Grant Zeng, CFA

IMUC’s ICT-107 on R&D Directions Top 100 Investigational Drugs

Recently, ImmunoCellular Therapeutics (IMUC) announced that its lead drug candidate ICT-107 was selected by R&D Directions for the magazine’s 10th annual list of “100 Great Investigational Drugs” featured as the cover article in the March 2011 issue.

For those unfamiliar, R&D Directions is a leading publication for the pharmaceutical industry and is focused on the progress of drugs advancing through research and development. The list is kind of like the Academy Awards for drugs currently in development.  The list includes only compounds that are currently in clinical development (from Phase I to Phase III studies) and represents innovative treatments for diseases of unmet need.  Several drugs that have made the list in the past eventually go on to receive FDA approval.  Bristol-Myers Squibb’s ipilimumab (Yervoy), which was on last year’s list, was just approved for melanoma on March 25, 2011.

Oncology continues to represent an area of enormous unmet need for physicians and patients, as well as a significant commercial opportunity for investors.  As in previous years, oncology drugs dominated this year’s list, taking 35 of the 100 spots.  Neuroscience drugs came in a distant second with 13 compounds.  

Cancer immunotherapies are a new class of drugs that recruit patients’ own immune system to target tumors.  The first cancer immunotherapy to be approved by the FDA was Dendreon’s prostate cancer vaccine Provenge and just last month, the FDA approved Yervoy (ipilimumab) for newly diagnosed and metastatic melanoma. Ipilimumab is an anti-CTLA4 antibody that activates patients’ T-cells to illicit an immune response against cancer cells. With the approval of these two immunotherapy drugs in the last one year, it is no surprise that the number of cancer immunotherapies on the Top 100 list continues to expand.  Last year, there were three cancer immunotherapies on the R&D Design Top 100 Investigational Drug list, and this year, seven drugs in this class were recognized.  Below we highlight some of the innovative cancer immunotherapies that made onto this year’s list.

OncoVex GM-CSF is a genetically engineered herpes simplex virus type 1 (HSV-1) that when injected into tumors, selectively replicates in and kills cancer cells.  OncoVex also induces an immune response to attack cancer cells by stimulating dendritic cells via GM-CSF expression.  Phase II study results in patients with melanoma were promising showing an overall survival rate of 58% at one year compared to a historical one-year OS rate of 26%.  The product is currently in Phase III studies for metastatic melanoma and head and neck cancer.  The melanoma trial is a controlled, open label, randomized study and results are expected mid-2012.  OncoVEX GM-CSF is developed by Biovex, which was recently acquired by Amgen (AMGN) for up to $1 billion in upfront, royalty, and milestone payments.

Rindopepimut (CDX-110) from Celldex (Ticker:CLDX) is a peptide vaccine that targets EGFRvIII, a tumor-specific mutation expressed in 25-30% of glioblastoma multiforme (GBM) patients. Phase II study in newly diagnosed GBM patients has earlier demonstrated a median progression free survival of 12.6 months compared to historical 6.9 months and overall survival of 23.0 months compared to 14.6 months.  The company plans to start a Phase III, randomized, controlled trial by the end of the year.  Although Celldex stocks fell significantly back in September when Pfizer decided to cancel its partnership, the stock is trading at levels prior to deal termination again.

Blinatumomab (MT103), which is developed by Micromet (Ticker:MITI), is a monoclonal antibody that belongs to a class of antibodies known as bi-specific T-cell engagers (BiTEs).  BiTEs can direct patients’ T-cells to recognize malignant tumor cells.  Results from a Phase II trial in adult patients with acute lymphoblastic leukemia (ALL) have been promising.  The company has initiated a pivotal Phase III trial in ALL patients whose results are not expected until 2014.  MITI’s shares have dropped by a third since peaking at the end of the year but have rebounded recently as investors anticipate interim results at ASCO this year.

ICT-107 from ImmunoCellular Therapeutics’ (Ticker:IMUC) may be quite different from other cancer immunotherapy drugs on the Top 100 Investigational Drug list this year. ICT-107 is also a dendritic cell based cancer vaccine candidate, which elicits an immune response to target not only cancer cells but also cancer stem cells, which are widely perceived as roots of cancers.  Thus, targeting cancer stem cells is expected to delay disease progression and improve patient survival.  Results from a single arm Phase I study in patients treated with ICT-107 for newly diagnosed GBM were quite promising demonstrating more than doubling of disease free survival as well as overall survival.  About 40% of patients continue to be disease free more than 2 years. More updated data will be presented at ASCO in June. The company recently launched Phase II, randomized, double-blind, multicenter study for ICT-107 in patients with newly diagnosed GBM and expects to have interim analysis in 18 months.  Although company’s stock price has moved up significantly in the last year, its market cap is still small ($65 million) by comparison to other companies on the Top 100 list.

With oncologists looking for new modalities to fight cancer as survival rates in a number of cancers have barely moved in the last 30 years, this selected list of cancer immunotherapy companies gives some insights into new products likely to add to oncologist’s arsenal over the next few years as well as new leaders  likely to be on the forefront.

For a free copy of the research report, please email scr@zacks.com with IMUC as the subject.

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