Genome & Company Announces Clinical Trial Collaboration and Supply Agreement with Merck KGaA, Darmstadt, Germany, and Pfizer to Evaluate GEN-001 in Combination with Avelumab (BAVENCIO®) for Multiple Oncology Indications

--Clinical collaboration regarding the Phase 1/1b combination clinical trial, evaluating Genome & Company’s microbiome-based immuno-oncology therapy GEN-001 in combination with the PD-L1 antibody avelumab (BAVENCIO®) from Merck KGaA, Darmstadt, Germany, and Pfizer Inc.^®) Efficacy in Multiple Tumor Indications-- 

SEOUL, South Korea, Jan. 14, 2020 /PRNewswire/ -- Genome & Company (KONEX: 314130) is pleased to announce that it has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany, and Pfizer Inc. to evaluate the safety, tolerability, and biological and clinical activity of GEN-001 in combination with the human PD-L1 antibody therapy avelumab for the treatment of multiple cancer indications.

Under the terms of the agreement, Genome & Company will sponsor the study; Merck Group (Darmstadt, Germany) and Pfizer will provide avelumab for the Phase 1/1b clinical trial, which is expected to commence in the United States in 2020. Both parties will have access to the clinical data.

This combination trial is designed as a first-in-human study, including dose escalation and expansion cohorts, to assess safety and preliminary efficacy.

Dr. Jisoo Pae, CEO of Genome & Company, stated, “GEN-001 is the cornerstone therapy in Genome & Company’s immuno-oncology portfolio. We are pleased to collaborate with global oncology leaders, including Merck Group (Darmstadt, Germany) and Pfizer, on a Phase 1/1b clinical trial evaluating the combination of GEN-001 and avelumab. We are also excited about translating the preclinical data of this combination therapy into tangible clinical benefits for patients. We look forward to initiating this clinical trial in the coming months.”

Approved for UseIndications for Avelumab 

In the United States, avelumab (BAVENCIO®) in combination with axitinib has been approved for first-line treatment of patients with advanced renal cell carcinoma.

The U.S. Food and Drug Administration (FDA) has also granted accelerated approval for avelumab (BAVENCIO®) for the treatment of (i) adult and pediatric patients aged 12 years and older with metastatic Merkel cell carcinoma (mMCC), and (ii) patients with locally advanced or metastatic urothelial carcinoma of the bladder (mUC) who have experienced disease progression during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for use in patients across 50 countries worldwide, with the majority of its indications not restricted to specific lines of therapy.

From the U.S. Food and Drug Administration-approved labelingavelumabImportant Safety Information

Warnings and precautions for avelumab (BAVENCIO®) include immune-mediated adverse reactions (such as pneumonitis and hepatitis, including fatal cases), colitis, endocrinopathies, nephritis and renal impairment, and other adverse reactions (which may be serious, including fatal cases), infusion-related reactions, hepatotoxicity, major adverse cardiovascular events (which may be serious, including fatal cases), and embryo-fetal toxicity.

Common adverse reactions (occurring in at least 20% of patients) treated with BAVENCIO® monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, peripheral edema, decreased appetite/vision, urinary tract infections, and rash. Common adverse reactions (occurring in at least 20% of patients) treated with BAVENCIO® in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, muscle spasms, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain, and headache. In patients treated with BAVENCIO® monotherapy, at least 10% experienced Grade 3-4 clinical chemistry and hematological laboratory abnormalities, including hyponatremia, lymphopenia, and increased GGT; in patients treated with BAVENCIO® in combination with axitinib, Grade 3-4 clinical chemistry and hematological laboratory abnormalities included hypertriglyceridemia and increased lipase.

To view the full Prescribing Information and Medication Guide for BAVENCIO®, please visit:www.BAVENCIO.com。