Genome & Company Enters Second Clinical Collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer to Advance Immuno-Oncology Microbiome Therapy GEN-001

SEOUL, South Korea, March 9, 2021 /PRNewswire/ -- Genome & Company (KOSDAQ Code: 314130), a global leader in the development of microbiome-based anticancer therapeutics, has signed a second clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany, and Pfizer to develop the world’s first immuno-oncology microbiome therapeutic. This renewed partnership among the three companies comes just one year after they initially entered into a collaboration and supply agreement in December 2019 to conduct the first clinical trial combining avelumab (BAVENCIO®) and GEN-001 (NCT04601402, the “101 Study”).

Pursuant to the recently executed Clinical Trial Collaboration and Supply Agreement, the objective of the clinical trial (the “Study 201”) is to evaluate the efficacy and safety of combination therapy with GEN-001 and avelumab for gastroesophageal junction cancer and gastric cancer, which have long posed significant treatment challenges. The trial will be conducted simultaneously at more than six hospitals and medical centers in South Korea.

Genome & Company will conduct a Phase 2a clinical trial using the recommended Phase 2 dose (RP2D) of GEN-001 in combination with avelumab to evaluate the efficacy and safety of the GEN-001 and avelumab regimen. Merck KGaA, Darmstadt, Germany, and Pfizer will provide avelumab for the new “Study 201” clinical trial led by Genome & Company. The expansion of the clinical collaboration between Genome & Company and Merck KGaA, Darmstadt, Germany, and Pfizer marks a significant milestone in the field of tumor immunotherapy.First timeTwo institutions have engaged in two consecutive rounds of clinical development collaboration.

Genome & Company, in collaboration with experts, developed GEN-001 through an effective clinical development roadmap. The company led the clinical trials in a systematic manner, launching Phase II studies immediately after the completion of Phase I. Genome & Company also obtained approval for new drug clinical trials from the U.S. Food and Drug Administration (FDA) and the Ministry of Food and Drug Safety (MFDS) of South Korea, covering various patient populations and tumor types.

Dr. Jisoo Pae, CEO of Genome & Company, stated, “The signing of the second clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany, and Pfizer underscores our exceptional R&D capabilities and represents an achievement built upon the clinical collaboration established during the 101 study. We can leverage immuno-oncology microbiome therapeutics to become a leader in the field of oncology, particularly by securing a dominant position in the Asian market.”

Under the agreement, Genome & Company will fund two studies, while Merck Group in Darmstadt, Germany, and Pfizer will provide avelumab for Study 101 and Study 201. All three collaborating parties will have access to the clinical data.

AboutGenome & Company

Since its establishment in 2015, Genome & Company has been developing a new wave of innovative immuno-oncology therapies through anti-cancer microbial drugs and novel targeted immune checkpoint inhibitors. Following the acquisition of the U.S. biotechnology company Scioto Biosciences in August 2020, the company expanded its global microbiome product portfolio into the field of brain diseases, consistently leading the market and evolving into a global microbiome healthcare group with integrated R&D and manufacturing capabilities. For more information, please visit our official website:http://www.genomecom.co.kr.

AboutGEN-001

GEN-001 is an oral microbiome-based therapeutic candidate designed to exhibit immunomodulatory activity, thereby offering potential synergy with immune checkpoint inhibitors. GEN-001 comprises a single bacterial strain isolated from the intestines of healthy human volunteers, which has been demonstrated to activate dendritic cell, macrophage, and T-cell responses. In preclinical studies, GEN-001 demonstrated optimal safety and synergistic effects when combined with immune checkpoint inhibitors, enhancing efficacy in suppressing tumor growth in both sensitive and resistant models. Phase 1/1b clinical trials are currently underway in the United States and South Korea.

Approved for UseavelumabIndications

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

In the United States, avelumab in combination with axitinib is 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 adult and pediatric patients aged 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 for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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

avelumab（BAVENCIO^®) Warnings and precautions include immune-mediated adverse reactions (such as fatal cases of pneumonitis and hepatitis, colitis, endocrinopathies, nephritis and renal impairment, and other serious or potentially fatal adverse reactions), infusion-related reactions, hepatotoxicity associated with avelumab in combination with axitinib, serious or potentially fatal cardiovascular adverse events, and embryo-fetal toxicity.

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

For complete prescribing information and medication guidelines for BAVENCIO, please visit:http://www.BAVENCIO.com.

BAVENCIO® is a trademark of Merck Group, Darmstadt, Germany