Genexine is transforming itself from “Korea, Inc.” to “Global, Inc.” as its developed-in-Korea products expand into global markets.
This change in outlook has largely occurred during the past year. H. Michael Keyoung, MD, PhD, Genexine’s new president and CEO, has significant experience and established networks in the West. He left Genexine’s board of directors to become CEO in summer 2015. Since then, the executive team has welcomed the addition of others who also have global experience.
H. Michael Keyoung, Genexine
“We have six assets in Phase II trials this year in Europe and Asia,” Keyoung said. Trials are expected to begin in the US later in 2016/early 2017. He says he is looking forward to adding more European and American partners to the group of largely Asian companies with which Genexine currently works.
“Disease has no boundaries. The drugs we’re developing benefit patients beyond local Asian markets.”
One of Genexine’s leading development programs dramatically extends the life of drugs after administration, making it possible to replace daily injections with weekly, bi-monthly or monthly injections.
Genexine’s hybrid Fc platform, dubbed HyFc, fuses IgG4 and IgD to active pharmaceutical ingredients. “We can tweak the platform to support delivery weekly, every two weeks or as long as once monthly,” Keyoung said.
“It has been tested in hundreds of patients and shown no immunogenicity or other safety concerns. Other longer-acting technologies are out there, but ours seems longer-acting than most and is safe. That’s a key differentiation.”
Three drugs using the HyFc technology are in the clinic already. “Our lead asset is a long-acting growth hormone, currently in Phase II trials in Europe and Korea,” Keyoung said. Growth hormones are well-understood scientifically, off patent and generate about USD 4 billion in annual sales as generic biologics. “The standard of care still requires daily injections,” he said.
“Children needing growth hormones would require 1,400 injections in a four-year treatment period. But, if injections could be reduced to one every one or two weeks, injections could be decreased by 7- to 14-fold.”
Phase I data from healthy adult volunteers and partial Phase II data from adults with growth hormone deficiencies were presented at the Endocrinology Society meeting in Boston, just before the BIO-Europe Spring® conference in Stockholm. “We hope to show we have a weekly and semimonthly drug.”
Genexine is looking for a global or regional partner to help with Phase III trials or as a commercial partner. Ideally, the partner will have expertise in the growth hormone market and may currently sell a first-generation growth hormone. “This is a sizeable market for an orphan indication, but a huge commercial team isn’t necessary,” Keyoung said.
The company also is looking for an early development partner for a novel PDL1 agonist fused to HyFc platform. Genexine has two proof of concept in animals with this novel long-acting immunomodulator to target inflammatory bowel diseases and psoriasis. Genexine is also considering to target lupus, rheumatoid arthritis and other autoimmune diseases. “We expect this novel PD-L1 agonist to enter the clinic in 2017,” Keyoung said.
Immunotherpy is another important development platform. Genexine’s nearly 20-year history of vaccine development provides the foundation to develop therapeutic DNA vaccines.
Gx-188E, for example, targets cervical dysplasia and also HPV-associated cancers in men and women, and is efficacious in lupus, rheumatoid arthritis and other autoimmune diseases. Phase II data is expected this spring from a Korean study, followed by data from Europe in 1H 2017. “We’re looking for partnerships related to HPV-associated high-grade cervical dysplasia,” he said.
Funding despite financial downturn
“During the past four years, biotech companies throughout the world have received a lot of venture capital and public equities funding. Biotech companies are maturing, and there’s broad attention to the technology and the clinical data coming from these companies. Biotech is elevated in investors’ eyes with recent financial and clinical successes,” he said. Therefore, the financial corrections of the past year, which began in Asia last summer and echoed around the world, have had little effect on the ability of most biotech companies to raise capital.
The combination of maturing companies, innovative technology and promising clinical data drives valuation and attracts the capital these companies need to move forward. “So,” Keyoung said, “post recent market correction, funding should continue to innovative companies, and VCs and public investors can get great returns.
“In China, Taiwan and Korea, there’s substantial support for non-dilutive grants as well as government policies to foster development and commercialization of biopharmaceuticals. This is especially true for biologicals,” Keyoung said.
Last summer, for example, China introduced new policies to speed development and commercialization. “We’re taking advantage of those opportunities with really good Chinese partners,” Keyoung said.
As examples, he cites ventures with Fosun Pharma, one of China’s top five pharmaceutical companies, which was announced in February, and with Tasly, one of China’s top 15 pharmaceutical companies, which was announced last October. Genexine also has a joint venture with Simcere, another leading Chinese pharmaceutical company.
“Korean biotech companies are at an inflection point,” Keyoung said. “We’re getting clinical data from Phase Ib and Phase II trials. Homegrown assets and technology are resulting in meaningful data that’s partnerable.”
Last year’s deals between Eli Lilly and Hanmi Pharmaceutical Co., Ltd., and between Sanofi and Hanmi are two examples. “Korean biotech will become more of a focus in other companies,” Keyoung predicted.
There’s a strong case for clinical trials to be conducted in Korea, Keyoung said. “Those who conduct clinical trials here will vouch for the expertise of Korean clinicians.” Many have Western or comparable training. Keyoung himself is a Howard Hughes Medical Institute Research fellow who did his biomedical fellowship at Memorial Sloan Kettering Institute and Rockefeller University.
He’s far from alone. “Many oncologists in Korea are comparable to those at Sloan Kettering and MD Anderson cancer centers,” he said. Korean clinicians also see a lot of infectious disease patients, particularly hepatitis B, making the country a reliable place to recruit cancer and hepatitis B patients for trials.
With this combination of physician expertise and patient accessibility, “companies can conduct proof of concept trials here as well as Phase I, II and III. Because of the harmonization between the FDA and Korea’s Ministry of Food and Drug Safety (MFDS), researchers who conduct Phase I trials in Korea can go straight to Phase II trials in the US,” Keyoung said. “We’ve taken advantage of that, and so have a lot of our peers.”
Keyoung touts Korea as “a great place to invest. There are really good clinical assets here that should start getting us on the map. In that regard, we’re ahead of China.”
China, he said, needs innovative drugs and partners to help bring those innovations to the market. “Chinese scientists are great at small molecules,” but they are behind in biologics work, he explained.
“For the next five years, the trend will be for China to buy assets.” During the 5 to 10 years after that, as its preclinical assets enter the clinic, China will become a force to be reckoned with. “At that point, we’ll see innovation coming out of China,” Keyoung said, and global companies will begin buying Chinese assets.
“It’s important to do deals in China as part of drug development, and non-Chinese can forge lucrative deals there,” Keyoung said. Genexine has several ventures in China, “and I’d love to do additional China deals. I’m eager to answer questions to help others do deals there, too.”
Keyoung shared his expertise on partnering and fundraising in China as part of a panel discussion at BIO-Europe Spring 2016, April 4–6, in Stockholm, and is looking forward to attending ChinaBio® Partnering Forum May 18–19 in Suzhou, China.