Glembatumumab Vedotin is the latest stage drug candidate of Celldex Therapeutics, Inc. (NASDAQ:CLDX). It is an ADC that targets glycoprotein NMB, and it is in the METRIC trial in subjects with triple negative breast cancer. The firm mentioned that enrollment closure is anticipated in this September. In November 2016, the company closed the acquisition of Kolltan Pharmaceuticals, a privately held firm, adding more drug candidates.
The details
CDX-0158 is a humanized monoclonal antibody anti-KIT. A Phase I dose escalation trial in people with advanced refractory GIST and other KIT positive tumors released to registration in December 2015. It also bought the TAM plan, an antibody discovery platform to generate antibodies that aim the TAM group of receptor tyrosine kinases, constituted of Tyro3, MerTK and AXL which are shown on dendritic cells, tumor-infiltrating macrophages and some tumors.
Celldex also has other candidates in clinical development. So far, the company has recorded no product revenue and posted an accumulated deficit of $719.5 million as of December 31, 2016. The company needs to raise capital to manage its business. As of close of December 31, cash/equivalents were $189.8 million and, according to the firm, should be enough to support operations through 2018.
The company expected to close enrollment of the Phase IIb METRIC study by late September 2017. It will report data from glembatumumab and varlilumab arm in melanoma in Q4 2017. Data from Phase I of CDX-0158 in subjects with gastrointestinal stromal tumors and KIT+ tumors during the last quarter of this year.
Celldex is undervalued for 3 key reasons. The first reason being Rindopepimut failure, then slow enrollment for METR IC’s and poor results from preliminary study of varlilumab.
In the last trading session, the stock price of Celldex declined more than 1% to close the day at $3.06. The decline came at a share volume of 1.90 million compared to average share volume of 1.51 million.