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Friday, June 1, 2018

US-China Xynomic preps broad push for HDAC cancer drug after new financing


U.S.-China biotech Xynomic Pharma has raised additional funding to take an HDAC inhibitor in-licensed last year into seven new cancer trials.
The company hasn’t revealed the amount of the series B financing but says it will be enough to start trials of abexinostat—originally developed by Pharmacyclics—in blood cancers and solid tumors over the next 12 months. It will also fund initial clinical testing of XP-102, a pan-RAF inhibitor licensed from Boehringer Ingelheim in a $502 million deal last November, in colorectal cancer and melanoma.
Four of the seven abexinostat trials will be pivotal studies that could support registration, saysXynomic, including a multicountry study testing the drug as a monotherapy for follicular lymphoma and a similar trial in China. The other pivotal studies include a Chinese trial of abexinostat in diffuse large B-cell lymphoma (DLBCL) and a multicountry combination trial pairing the drug with Novartis’ Votrient (pazopanib) in patients with locally advanced or metastatic renal cell carcinoma.

The other three nonpivotal studies include a phase 1/2 assessment of abexinostat with Johnson & Johnson’s Imbruvica (ibrutinib) in DLBCL and mantle cell lymphoma, a phase 1b trial of the drug alongside Merck & Co.’s Keytruda (pembrolizumab) in multiple solid tumors, and a combination study in estrogen receptor-positive breast cancer.
Xynomic acquired exclusive rights to abexinostat in February 2017, without revealing any financial details or even who it had licensed the drug from. While Pharmacyclics originated the drug, it was initially licensed to French drugmaker Servier, which gave back rights to it in 2014 ahead of Pharmacyclics’ $21 billion takeover by AbbVie the following year.
The HDAC inhibitor class has come under pressure of late after an ASCO abstract for one of the leaders in the category, Syndax’s entinostat, revealed less-than-stellar results in a Keytruda combination trial which spooked investors and led to a dip in the company’s share price.
Meanwhile, Xynomic says it launched a dedicated R&D center in Shanghai last month that will focus on the discovery and early-stage development of small-molecule drugs focused on kinase inhibition, immuno-oncology and epigenetic modification. It’s already working on two candidates, says the biotech, namely XP-103, a TRK/Fra-1 inhibitor, and XP-104, a RET inhibitor.
Northern Light Venture Capital, Zhongshan Bison Healthcare Investment and Hakim Unique Internet Company led the round, with Xynomic’s existing investors—including Prosperico Ventures and the company’s founder and chairman Yinglin Mark Xu—also taking part.

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