HONG KONG – Shanghai-based Carsgen Therapeutics Ltd. closed a $30 million series B financing and now aims to push more of its products to clinical trials at home and abroad. Carsgen plans to complete phase I studies of the two therapeutics, CSG-EGFR and CSG-GPC3 by the end of 2016. The drugs are being developed to treat brain, lung and liver cancers. The primary market is China.

The new funding may have provided Carsgen with more possibilities for clinical studies, but the main challenge ahead is the lack of cell therapy regulations in China, whereas the U.S. has long used biologic license application for the technology.

"We have tried to launch the conversation with the CFDA and there has no clear response yet [since the company] is seeking guidelines from the CFDA and there’s no specific rule to comply with yet," He Sunwei, director of business development at Carsgen, told BioWorld Today. "We hope that we can get it through as soon as possible."

At the same time, the Chinese biotech is also looking at opportunities overseas.

"We would like to start the preparation work in the U.S., including liaison with contract manufacturing organizations and clinical organizations," said He. "We expect to bring in at least 30 cases for clinical trial. But it might take one year or even longer for us to reach that stage in the U.S."

The company aims to finish the preclinical studies and file investigational new drug applications to the FDA by the second quarter of 2017.

This round of financing involves quite a number of major Asian venture capital firms, including Korea-based KTB Ventures and China-based Jolly Pharma-backed Jolly Innovation Ventures, which have a very specific focus on novel pharmaceutical products. Kaitai Capital and JIC Genesis Fountain Healthcare Ventures also participated in the investment.

"We are trying to help Carsgen to obtain the U.S. FDA and CFDA approval. Maybe in the future we can sell our products to Korea and to other Western countries," said Amy Yeh, executive director of KTB Ventures. "I believe that Carsgen has very competitive and advanced solutions for their cancer treatment compared to other Chinese pharmaceutical start-ups.

"The first round of funding bridged us from animal testing to human clinical trials, which is a huge progress and the second round of financing, which is much larger, will help us go abroad," said He. "All of our existing investors are from Asia. To support our global expansion, we will look for investors with not only money, but also international presence in the future."

In November 2014, the company successfully closed an investment from a local science-focused private equity fund BVCF. The amount was not disclosed.

Last year, the company inked a partnership with Shanghai Cancer Institute to initiate for a five-year research program to develop novel CAR-T candidates as well as next-generation CAR-T technologies.

It also partnered with Shanghai Renji Hospital to initiate a phase I study for its therapeutic KJgpc3-001 that genetically modifies T cells to express a chimeric antigen receptor (CAR) for glypican-3 (GPC3) to attack liver cancer cells.

"[Liver Cancer] is the fifth most common cancer and the third most common cause of cancer mortality worldwide," said Zonghai Li, president and CEO of Carsgen. "The vast majority of liver cancer patients live in China and unfortunately, it remains underdiagnosed and inadequately treated, with a very high rate of death within the first five years of diagnosis."

There are currently eight more candidates other than anti-EGFR and anti-GPC3 in the company's pipeline, some are expected to enter clinical trials this year.

"We will push to advance all other products with this round of funding and hopefully see more of them enter clinical studies soon," said He.

Under terms of the agreement, KTB's investment director in Shanghai, Chi Hoon Hyun, will join the board of the start-up.