http://www.bioworld.com/content/shenogen-classic-east-meets-west-returnee-story

Shenogen: A Classic East-Meets-West Returnee Story

Modified Time: 2013-11-14  Source: BioWorld

By Shannon Ellis

Staff Writer

Wednesday, November 6, 2013

SHANGHAI – For Shenogen, one of the growing number of innovative drug development companies in China, industry accolades are a welcome acknowledgement of years of hard work.

Shenogen’s estrogen receptor-α36 (ER-α36) platform – which includes a drug candidate for breast cancer in Phase I and another still at the preclinical stage for liver cancer – is the company’s winning achievement.

Venture capitalists have taken note. In August, the company raised $20 million in Series C funding from VCs to initiate Phase IIb trials for its lead drug Icaritin, a small molecule that targets estrogen.

The company also has plans to go public while another $10 million is available to investors as warrants.

The lead investors in this third round were Qiming Venture Partners LLC, of Shanghai, and Legend Capital, of Beijing, which is an affiliate of tech company Lenovo. Other VC partners include China Investment Wealth Venture Fund and Shenzhen Venture, a venture arm of the municipal government. The lead funders from the Series B round also joined in, including IDG Venture and Lapham Group Inc.

The six-year-old company is now in a strong financial position but is getting ready for some growing pains.

In the beginning funding was the biggest challenge – nobody believed in the target, nobody believed in Chinese scientists,” Shenogen’s Senior Vice President and Chief Business Officer Jun Bao told BioWorld Asia. “Now, we are in the position to turn down some investors. The challenge is to really grow up and transition from a drug discovery to a drug development organization.”

Shenogen is a classic example of the East meets West returnee story – one where Chinese-born, Western-educated scientists and managers bring their global professional experience to China to form their own company. But in this case the story goes a step further. The scientific discovery was performed in a modern lab at a U.S. university while the original compound stems from ancient Chinese medical tradition.

Shenogen’s lead project, Icaritin, is known in Traditional Chinese Medicince (TCM) as yingyang huo, a perennial grass whose name translates as “horny goat weed” but is also known as Epimeium or Barrenwort. It is found in the wet and sunny climes of southern China.

Shenogen is interested in its use as a treatment for breast cancer and liver fibrosis, though as the name suggests, it is also known in China for its treatment for male impotence.

Company founders Kun Meng and Charlie Wang were lab mates doing advanced degrees at Washington University when they first met. Both moved on in their careers but kept in touch.

Wang continued his scientific focus and cloned the alpha 36 target at Creighton University, in Omaha, Neb. His work determined that ER-α36 was significant in the estrogen signaling process.

Meng became an executive in a TCM company and found that some compounds had interesting properties in relation to ER-α36.

In 2007, with $100,000 angel investment, they licensed the technology and officially set up Shenogen.

The team has decided to keep the drug’s origins from botanical sources with an eye to go to synthetic manufacturing at a later point. This is in part due to a strategy adopted to stay under the auspices of the Botanical Division of the China Food and Drug Administration (CFDA).

We plan to file the NDA under the botanical class 1 drug guidelines. If successful, it will be the first in a long time,” said Bao.

In the meantime, “we will secure a plantation to make sure the supply is abundant and quality is secure. We have found a subspecies that has a high content of the drug”.

Being an estrogen receptor, Phase I trials were initially conducted on breast cancer patients. Twenty-four women with late stage breast cancer participated in a single dose escalation study.

Interim results were presented at the 2013 American Society of Clinical Oncology meeting. Data demonstrated a favorable safety profile in breast and hepatocellular carcinoma (HCC) patients along with emerging clinical efficacy signals.

Liver cancer is prevalent in China and has fewer treatment options. After talks with the CFDA, a proof of concept for HCC was launched. The Phase Ib trials were conducted with a mixture of patients – 28 breast cancer and 18 HCC patients. Again, efficacy signals were identified.

Patients are now enrolled for the Phase IIb study, a single arm, open label study for both breast and liver cancer. The study is designed to measure time to tumor progression (TTP). The team is hoping to repeat or beat 168 days, the TTP number presented at ASCO. Plans are to enroll 150 advanced first or second line HCC patients.

Shenogen held a Phase II advisory meeting in June at which it agreed the HCC trial will enroll up to 150 HCC patients in China and Taiwan.

Also in Shenogen’s preclinical pipe are a monoclonal antibody (SNG-8023) and another small molecule. Executives declined to reveal indications or status for these two programs.

Bao is keen find the right development partner for Shenogen and to take the company public. Chinese stock exchanges are a tough place for promising drug discovery companies, since they fail a key requirement for listing on the mainland: profitability. Still, the hope is to list on a U.S. stock exchange.

We operate like a U.S. company, just one that is located in China” said Bao.

After years of support from the Chinese government there is also the intention to give back, to continue to improve and bring these gains to the scene here.

The ideal partner would be willing to co-develop Icaritin, “we want to learn how they do it outside of China and we can translate back how to do it better in China and make ourselves truly into a development company.”

2013年11月14日

Shenogen: A Classic East-Meets-West Returnee Story

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