatal] and embryo-fetal toxicity.
Common side effects (reported by at least 20% of patients) in patients treated with BAVENCIO® monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, peripheral edema associated with infusions, decreased appetite, urinary tract infections and rash. Common side effects (reported by at least 20% of patients) in patients receiving BAVENCIO® in combination with axitinib include diarrhea, fatigue, high blood pressure, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased Appetite, hypothyroidism, rash, hepatotoxicity, cough, shortness of breath, abdominal pain and headache. In at least 10% of the patients with Merkel cell carcinoma who were treated with BAVENCIO® monotherapy, the hematological laboratory values of grade 3-4 show anomalies of lymphopenia; In patients receiving BAVENCIO® in combination with axitinib, blood triglycerides and lipase increases in grade 3-4 clinico-chemical abnormalities.
The full US Prescribing Guide for BAVENCIO® is available at http://www.BAVENCIO.com.
Information on Genome & Company
Founded in 2015, Genome & Company has been developing the next waves of innovative drugs, including anti-cancer microbiome therapeutics and novel target immune checkpoint inhibitors. With the acquisition of US-based biotech company Scioto Biosciences in August this year, the company expanded its global microbiome pipeline in the field of brain diseases and continues to pioneer the market to become a global microbiome health company, which is part of the Is able to conduct research, development and production. More information on the website: http://www.genomecom.co.kr.
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