In December 2012, we had our end of Phase 2b meeting with the United States Federal Drug Administration, or FDA, for our CDX-011 program, which we have characterized as positive. Based on this meeting, we intend to initiate a CDX-011 study suitable for accelerated approval in the second half of 2013. We are currently finalizing the clinical trial design and will update investors on our plans for the accelerated approval trial on our year-end 2012 call in early March 2013. Also in December 2012, we announced final results, as shown below, from the EMERGE study which suggested that CDX-011 induces significant response rates compared to currently available therapies in patient subsets with advanced, refractory breast cancers with high glycoprotein NMB, referred to as GPNMB, expression (expression in greater than 25% of tumor cells) and in patients with triple negative breast cancer. The overall survival and progression free survival of patients treated with CDX-011 was also observed to be greatest in patients with triple negative breast cancer who also highly express GPNMB and all patients with high GPNMB expression.
The data is the same like the one we've already seen from the report last year.
I think CLDX is doing the right things at the right time here, given the early results of their CDX-011 study.
Here is what makes sense to me:
1) Trying to pursue Accelerated Approval which is the quickest and least costly way to get this particular product to market ( that is, of course, if the drug "works" )....and having careful input and guidance, prior to final study design, from the FDA.
2) Trying to seek equity funding, to help finance a potentially pivotal registrational study rather than partnering right now from a position of relative weakness and relinquish a large measure of future control of the product.
The fact that a partner was not announced presently, has no bearing in my investment thesis at this time. Even if the company was approached, I feel that equity financing is a much better strategy selection at this juncture.
Frankly, it all comes down to whether this drug "works". I am "reasonably" confident that, in a properly designed larger study, the drug will "likely" show benefit in GPNMB highly positive ( 25% or greater ) and triple neg breast cancer patients. It would be nice if they could also show benefit in larger subsets of triple neg disease as well.
I personally rate CLDX a hold and have a significant position in the shares......although not nearly as large as my SGEN long term position.
The above is only my PERSONAL opinion. Do NOT take it to the bank. Each investor must make the decision on whether to buy, sell or hold by themselves. Investing in early stage biotech involves considerable risk. Caveat emptor !!