Genome & Company announces a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer

-- Clinical partnership of phase 1/1b combination clinical trial with Genome & Company's GEN-001, microbiome-based immuno-oncology therapy, and avelumab (BAVENCIO®), Merck KGaA, Darmstadt, Germany and Pfizer Inc.'s anti-PD-L1 antibody in oncology indications --

SEOUL, South Korea I January 13, 2020 I 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, 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, Darmstadt, Germany and Pfizer will supply avelumab for the phase 1/1b clinical trial that is expected to be commenced in 2020 in the U.S. Both parties will have access to the clinical data.

The combination trial is designed to be a first-in-human (FIH) study including dose escalation and expansion cohorts to evaluate the safety and preliminary efficacy.

"GEN-001 has been developed as the backbone of Genome & Company's immuno-oncology pipeline, and we are delighted to collaborate with the global leaders in oncology such as Merck KGaA, Darmstadt, Germany and Pfizer on this phase 1/1b clinical trial for this combination of GEN-001 and avelumab. We are excited to investigate how the preclinical data of this combination will be translated to humans. We look forward to initiating this clinical trial in the coming months," said Dr. Jisoo Pae, CEO of Genome & Company.

Avelumab Approved Indications

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

The US Food and Drug Administration (FDA) also granted accelerated approval for avelumab (BAVENCIO®) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) 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. 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 patients with in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

About GEN-001

GEN-001 is an oral microbiome therapeutic candidate developed to have immune modulating activities, resulting in potential partnership with immune checkpoint inhibitors. GEN-001 consists a single strain bacteria isolated from gut of healthy human volunteers that has been shown to activate dendritic cells, macrophages and T cell response. In preclinical studies, GEN-001 has shown optimal safety margin and synergistic effects in combination with immune checkpoint inhibitors by enhancing the effect of suppressing the growth of both immune checkpoint inhibitor sensitive and resistant tumor models.

About Genome & Company

Genome & Company is a clinical-stage biotechnology company based in Seongnam, Republic of Korea that focuses on discovering and developing the next waves of innovative therapeutics in immuno-oncology through diverse modalities of microbiome, novel target immune checkpoint inhibitors and fusion proteins to fulfill the unmet needs of cancer patients.

BAVENCIO® is a trademark of Merck KGaA, Darmstadt, Germany.

SOURCE: Genome & Company

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