After Celldex’s (CLDX) flubbed pre-ASCO abstract release led investors to question interim Phase II trial data for its cancer vaccine CDX-110 (PF-04948568) (also with the generic name Rindopepimut), they made sure to get things straight at ASCO. As a reminder, the abstract stated 70% of patients on drug were alive and progression free at 5.5 months. This stood in sharp contrast to previously presented data of ~95% alive and progression free at 6 months. Celldex tried to assure investors the numbers were equivalent, but questions remained.
On June 5 at ASCO, Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics, declared, "70 percent of ACT III patients were progression-free at 5.5 months after initiating treatment with rindopepimut, which corresponds to the 8.5 months seen in ACT II and ACTIVATE when measured from diagnosis and surgery. The earlier ACTIVATE and ACT II trials reported progression free rates at 8.5 months of 70 and 80 percent, respectively.”
It is unlikely this clarification will move CLDX’s stock price as there were no surprises in the actual results. Investors have had weeks to digest the initial data and no doubt understand the reasons for the discrepancies now. The next move will likely be information on initiation of Phase III trials once those decisions have been finalized between Celldex, Pfizer (PFE), and the FDA.
One should not count on CDX-110 to bring in huge revenues. With only 10,000 new GBM cases per year, and 30% with the EGFRvIII mutation, the market only consists of 3000 patients. CDX-110 will be no blockbuster. Dendreon (DNDN) has set the bar for a cancer immunotherapy, pricing Provenge at $93,000. Given the data seen to date, CDX-110 should easily get that or more. Assuming $100,000/yr will still only bring in $300 Million. There is likely to be off-label use for other EGFRvIII positive cancers and each patient may be on CDX-110 for over a year, so the gross may be somewhat higher.
A product that holds a great deal of promise for Celldex is CDX-011, their Antibody-Drug-Conjugate directed toward glycoprotein NMB (GPNMB). This drug has shown very good results in advanced breast cancer patients in a small Phase I/II study, especially those with expression of GPNMB. For all patients treated at the highest dose, mean Progression Free Survival of 9.1 weeks was reached.
For the subset of patients expressing high levels of GPNMB, PFS was increased markedly to 17.3 weeks.
Celldex has now developed a new diagnostic test for detection of GPNMB for use in their planned Phase IIb trial. This will be a controlled, randomized, multicenter trial enrolling 120 patients. If successful, it would seem this trial could form the basis of an NDA filing.
In the near future, there should be pivotal trials ongoing for two Celldex drugs. One, CDX-110, has been licensed to Pfizer. The second, CDX-011, is still wholly owned by Celldex. Investors should start to focus on the latter.
Disclosure: Long CLDX
Source: Celldex Sets It Straight at ASCO