Predictions about development-stage biotechs are about as reliable as politicians' campaign promises. In spite of this unfortunate reality, there are a few predictions that I think have a good likelihood to come true for Celldex Therapeutics(CLDX 8.11%) in 2016. Here are three developments that seem probable for the small biotech over the next 12 months.
1. Successful next ACT for Rintega
Celldex shareholders are most excited about the potential for cancer-fighting Rintega. The immunotherapy targets cells that express EGFRvIII, a mutation of the epidermal growth factor receptor protein. Rintega successfully completed three different phase 2 clinical studies focusing on treatment of EGFRvIII-positive glioblastoma. Investors hoped that those studies would be enough for Celldex to file for regulatory approval, but the FDA wanted a phase 3 study of Rintega.
The first interim analysis from that phase 3 study, called ACT IV, wrapped up in June 2015. After this initial review, Celldex needed to wait until enough events occurred (which, sadly, were patient deaths). Early this year, the biotech will complete the second interim analysis.
Rintega's most important results, though, won't be available until after November 2016. That's when the final data collection for the study is expected to be completed. I predict the ACT IV study will be a rousing success for Celldex.
2. Varli good news
While Rintega is the crown jewel for Celldex for now, the company claims several other promising drugs in its pipeline. One of those in particular -- varlilumab (also known as varli) -- should generate some good news in 2016.
Celldex partnered with Roche (RHHBY 2.34%) in March 2015 to study varli in combination with Roche's atezolizumab. Like varli, atezolizumab is a developmental-stage monoclonal antibody. The phase 1/2 study of the two drugs in treating kidney cancer kicked off in December. Roche didn't contribute to the funding of this study, so Celldex is footing the bill on its own.
Bristol-Myers Squibb (BMY 1.49%), however, did pony up $5 million in 2014 and is splitting the costs for another varli study. The two companies are conducting a phase 1/2 study of varli in combination with Bristol's nivolumab. That clinical trial started early last year and covers multiple tumor types.
Neither of the studies involving the Roche and Bristol-Myers Squibb drugs will finish until the end of 2017. However, Celldex expects multiple data readouts from the various varli studies in 2016.
3. Continued roller coaster ride
Last year, Celldex shareholders probably felt like they were on a roller coaster. Shares of the biotech started out 2015 with a bang, soaring by more than 70% by April. However, Celldex's stock was down over 30% for the year by October. Shares closed out 2015 down nearly 15%.
I fully expect that in 2016 the roller coaster ride will continue. The stock dropped nearly 15% in just the first week of January. It could fall more if the overall market tumbles further. However, I think the stock could easily end the year with nice gains -- particularly if there is good news from Rintega.
Predictions come with an asterisk
As you might guess, my take on Celldex's long-term prospects is positive. If I'm right about the chances for Rintega doing well in phase 3, the biotech should be able to win FDA approval in 2017. I also am generally bullish on Celldex's pipeline, including varli and antibody-drug conjugate glembatumumab vedotin (glemba).
But it is entirely possible that things might not play out as nicely as I think they will. Celldex could probably weather some disappointing news from varli or glemba, but if Rintega flops it would be a disaster. In that case, my predictions (at least the first two) will turn out to be like many politicians' promises -- nothing but hot air.