Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced new safety and immune response data from the Phase 1 portion of a Phase 1/2 dose escalation and cohort expansion study examining the investigational combination of varlilumab, Celldex’s CD27 targeting investigational immune-activating antibody, and Bristol-Myers Squibb’s anti-PD-1 immunotherapy Opdivo®(nivolumab). The data were presented today in a poster at the American Association for Cancer Research (AACR) Annual Meeting 2016 in New Orleans. The Phase 1 portion of the study, conducted in patients with solid tumors, has completed enrollment (n=36) and primarily enrolled patients with colorectal (n=20) and ovarian cancer (n=8). The primary objective of the Phase 1 portion of the study was to evaluate the safety and tolerability of the combination. The Phase 2 portion of the study is open to enrollment.

Key Highlights:

  • Combining the potent immune activator, varlilumab, with the PD-1 inhibitor, nivolumab, showed acceptable tolerability and safety across all dose levels without any evidence of increased autoimmunity or inappropriate immune activation.
  • Combination therapy led to marked changes in the tumor microenvironment including increased infiltrating CD8+ T cells and increased PD-L1 expression, which have been shown to correlate with a greater magnitude of treatment effect from checkpoint inhibitors in other clinical studies.
    • Additional favorable immune biomarkers, such as increase in inflammatory chemokines and decrease in T regulatory cells, were also noted.
  • In a subset of patients (n=17) on study who had both pre- and post-tumor biopsies available, preliminary evidence suggest a correlation between biomarker data and stable disease or better in seven of these patients (4 ovarian cancer, 2 colorectal cancer, 1 squamous cell carcinoma of the head and neck).

“The combination of varlilumab and nivolumab demonstrated acceptable tolerability across all dose levels of varlilumab, showing that immune stimulation through CD27 was safely combined with PD-1 blockade,” said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. “In addition, we observed favorable changes in intratumoral immune biomarkers, most notably an increase in tumor infiltrating lymphocytes, which is recognized to correlate with improved clinical outcome. Based on the strong preclinical data, scientific rationale and these recent results, we are very excited for the Phase 2 portion of the trial, which is now open to enrollment across six different indications.”

The Phase 2 portion of the study includes cohorts in advanced non-small cell lung cancer (n=35), colorectal cancer (n=18), ovarian cancer (n=18), head and neck squamous cell carcinoma (n=18), renal cell carcinoma (n=25) and glioblastoma (n=20). The primary objective of the Phase 2 study is overall response rate for all cohorts except glioblastoma, where the primary objective is the rate of 12-month overall survival. Secondary objectives include pharmacokinetics assessments, determining the immunogenicity of varlilumab when given in combination with nivolumab and further assessing the anti-tumor activity of combination treatment, including duration of response, time to response, progression-free survival and overall survival. The study is being conducted by Celldex under a clinical trial collaboration with Bristol-Myers Squibb Company. The companies are sharing development costs.(Original Source)

Shares of Celldex closed last Friday at $4.64, up $0.04 or 0.87%. CLDX has a 1-year high of $30.28 and a 1-year low of $2.96. The stock’s 50-day moving average is $4.49 and its 200-day moving average is $10.57.

On the ratings front, Celldex has been the subject of a number of recent research reports. In a report issued on March 8, Brean Murray Carret analyst Jonathan Aschoff reiterated a Buy rating on CLDX, with a price target of $24, which represents a potential upside of 417.2% from where the stock is currently trading. Separately, on the same day, Cowen’s Boris Peaker maintained a Buy rating on the stock and has a price target of $12.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jonathan Aschoff and Boris Peaker have a total average return of -8.7% and 14.7% respectively. Aschoff has a success rate of 38.6% and is ranked #3747 out of 3795 analysts, while Peaker has a success rate of 45.7% and is ranked #175.

Overall, 4 research analysts have assigned a Hold rating and 5 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $6.00 which is 29.3% above where the stock closed last Friday.

Celldex Therapeutics, Inc. engages in the research, development, and manufacture of biopharmaceutical products. Its portfolio includes therapeutic antibodies, antibody drug conjugates, vaccines, and immune system modulators. Its drug candidates include Glembatumumab vedotin, Varlilumab, CDX-1401, CDX-301, and Rintega. The company was founded by Anthony S. Marucci and Tibor Keler in 1983 and is headquartered in Hampton, NJ.