CRO

Celgene in Asia-Pacific collab with Antengene, Tigermed as clinical support

Celgene is licensing rights to develop its TORC1/2 inhibitor CC-223 in East and Southeast Asia to Antengene, and CRO Tigermed will help the latter with clinical development.

This marks the first licensing deal for Celgene in the Asia-Pacific region and lays the foundation for a strategic partnership between the two companies, meaning this is not a one-time deal.

Celgene will obtain an equity position in the China-based biotech, in addition to a position on the board of directors, according to a press release put forward by Antengene and shared with FierceBiotech (financial details were not disclosed).

“This is significant to a young company like Antengene, as a sign of confidence in Antengene’s future, and interest in this long-term partnership to bring novel drugs to patients in China more quickly,” Dr. Jay Mei, founder and chairman of Antengene, told FierceBiotech. Mei said the second deal is already under discussion.

Founded in 2016, Antengene will become a partner to Celgene in the Asia-Pacific region, and the two will work together to “address the unmet medical needs for certain diseases disproportionately inflicting Asian patients,” said Mei in the release. “In oncology alone, we will be initially focusing on liver, gastric, esophageal, as well as breast and lung malignancies.”

As for CC-223, it has been tested in a phase 1 trial as a combo therapy with either erlotinib or oral azacitidine for the treatment of advanced non-small cell lung cancer. In another ongoing phase 1 trial, Celgene is testing the med, along with two others, in different combinations with Rituxan for large B-cell lymphoma and follicular lymphoma. It has demonstrated preliminary clinical activities in metastatic hepatocellular carcinoma and in glioblastoma, with a well-characterized pharmacokinetics profile, said Antengene in the release.

To help it advance its clinical projects, Antengene tapped Tigermed, one of the largest China-based CROs, through a strategic collaboration formed in December 2016. Tigermed will provide full clinical service to Antengene’s clinical studies, including CC-223 (ATG-008), in various countries and regions.

The collaborations between Celgene and Antengene and between Antengene and Tigermed are no coincidence. In fact, since 2008 (prior to founding Antengene), Mei was working at Celgene as an executive director in global clinical development. He initiated and led the registration of Celgene’s star product Revlimid in China from its clinical trial application in 2009 to its NDA approval by China’s FDA in January 2013, along with several other clinical trials of the med globally.

Guess who the CRO was behind those Chinese registration trials? None other than Tigermed. It was that successful collaboration with Celgene that turned Tigermed from a relatively small business into one of the major CRO players in China, and saw it go public in August 2012. Both Mei and Tigermed were also involved in MDS drug Vidaza’s foreign drug registration trials in China. The med is currently under NDA review by the CFDA.

Mei is also no stranger to Celgene’s collaboration pattern—equity investment plus board addition—which Celgene has followed in its partnerships with Agios since 2010 and with Juno, formed in 2015.

The team-up with Agios has most recently culminated in an FDA priority review of enasidenib (AG-221) in relapsed or refractory acute myeloid leukemia. That NDA was based on a single-arm phase 1/2 study, which Mei was part of from the Celgene side. Celgene paid $1 billion to reach the 10-year deal with Juno, including paying $93 a share to take up 9.1 million shares of the latter, and added its R&D chief Tom Daniel as a director on Juno’s board.