Genome & Company (CEO Bae Ji-soo and Park Han-soo), a global company specializing in immuno-anticancer drugs, will begin full-scale phase 2 clinical trials for its anti-cancer immunotherapy microbiome treatment, starting with approval from the Ministry of Food and Drug Safety (MFDS) on the 8th.
This clinical trial (Study 201) is for Bavencio® (ingredient name: Avelumab, hereinafter referred to as Bavencio) in patients with PD-(L)1 positive advanced gastric cancer or gastroesophageal junction adenoma cancer who have not received immunotherapy. This is a test to confirm the safety and effectiveness of the combination therapy of ) and ‘GEN-001’. It will be conducted based on the ‘GEN-001’ dosage (recommended phase 2 clinical dose (RP2D)) that will be confirmed in the existing phase 1/1b clinical trial (NCT04601402, Study 101).
The driving force behind the rapid progress of clinical trials is Genome & Company’s establishment of its own ‘new drug development approval roadmap’. This clinical trial was conducted at more than four leading research collaboration hospitals in Korea, and Study 101 and Study 201 were conducted simultaneously to maximize the efficiency of the clinical process and minimize unnecessary gaps. In addition, in March of this year, we signed a second joint development agreement (CTCSA) with Merck KGaA, Darmstadt, Germany and Pfizer, solidifying our partnership with the company and developing Bavencio® required for ‘Study 201’. It will also be supplied free of charge.
Bae Ji-su, CEO of Genome & Company, said, “Genome & Company’s microbiome clinical research is progressing smoothly. “We will solidify our position as a global leader in the microbiome industry by steadily strengthening our pipeline and expanding indications,” he said.
Meanwhile, most of the previously released anti-cancer immunotherapies are PD-(L)1-targeted treatments and have been in the spotlight for their excellent therapeutic efficacy. However, they show anti-cancer effects in only about 20% of patients, so there is a need for treatment alternatives for patients who do not respond to immunotherapy anti-cancer drugs. Genome & Company’s anti-cancer immunotherapy microbiome treatment ‘GEN-001’ is a clinical trial 1 candidate for oral microbiome treatment based on a single strain of Lactococcus lactis isolated and identified from healthy people. /In Phase 1b, it has been recognized for its safety and tolerability of its immuno-anti-cancer efficacy through activating the immune system of cancer patients, and is attracting attention as a treatment alternative for patients refractory to existing immuno-anti-cancer drugs.
Source: Pangyo Techno Valley Official Newsroom
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