Celldex Therapeutics, Inc. (NASDAQ:CLDX) recently reported that enrollment is ongoing in its Phase I trial of CDX-014. The trial in advanced renal cell carcinoma is designed to know the maximum tolerated dose and to suggest a dose level for further trial. The company anticipates the Phase I dose-escalation portion of the trial will complete registration by year-end 2017.
Celldex considers that the cash/cash equivalents at the close of December 2016 together with the projected proceeds from future sales of their common stock under its Cantor agreement, are adequate to fulfill projected working capital needs and fund planned activities through 2018; however, this projection assumes they elect to compensate future Kolltan dependent milestones, if any, in equity rather than cash.
The Phase 1 trial of CDX-0158, formerly KTN0158, continues to register patients. This dose-escalation trial in subjects with advanced refractory GIST and other KIT-positive tumors is intended to know the maximum tolerated dose, suggest a dose for further trial and illustrate the safety profile of CDX-0158. Report from the trial is anticipated to be released by year-end 2017.
Celldex is currently exploring its plans for advancement of CDX-3379, formerly known as KTN3379, into Phase II trial. Moreover, the Phase II trial of Opdivo and varlilumab continues to register patients across multiple indications, which stands at 18 for colorectal cancer, 54 for ovarian cancer (n=54), 54 for neck and head squamous cell carcinoma, 25 for renal cell carcinoma and 20 in case of glioblastoma.
The Company expects that report from the Phase I trial of Opdivo and varlilumab will be showcased mid-year 2017. It intends to close registration across all cohorts in the Phase II portion of the trial in Q1 2018 and will coordinate with BMS to showcase data from the trial at an upcoming medical meeting.
Provided the movement of varlilumab into a Phase II trial with BMS and efforts to list parts for cost-containment, Celldex has determined not to advance the varlilumab/Sutent® and the varlilumab/Tecentriq® combination trials in renal cell carcinoma to Phase II.
This report is for information purposes only, and is neither a solicitation or recommendation to buy nor an offer to sell securities. Financials Trend is not-a-registered-investment-advisor. Financials Trend is not a broker-dealer. Information, opinions and analysis contained herein are based on sources believed to be reliable, but no representation, expressed or implied, is made as to its accuracy, completeness or correctness. The opinions contained herein reflect our current judgment and are subject to change without notice. Financials Trend accepts no liability for any losses arising from an investor's reliance on the use of this material. Financials Trend sometimes gets compensated up to one hundred and fifty thousand dollars per month for featuring particular stocks. See site disclaimer for complete compensation. Financials Trend and its affiliates or officers currently hold no shares of these stocks. Financials Trend and its affiliates or officers will purchase and sell shares of common stock of these stocks, in the open market at any time without notice. Financials Trend will not update its purchases and sales of these stocks in any future postings on Financials Trend's websites. Certain information included herein is forward-looking within the context of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning manufacturing, marketing, growth, and expansion. The words "may", "would," "will," "expect," "estimate," "anticipate," "believe," "intend," " project," and similar expressions and variations thereof are intended to identify for ward-looking statements. Such forward- looking information involves important risks and uncertainties that could affect actual results and cause them to differ materially from expectations expressed herein. *Financials Trend does not set price targets on securities. Never invest into a stock discussed on this web site or in this email alert unless you can afford to lose your entire investment.