[INTERVIEW] 'Microbiome to be game changer in immunotherapy'

Genome & Company CEO Pae Ji-soo speaks during an interview with The Korea Times at the newspaper's newsroom in Jung-gu, Seoul, Jan. 25. Korea Times photo by Kim Kang-min

Genome & Company CEO pursues microbiome healthcare group

By Nam Hyun-woo

One of the most rapidly growing sectors in the biopharmaceutical industry is microbiome medicine. Big name tycoons including Bill Gates and Mark Zuckerberg have already noticed the potential of microbiomes and either invested or donated money to businesses and research in this field, which is quickly evolving into a new money magnet.

This is also the case of Genome & Company, a Korea-based microbiome biotech focusing on immuno-oncology drugs to treat cancers. In December last year, Genome & Company made its transfer to Korea's tech-heavy Kosdaq from the KONEX, the country's third bourse for startups and venture companies preparing to list on the junior bourse. In its Kosdaq debut trading session Dec. 23, the company's market cap reached 1.14 trillion won ($1 billion), which was the 44th-largest on the market.

Pae Ji-soo, a medical doctor and CEO of Genome & Company, says many investors are paying attention to microbiomes because they are anticipated to change the landscape of the healthcare industry in the next decade, highlighted by side-effect free and personalized medicine.

"One of the best advantages of microbiome medicine is that it has no side effects, because it is based on bacteria already living in the human body. So it can be used in combination with other cancer drugs." Pae said during an interview with The Korea Times. "With this technology, maybe in the next 10 years, we will be able to find personalized cancer treatments, and cancer will no longer be a severe disease."

Make your immune system work

Microbiome refers to the community of microbes, such as bacteria, living in the human body. The recent progress in DNA sequencing technologies has found that microbiomes have a huge impact on determining whether people develop various diseases and enabled scientists to find out which bacteria are beneficial and can be developed into treatments.

Genome & Company is focusing on three specific diseases ― cancer, skin disease and central nervous system disorders such as autism ― and garnering the most attention is the microbiome-based immuno-oncology drug candidate, codenamed GEN-001.

The human immune system is designed to attack tumor cells. To counter this, tumor cells have an arm (checkpoint) called PD-L1 which connects to PD-1, which is the arm of immune cells like T-cells, which then signal the immune cell to forget its role. Immuno-oncology drugs use antibodies to block the connection, so the immune cell can do its job and attack the cancer cells.

Pae said the company has learned that the efficacy of such drugs, called immune checkpoint inhibitors, are affected by the condition of a cancer patient's gut microbiomes, and the bacteria used for GEN-001 enhances the efficacy of such drugs, as well as its own efficacy to vitalize the immune system.

In December, Genome & Company signed a clinical trial collaboration and supply agreement with Merck and Pfizer. Following the agreement, Merck and Pfizer have been supplying their jointly-developed anti-PD-L1 Bavencio, worth 10 billion won, for GEN-001's Phase 1 and 1b clinical trials in the U.S., as well as accessing the trial data.

"Most of clinical phase 1 studies are targeting normal people. But GEN-001 is a cancer treatment, so we have enrolled cancer patients for the Phase 1 study," Pae said. "When the study progresses, we believe we can obtain much more meaningful data from the patients."

Recognizing the potential of GEN-001, LG Chem, one of the major pharmaceutical companies in Korea, signed a license-out deal with Genome & Company in December, allowing the LG Group unit to have commercial rights to GEN-001 in Korea, China and Japan.

"There are many companies attempting to combine immuno-oncology drugs. Since both drugs have side effects, however, combining them may result in unexpected side effects," Pae said. "The main advantage of a microbiome-based drug is that it has no side effects, because the bacteria already lives in the human body. So it can be used in combination with other cancer drugs."

A researcher in research at Genome & Company's lab in Seongnam, Gyeonggi Province, Feb. 4. Korea Times photo by Kim Kang-min

Prospective market

Despite the advantages of microbiomes, less than 30 biotechnology firms have made it into clinical stage trial of their treatments, because microbiome medicine is still in its infancy, with Pae saying less than 10 years have passed since companies began full-fledged research.

But he stressed that the microbiome industry is growing at a daunting speed.

"When I attended an international conference on microbiomes five years ago, the discussion was so preliminary, such as how we can get patients and what government regulations would look like," Pae said. "The discussions made huge progress when I attended the conference three years ago, such as how we can achieve contract development and manufacturing and now we are talking about clinical studies."

According to a 2017 research by MarketsandMarkets, the global microbiome treatment market will grow 21.9 percent annually to reach $649 million in 2023.

"At the current stage, only 20 out of 100 patients are effective in immunotherapy, meaning there are unmet needs from 80 patients," Pae said. "So there is lots of potential and possibilities to develop other immunotherapies."

Evolving into healthcare group

Another aspect of Genome & Company's pipeline drawing attention are novel target immune checkpoint inhibitors, meaning drugs targeting checkpoints other than PD-L1. Pae said the company's GENA-104 and GENA-105 candidates each have different targets and are expected to have efficacy in various types of cancer, including breast, prostate and skin cancers.

He said the company held discussions with one of the "very promising global big pharmaceuticals in Europe" over novel target immune checkpoint inhibitors during last month's J.P. Morgan Health Care Conference, and he hopes to sign a license-out deal within a year or two.

Buoyed by the rosy outlook, Pae said he has a lot of strategies to expand the company's business models, and eventually build a healthcare conglomerate which covers development, manufacturing and sales.

"Now we are in talks with a well-known CDMO (contract development and manufacturing organization). We think we will be able to sign a deal to acquire some of the CDMO facilities in the near future … maybe later this year," he said, without elaborating on the CDMO's identity.

"Last October, we acquired U.S.-based microbiome company Scioto Biosciences. With that company, we obtained promising pipeline treatments which target autism. I think we can make a blockbuster drug from that," he said. "We also plan to use this company as our basecamp in the U.S., so we can expand our network in the country."