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Biotech Stock Mailbag: Dynavax, ImmunoCellular, Celldex and Medgenics

Of course, a comparison of data from a single-arm study to historic (read: ancient) results is meaningless nonsense. But it makes for a good headline and comes in handy when someone wants to convince retail investors to buy stock.

Institutional investors aren't fooled so easily. ImmunoCellular's current institutional ownership sits at a miniscule 11%. Retail investors own more than 80%, according to CapitalIQ. That's a bad ownership ratio.

I don't put ImmunoCellular in the same "bio-crap" category as Cel-Sci and Generex because we haven't seen enough data yet to assess ICT-107. We won't have enough data until the ongoing phase II study -- randomized and placebo-controlled -- reports top-line results at the end of the year. The interim analysis expected later this quarter will not tell us enough about ICT-107 to warrant lowered skepticism.

Before final results at the end of the year, be wary of people trying to convince you that ImmunoCellular is the next cancer vaccine blockbuster. They're just guessing, or worse.

PKR19 writes, "What do you make of Celldex Therapeutics (CLDX - Get Report) raising money before telling us about its FDA meeting? It seems positive to me. They'd be crazy to do this and then tell us that FDA won't let them go for the accelerated approval. What do you think?"

Positive, I agree. It's also bit odd for Celldex to tease us with hints about the next steps in the clinical development of CDX-011 in advanced breast cancer, but my educated guess is the company is waiting for the minutes from the FDA meeting and sign-off on the pivotal trial design before full disclosure.

This is what Celldex said about CDX-011 in the prospectus filed with the SEC on Feb. 4:

In December 2012, we had our end of Phase 2b meeting with the 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.

A CDX-011 pivotal study "suitable for accelerated approval" means a primary endpoint of overall response rate (ORR) or progression-free survival (PFS) and not overall survival. That's important because an ORR or PFS trial can be completed faster. Again, my guess is FDA will ask for a PFS primary endpoint. Response rate and overall survival will be key secondary endpoints.

I'm also going to assume FDA wants Celldex to include a control arm in the CDX-011 pivotal study. The control arm will likely be offered treatment with doctor's best choice of alternative therapies, or perhaps best supportive care.

Celldex has already said it wants the pivotal study to enroll women with heavily pre-treated, triple-negative breast cancer over-expressing the GPNMB protein that serves as the honing target for CDX-011.
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