Genome & Company, which led the development of microbiome drugs in Korea, has revised its drug development strategy to antibody-drug conjugates (ADCs) after struggling to produce significant business results, including technology transfer.

The company plans to complete the phase 2 clinical trials of its existing microbiome pipeline by the end of the year and will not pursue additional microbiome drug development.

In the future, Genome & Company plans to strengthen ADC drug development by discovering new target antibodies. The company has just started ADC drug development, so it is taking a technology transfer strategy through early research rather than clinical development. For this reason, early research personnel are the core of the company rather than clinical development.

GEN-001, phase 2 study in gastric cancer, will report results by year-end

Genome & Company has been focused on clinical development of GEN-001 since its inception. It has conducted clinical trials in combination with PD-(L)1 immune checkpoint inhibitors in gastric and biliary cancers. However, in March of this year, it terminated the Keytruda (pembrolizumab) combination trial in biliary tract cancer early.

The only ongoing clinical trial is in gastric cancer in combination with Bavencio (avelumab). This trial will receive a Clinical Study Report (CSR) later this year. Once that trial is completed, the company says it will wrap up the microbiome drug.

Gastric cancer is currently treated with chemotherapy as the standard of care, with immune checkpoint inhibitors Opdivo (nivolumab) and Keytruda and ADCs, including Enhertu (trastuzumab deruxtecan), being prescribed depending on HER2 expression.

Bavencio is expanding indications into cancers where existing immune checkpoint inhibitors such as Keytruda and Opdivo have limited effectiveness, including metastatic Merkel cell carcinoma and bladder cancer. The technology transfer will be determined by the clinical effectiveness of the combination of GEN-001 and Bavencio compared to Opdivo, which is already prescribed for gastric cancer.

"We expect to receive the CSR for the GEN-001 gastric cancer phase 2 results within the year and will proceed with the technology transfer based on the results," a company official said. "We do not plan to conduct additional microbiome studies and will focus on ADC development."

Focusing on new ADC drug discovery by expanding clinical workforce

After focusing on microbiome clinical development, Genome & Company is shifting its initial focus to ADCs using novel targeted antibodies. This strategy was materialized last year. In June last year, the company signed a technology transfer agreement for GENA-111 with Swiss company Debiopharm.

"Our goal is to repeatedly discover new ADC antibodies for new targets over the next two to three years and achieve technology transfer at the preclinical stage," Genome & Company CEO Hong Yoo-seok said at a press conference in June last year. "This will increase the likelihood of commercialization without additional investment in the clinical stage."

As Genome & Company focuses on early ADC development in microbiome clinical trials, the R&D staff has changed. Vice President Park Kyung-mi, who led the overall clinical development, left the company last year, and Executive Vice President Cha Mi-young took over the new drug development. Cha leads the drug discovery lab and has experience in drug research at Hanmi Pharmaceutical and Platbio (now Kolon Pharma).

Along with Cha, Yoo Hyun-kyung, who joined the company in 2020, leads pharmacotoxicity research and oversees ADC research. Yoo also focused on drug development at Hanmi Pharmaceutical and Platbio.

As Genome & Company shifts its research direction to ADCs, the number of people in the drug research center is increasing compared to the microbiome research center. As of 2021, the microbiome lab had 19 employees, which dropped to 13 this year.

In contrast, as of the first quarter of this year, drug discovery labs had 25 researchers, making them larger organizations than microbiome labs.